Sunteți pe pagina 1din 165

CUMULATIVE

SUPPLEMENT 10
OCTOBER 2015

APPROVED

DRUG PRODUCTS

WITH

THERAPEUTIC EQUIVALENCE EVALUATIONS

35th EDITION

Department of Health and Human Services


Food and Drug Administration

Office of Medical Products and Tobacco

Center for Drug Evaluation and Research

Office of Generic Drugs

2015

Prepared By

Office of Generic Drugs

Office of Medical Products and Tobacco

Center for Drug Evaluation and Research

Food and Drug Administration

APPROVED DRUG PRODUCTS

with

THERAPEUTIC EQUIVALENCE EVALUATIONS

35th EDITION Cumulative


Supplement 10

October 2015
CONTENTS
PAGE
1.0 INTRODUCTION ........................................................................................................................................ iii

1.1 How to use the Cumulative Supplement ........................................................................................... iii

1.2 Cumulative Supplement Content ...................................................................................................... iv

1.3 Applicant Name Changes .................................................................................................................. v

1.4 Levothyroxine Sodium ....................................................................................................................... .v

1.5 Availability of the Edition.................................................................................................................... vi

1.6 Report of Counts for the Prescription Drug Product List .................................................................. vii

1.7 Cumulative Supplement Legend ...................................................................................................... viii

DRUG PRODUCT LISTS

Prescription Drug Product List ...................................................................................................... 1-1

OTC Drug Product List .................................................................................................................. 2-1

Drug Products with Approval under Section 505 of the Act

Administered by the Center for Biologics Evaluation and Research List ................................... 3-1

Orphan Product Designations and Approvals List ........................................................................ 4-1

Drug Products W hich Must Demonstrate in vivo Bioavailability

Only if Product Fails to Achieve Adequate Dissolution ............................................................. 5-1

PATENT AND EXCLUSIVITY INFORMATION ADDENDUM


A. Patent and Exclusivity Lists ................................................................................................... A-1

B. Patent and Exclusivity Terms ................................................................................................ B-1

APPROVED DRUG PRODUCTS

with

THERAPEUTIC EQUIVALENCE EVALUATIONS

35th EDITION CUMULATIVE


SUPPLEMENT 10

October 2015

1.0 INTRODUCTION

1.1

HOW TO USE THE CUMULATIVE SUPPLEMENT


This Cumulative Supplement is one of a series of monthly updates to the
Approved Drug Products with Therapeutic Equivalence Evaluations, 35th
Edition (the List). The List is composed of four parts: approved
prescription drug products with therapeutic equivalence evaluations;
over-the-counter (OTC) drug products that require approved applications
as a condition of marketing; drug products with approval under Section
505 of the Act administered by the Center for Biologics Evaluation and
Research; and products that have never been marketed, are for
exportation, are for military use, have been discontinued from marketing
or that have had their approvals withdrawn for other than safety or
efficacy reasons.
The Cumulative Supplement provides, among other things, information on
newly approved drugs and, if necessary, revised therapeutic equivalence
evaluations and updated patent and exclusivity data. The Addendum
contains appropriate drug patent and exclusivity information required of
the Agency by the "Drug Price Competition and Patent Term Restoration Act
of 1984" for the Prescription, OTC, and Drug Products with Approval under
Section 505 of the Act Administered by the Center for Biologics
Evaluation and Research Lists.
Because all parts of the publication are subject to changes, additions,
or deletions, the List must be used in conjunction with the most current
Cumulative Supplement. Users may wish to mark to the left of the
ingredient(s) in the List to indicate that changes to that entry appear
in the Cumulative Supplement. Drug product information is provided in
each Cumulative Supplement for completeness to assist in locating the
proper place in the List for the revision.
The presence of any therapeutic equivalence code indicates that the drug
product is multisource; the deletion of a therapeutic equivalence code
indicates that the drug product has become single source. (An infrequent
exception exists when a therapeutic equivalence code is revised. In that
case, the deletion of the therapeutic equivalence code is followed
immediately by the addition of the revised one.)
Products that have never been marketed, are for exportation, are for
military use, or have been discontinued from marketing or that have had
their approvals withdrawn for other than safety or efficacy reasons, will
be flagged in this Cumulative Supplement with the "@" symbol to designate
their non-marketed status. All products having a "@" symbol in the 12th
Cumulative Supplement of this Edition List will then be added to the
"Discontinued Drug Product List" appearing in the next Edition. The
current Annual Edition Section 2.1, How To Use The Drug Product Lists,
describes the layout and usage of the List.

iii

New additions to the Prescription Drug Product List and OTC Drug Product
List are indicated by the symbol >A>. The Patent and Exclusivity List
new additions are indicated by the symbol >A> to the left of Patent
Number or Exclusivity Code. The >A> symbol is then dropped in subsequent
Cumulative Supplements for that item.
New deletions to the Prescription Drug Product List and OTC Drug Product
List are indicated by the symbol >D> (DELETE) to the left of the line.
The information line with the >D> symbol is dropped in subsequent
Cumulative Supplements for that item.
The Patent and Exclusivity List is arranged in alphabetical order by
active ingredient name(s) and trade name. The trade name will follow the
active ingredient name separated by a dash symbol. Also shown is the
application number and product number (FDA's internal file number) for
reference purposes. All patents with their expiration dates are
displayed for each application number. Drug substance and drug product
patents are indicated as such with DS or DP in the Patent codes column.
Use patents are indicated with the symbol "U" followed by a number
representing a specific use. Exclusivity information for a specific drug
is indicated by an abbreviation followed by the date upon which the
exclusivity expires. Refer to the Exclusivity Terms, Section B, in the
Patent and Exclusivity Information Addendum for an explanation of all
codes and abbreviations. Refer to Section 1.3 for internet access to the
most current list of Patent and Exclusivity terms.

1.2

CUMULATIVE SUPPLEMENT CONTENT


Since February 2005, we have been providing daily Electronic Orange Book
(EOB) product information for new generic drug approvals. Daily generic
updates provide the consumer with the current list of approved generic
products which is important for substitution purposes. Previously, a
first-time-generic product approved early in the month would not be
published in the Cumulative Supplement (CS) for several weeks.
The CS monthly update publish goal is by the end of the following months
second work week (e.g., Novembers supplement will be updated by the end
of the second full work week in December).
Currently, the monthly PDF CS includes:

Generic product ANDA (Abbreviated New Drug Approval) approvals as of


the date of publication.

All product changes received and processed as of the date of


publication.
o Refer to CS Section 1.8 Cumulative Supplement Legend for
types of changes
o Discontinued products will be processed as of the date of
publication. There will be circumstances where a product is
discontinued in one month, however, it will be reported in
a different month's CS. For example, the Orange Book Staff
received a letter November 7 that the product has been
discontinued from manufacturing and marketing. The Orange
Book subsequently publishes the October CS on November 14.
The product will show in the October CS that it is
discontinued even though the date of discontinuance is the
day that the Orange Book Staff receives notification (November 7).
New Drug Application (NDA) approvals appear in the CS month they were
approved.

iv

Patent information, also updated daily in the EOB, is current to


the date of publication.

Exclusivity information is updated monthly and current to the date of


publication.

Every effort is made to ensure the Cumulative Supplement is current and


accurate. Applicant holders are requested to inform the FDA Orange Book
Staff (OBS) of any changes or corrections. The OBS can be contacted by
email at orangebook@fda.hhs.gov. Send changes by FAX: 301-595-1446.
mail to:

1.3

FDA/CDER Orange Book Staff

Office of Generic Drugs

7620 Standish Place

Rockville, MD 20855-2773

APPLICANT NAME CHANGES


It is not practical to identify in the Cumulative Supplement each and
every product involved when an applicant transfers its entire line of
approved drug products to another applicant, or when an applicant changes
its name. Therefore, the cumulation of these transfers and name changes
will be identified in this section only. Where only partial lines of
approved products are transferred between applicants, each approved
product involved will appear as an applicant name change entry in the
Cumulative Supplement.
It is also not practical to identify each and every product involved when
an applicant name is changed to meet internal publication standards
(e.g., MSD or Zenith [Former Abbreviated Names] are changed, respectively
to Merck Sharp Dohme or Zenith Labs [New Abbreviated Names]). When this
occurs, each product involved (either currently in the Cumulative
Supplement or in the following year's edition) will reflect the new
abbreviated name. Consequently, it will not appear as an applicant name
change entry in the Cumulative Supplement nor will the cumulation of
these name changes appear in this section. The Electronic Orange Book
Query, updated monthly, will contain the most current applicant holder
name.
FORMER APPLICANT NAME
(FORMER ABBREVIATED NAME)

1.4

NEW APPLICANT NAME


(NEW ABBREVIATED NAME)

AGILA SPECIALTIES PRIVATE LTD


(AGILA SPECLTS)

MYLAN LABORORATORIES LTD


(MYLAN LABS LTD)

EXCELLIUM PHARMACEUTICAL INC


(EXCELLIUM)

LEADING PHARMA LLC


(LEADING PHARMA LLC)

MYLAN PHARMACEUTICALS INC


(MYLAN PHARMS INC)

MYLAN LABORATORIES LTD


(MYLAN LABS LTD)

ONCO THERAPIES LTD


(ONCO THERAPIES LTD)

MYLAN LABORATORIES LTD


(MYLAN LABS LTD)

REDKITT BENCKISER
PHARMACEUTICALS INC
(RECKITT BENCKISER)

INDIVIOR INC
(INDIVIOR INC)

LEVOTHYROXINE SODIUM
Because there are multiple reference listed drugs of levothyroxine sodium
tablets and some reference listed drugs' sponsors have conducted studies
v

to establish their drugs' therapeutic equivalence to other reference


listed drugs, FDA has determined that its usual practice of assigning two
or three character TE codes may be potentially confusing and inadequate
for these drug products. Accordingly, FDA provides the following
explanation and chart of therapeutic equivalence evaluations for
levothyroxine sodium drug products.
Levothyroxine Sodium (Mylan ANDA 76187) and Levo-T (Alara NDA 21342)
tablets have been determined to be therapeutically equivalent to
corresponding strengths of Unithroid (Jerome Stevens NDA 021210) tablets.
Levo-T (Alara NDA 021342), Levothyroxine Sodium (Mylan ANDA 76187),
Unithroid (Jerome Stevens NDA 021210), and Levothyroxine Sodium (Merck
KGAA ANDA 76752)tablets have been determined to be therapeutically
equivalent to corresponding strengths of Synthroid (Abbott NDA 021402)
tablets.
Levo-T (Alara NDA 021342), Unithroid (Jerome Stevens NDA 021210),
Levothyroxine Sodium (Mylan ANDA 076187), and Levothyroxine Sodium (Merck
KGAA ANDA 76752) tablets have been determined to be therapeutically
equivalent to corresponding strengths of Levoxyl (King Pharms NDA 021301)
tablets.
Levothyroxine Sodium (Mylan ANDA 76187) tablets have been determined to
be therapeutically equivalent to corresponding strengths of Levothroid
(Lloyd NDA 021116) tablets.
The chart outlines TE codes for all 0.025mg products. Other product
strengths may be similar. Therapeutic equivalence has been established
between products that have the same AB+number TE code. More than one TE
code may apply to some products. One common TE code indicates therapeutic
equivalence between products.

Trade Name

Applicant

Potency

Appl No

Product No

UNITHROID
LEVOTHYROXINE
SODIUM
LEVOXYL
SYNTHROID
LEVO-T

STEVENS J
MYLAN

0.025MG AB1
0.025MG AB1

TE Code

21210
76187

001
001

KING PHARMS 0.025MG AB1


ABBOTT
0.025MG AB1
ALARA PHARM 0.025MG AB1

21301
21402
21342

001
001
001

SYNTHROID
LEVOTHYROXINE
SODIUM
LEVO-T
UNITHROID

ABBOTT
MYLAN

0.025MG AB2
0.025MG AB2

21402
76187

001
001

ALARA PHARM 0.025MG AB2


STEVENS J
0.025MG AB2

21342
21210

001
001

LEVOXYL
LEVO-T
UNITHROID
LEVOTHYROXINE
SODIUM

KUNG PHARMS
ALARA PHARM
STEVENS J
MYLAN

0.025MG
0.025MG
0.025MG
0.025MG

AB3
AB3
AB3
AB3

21301
21342
21210
76187

001
001
001
001

LEVOTHROID
LEVOTHYROXINE
SODIUM

LLOYD
MYLAN

0.025MG AB4
0.025MG AB4

21116
76187

001
001

1.5 AVAILABILITY OF THE EDITION


Since 1997, the Electronic Orange Book Query (EOBQ)
http://www.accessdata.fda.gov/scripts/cder/ob/default.cfm, has been
available on the internet and has become the updated-every-month Orange
Book. The Query provides searching of the approved drug list by active
ingredient, proprietary name, applicant holder, applicant number or patent
vi

number. Product search categories are: prescription, over-the-counter,


discontinued drugs. There are links to patent and exclusivity information
that may be applicable to each product.
Commencing with the 25th edition, the Annual Edition and monthly
Cumulative Supplements have been provided in downloadable Portable
Document Format (PDF) at the EOB home page by clicking on Publications.
The PDF annual and cumulative supplements duplicate previous paper
versions. Over time, there will be an archive for the annuals and each
year's December Cumulative Supplement.
The downloaded Annual Edition and Cumulative Supplements are also
available in a paper version (Approved Drug Products with Therapeutic
Equivalence Evaluations, ADP) from the U.S. Government Printing Office:
http://bookstore.gpo.gov; toll free 866-512-1800.
There are historical lists of Orange Book cumulative supplement product
monthly changes at
http://www.fda.gov/Drugs/InformationOnDrugs/ucm086229.htm. There are
ASCII text files of the Orange Book drug product, patent, and exclusivity
data at http://www.fda.gov/Drugs/InformationOnDrugs/ucm129689.htm. The
drug product text files are provided in eobzip.zip format. The files are
updated concurrently with the monthly cumulative supplements. The annual
Orange Book Edition Appendices A, B, and C in PDF format are updated
quarterly.
Effective August 18, 2003, patent submissions for publication in the
Orange Book and Docket *95S-0117 need to be submitted on form FDA-3542
which may be downloaded from the FDA Forms List,
http://www.fda.gov/opacom/morechoices/fdaforms/default.html.
The current listing of the Orphan Product Designations and Approvals is
available at http://www.fda.gov/orphan/designat/list.htm.

1.6 REPORT OF COUNTS FOR THE PRESCRIPTION DRUG PRODUCT LIST


DESCRIPTION OF REPORT
This report provides summary counts derived from the product information
in the Prescription Drug Product List and the current Cumulative
Supplement. Products included in the counts are domestically marketed
drug products approved for both safety and effectiveness under section
505 of the Federal Food, Drug, and Cosmetic Act. Excluded are approved
drug products marketed by distributors; those marketed solely abroad; and
those now regarded as medical devices, biologics or foods.
The baseline column (December of the previous Annual Edition) refers to
the products in the Prescription Drug Product List. For each three-month
period, a column of quarterly data is added which incorporates counts of
product activity from the previous quarter(s) with those in the baseline
count.
DEFINITIONS
Drug Product
For this report, a drug product is the representation in the Prescription
Drug Product List of an active moiety (molecular entity and its salts,
esters and derivatives) either as a single ingredient or as a combination
product provided in a specific dosage form and strength for a given route
of administration with approval for marketing by a firm under a
particular generic or trade name.

vii

New Molecular Entity


A new molecular entity is considered an active moiety that has not
previously been approved (either as the parent compound or as a salt,
ester or derivative of the parent compound) in the United States for use
in a drug product either as a single ingredient or as part of a
combination.
REPORT OF COUNTS FOR THE PRESCRIPTION DRUG PRODUCT LIST
COUNTS CUMULATIVE BY QUARTER
CATEGORIES COUNTED

DEC 2014

MAR 2015

JUN 2015

SEPT 2015

DRUG PRODUCTS LISTED


SINGLE SOURCE

16150
2572
(15.9%)

16352
2608
(15.9%)

16543
2586
(15.6%)

16824

2613

(15.5%)

MULTISOURCE

13578
(84.1%)

13744
(84.1%)

13957
(84.4%)

14211

(84.5%)

THERAPEUTICALLY
EQUIVALENT

13443
(83.2%)

13610
(83.2%)

13832
(83.6%)

14089

(83.7%)

NOT THERAPEUTICALLY
EQUIVALENT

135
(0.8%)

134
(0.8%)

125
(0.8%)

122

(0.7%)

77
(0.5%)

75
(0.5%)

75
(0.5%)

75
(0.4%)

NEW MOLECULAR ENTITIES

APPROVED

13

22

12

37

NUMBER OF APPLICANTS

927

935

957

975

EXCEPTIONS1

DEC 2015

Amino acid-containing products of varying composition (see Introduction, page xx of the


List).

1.7 CUMULATIVE SUPPLEMENT LEGEND


The List is sorted by Ingredient(s) and, within each grouping, by the
Dosage Form; Route and then by trade name.
The individual product record contains the Therapeutic Equivalence Code,
Reference Listed Drug symbol, applicant holder, strength(s), New Drug
Application number, product number, and approval date. The application
number preceded by N is a New Drug Application (NDA or innovator). The
application number preceded by an A is an Abbreviated New Drug
Application (ANDA or generic). The last two columns describe the action.
The Action Month is the CS month the action occurred. The OB Action is
the type of change that has occurred.
New ingredient(s), new dosage form; route(s), new trade names, and new
product additions are preceded by >A> during the action month. The change
month is the current CS month; the change code for new approvals is NEWA.
Following months will display the same information without the >A>.
Changes to currently listed products will list two records. The deleted
product record will be proceeded by >D>. The product record change
addition being made will be preceded by >A>. Following months will
display only the >A> record without the >A>. All changes that occur to
the product through the Annual year will be listed. The change month and
change code will document the change.
The change code and description:
NEWA
CAHN

New drug product approval usually in the supplement


month.
Applicant holder firm name has changed.
viii

CAIN
CDFR
CFTG
CMFD
CMS1
CMS2
CPOT
CRLD
CTEC
CTNA
DISC

Change. There has been a change in the Ingredient(s) name.


All products will be deleted under the old name and all
products will be added under the changed ingredient(s) name.
Change. Dosage Form; Route of Administration.
Change. A first time generic for the innovator product. A
TE Code is added.
Change. The product is moved from the Discontinued Section
due to a change in marketing status.
Change. Miscellaneous addition to list.
Change. Miscellaneous deletion from list.
Change. Potency amount/unit.
Change. Reference Listed Drug.
Change. Therapeutic Equivalence Code.
Change. Trade Name.
Discontinued. The Rx or OTC listed product is not
being marketed and will be moved to the discontinued
section in the next edition.

ix

PRESCRIPTION DRUG PRODUCT LIST


RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT

35TH

1 -1

2015

N 204767

001 Oct 28, 2015

Oct NEWA

A 205120

001 Oct 30, 2015

Oct NEWA

A 089987
A 089987

001 Oct 26, 1992


001 Oct 26, 1992

Oct CTEC
Oct CTEC

ACETAMINOPHEN; BUTALBITAL; CAFFEINE


TABLET;ORAL
FIORICET
@ ACTAVIS LABS UT INC
325MG;50MG;40MG

A 088616

001 Nov 09, 1984

Feb CAHN

AB

ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE


CAPSULE;ORAL
FIORICET W/ CODEINE
+
ACTAVIS LABS UT INC
325MG;50MG;40MG;30MG

N 020232

001 Jul 30, 1992

Jan CAHN

AA
AA

ACETAMINOPHEN; CODEINE PHOSPHATE


TABLET;ORAL
ACETAMINOPHEN AND CODEINE PHOSPHATE
SUN PHARM INDS LTD
300MG;30MG
300MG;60MG

A 085868
A 087083

001
001

Apr CAHN
Apr CAHN

A 040846
A 040826

001 Jun 09, 2010


001 Aug 16, 2007

Feb CTEC
Apr CAHN

A 040148
A 040148

004 Jul 07, 2014


005 Jul 07, 2014

Feb NEWA
Feb NEWA

>A>

>A> AA
>D>
>A> AA

1GM/100ML (10MG/ML)

ACETAMINOPHEN; BUTALBITAL
TABLET;ORAL
BUTALBITAL AND ACETAMINOPHEN
TEDOR PHARMA INC
325MG;50MG
BUTAPAP
+
MIKART
325MG;50MG
+
325MG;50MG

EDITION

October

ACETAMINOPHEN
SOLUTION;IV (INFUSION)
ACETAMINOPHEN
FRESENIUS KABI USA

10

AA
AA

ACETAMINOPHEN; HYDROCODONE BITARTRATE


TABLET;ORAL
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
+
MIKART
325MG;2.5MG
@ SUN PHARM INDS LTD
325MG;10MG
NORCO
ACTAVIS LABS FL INC
325MG;2.5MG
325MG;5MG

AB

ACETAZOLAMIDE
CAPSULE, EXTENDED RELEASE;ORAL
DIAMOX
+
TEVA BRANDED PHARM
500MG

N 012945

001

Jun CAHN

ACETOHEXAMIDE
TABLET;ORAL
ACETOHEXAMIDE
@ ANI PHARMS INC
@

A 070869
A 070870

001 Feb 09, 1987


001 Feb 09, 1987

Jul CAHN
Jul CAHN

A 203173
A 203624

001 Mar 24, 2015


001 Jun 19, 2015

Mar NEWA
Jun NEWA

A 204674
A 203853

001 Feb 11, 2014


001 Jun 21, 2012

Sep CAHN
Sep CAHN

A 202148
A 203707
A 203707
A 202148
A 204633
A 204633
A 204633

001
001
002
002
001
002
003

Aug
Aug
Aug
Aug
May
May
May

AA

AP
AP

AN
AN

AB
AB
AB
AB
AB
AB
AB

250MG
500MG

ACETYLCYSTEINE
INJECTABLE;INTRAVENOUS
ACETYLCYSTEINE
AKORN INC
6GM/30ML (200MG/ML)
MYLAN INSTITUTIONAL
6GM/30ML (200MG/ML)
SOLUTION;INHALATION, ORAL
ACETYLCYSTEINE
ALVOGEN INC
10%
20%
ACITRETIN
CAPSULE;ORAL
ACITRETIN
MYLAN PHARMS INC

SIGMAPHARM LABS LLC

10MG
17.5MG
22.5MG
25MG
10MG
17.5MG
22.5MG

Sep
Sep
Sep
Sep
May
May
May

10,
10,
10,
10,
22,
22,
22,

2015
2015
2015
2015
2015
2015
2015

NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT

10

1 -2

October

2015

A 204633

004 May 22, 2015

May NEWA

N 202450
N 202450

001 Jul 23, 2012


001 Jul 23, 2012

Apr CAHN

Aug CPOT

A 074980
A 074980

001 Sep 30, 1998


002 Sep 30, 1998

Apr CAHN

Apr CAHN

A 203790

001 Sep 30, 2015

Sep NEWA

N 022320

001 Dec 08, 2008

Sep CFTG

N 207917
N 207917

001 Jul 15, 2015


001 Jul 15, 2015

Aug CAHN

Jul NEWA

CAPSULE;ORAL
ACITRETIN
AB

25MG
ACLIDINIUM BROMIDE
POWDER, METERED;INHALATION
TUDORZA PRESSAIR
+
ASTRAZENECA PHARMS
0.375MG/INH
+
0.4MG/INH

AB
AB

AB
AB

AP

AA

ACYCLOVIR
TABLET;ORAL
ACYCLOVIR
SUN PHARM INDS LTD

400MG
800MG

ADAPALENE; BENZOYL PEROXIDE


GEL;TOPICAL
ADAPALENE AND BENZOYL PEROXIDE
ACTAVIS MID ATLANTIC
0.1%;2.5%
EPIDUO
+
GALDERMA LABS LP
0.1%;2.5%
EPIDUO FORTE
+
GALDERMA LABS
0.3%;2.5%
+
GALDERMA R AND D
0.3%;2.5%
ADENOSINE
INJECTABLE;INJECTION
ADENOSINE
EUROHLTH INTL SARL
@
@ WOCKHARDT

3MG/ML
3MG/ML
3MG/ML

A 076500
A 076501
A 090220

001 Jun 16, 2004


001 Jun 16, 2004
001 Jul 20, 2009

Jun CAHN

Sep CAHN

May DISC

ALBENDAZOLE
TABLET, CHEWABLE;ORAL
ALBENZA
+
AMEDRA PHARMS LLC

200MG

N 207844

001 Jun 11, 2015

Jun NEWA

N 205636

001 Mar 31, 2015

Mar NEWA

A 074454

001 Sep 25, 1995

Apr CAHN

N 020291

001 Oct 24, 1996

May DISC

A 090221

001 Aug 10, 2012

Feb DISC

N 021287

001 Jun 12, 2003

Jun CAHN

N 022545
N 022545
N 022545
N 022545

001
002
003
004

May
May
May
May

ALBUTEROL SULFATE
POWDER, METERED;INHALATION
PROAIR RESPICLICK
+
TEVA BRANDED PHARM
EQ 0.090MG BASE/INH
SYRUP;ORAL
ALBUTEROL SULFATE
G AND W LABS INC
EQ 2MG BASE/5ML
ALBUTEROL SULFATE; IPRATROPIUM BROMIDE
AEROSOL, METERED;INHALATION
COMBIVENT
@ BOEHRINGER INGELHEIM
EQ 0.09MG BASE/INH;0.018MG/INH

AB

ALFUZOSIN HYDROCHLORIDE
TABLET, EXTENDED RELEASE;ORAL
ALFUZOSIN HYDROCHLORIDE
@ WOCKHARDT LTD
10MG
UROXATRAL
+
CONCORDIA PHARMS INC
10MG
ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE
TABLET;ORAL
TEKAMLO
@ NOVARTIS
EQ 150MG BASE;EQ
@
EQ 150MG BASE;EQ
@
EQ 300MG BASE;EQ
@
EQ 300MG BASE;EQ

5MG BASE
10MG BASE
5MG BASE
10MG BASE

Aug
Aug
Aug
Aug

26,
26,
26,
26,

2010
2010
2010
2010

DISC

DISC

DISC

DISC

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT

10

October

ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE



TABLET;ORAL
AMTURNIDE
@ NOVARTIS
EQ 150MG BASE;EQ 5MG BASE;12.5MG
N 200045
@
EQ 300MG BASE;EQ 5MG BASE;12.5MG
N 200045
@
EQ 300MG BASE;EQ 5MG BASE;25MG
N 200045
@
EQ 300MG BASE;EQ 10MG BASE;12.5MG
N 200045
@
EQ 300MG BASE;EQ 10MG BASE;25MG
N 200045

>A> AB
>A> AB
AB
AB
AB
AB

AB
AB
AB
AB

AB
AB
AB
AB
AB
AB
AB
AB

AB
AB
AB
AB

AB

>D> AA
>A>
>D> AA
>A>

ALMOTRIPTAN MALATE
TABLET;ORAL
ALMOTRIPTAN MALATE
MYLAN PHARMS INC
TEVA PHARMS USA
AXERT
JANSSEN PHARMS
+

EQ
EQ
EQ
EQ

001
002
003
004
005

Dec
Dec
Dec
Dec
Dec

21,
21,
21,
21,
21,

2010
2010
2010
2010
2010

May
May
May
May
May

DISC

DISC

DISC

DISC

DISC

Nov
Nov
Jul
Jul

09,
09,
07,
07,

2015
2015
2015
2015

Oct
Oct
Jun
Jun

NEWA

NEWA

NEWA

NEWA

BASE
BASE
BASE
BASE

A 205171
A 205171
A 078027
A 078027

001
002
001
002

EQ 6.25MG BASE
EQ 12.5MG BASE

N 021001
N 021001

001 May 07, 2001


002 May 07, 2001

Jun CFTG

Jun CFTG

0.5MG BASE
1MG BASE

A 200652
A 200652

001 May 04, 2015


002 May 04, 2015

Apr NEWA

Apr NEWA

0.5MG BASE
1MG BASE

N 021107
N 021107

002 Dec 23, 2003


001 Feb 09, 2000

Apr CFTG

Apr CFTG

A 074085
A 074085
A 074085
A 074085
A 203346
A 203346
A 203346
A 203346
A 200739
A 200739
A 200739
A 200739

001
002
003
004
001
002
003
004
001
002
003
004

Feb
Feb
Feb
Feb
Jul
Jul
Jul
Jul
Apr
Apr
Apr
Apr

16,
16,
16,
26,
31,
31,
31,
31,
15,
15,
15,
15,

1994
1994
1994
1996
2015
2015
2015
2015
2015
2015
2015
2015

Jul
Jul
Jul
Jul
Jul
Jul
Jul
Jul
Mar
Mar
Mar
Mar

CAHN

CAHN

CAHN

CAHN

NEWA

NEWA

NEWA

NEWA

NEWA

NEWA

NEWA

NEWA

A 078489
A 078489
A 078489
A 078489

001
002
003
004

Oct
Oct
Oct
Oct

17,
17,
17,
17,

2008
2008
2008
2008

Sep
Sep
Sep
Sep

CAHN

CAHN

CAHN

CAHN

ALOSETRON HYDROCHLORIDE
TABLET;ORAL
ALOSETRON HYDROCHLORIDE
ROXANE
EQ
EQ
LOTRONEX
PROMETHEUS LABS
EQ
+
EQ

6.25MG
12.5MG
6.25MG
12.5MG

1 -3

2015

ALPRAZOLAM
TABLET;ORAL
ALPRAZOLAM
@ ANI PHARMS INC
@
@
@
AUROBINDO PHARMA LTD

0.25MG
0.5MG
1MG
2MG
0.25MG
0.5MG
1MG
2MG
NATCO PHARMA LTD
0.25MG
0.5MG
1MG
2MG
TABLET, EXTENDED RELEASE;ORAL
ALPRAZOLAM
HERITAGE PHARMS INC
0.5MG
1MG
2MG
3MG

AMANTADINE HYDROCHLORIDE
CAPSULE;ORAL
AMANTADINE HYDROCHLORIDE
BANNER LIFE SCIENCES
SYRUP;ORAL
AMANTADINE HYDROCHLORIDE
@ G AND W LABS INC
+
SILARX
@
+
VINTAGE
@

100MG

A 078720

001 May 29, 2008

Jan CAHN

50MG/5ML
50MG/5ML
50MG/5ML
50MG/5ML
50MG/5ML

A 072655
A 076352
A 076352
A 077992
A 077992

001
001
001
001
001

May
Oct
Oct
Oct
Oct

AMIKACIN SULFATE
INJECTABLE;INJECTION
AMIKACIN SULFATE
@ IGI LABS INC
@

EQ 50MG BASE/ML
EQ 250MG BASE/ML

A 063167
A 063169

001 Dec 14, 1995


001 Dec 14, 1995

Oct
Sep
Sep
Dec
Dec

30,
10,
10,
12,
12,

1990
2004
2004
2006
2006

CAHN

DISC

DISC

DISC

DISC

Mar CAHN

Mar CAHN

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT

AB

10

1 -4

October

2015

AMILORIDE HYDROCHLORIDE

TABLET;ORAL

AMILORIDE HYDROCHLORIDE

ZYDUS PHARMS USA INC
5MG

A 204180

001 Aug 07, 2015

Jul NEWA

AMINO ACIDS

INJECTABLE;INJECTION

BRANCHAMIN 4% IN PLASTIC CONTAINER

@ BAXTER HLTHCARE
4% (4GM/100ML)

N 018684

001 Sep 28, 1984

Feb DISC

AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE

INJECTABLE;INJECTION

TRAVASOL 3.5% SULFITE FREE W/ ELECTROLYTES IN PLASTIC CONTAINER

@ BAXTER HLTHCARE
3.5%;51MG/100ML;131MG/100ML;218MG/ N 020177 001 Oct 23, 1995
Feb DISC

100ML;35MG/100ML

AA

AB

AMINOCAPROIC ACID

SYRUP;ORAL

AMINOCAPROIC ACID

VERSAPHARM INC
TABLET;ORAL

AMINOCAPROIC

VERSAPHARM INC

1.25GM/5ML

A 074759

001 Sep 02, 1998

May CAHN

500MG

A 075602

001 May 24, 2001

May CAHN

A 084910
A 085031
A 085032
A 085030

003
001
001
001

Aug
Aug
Aug
Aug

N 016949

001

Jul CAHN

N 016949

002

Jul CAHN

A 090752
A 090752
A 078224
A 078224
A 078224
A 204900
A 204900
A 204900
A 077974
A 077974
A 077974

001
002
001
002
003
001
002
003
001
002
003

Apr
Apr
Feb
Feb
Feb
Jul
Jul
Jul
Jul
Jul
Jul

15,
15,
27,
27,
27,
23,
23,
23,
09,
09,
09,

2011
2011
2008
2008
2008
2015
2015
2015
2007
2007
2007

Mar
Mar
Sep
Sep
Sep
Jul
Jul
Jul
Apr
Apr
Apr

CAHN

CAHN

CAHN

CAHN

CAHN

NEWA

NEWA

NEWA

CAHN

CAHN

CAHN

A 200797
A 200797
A 200797
A 200797
A 200797
A 201087
A 201087
A 201087
A 201087
A 201087
A 200435
A 200435
A 200435
A 200435

001
002
003
004
005
001
002
003
004
005
001
002
005
003

Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Sep
Sep
Sep
Sep

03,
03,
03,
03,
03,
01,
01,
01,
01,
01,
25,
25,
25,
25,

2015
2015
2015
2015
2015
2015
2015
2015
2015
2015
2012
2012
2012
2012

May
May
May
May
May
May
May
May
May
May
May
May
May
May

NEWA

NEWA

NEWA

NEWA

NEWA

NEWA

NEWA

NEWA

NEWA

NEWA

CAIN

CAIN

CAIN

CAIN

AMITRIPTYLINE HYDROCHLORIDE

TABLET;ORAL

AMITRIPTYLINE HYDROCHLORIDE

@ ANI PHARMS INC
10MG
@
25MG
@
50MG
@
75MG
AMITRIPTYLINE HYDROCHLORIDE; CHLORDIAZEPOXIDE

TABLET;ORAL

LIMBITROL

@ HERITAGE PHARMS INC
EQ 12.5MG BASE;5MG
LIMBITROL DS

@ HERITAGE PHARMS INC
EQ 25MG BASE;10MG

AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB

AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB

AMLODIPINE BESYLATE

TABLET;ORAL

AMLODIPINE BESYLATE

CHINA RESOURCES
MYLAN PHARMS INC

SOVEREIGN PHARMS

SUN PHARM INDS LTD

EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ

5MG BASE
10MG BASE
2.5MG BASE
5MG BASE
10MG BASE
2.5MG BASE
5MG BASE
10MG BASE
2.5MG BASE
5MG BASE
10MG BASE

AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN



TABLET;ORAL

AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE

LUPIN LTD
5MG;12.5MG;160MG
5MG;25MG;160MG
10MG;12.5MG;160MG
10MG;25MG;160MG
10MG;25MG;320MG
PAR PHARM
5MG;12.5MG;160MG
5MG;25MG;160MG
10MG;12.5MG;160MG
10MG;25MG;160MG
10MG;25MG;320MG
TEVA PHARMS
5MG;12.5MG;160MG
5MG;25MG;160MG
10MG;12.5MG;160MG
10MG;25MG;160MG

CAHN

CAHN

CAHN

CAHN

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT

2015

A 200435
A 201593
A 201593
A 201593
A 201593
A 201593
A 201593
A 201593
A 201593
A 201593
A 201593

004
001
001
002
002
003
003
004
004
005
005

AMLODIPINE BESYLATE; PERINDOPRIL ARGININE


TABLET;ORAL
PRESTALIA
SYMPLMED PHARMS LLC
EQ 2.5MG BASE;3.5MG
EQ 5MG BASE;7MG
+
EQ 10MG BASE;14MG

N 205003
N 205003
N 205003

001 Jan 21, 2015


002 Jan 21, 2015
003 Jan 21, 2015

Jan NEWA
Jan NEWA
Jan NEWA

AMLODIPINE BESYLATE; VALSARTAN


TABLET;ORAL
AMLODIPINE BESYLATE AND VALSARTAN
ALEMBIC PHARMS LTD
EQ 5MG BASE;160MG
EQ 5MG BASE;320MG
EQ 10MG BASE;160MG
EQ 10MG BASE;320MG
LUPIN
EQ 5MG BASE;160MG
EQ 5MG BASE;320MG
EQ 10MG BASE;160MG
EQ 10MG BASE;320MG
MATRIX LABS LTD
EQ 5MG BASE;160MG
EQ 5MG BASE;320MG
EQ 10MG BASE;160MG
EQ 10MG BASE;320MG
MYLAN PHARMS INC
EQ 5MG BASE;160MG
EQ 5MG BASE;320MG
EQ 10MG BASE;160MG
EQ 10MG BASE;320MG
NOVEL LABS INC
EQ 5MG BASE;160MG
EQ 5MG BASE;320MG
EQ 10MG BASE;160MG
EQ 10MG BASE;320MG
TEVA PHARMS USA
EQ 5MG BASE;160MG
EQ 5MG BASE;320MG
EQ 10MG BASE;160MG
EQ 10MG BASE;320MG
TORRENT PHARMS LTD
EQ 5MG BASE;160MG
EQ 5MG BASE;320MG
EQ 10MG BASE;160MG
EQ 10MG BASE;320MG

A 202713
A 202713
A 202713
A 202713
A 090245
A 090245
A 090245
A 090245
A 090483
A 090483
A 090483
A 090483
A 090483
A 090483
A 090483
A 090483
A 202829
A 202829
A 202829
A 202829
A 091235
A 091235
A 091235
A 091235
A 202377
A 202377
A 202377
A 202377

001
003
002
004
001
003
002
004
001
003
002
004
001
003
002
004
001
003
002
004
001
003
002
004
001
002
003
004

Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Apr
Apr
Apr
Apr
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar

>A> AP
AP

AMMONIA N-13
INJECTABLE;INTRAVENOUS
AMMONIA N 13
3D IMAGING DRUG
BIOMEDCL RES FDN

A 203779
A 204352

001 Oct 19, 2015


001 May 01, 2015

Oct NEWA
Apr NEWA

AP

CENTRAL RADIOPHARM
IBA MOLECULAR N AM

A 204539
A 204667

001 Jun 23, 2015


001 Apr 22, 2015

Jun NEWA
Apr NEWA

A 204515
A 204510
A 204547
A 204455

001
001
001
001

Jan
Oct
Aug
Apr

A 065016
A 065016

001 Apr 08, 1999


002 Apr 08, 1999

AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB

>A> AP
AP

AB
AB

1 -5

October

AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB

10

TABLET;ORAL
AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE
10MG;25MG;320MG
TORRENT PHARMS LTD
5MG;12.5MG;160MG
5MG;12.5MG;160MG
5MG;25MG;160MG
5MG;25MG;160MG
10MG;12.5MG;160MG
10MG;12.5MG;160MG
10MG;25MG;160MG
10MG;25MG;160MG
10MG;25MG;320MG
10MG;25MG;320MG

NCM USA BRONX LLC


PETNET
PRECISION NUCLEAR
SPECTRON MRC LLC
AMOXICILLIN
CAPSULE;ORAL
AMOXICILLIN
SUN PHARM INDS LTD

30mCi-300mCi/8ML (3.75-37.5mCi/ML)
48.75mCi-487.5mCi/13ML (3.7537.5mCi/ML)
3.75-260mCi/ML
18.8mCi-188mCi/5ML (3.7537.5mCi/ML)
3.75-260mCi/mL
30mCi-300mCi (3.75-37.5mCi/ML)
3.75-260mCi/ML
30mCi-300mCi/8ML (3.75-37.5mCi/ML)

250MG
500MG

Sep
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun

Apr
Apr
Apr
Apr
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar

Feb
Nov
Aug
Apr

25,
03,
04,
03,
04,
03,
04,
03,
04,
03,
04,

03,
03,
03,
03,
30,
30,
30,
30,
30,
30,
30,
30,
30,
30,
30,
30,
30,
30,
30,
30,
30,
30,
30,
30,
30,
30,
30,
30,

04,
02,
14,
23,

2012
2015
2015
2015
2015
2015
2015
2015
2015
2015
2015

2015
2015
2015
2015
2015
2015
2015
2015
2015
2015
2015
2015
2015
2015
2015
2015
2015
2015
2015
2015
2015
2015
2015
2015
2015
2015
2015
2015

2015
2015
2015
2015

May
Sep
May
Sep
May
Sep
May
Sep
May
Sep
May

CAIN
CMS1
NEWA
CMS1
NEWA
CMS1
NEWA
CMS1
NEWA
CMS1
NEWA

NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
CAHN
CAHN
CAHN
CAHN
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA

NEWA
NEWA
NEWA
NEWA

Apr CAHN
Apr CAHN

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT

AB
AB

AB

FOR SUSPENSION;ORAL

AMOXICILLIN

@ SUN PHARM INDS LTD
@
TABLET;ORAL

AMOXICILLIN

SUN PHARM INDS LTD
TABLET, CHEWABLE;ORAL

AMOXICILLIN

SUN PHARM INDS LTD
@

AB
@

AB
AB
AB

AB

AB
AB

1 -6

October

2015

200MG/5ML
400MG/5ML

A 065113
A 065113

001 Nov 29, 2002


002 Nov 29, 2002

Apr CAHN

Apr CAHN

500MG
875MG

A 065059
A 065059

001 Nov 24, 2000


002 Nov 24, 2000

Apr CAHN

Apr CAHN

125MG
200MG
250MG
400MG

A 065021
A 065060
A 065021
A 065060

001
001
002
002

Apr
Apr
Apr
Apr

A 065132
A 065132
A 065207

001 Mar 19, 2003


002 Mar 19, 2003
002 Jan 30, 2007

Apr CAHN

Apr CAHN

Apr CAHN

A 065109
A 065102

001 Nov 04, 2002


001 Sep 17, 2002

Apr CAHN

Apr CAHN

A 065161
A 065161

001 Dec 03, 2003


002 Dec 03, 2003

Apr CAHN

Apr CAHN

N 208147

001 Oct 19, 2015

Oct NEWA

AMOXICILLIN; CLAVULANATE POTASSIUM



FOR SUSPENSION;ORAL

AMOXICILLIN AND CLAVULANATE POTASSIUM

SUN PHARM INDS LTD
200MG/5ML;EQ 28.5MG BASE/5ML
400MG/5ML;EQ 57MG BASE/5ML
600MG/5ML;EQ 42.9MG BASE/5ML
TABLET;ORAL

AMOXICILLIN AND CLAVULANATE POTASSIUM

@ SUN PHARM INDS LTD
500MG;EQ 125MG BASE
875MG;EQ 125MG BASE
TABLET, CHEWABLE;ORAL

AMOXICILLIN AND CLAVULANATE POTASSIUM

SUN PHARM INDS LTD
200MG;EQ 28.5MG BASE
400MG;EQ 57MG BASE

10

Dec
Nov
Dec
Nov

23,
29,
23,
29,

1999
2000
1999
2000

CAHN

CAHN

CAHN

CAHN

>A>
>A>
>A>

AMPHETAMINE

SUSPENSION, EXTENDED RELEASE;ORAL

DYANAVEL XR

+
TRIS PHARMA INC
EQ 2.5MG BASE/ML

>A>
>A>
>A>
>A>
>A>
>A>
>A>

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE



TABLET;ORAL

DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE

COREPHARMA
1.875MG;1.875MG;1.875MG;1.875MG
A 040444 005 Nov 03, 2014
May NEWA

3.125MG;3.125MG;3.125MG;3.125MG
A 040444 006 Nov 03, 2014
May NEWA

3.75MG;3.75MG;3.75MG;3.75MG
A 040444 007 Nov 03, 2014
May NEWA

MYLAN PHARMS INC
1.25MG;1.25MG;1.25MG;1.25MG
A 206721 001 Nov 10, 2015
Oct NEWA

1.875MG;1.875MG;1.875MG;1.875MG
A 206721 002 Nov 10, 2015
Oct NEWA

2.5MG;2.5MG;2.5MG;2.5MG
A 206721 003 Nov 10, 2015
Oct NEWA

3.125MG;3.125MG;3.125MG;3.125MG
A 206721 004 Nov 10, 2015
Oct NEWA

3.75MG;3.75MG;3.75MG;3.75MG
A 206721 005 Nov 10, 2015
Oct NEWA

5MG;5MG;5MG;5MG
A 206721 006 Nov 10, 2015
Oct NEWA

7.5MG;7.5MG;7.5MG;7.5MG
A 206721 007 Nov 10, 2015
Oct NEWA

AB
AB
AB
AB
AB
AB
AB
AB
AB
AB

AMPHETAMINE SULFATE

TABLET;ORAL

EVEKEO

ARBOR PHARMS LLC
+

AP
AP
AP
AP
AP
>A> AP

AMPICILLIN SODIUM

INJECTABLE;INJECTION

AMPICILLIN SODIUM

HOSPIRA INC

SAGENT PHARMS

5MG
10MG

A 200166
A 200166

001 Aug 09, 2012


002 Aug 09, 2012

Mar CTNA

Mar CTNA

EQ
EQ
EQ
EQ
EQ
EQ

A 202864
A 202864
A 202864
A 202864
A 202865
A 090581

001
002
003
004
001
001

Aug
Aug
Aug
Aug
Aug
Oct

A 061741

001

250MG BASE/VIAL
500MG BASE/VIAL
1GM BASE/VIAL
2GM BASE/VIAL
10GM BASE/VIAL
10GM BASE/VIAL

AMPICILLIN/AMPICILLIN TRIHYDRATE; PROBENECID



FOR SUSPENSION;ORAL

PROBAMPACIN

@ G AND W LABS INC
EQ 3.5GM BASE/BOT;1GM/BOT

Sep
Sep
Sep
Sep
Sep
Oct

04,
04,
04,
04,
04,
20,

2015
2015
2015
2015
2015
2015

NEWA

NEWA

NEWA

NEWA

NEWA

NEWA

Apr CAHN

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT

ANASTROZOLE
TABLET;ORAL
ANASTROZOLE
@ KREMERS URBAN PHARMS

AP
AP

AP

AA
AA
AA

AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB

AB
AB
AB
AB

ARGATROBAN
INJECTABLE;INJECTION
ARGATROBAN
FRESENIUS KABI USA
+
PFIZER
INJECTABLE;IV (INFUSION)
ARGATROBAN
FRESENIUS KABI USA
ARIPIPRAZOLE
SOLUTION;ORAL
ARIPIPRAZOLE
AMNEAL PHARMS
APOTEX INC
SILARX PHARMS INC
TABLET;ORAL
ABILIFY
OTSUKA
+
+

ARIPIPRAZOLE
ALEMBIC PHARMS LTD

1 -7

October

2015

1MG

A 091331

001 Jan 05, 2011

Mar CAHN

250MG/2.5ML (100MG/ML)
250MG/2.5ML (100MG/ML)

N 201811
N 020883

001 Mar 23, 2015


001 Jun 30, 2000

Apr CDFR
Aug CTNA

250MG/2.5ML (100MG/ML)

N 201811

001 Mar 23, 2015

Mar NEWA

1MG/ML
1MG/ML
1MG/ML

A 203906
A 204094
A 204171

001 Aug 14, 2015


001 Sep 30, 2015
001 Aug 14, 2015

Aug NEWA
Sep NEWA
Aug NEWA

2MG
5MG
10MG
15MG
20MG
30MG

N 021436
N 021436
N 021436
N 021436
N 021436
N 021436

006
005
001
002
003
004

Nov
Nov
Nov
Nov
Nov
Nov

15,
15,
15,
15,
15,
15,

2002
2002
2002
2002
2002
2002

Apr
Apr
Apr
Apr
Apr
Apr

CFTG
CFTG
CFTG
CFTG
CFTG
CFTG

A 202101
A 202101
A 202101
A 202101
A 202101
A 202101
A 078583
A 078583
A 078583
A 078583
A 078583
A 078583
A 203908
A 203908
A 203908
A 203908
A 203908
A 203908
A 205064
A 205064
A 205064
A 205064
A 205064
A 205064
A 078607
A 078607
A 078608
A 078708
A 078708
A 078708
A 201519
A 201519
A 201519
A 201519
A 201519
A 201519

001
002
003
004
005
006
001
002
003
004
005
006
001
002
003
004
005
006
001
002
003
004
005
006
001
002
001
001
002
003
001
003
002
004
005
006

Apr
Apr
Apr
Apr
Apr
Apr
Jul
Jul
Jul
Jul
Jul
Jul
Oct
Oct
Oct
Oct
Oct
Oct
Apr
Apr
Apr
Apr
Apr
Apr
Apr
Apr
Apr
Apr
Apr
Apr
Apr
Apr
Apr
Apr
Apr
Apr

28,
28,
28,
28,
28,
28,
24,
24,
24,
24,
24,
24,
08,
08,
08,
08,
08,
08,
28,
28,
28,
28,
28,
28,
28,
28,
28,
28,
28,
28,
28,
28,
28,
28,
28,
28,

2015
2015
2015
2015
2015
2015
2015
2015
2015
2015
2015
2015
2015
2015
2015
2015
2015
2015
2015
2015
2015
2015
2015
2015
2015
2015
2015
2015
2015
2015
2015
2015
2015
2015
2015
2015

Apr
Apr
Apr
Apr
Apr
Apr
Jul
Jul
Jul
Jul
Jul
Jul
Sep
Sep
Sep
Sep
Sep
Sep
Apr
Apr
Apr
Apr
Apr
Apr
Apr
Apr
Apr
Apr
Apr
Apr
Apr
Apr
Apr
Apr
Apr
Apr

NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA

N 021729
N 021729

002 Jun 07, 2006


003 Jun 07, 2006

Apr CFTG
Apr CFTG

A 202102
A 202102

001 Apr 28, 2015


002 Apr 28, 2015

Apr NEWA
Apr NEWA

2MG
5MG
10MG
15MG
20MG
30MG
APOTEX INC
2MG
5MG
10MG
15MG
20MG
30MG
AUROBINDO PHARMA LTD
2MG
5MG
10MG
15MG
20MG
30MG
HETERO LABS LTD V
2MG
5MG
10MG
15MG
20MG
30MG
TEVA PHARMS USA
2MG
5MG
10MG
15MG
20MG
30MG
TORRENT PHARMS LTD
2MG
10MG
5MG
15MG
20MG
30MG
TABLET, ORALLY DISINTEGRATING;ORAL
ABILIFY
+
OTSUKA
10MG
15MG
ARIPIPRAZOLE
ALEMBIC PHARMS LTD
10MG
15MG

10

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT

>A>

>A>

>A>

>A>

>A>

>A>

ARIPIPRAZOLE LAUROXIL

SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR

ARISTADA

ALKERMES INC
441MG/1.6ML (275.63MG/ML)
662MG/2.4ML (275.83MG/ML)
+
882MG/3.2ML (275.63MG/ML)

10

October

2015

N 207533
N 207533
N 207533

001 Oct 05, 2015


002 Oct 05, 2015
003 Oct 05, 2015

1 -8

Oct NEWA

Oct NEWA

Oct NEWA

ASCORBIC ACID; BIOTIN; CYANOCOBALAMIN; DEXPANTHENOL; ERGOCALCIFEROL; FOLIC ACID; NIACINAMIDE;

PYRIDOXINE; RIBOFLAVIN 5'-PHOSPHATE SODIUM; THIAMINE; VITAMIN A; VITAMIN E



INJECTABLE;INJECTION

M.V.I.-12 LYOPHILIZED

@ IGI LABS INC
100MG/VIAL;0.06MG/VIAL;0.005MG/VIA N 018933 002 Aug 08, 1985
Jun CAHN

L;15MG/VIAL;5MCG/VIAL;0.4MG/VIAL;4

0MG/VIAL;4MG/VIAL;3.6MG/VIAL;3MG/V

IAL;1MG/VIAL;10MG/VIAL

ASCORBIC ACID; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM ASCORBATE; SODIUM CHLORIDE; SODIUM

SULFATE

FOR SOLUTION;ORAL

PEG-3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM ASCORBATE AND ASCORBIC ACID

@ NOVEL LABS INC
4.7GM;100GM;1.015GM;5.9GM;2.691GM; A 090145 001 Jan 25, 2012
Aug CTNA

7.5GM

ASENAPINE MALEATE

TABLET;SUBLINGUAL

SAPHRIS

FOREST LABS LLC
+

EQ 5MG BASE
EQ 10MG BASE

N 022117
N 022117

001 Aug 13, 2009


002 Aug 13, 2009

Jun CAHN

Jun CAHN

N 200671

001 Sep 04, 2015

Sep NEWA

N 017534

005 Apr 16, 1986

Jan CAHN

N 017534

003 Apr 16, 1986

Jan CAHN

A 203335

001 Oct 30, 2015

Oct NEWA

N 019429

003 Oct 26, 1990

Jan CAHN

ASPIRIN; CAFFEINE; DIHYDROCODEINE BITARTRATE



CAPSULE;ORAL

SYNALGOS-DC

+
SUN PHARM INDS
356.4MG;30MG;16MG

N 011483

004 Sep 06, 1983

Aug CAHN

ASPIRIN; CAFFEINE; ORPHENADRINE CITRATE



TABLET;ORAL

ORPHENADRINE CITRATE, ASPIRIN, AND CAFFEINE

SANDOZ
385MG;30MG;25MG
+
770MG;60MG;50MG

A 074654
A 074654

001 Dec 31, 1996


002 Dec 31, 1996

Mar CTEC

Mar CTEC

A 090084

001 Mar 22, 2011

Mar CAHN

ASPIRIN

CAPSULE, EXTENDED RELEASE;ORAL

DURLAZA

+
NEW HAVEN PHARMS
162.5MG
ASPIRIN; BUTALBITAL; CAFFEINE

CAPSULE;ORAL

FIORINAL

AA

+
ACTAVIS LABS UT INC
325MG;50MG;40MG
TABLET;ORAL

FIORINAL

@ ACTAVIS LABS UT INC
325MG;50MG;40MG
ASPIRIN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE

CAPSULE;ORAL

BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE

>A> AB

COASTAL PHARMS
325MG;50MG;40MG;30MG
FIORINAL W/CODEINE

AB

+
ACTAVIS LABS UT INC
325MG;50MG;40MG;30MG

ASPIRIN; OXYCODONE HYDROCHLORIDE



TABLET;ORAL

OXYCODONE AND ASPIRIN

AA

ACTAVIS LABS FL INC
325MG;4.8355MG

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT

AB
AB
AB

AB
AB
AB

AB
AB
AB
AB

AB
AB
AB
AB
AB
AB
AB
AB

AB

AP
AP

ATENOLOL
TABLET;ORAL
ATENOLOL
ALVOGEN IPCO SARL

@ DAVA PHARMS INC


TENORMIN
ALVOGEN IPCO SARL
+

2015

N 206353

001 Jan 29, 2015

Jan NEWA

25MG
50MG
100MG
25MG

A 073646
A 072303
A 072304
A 074099

001
001
001
001

Jul
Jul
Jul
Jun

25MG
50MG
100MG

N 018240
N 018240
N 018240

004 Apr 09, 1990


001
002

Feb CAHN
Feb CAHN
Feb CAHN

A 072301
A 072302

001 May 31, 1990


001 May 31, 1990

Jul CAHN
Jul CAHN

N 018760

001 Jun 08, 1984

Feb CAHN

N 018760

002 Jun 08, 1984

Feb CAHN

ATENOLOL; CHLORTHALIDONE
TABLET;ORAL
ATENOLOL AND CHLORTHALIDONE
ALVOGEN IPCO SARL
50MG;25MG
100MG;25MG
TENORETIC 100
+
ALVOGEN IPCO SARL
100MG;25MG
TENORETIC 50
ALVOGEN IPCO SARL
50MG;25MG
ATORVASTATIN CALCIUM
TABLET;ORAL
ATORVASTATIN CALCIUM
KREMERS URBAN PHARMS

1 -9

October

ATAZANAVIR SULFATE; COBICISTAT



TABLET;ORAL

EVOTAZ
+
BRISTOL MYERS SQUIBB EQ 300MG BASE;150MG

10

Jul
Jul
Jul
Apr

31,
15,
15,
28,

1992
1988
1988
1992

CAHN
CAHN
CAHN
DISC

EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ

10MG
20MG
40MG
80MG
10MG
20MG
40MG
80MG

BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE

A 091624
A 091624
A 091624
A 091624
A 076477
A 076477
A 076477
A 076477

001
002
003
004
001
002
003
004

Apr
Apr
Apr
Apr
Nov
Nov
Nov
Nov

05,
05,
05,
05,
30,
30,
30,
30,

2013
2013
2013
2013
2011
2011
2011
2011

Mar
Mar
Mar
Mar
Apr
Apr
Apr
Apr

CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN

ATORVASTATIN CALCIUM; EZETIMIBE


TABLET;ORAL
LIPTRUZET
@ MERCK SHARP DOHME
EQ
@
EQ
@
EQ
@
EQ

10MG
20MG
40MG
80MG

BASE;10MG
BASE;10MG
BASE;10MG
BASE;10MG

N 200153
N 200153
N 200153
N 200153

001
002
003
004

May
May
May
May

03,
03,
03,
03,

2013
2013
2013
2013

May
May
May
May

DISC
DISC
DISC
DISC

A 091211

002 Apr 06, 2015

Mar NEWA

A 206011

001 Apr 08, 2015

Mar NEWA

A 206010

001 Apr 08, 2015

Mar NEWA

N 206289

001 Jul 18, 2014

May CRLD

N 017744

002

Feb CAHN

N 017744

001

Feb CAHN

SUN PHARM INDS LTD

ATOVAQUONE; PROGUANIL HYDROCHLORIDE


TABLET;ORAL
ATOVAQUONE AND PROGUANIL HYDROCHLORIDE
GLENMARK GENERICS
62.5MG;25MG
ATRACURIUM BESYLATE
INJECTABLE;INJECTION
ATRACURIUM BESYLATE
AUROBINDO PHARMA LTD
10MG/ML
ATRACURIUM BESYLATE PRESERVATIVE FREE
AUROBINDO PHARMA LTD 10MG/ML
ATROPINE SULFATE
SOLUTION/DROPS;OPHTHALMIC
ATROPINE SULFATE
+
AKORN
1%
ATROPINE SULFATE; DIFENOXIN HYDROCHLORIDE
TABLET;ORAL
MOTOFEN
+
SEBELA IRELAND LTD
0.025MG;1MG
MOTOFEN HALF-STRENGTH
@ SEBELA IRELAND LTD
0.025MG;0.5MG

October

2015

1 -10

ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE


TABLET;ORAL
DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE
@ ANI PHARMS INC
0.025MG;2.5MG

A 086727

001

Jul CAHN

AVIBACTAM SODIUM; CEFTAZIDIME


POWDER;IV (INFUSION)
AVYCAZ
+
CEREXA INC
EQ 0.5GM BASE;2GM/VIAL

N 206494

001 Feb 25, 2015

Feb NEWA

AZELAIC ACID
AEROSOL, FOAM;TOPICAL
FINACEA
+
BAYER HLTHCARE

N 207071

001 Jul 29, 2015

Jul NEWA

A 090176

001 Jul 28, 2015

Jul NEWA

EQ 100MG BASE/5ML
EQ 200MG BASE/5ML

A 065488
A 065488

001 May 15, 2015


002 May 15, 2015

May NEWA
May NEWA

EQ 500MG BASE/VIAL

A 203294

001 Jun 19, 2015

Jun NEWA

EQ 250MG BASE
EQ 500MG BASE
EQ 600MG BASE

A 065398
A 065399
A 065400

001 May 15, 2015


001 May 15, 2015
001 May 15, 2015

May NEWA
May NEWA
May NEWA

750MG

N 020610

001 Jul 18, 2000

Jul CAHN

1.1GM

A 206336

001 Sep 08, 2015

Aug NEWA

1.1GM
1.1GM

N 022205
N 022205

001 Feb 03, 2012


001 Feb 03, 2012

Aug CFTG
Jul CAHN

AB
AB
AB
AB
AB
AB
AB
AB

BENAZEPRIL HYDROCHLORIDE
TABLET;ORAL
BENAZEPRIL HYDROCHLORIDE
AMNEAL PHARMS LLC
5MG
10MG
20MG
40MG
SUN PHARM INDS LTD
5MG
10MG
20MG
40MG

A 076820
A 076820
A 076820
A 076820
A 076344
A 076344
A 076344
A 076344

001
002
003
004
001
002
003
004

Feb
Feb
Feb
Feb
Feb
Feb
Feb
Feb

03,
03,
03,
03,
11,
11,
11,
11,

2006
2006
2006
2006
2004
2004
2004
2004

Jan
Jan
Jan
Jan
Apr
Apr
Apr
Apr

CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN

AB
AB
AB
AB

BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE


TABLET;ORAL
BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
SUN PHARM INDS LTD
5MG;6.25MG
10MG;12.5MG
20MG;12.5MG
20MG;25MG

A 077483
A 077483
A 077483
A 077483

001
002
003
004

Sep
Sep
Sep
Sep

08,
08,
08,
08,

2005
2005
2005
2005

Apr
Apr
Apr
Apr

CAHN
CAHN
CAHN
CAHN

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT

AB

AB
AB

AP

AB
AB
AB

AB

AB
AB

15%

AZELASTINE HYDROCHLORIDE
SPRAY, METERED;NASAL
AZELASTINE HYDROCHLORIDE
BRECKENRIDGE PHARMS
EQ 0.125MG BASE/SPRAY
AZITHROMYCIN
FOR SUSPENSION;ORAL
AZITHROMYCIN
LUPIN LTD
INJECTABLE;INJECTION
AZITHROMYCIN
AUROBINDO PHARMA LTD
TABLET;ORAL
AZITHROMYCIN
LUPIN LTD

BALSALAZIDE DISODIUM
CAPSULE;ORAL
COLAZAL
+
VALEANT PHARMS INTL
TABLET;ORAL
BALSALAZIDE DISODIUM
PAR PHARM INC
GIAZO
+
VALEANT PHARMS INTL
+

10

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT

2015

A 091310
A 091310
A 081297
A 081297
A 202765
A 091133
A 091133
A 091133
A 091133

001
002
001
002
001
001
002
001
002

N 050819

001 Oct 23, 2008

Jun CFTG

A 205128
A 202440

001 Jun 19, 2015


001 Sep 21, 2015

Jun NEWA
Sep NEWA

N 050819

002 Nov 24, 2014

Jan CRLD

A 065385

001 Sep 18, 2015

Sep NEWA

A 090968

001 Jul 20, 2010

Jun CRLD

N 012427

002

Jun DISC

A 204713
A 204713
A 204713

001 Apr 14, 2015


002 Apr 14, 2015
003 Apr 14, 2015

Mar NEWA
Mar NEWA
Mar NEWA

BETAMETHASONE DIPROPIONATE
LOTION;TOPICAL
BETAMETHASONE DIPROPIONATE
G AND W LABS INC
EQ 0.05% BASE
@
EQ 0.05% BASE

A 071467
A 071882

001 Aug 10, 1987


001 Jun 06, 1988

Apr CAHN
Apr CAHN

>A>
>A>
>A>

BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE


AEROSOL, FOAM;TOPICAL
ENSTILAR
+
LEO PHARMA AS
0.064%;0.005%

N 207589

001 Oct 16, 2015

Oct NEWA

>A> AB

BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE


CREAM;TOPICAL
CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE
GLENMARK PHARMS LTD
EQ 0.05% BASE;1%

A 202894

001 Oct 30, 2015

Oct NEWA

EQ 0.1% BASE

N 018642

001 Mar 24, 1983

Aug CAHN

EQ 0.1% BASE

A 070072

001 Jun 27, 1985

Apr CAHN

EQ 0.1% BASE
EQ 0.1% BASE

A 070069
A 070069

001 Dec 19, 1985


001 Dec 19, 1985

Oct CAHN
Oct CAHN

AA
AA
AA
AA
AA
AA
AA
AA
AA

AB
AB
AB

AB

AA

AA
AA
AA

AB

AB

AB

>A> AB
>D>

BANNER LIFE SCIENCES


CSPC NBP PHARM CO
STRIDES ARCOLAB LTD
STRIDES PHARMA

100MG
200MG
100MG
200MG
200MG
100MG
200MG
100MG
200MG

BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE


GEL;TOPICAL
ACANYA
+
DOW PHARM
2.5%;EQ 1.2% BASE
CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE
ACTAVIS LABS UT INC
2.5%;EQ 1.2% BASE
PERRIGO ISRAEL
5%;EQ 1% BASE
ONEXTON
+
DOW PHARM
3.75%;EQ 1.2% BASE
BENZOYL PEROXIDE; ERYTHROMYCIN
GEL;TOPICAL
ERYTHROMYCIN AND BENZOYL PEROXIDE
LYNE
5%;3%
BENZPHETAMINE HYDROCHLORIDE
TABLET;ORAL
BENZPHETAMINE HYDROCHLORIDE
+
KVK TECH
50MG
DIDREX
@ PHARMACIA AND UPJOHN 50MG
BENZTROPINE MESYLATE
TABLET;ORAL
BENZTROPINE MESYLATE
NUVO PHARM INC

BETAMETHASONE VALERATE
CREAM;TOPICAL
BETA-VAL
G AND W LABS INC
LOTION;TOPICAL
BETA-VAL
G AND W LABS INC
OINTMENT;TOPICAL
BETA-VAL
G AND W LABS INC
@ TEVA

0.5MG
1MG
2MG

1 -11

October

BENZONATATE
CAPSULE;ORAL
BENZONATATE
APOTEX INC

10

Jan
Jan
Jan
Oct
Jul
Jul
Jul
Jul
Jul

16,
16,
29,
30,
31,
30,
30,
30,
30,

2015
2015
1993
2007
2015
2015
2015
2015
2015

Jan
Jan
Jan
Jan
Jul
Jul
Jul
Aug
Aug

NEWA
NEWA
CAHN
CAHN
NEWA
NEWA
NEWA
CAHN
CAHN

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT

AA
AA
AA
AA
AA
AA

BETHANECHOL CHLORIDE
TABLET;ORAL
BETHANECHOL CHLORIDE
HERITAGE PHARMA

LANNETT HOLDINGS INC


DUVOID
WELLSPRING PHARM

AA
AA
AA

10

1 -12

October

2015

5MG
10MG
25MG
50MG
5MG
50MG

A 091256
A 091256
A 091256
A 091256
A 040703
A 040677

001
002
003
004
001
001

10MG
25MG
50MG

A 086262
A 086263
A 085882

001
001
003

Jan CMFD
May CMFD
May CMFD

75MG
75MG

A 203174
A 203174

001 Aug 12, 2014


001 Aug 12, 2014

Jun CMFD
Jan CAHN

75MG

N 021055

001 Dec 29, 1999

Jun CTEC

May
May
May
May
Mar
Mar

04,
04,
04,
04,
27,
27,

2010
2010
2010
2010
2008
2008

Mar
Mar
Mar
Mar
Feb
Feb

CAHN
CAHN
CAHN
CAHN
CMFD
CMFD

AB

BEXAROTENE
CAPSULE;ORAL
BEXAROTENE
BANNER LIFE SCIENCES
@
TARGRETIN
+
VALEANT LUXEMBOURG

AB
AB

BICALUTAMIDE
TABLET;ORAL
BICALUTAMIDE
APOTEX INC
STASON PHARMS

50MG
50MG

A 200274
A 091011

001 May 21, 2015


001 Jun 10, 2015

May NEWA
May NEWA

BIMATOPROST
SOLUTION/DROPS;OPHTHALMIC
BIMATOPROST
ALCON RES LTD
APOTEX INC
+
LUPIN LTD
+
+

0.03%
0.03%
0.03%
0.03%
0.03%

A 202565
A 090449
A 203991
A 203991
A 203991

001
001
001
001
001

Apr
Jul
Apr
Mar
Feb

BIPERIDEN HYDROCHLORIDE
TABLET;ORAL
AKINETON
@ ABBVIE

2MG

N 012003

001

Aug DISC

N 050786

001 Sep 28, 2006

Jul CAHN

250MG/VIAL
250MG/VIAL

A 090811
A 090816

001 Jul 14, 2015


001 Jul 14, 2015

Jun NEWA
Jun NEWA

EQ 100MG BASE
EQ 500MG BASE

N 203341
N 203341

001 Sep 04, 2012


002 Sep 04, 2012

Jun CRLD
Jun CRLD

0.25MG
0.5MG
1MG
2MG
3MG
4MG

N 205422
N 205422
N 205422
N 205422
N 205422
N 205422

001
002
003
004
005
006

Jul
Jul
Jul
Jul
Jul
Jul

AB

AT
AT
AT
AT

BISMUTH SUBCITRATE POTASSIUM; METRONIDAZOLE; TETRACYCLINE


CAPSULE;ORAL
PYLERA
+
FOREST LABS LLC
140MG;125MG;125MG

AP
AP

BIVALIRUDIN
INJECTABLE;INTRAVENOUS
BIVALIRUDIN
HOSPIRA INC

BOSUTINIB MONOHYDRATE
TABLET;ORAL
BOSULIF
+
WYETH PHARMS INC

BREXPIPRAZOLE
TABLET;ORAL
REXULTI
OTSUKA PHARM CO LTD

May
Jul
Feb
Feb
Feb

Jul
Jul
Jul
Jul
Jul
Jul

05,
20,
20,
20,
20,

10,
10,
10,
10,
10,
10,

2015
2015
2015
2015
2015

2015
2015
2015
2015
2015
2015

NEWA
NEWA
CTEC
CTEC
NEWA

NEWA
NEWA
NEWA
NEWA
NEWA
NEWA

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT

AT2
AT2
AT1
AT2
AT1

BROMFENAC SODIUM
SOLUTION/DROPS;OPHTHALMIC
BROMDAY
@ BAUSCH AND LOMB INC
+
BROMFENAC SODIUM
APOTEX INC
+
COASTAL PHARMS
HI-TECH PHARMACAL
PADDOCK LLC

2015

EQ 0.09% ACID
EQ 0.09% ACID

N 021664
N 021664

002 Oct 16, 2010


002 Oct 16, 2010

Sep DISC

May CTEC

EQ
EQ
EQ
EQ

A 202620
A 201211
A 203395
A 201941

001
001
001
001

May
May
May
Jan

N 205613

001 Oct 07, 2014

Apr CAHN

A 078949

001 May 12, 2014

Mar CTEC

N 203634

001 Jan 14, 2013

Aug CAHN

0.25MG/ML

A 079196

001 Apr 30, 2008

Jun CAHN

0.5MG
0.5MG
1MG
1MG
2MG
2MG

N 018225
N 018225
N 018225
N 018225
N 018225
N 018225

002
002
001
001
003
003

Feb
Feb
Feb
Feb
Jun
Jun

28,
28,
28,
28,
14,
14,

1983
1983
1983
1983
1985
1985

Oct
Oct
Oct
Oct
Oct
Oct

CMFD

CMFD

CMFD

CMFD

CMFD

CMFD

75MCG
150MCG
300MCG
450MCG
600MCG
750MCG
900MCG

N 207932
N 207932
N 207932
N 207932
N 207932
N 207932
N 207932

001
002
003
004
005
006
007

Oct
Oct
Oct
Oct
Oct
Oct
Oct

23,
23,
23,
23,
23,
23,
23,

2015
2015
2015
2015
2015
2015
2015

Oct
Oct
Oct
Oct
Oct
Oct
Oct

NEWA

NEWA

NEWA

NEWA

NEWA

NEWA

NEWA

0.3MG BASE/ML

A 206586

001 Jul 28, 2015

Jul NEWA

2MG
8MG
2MG
8MG
2MG
8MG

A 090819
A 090819
A 201066
A 201066
A 090279
A 090279

001
002
001
002
001
002

Feb
Feb
Mar
Mar
Jun
Jun

19,
19,
06,
06,
10,
10,

2015
2015
2015
2015
2015
2015

Feb
Feb
Feb
Feb
May
May

NEWA

NEWA

NEWA

NEWA

NEWA

NEWA

N 022410
N 022410
N 022410
N 022410

001
003
002
004

Aug
Aug
Aug
Aug

30,
10,
30,
10,

2010
2012
2010
2012

Sep
Sep
Sep
Sep

CDFR

CDFR

CDFR

CDFR

A 204431
A 204431

001 Oct 16, 2015


002 Oct 16, 2015

Oct NEWA

Oct NEWA

N 204242

005 Jun 04, 2015

Jun NEWA

ACID
ACID
ACID
ACID

BUDESONIDE
AEROSOL, FOAM;RECTAL
UCERIS
+
VALEANT PHARMS INTL
2MG/ACTUATION
SPRAY, METERED;NASAL
BUDESONIDE
APOTEX INC
0.032MG/INH
TABLET, EXTENDED RELEASE;ORAL
UCERIS
+
VALEANT PHARMS INTL
9MG

AP

>D>
>A> AB
>D>
>A> AB
>D>
>A> AB
>A>
>A>
>A>
>A>
>A>
>A>
>A>
>A>
>A>
>A>

BUMETANIDE
INJECTABLE;INJECTION
BUMETANIDE
EUROHLTH INTL SARL
TABLET;ORAL
BUMEX
@ VALIDUS PHARMS INC
@
@

BUPRENORPHINE HYDROCHLORIDE
FILM;BUCCAL
BELBUCA
ENDO PHARMS INC

AP

AB
AB
AB
AB
AB
AB

>A> AB
>A> AB

INJECTABLE;INJECTION
BUPRENORPHINE HYDROCHLORIDE
PAR STERILE PRODUCTS
EQ
TABLET;SUBLINGUAL
BUPRENORPHINE HYDROCHLORIDE
ACTAVIS ELIZABETH
EQ
EQ
MYLAN PHARMS INC
EQ
EQ
SANDOZ INC
EQ
EQ

BASE
BASE
BASE
BASE
BASE
BASE

BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE


FILM;BUCCAL, SUBLINGUAL
SUBOXONE
INDIVIOR INC
EQ 2MG BASE;EQ 0.5MG BASE
EQ 4MG BASE;EQ 1MG BASE
EQ 8MG BASE;EQ 2MG BASE
+
EQ 12MG BASE;EQ 3MG BASE
TABLET;SUBLINGUAL
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
ETHYPHARM USA CORP
EQ 2MG BASE;EQ 0.5MG BASE
EQ 8MG BASE;EQ 2MG BASE
ZUBSOLV
OREXO AB
EQ 2.9MG BASE;EQ 0.71MG BASE

1 -13

October

0.09%
0.09%
0.09%
0.09%

10

Jun
May
Jan
Feb

23,
11,
22,
10,

2014
2011
2014
2015

CTEC

CRLD

CTEC

NEWA

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT

AB1
AB1
AB1
AB2

AB
AB
AB
AB

1 -14

October

2015

BUPROPION HYDROBROMIDE

TABLET, EXTENDED RELEASE;ORAL

APLENZIN

VALEANT PHARMS NORTH
174MG
348MG
+
522MG

N 022108
N 022108
N 022108

001 Apr 23, 2008


002 Apr 23, 2008
003 Apr 23, 2008

Feb CAHN

Feb CAHN

Feb CAHN

BUPROPION HYDROCHLORIDE

TABLET, EXTENDED RELEASE;ORAL

BUPROPION HYDROCHLORIDE

PRINSTON INC
100MG
150MG
200MG
SANDOZ INC
150MG
@ WOCKHARDT LTD
100MG
@
150MG
@
200MG

A 202304
A 202304
A 202304
A 077475
A 201331
A 201331
A 201331

001
002
003
001
001
002
003

May
May
May
Mar
Aug
Aug
Aug

26,
26,
26,
12,
30,
30,
30,

2015
2015
2015
2008
2012
2012
2012

May
May
May
Mar
May
May
May

NEWA

NEWA

NEWA

CAHN

DISC

DISC

DISC

BUSPIRONE HYDROCHLORIDE

TABLET;ORAL

BUSPIRONE HYDROCHLORIDE

EMCURE PHARMS USA
5MG
10MG
15MG
30MG

A 204582
A 204582
A 204582
A 204582

001
002
003
004

Sep
Sep
Sep
Sep

18,
18,
18,
18,

2015
2015
2015
2015

Sep
Sep
Sep
Sep

NEWA

NEWA

NEWA

NEWA

30MG/5ML

A 085380

001

Jul DISC

50MG

N 000793

003

May DISC

BUTABARBITAL SODIUM

ELIXIR;ORAL

BUTISOL SODIUM

@ MEDA PHARMS
TABLET;ORAL

BUTISOL SODIUM

@ MEDA PHARMS

10

BUTOCONAZOLE NITRATE

CREAM;VAGINAL

BUTOCONAZOLE NITRATE

@ ELAN PHARMA INTL LTD
GYNAZOLE-1

+
PERRIGO ISRAEL

2%

N 019881

001 Feb 07, 1997

May CTNA

2%

A 200923

001 May 18, 2012

Jun CTNA

AP

CAFFEINE CITRATE

SOLUTION;INTRAVENOUS

CAFFEINE CITRATE

AUROBINDO PHARMA LTD

EQ 30MG BASE/3ML (EQ 10MG BASE/ML) A 205013

001 Sep 22, 2015

Sep NEWA

AB

CALCIPOTRIENE

CREAM;TOPICAL

CALCIPOTRIENE

GLENMARK PHARMS LTD

0.005%

A 205772

001 Jun 09, 2015

May NEWA

200 IU/ML

A 073690

001 Apr 14, 1995

Mar CAHN

100 IU/ML
200 IU/ML

N 017808
N 017808

001 Jul 03, 1986


002 Mar 29, 1991

Aug CAHN

Aug CAHN

AB

CALCITONIN SALMON

INJECTABLE;INJECTION

CALCITONIN-SALMON

@ IGI LABS INC
MIACALCIN

@ MYLAN IRELAND LTD
+
SPRAY, METERED;NASAL

MIACALCIN

+
MYLAN IRELAND LTD

200 IU/SPRAY

N 020313

002 Aug 17, 1995

Aug CAHN

0.25MCG
0.5MCG
0.25MCG
0.5MCG

A 091174
A 091174
A 091356
A 091356

001
002
001
002

Jan
Jan
Jan
Jan

AB
AB
AB
AB

CALCITRIOL

CAPSULE;ORAL

CALCITRIOL

BANNER LIFE SCIENCES
STRIDES PHARMA

May
May
Dec
Dec

24,
24,
12,
12,

2013
2013
2014
2014

CAHN

CAHN

CAHN

CAHN

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT

INJECTABLE;INJECTION

CALCIJEX

@ ABBVIE
@
CALCITRIOL

@ AKORN
@ FRESENIUS KABI USA
@
@ FRESENIUS MEDCL
@
@ LUITPOLD
@
@ SAGENT PHARMS

AB

AB

>A> AB

AB

AB

AB

>A>

>D>

CALCIUM ACETATE

CAPSULE;ORAL

CALCIUM ACETATE

HERITAGE PHARMS INC
LUPIN LTD
NOSTRUM LABS INC
ZYDUS PHARMS USA INC
TABLET;ORAL

CALCIUM ACETATE

HERITAGE PHARMS INC
ZYDUS PHARMS USA INC

>D>

>A>

>D>

>D>

0.001MG/ML
0.002MG/ML

N 018874
N 018874

001 Sep 25, 1986


002 Sep 25, 1986

Jun DISC

Jun DISC

0.002MG/ML
0.001MG/ML
0.002MG/ML
0.001MG/ML
0.002MG/ML
0.001MG/ML
0.002MG/ML
0.001MG/ML

A 078066
A 075836
A 075836
A 075766
A 075766
A 075746
A 075746
A 077102

002
001
002
001
002
001
002
001

Jan
Dec
Dec
Feb
Feb
Sep
Sep
Feb

29,
31,
31,
20,
20,
26,
26,
08,

2008
2002
2002
2003
2003
2003
2003
2006

Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun

DISC

DISC

DISC

DISC

DISC

DISC

DISC

DISC

EQ
EQ
EQ
EQ

CALCIUM
CALCIUM
CALCIUM
CALCIUM

A 202315
A 202127
A 203179
A 202315

001
001
001
001

Jun
Jul
Oct
Jun

29,
09,
26,
29,

2015
2015
2015
2015

Sep
Jun
Oct
Jun

CAHN

NEWA

NEWA

NEWA

EQ 169MG CALCIUM
EQ 169MG CALCIUM

A 202885
A 202885

001 Jan 22, 2015


001 Jan 22, 2015

GAMBRO RENAL PRODS

Sep CAHN

Jan NEWA

N/A/1000ML;20GM/1000ML;5.4GM/1000M N 021703
L;3.05GM/1000ML;0.157GM/1000ML;2.2

1GM/1000ML;7.07GM/1000ML (5000ML)

010 Oct 10, 2008

Oct CAHN

N/A/1000ML;20GM/1000ML;5.4GM/1000M N 021703
L;3.05GM/1000ML;0.157GM/1000ML;2.2

1GM/1000ML;7.07GM/1000ML (5000ML)

010 Oct 10, 2008

Jan CPOT

N 021703

012 Oct 10, 2008

Oct CAHN

N 021703

012 Oct 10, 2008

Oct CAHN

N 021703

012 Oct 10, 2008

Jan CPOT

N 021703

011 Oct 10, 2008

Oct CAHN

N/A/1000ML;20GM/1000ML;5.4GM/1000M N 021703
L;3.05GM/1000ML;0.314GM/1000ML;2.2

1GM/1000ML;7.07GM/1000ML (5000ML)

011 Oct 10, 2008

Oct CAHN

N/A/1000ML;20GM/1000ML;5.4GM/1000M N 021703
L;3.05GM/1000ML;0.314GM/1000ML;2.2

1GM/1000ML;7.07GM/1000ML (5000ML)

011 Oct 10, 2008

Jan CPOT

013 Oct 10, 2008

Oct CAHN

013 Oct 10, 2008

Oct CAHN

PRISMASOL B22GK 2/2.5 IN PLASTIC CONTAINER

@ BAXTER HLTHCARE
3.68GM/1000ML;20GM/1000ML;5.4GM/10
00ML;3.05GM/1000ML;0.157GM/1000ML;

2.21GM/1000ML;7.07GM/1000ML

(5000ML)

@ GAMBRO RENAL PRODS


3.68GM/1000ML;20GM/1000ML;5.4GM/10
00ML;3.05GM/1000ML;0.157GM/1000ML;

2.21GM/1000ML;7.07GM/1000ML

(5000ML)

@
3.68GM/1000ML;20GM/1000ML;5.4GM/10
00ML;3.05GM/1000ML;0.157GM/1000ML;

2.21GM/1000ML;7.07GM/1000ML

(5000ML)

PRISMASOL B22GK 4/0 IN PLASTIC CONTAINER



+
BAXTER HLTHCARE
N/A/1000ML;20GM/1000ML;5.4GM/1000M
L;3.05GM/1000ML;0.314GM/1000ML;2.2

1GM/1000ML;7.07GM/1000ML (5000ML)

+

>A>

2015

CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE;

SODIUM CHLORIDE

INJECTABLE;INJECTION

PRISMASOL B22GK 2/0 IN PLASTIC CONTAINER

+
BAXTER HLTHCARE
N/A/1000ML;20GM/1000ML;5.4GM/1000M N 021703 010 Oct 10, 2008
Oct CAHN

L;3.05GM/1000ML;0.157GM/1000ML;2.2

1GM/1000ML;7.07GM/1000ML (5000ML)

>A>

1 -15

October

169MG
169MG
169MG
169MG

10

GAMBRO RENAL PRODS

PRISMASOL B22GK 4/2.5 IN PLASTIC CONTAINER



BAXTER HLTHCARE
3.68GM/1000ML;20GM/1000ML;5.4GM/10 N 021703
00ML;3.05GM/1000ML;0.314GM/1000ML;

2.21GM/1000ML;7.07GM/1000ML

(5000ML)

+
GAMBRO RENAL PRODS
3.68GM/1000ML;20GM/1000ML;5.4GM/10 N 021703
00ML;3.05GM/1000ML;0.314GM/1000ML;

2.21GM/1000ML;7.07GM/1000ML

(5000ML)

+

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT

>A>

>D>

>A>

>D>

GAMBRO RENAL PRODS

GAMBRO RENAL PRODS

>A>

>D>

>A>

>D>

>A>

>D>

Oct CAHN

3.68GM/1000ML;20GM/1000ML;5.4GM/10
N 021703
006 Oct 25, 2006

00ML;3.05GM/1000ML;N/A/1000ML;3.09

GM/1000ML;6.46GM/1000ML (5000ML)

Jan CPOT

Oct CAHN

N/A/1000ML;20GM/1000ML;5.4GM/1000M
N 021703
002 Oct 25, 2006

L;2.03GM/1000ML;0.157GM/1000ML;3.0

9GM/1000ML;6.46GM/1000ML (5000ML)

Oct CAHN

N/A/1000ML;20GM/1000ML;5.4GM/1000M
N 021703
002 Oct 25, 2006

L;2.03GM/1000ML;0.157GM/1000ML;3.0

9GM/1000ML;6.46GM/1000ML (5000ML)

Jan CPOT

N 021703
003 Oct 25, 2006

Oct CAHN

N 021703
003 Oct 25, 2006

Oct CAHN

N 021703
003 Oct 25, 2006

Jan CPOT

N 021703
005 Oct 25, 2006

Oct CAHN

@ GAMBRO RENAL PRODS

N/A/1000ML;20GM/1000ML;5.4GM/1000M
N 021703
005 Oct 25, 2006

L;3.05GM/1000ML;0.314GM/1000ML;3.0

9GM/1000ML;6.46GM/1000ML (5000ML)

Oct CAHN

N/A/1000ML;20GM/1000ML;5.4GM/1000M
N 021703
005 Oct 25, 2006

L;3.05GM/1000ML;0.314GM/1000ML;3.0

9GM/1000ML;6.46GM/1000ML (5000ML)

Jan CPOT

PRISMASOL BGK 4/0/1.2 IN PLASTIC CONTAINER

BAXTER HLTHCARE
N/A/1000ML;20GM/1000ML;5.4GM/1000M
N 021703
015 Oct 10, 2008

L;2.44GM/1000ML;0.314GM/1000ML;3.0

9GM/1000ML;6.46GM/1000ML (5000ML)

GAMBRO RENAL PRODS

Oct CAHN

N/A/1000ML;20GM/1000ML;5.4GM/1000M
N 021703
015 Oct 10, 2008

L;2.44GM/1000ML;0.314GM/1000ML;3.0

9GM/1000ML;6.46GM/1000ML (5000ML)

Oct CAHN

N/A/1000ML;20GM/1000ML;5.4GM/1000M
N 021703
015 Oct 10, 2008

L;2.44GM/1000ML;0.314GM/1000ML;3.0

9GM/1000ML;6.46GM/1000ML (5000ML)

Jan CPOT

PRISMASOL BGK 4/2.5 IN PLASTIC CONTAINER

BAXTER HLTHCARE
3.68GM/1000ML;20GM/1000ML;5.4GM/10
N 021703
004 Oct 25, 2006

00ML;3.05GM/1000ML;0.314GM/1000ML;

3.09GM/1000ML;6.46GM/1000ML

(5000ML)

+
GAMBRO RENAL PRODS
3.68GM/1000ML;20GM/1000ML;5.4GM/10
N 021703
004 Oct 25, 2006

00ML;3.05GM/1000ML;0.314GM/1000ML;

3.09GM/1000ML;6.46GM/1000ML

(5000ML)

+

Jan CPOT

Oct CAHN

PRISMASOL BGK 2/3.5 IN PLASTIC CONTAINER

BAXTER HLTHCARE
5.15GM/1000ML;20GM/1000ML;5.4GM/10

00ML;2.03GM/1000ML;0.157GM/1000ML;

3.09GM/1000ML;6.46GM/1000ML

(5000ML)

+
GAMBRO RENAL PRODS
5.15GM/1000ML;20GM/1000ML;5.4GM/10

00ML;2.03GM/1000ML;0.157GM/1000ML;

3.09GM/1000ML;6.46GM/1000ML

(5000ML)

+
5.15GM/1000ML;20GM/1000ML;5.4GM/10

00ML;2.03GM/1000ML;0.157GM/1000ML;

3.09GM/1000ML;6.46GM/1000ML

(5000ML)

PRISMASOL BGK 4/0 IN PLASTIC CONTAINER

@ BAXTER HLTHCARE
N/A/1000ML;20GM/1000ML;5.4GM/1000M

L;3.05GM/1000ML;0.314GM/1000ML;3.0

9GM/1000ML;6.46GM/1000ML (5000ML)

+

1 -16

3.68GM/1000ML;20GM/1000ML;5.4GM/10
N 021703
006 Oct 25, 2006

00ML;3.05GM/1000ML;N/A/1000ML;3.09

GM/1000ML;6.46GM/1000ML (5000ML)

PRISMASOL BGK 2/0 IN PLASTIC CONTAINER

BAXTER HLTHCARE
N/A/1000ML;20GM/1000ML;5.4GM/1000M
N 021703
002 Oct 25, 2006

L;2.03GM/1000ML;0.157GM/1000ML;3.0

9GM/1000ML;6.46GM/1000ML (5000ML)

>D>

-
October
2015

INJECTABLE;INJECTION

PRISMASOL B22GK 4/2.5 IN PLASTIC CONTAINER

+
3.68GM/1000ML;20GM/1000ML;5.4GM/10
N 021703
013 Oct 10, 2008

00ML;3.05GM/1000ML;0.314GM/1000ML;

2.21GM/1000ML;7.07GM/1000ML

(5000ML)

PRISMASOL BGK 0/2.5 IN PLASTIC CONTAINER

+
BAXTER HLTHCARE
3.68GM/1000ML;20GM/1000ML;5.4GM/10
N 021703
006 Oct 25, 2006

00ML;3.05GM/1000ML;N/A/1000ML;3.09

GM/1000ML;6.46GM/1000ML (5000ML)

>A>

10

Oct CAHN

Oct CAHN

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT

>A>

>D>

>A>

>A>

>D>

>A>

>D>

1 -17

October

2015

N 021703

004 Oct 25, 2006

Jan CPOT

N 021703

008 Oct 25, 2006

Oct CAHN

N 021703

008 Oct 25, 2006

Oct CAHN

N 021703

008 Oct 25, 2006

Jan CPOT

N 021703

007 Oct 25, 2006

Oct CAHN

@ GAMBRO RENAL PRODS

N/A/1000ML;N/A/1000ML;5.4GM/1000ML N 021703
;3.05GM/1000ML;N/A/1000ML;3.09GM/1

000ML;6.46GM/1000ML (5000ML)

007 Oct 25, 2006

Oct CAHN

N/A/1000ML;N/A/1000ML;5.4GM/1000ML N 021703
;3.05GM/1000ML;N/A/1000ML;3.09GM/1

000ML;6.46GM/1000ML (5000ML)

007 Oct 25, 2006

Jan CPOT

014 Oct 10, 2008

Oct CAHN

N/A/1000ML;N/A/1000ML;5.4GM/1000ML N 021703
;2.44GM/1000ML;N/A/1000ML;3.09GM/1

000ML;6.46GM/1000ML (5000ML)

014 Oct 10, 2008

Oct CAHN

N/A/1000ML;N/A/1000ML;5.4GM/1000ML N 021703
;2.44GM/1000ML;N/A/1000ML;3.09GM/1

000ML;6.46GM/1000ML (5000ML)

014 Oct 10, 2008

Jan CPOT

001 Oct 25, 2006

Oct CAHN

5.15GM/1000ML;N/A/1000ML;5.4GM/100 N 021703
0ML;2.03GM/1000ML;N/A/1000ML;3.09G

M/1000ML;6.46GM/1000ML (5000ML)

001 Oct 25, 2006

Oct CAHN

5.15GM/1000ML;N/A/1000ML;5.4GM/100 N 021703
0ML;2.03GM/1000ML;N/A/1000ML;3.09G

M/1000ML;6.46GM/1000ML (5000ML)

001 Oct 25, 2006

Jan CPOT

009 Oct 25, 2006

Oct CAHN

009 Oct 25, 2006

Oct CAHN

009 Oct 25, 2006

Jan CPOT

PRISMASOL BK 0/0/1.2 IN PLASTIC CONTAINER



BAXTER HLTHCARE
N/A/1000ML;N/A/1000ML;5.4GM/1000ML N 021703
;2.44GM/1000ML;N/A/1000ML;3.09GM/1

000ML;6.46GM/1000ML (5000ML)

GAMBRO RENAL PRODS

>D>

INJECTABLE;INJECTION

PRISMASOL BGK 4/2.5 IN PLASTIC CONTAINER

+
3.68GM/1000ML;20GM/1000ML;5.4GM/10
00ML;3.05GM/1000ML;0.314GM/1000ML;

3.09GM/1000ML;6.46GM/1000ML

(5000ML)

PRISMASOL BGK 4/3.5 IN PLASTIC CONTAINER

@ BAXTER HLTHCARE
5.15GM/1000ML;20GM/1000ML;5.4GM/10
00ML;2.03GM/1000ML;0.314GM/1000ML;

3.09GM/1000ML;6.46GM/1000ML

(5000ML)

@ GAMBRO RENAL PRODS


5.15GM/1000ML;20GM/1000ML;5.4GM/10
00ML;2.03GM/1000ML;0.314GM/1000ML;

3.09GM/1000ML;6.46GM/1000ML

(5000ML)

@
5.15GM/1000ML;20GM/1000ML;5.4GM/10
00ML;2.03GM/1000ML;0.314GM/1000ML;

3.09GM/1000ML;6.46GM/1000ML

(5000ML)

PRISMASOL BK 0/0 IN PLASTIC CONTAINER

@ BAXTER HLTHCARE
N/A/1000ML;N/A/1000ML;5.4GM/1000ML
;3.05GM/1000ML;N/A/1000ML;3.09GM/1

000ML;6.46GM/1000ML (5000ML)

>D>

>A>

10

PRISMASOL BK 0/3.5 IN PLASTIC CONTAINER



BAXTER HLTHCARE
5.15GM/1000ML;N/A/1000ML;5.4GM/100 N 021703
0ML;2.03GM/1000ML;N/A/1000ML;3.09G

M/1000ML;6.46GM/1000ML (5000ML)

GAMBRO RENAL PRODS

PRISMASOL BK 4/2.5 IN PLASTIC CONTAINER

@ BAXTER HLTHCARE
3.68GM/1000ML;N/A/1000ML;5.4GM/100 N 021703
0ML;3.05GM/1000ML;0.314GM/1000ML;3

.09GM/1000ML;6.46GM/1000ML

(5000ML)

@ GAMBRO RENAL PRODS


3.68GM/1000ML;N/A/1000ML;5.4GM/100 N 021703
0ML;3.05GM/1000ML;0.314GM/1000ML;3

.09GM/1000ML;6.46GM/1000ML

(5000ML)

@
3.68GM/1000ML;N/A/1000ML;5.4GM/100 N 021703
0ML;3.05GM/1000ML;0.314GM/1000ML;3

.09GM/1000ML;6.46GM/1000ML

(5000ML)

CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE;

SODIUM CHLORIDE; SODIUM PHOSPHATE



INJECTABLE;INJECTION

PHOXILLUM B22K 4/0 IN PLASTIC CONTAINER

+
GAMBRO LUNDIA
N/A/1000ML;N/A/1000ML;N/A/1000ML;3 N 207026 002 Jan 13, 2015
Jan NEWA

.05GM/1000ML;0.314GM/1000ML;2.21GM

/1000ML;6.95GM/1000ML;0.187GM/1000

ML (5000ML)

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT

10

October

INJECTABLE;INJECTION

PHOXILLUM BK 4/2.5 IN PLASTIC CONTAINER

+
GAMBRO LUNDIA
3.68GM/1000ML;N/A/1000ML;N/A/1000M N 207026
L;3.05GM/1000ML;0.314GM/1000ML

;3.09GM/1000ML;6.34GM/1000ML;0.187

GM/1000ML (5000ML)

1 -18

2015

001 Jan 13, 2015

Jan NEWA

CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; OXIGLUTATIONE; POTASSIUM CHLORIDE; SODIUM BICARBONATE;

SODIUM CHLORIDE; SODIUM PHOSPHATE



SOLUTION;IRRIGATION

NAVSTEL

@ ALCON PHARMS LTD
0.154MG/ML;0.92MG/ML;0.2MG/ML;0.18 N 022193 001 Jul 24, 2008
Jun DISC

4MG/ML;0.38MG/ML;2.1MG/ML;7.14MG/M

L;0.42MG/ML

CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE;

SODIUM LACTATE

INJECTABLE;INJECTION

PLASMA-LYTE M AND DEXTROSE 5% IN PLASTIC CONTAINER

@ BAXTER HLTHCARE
37MG/100ML;5GM/100ML;30MG/100ML;11 N 017390 001
Mar DISC

9MG/100ML;161MG/100ML;94MG/100ML;1

38MG/100ML

CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM

LACTATE

INJECTABLE;INJECTION

PLASMA-LYTE R IN PLASTIC CONTAINER

@ BAXTER HLTHCARE
36.8MG/100ML;30.5MG/100ML;74.6MG/1 N 017438 001
Mar DISC

00ML;640MG/100ML;496MG/100ML;89.6M

G/100ML

CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE;
PHOSPHATE

INJECTABLE;INJECTION

PHOXILLUM B22K 4/0 IN PLASTIC CONTAINER

+
BAXTER HLTHCARE
N/A/1000ML;3.05GM/1000ML;0.314GM/1 N 207026 002
000ML;2.21GM/1000ML;6.95GM/1000ML;

0.187GM/1000ML (5000ML)

+
GAMBRO LUNDIA
N/A/1000ML;3.05GM/1000ML;0.314GM/1 N 207026 002
000ML;2.21GM/1000ML;6.95GM/1000ML;

0.187GM/1000ML (5000ML)

+
N/A/1000ML;3.05GM/1000ML;0.314GM/1 N 207026 002
000ML;2.21GM/1000ML;6.95GM/1000ML;

0.187GM/1000ML (5000ML)

PHOXILLUM BK 4/2.5 IN PLASTIC CONTAINER

+
BAXTER HLTHCARE
3.68GM/1000ML;3.05GM/1000ML;0.314G N 207026 001
M/1000ML

;3.09GM/1000ML;6.34GM/1000ML;0.187

+
GAMBRO LUNDIA
3.68GM/1000ML;3.05GM/1000ML;0.314G N 207026 001
M/1000ML

;3.09GM/1000ML;6.34GM/1000ML;0.187

+
3.68GM/1000ML;3.05GM/1000ML;0.314G N 207026 001
M/1000ML

;3.09GM/1000ML;6.34GM/1000ML;0.187

>A>

>D>

>A>

>D>

Jan 13, 2015

Oct CAHN

Jan 13, 2015

Oct CAHN

Jan 13, 2015

Feb CAIN

Jan 13, 2015

Oct CAHN

Jan 13, 2015

Oct CAHN

Jan 13, 2015

Feb CAIN

001 Aug 29, 1989

Sep DISC

A 204100
A 204100
A 204100

001 Feb 27, 2015


002 Feb 27, 2015
003 Feb 27, 2015

Feb NEWA

Feb NEWA

Feb NEWA

A 202593
A 202593

001 Apr 23, 2015


002 Apr 23, 2015

Apr NEWA

Apr NEWA

CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE



SOLUTION;IRRIGATION

LACTATED RINGER'S IN PLASTIC CONTAINER

@ BAXTER HLTHCARE
20MG/100ML;30MG/100ML;600MG/100ML; N 019933
310MG/100ML

CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE

TABLET;ORAL

CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE

AB
MACLEODS PHARMS LTD
16MG;12.5MG
AB
32MG;12.5MG
AB
32MG;25MG

AB
AB

CAPECITABINE

TABLET;ORAL

CAPECITABINE

ACCORD HLTHCARE

150MG
500MG

SODIUM CHLORIDE; SODIUM

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT

10

1 -19

October

2015

A 074433
A 074462
A 074483
A 074590
A 074433
A 074462
A 074483
A 074590
A 074433
A 074462
A 074483
A 074590
A 074433
A 074462
A 074483
A 074590
A 074434

001
001
001
004
002
002
002
002
003
003
003
001
004
004
004
003
004

Feb
Feb
Feb
Aug
Feb
Feb
Feb
Aug
Feb
Feb
Feb
Aug
Feb
Feb
Feb
Aug
Feb

13,
13,
13,
30,
13,
13,
13,
30,
13,
13,
13,
30,
13,
13,
13,
30,
13,

1996
1996
1996
1996
1996
1996
1996
1996
1996
1996
1996
1996
1996
1996
1996
1996
1996

Jul
Apr
Jul
Apr
Jul
Apr
Jul
Apr
Jul
Apr
Jul
Apr
Jul
Apr
Jul
Apr
May

CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CRLD

Dec
Dec
Dec
Dec

29,
29,
29,
29,

1997
1997
1997
1997

Apr
Apr
Apr
Apr

CAHN
CAHN
CAHN
CAHN

AB

CAPTOPRIL
TABLET;ORAL
CAPTOPRIL
@ G AND W LABS INC
@
@
@
@
@
@
@
@
@
@
@
@
@
@
@
+
MYLAN

AB
AB
AB
AB

CAPTOPRIL; HYDROCHLOROTHIAZIDE
TABLET;ORAL
CAPTOPRIL AND HYDROCHLOROTHIAZIDE
G AND W LABS INC
25MG;15MG
25MG;25MG
50MG;15MG
50MG;25MG

A 074827
A 074827
A 074827
A 074827

001
002
004
003

AB
AB
AB

CARBAMAZEPINE
CAPSULE, EXTENDED RELEASE;ORAL
CARBAMAZEPINE
MYLAN PHARMS INC
100MG
200MG
300MG

A 076697
A 076697
A 076697

001 May 20, 2011


002 May 20, 2011
003 May 20, 2011

May CAHN
May CAHN
May CAHN

N 203312
N 203312
N 203312
N 203312

001
002
003
004

Jan
Jan
Jan
Jan

N 203952

001 Jan 09, 2015

Jan NEWA

N 204370
N 204370
N 204370
N 204370

001
002
003
004

Sep
Sep
Sep
Sep

17,
17,
17,
17,

2015
2015
2015
2015

Sep
Sep
Sep
Sep

NEWA
NEWA
NEWA
NEWA

250MG
350MG
250MG
350MG

A 205126
A 205126
A 205513
A 205513

001
002
001
002

Jul
Jul
Nov
Nov

08,
08,
12,
12,

2015
2015
2015
2015

Jun
Jun
Oct
Oct

NEWA
NEWA
NEWA
NEWA

250MG

N 011792

004 Sep 13, 2007

Jun CTEC

3.125MG
6.25MG
12.5MG

A 077887
A 077887
A 077887

001 Sep 07, 2007


002 Sep 07, 2007
003 Sep 07, 2007

Jun DISC
Jun DISC
Jun DISC

12.5MG
12.5MG
12.5MG
12.5MG
25MG
25MG
25MG
25MG
50MG
50MG
50MG
50MG
100MG
100MG
100MG
100MG
100MG

CARBIDOPA; LEVODOPA
CAPSULE, EXTENDED RELEASE;ORAL
RYTARY
IMPAX LABS INC
23.75MG;95MG
36.25MG;145MG
48.75MG;195MG
+
61.25MG;245MG
SUSPENSION;ENTERAL
DUOPA
+
ABBVIE INC
4.63MG/ML;20MG/ML
CARIPRAZINE HYDROCHLORIDE
CAPSULE;ORAL
VRAYLAR
FOREST RES INST INC

AB
AA
>A> AB
>A> AA
AB

CARISOPRODOL
TABLET;ORAL
CARISOPRODOL
INDICUS PHARMA
SHASUN PHARMS LTD

SOMA
MEDA PHARMS

CARVEDILOL
TABLET;ORAL
CARVEDILOL
@ HIKMA
@
@

EQ
EQ
EQ
EQ

1.5MG BASE
3MG BASE
4.5MG BASE
6MG BASE

Jan
Jan
Jan
Jan

07,
07,
07,
07,

2015
2015
2015
2015

NEWA
NEWA
NEWA
NEWA

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT

AB
AB
AB
AB

AB
AB

AP
AP
AP
AP

AB
AB
AB
AB

TABLET;ORAL
CARVEDILOL
@
SUN PHARM INDS LTD

2015

A 077887
A 076989
A 076989
A 076989
A 076989

004
001
002
003
004

A 065115
A 065115
A 065115

001 Mar 26, 2003


002 Mar 26, 2003
003 Mar 26, 2003

Apr CAHN
Apr CAHN
Apr CAHN

A 063214
A 063207
A 063209
A 063209

001
001
001
002

Jan
Jan
Jan
Jan

N 207131

001 Aug 07, 2015

Sep CAHN

N 207131

001 Aug 07, 2015

Aug NEWA

100MG/5ML
200MG/5ML

A 204835
A 204835

001 Apr 14, 2015


002 Apr 14, 2015

Apr NEWA
Apr NEWA

100MG/5ML
200MG/5ML

A 065129
A 065355

001 Feb 23, 2004


001 Apr 10, 2007

Apr CFTG
Apr CFTG

A 063293
N 050588
A 063293
N 050588
N 050588

001
001
002
002
003

May
Mar
May
Mar
Mar

N 050694
N 050694

002 Jul 30, 1993


001 Jul 30, 1993

Mar CAHN
Mar CAHN

EQ 50MG BASE/5ML
EQ 100MG BASE/5ML

A 065082
A 065082

001 May 31, 2002


002 May 31, 2002

Apr CAHN
Apr CAHN

EQ 100MG BASE
EQ 200MG BASE

A 065083
A 065083

001 Aug 20, 2003


002 Aug 20, 2003

Apr CAHN
Apr CAHN

500MG/VIAL
500MG/VIAL
1GM/VIAL
1GM/VIAL
2GM/VIAL
2GM/VIAL
6GM/VIAL
6GM/VIAL
500MG/VIAL

N 050578
N 050578
N 050578
N 050578
N 050578
N 050578
N 050578
N 050578
N 050578

001
001
002
002
003
003
004
004
001

Oct
Jun
Oct
Jun
Oct
Jun
Oct
Jun
Oct

CEFADROXIL/CEFADROXIL HEMIHYDRATE
FOR SUSPENSION;ORAL
CEFADROXIL
SUN PHARM INDS LTD
EQ 125MG BASE/5ML
EQ 250MG BASE/5ML
EQ 500MG BASE/5ML
CEFAZOLIN SODIUM
INJECTABLE;INJECTION
CEFAZOLIN SODIUM
FACTA FARMA

EQ
EQ
EQ
EQ

500MG BASE/VIAL
1GM BASE/VIAL
10GM BASE/VIAL
20GM BASE/VIAL

+
SOLUTION;INTRAVENOUS
CEFAZOLIN IN PLASTIC CONTAINER
BAXTER HLTHCARE
EQ 2GM BASE/100ML (EQ 20MG
BASE/ML)
CELERITY PHARMS
EQ 2GM BASE/100ML (EQ 20MG
BASE/ML)
CEFIXIME
FOR SUSPENSION;ORAL
CEFIXIME
AUROBINDO PHARMA LTD
SUPRAX
LUPIN PHARMS

CEFOTETAN DISODIUM
INJECTABLE;INJECTION
CEFOTAN
@ IGI LABS INC
EQ 1GM BASE/VIAL
@
EQ 1GM BASE/VIAL
@
EQ 2GM BASE/VIAL
@
EQ 2GM BASE/VIAL
@
EQ 10GM BASE/VIAL
CEFOTAN IN PLASTIC CONTAINER
@ IGI LABS INC
EQ 20MG BASE/ML
@
EQ 40MG BASE/ML

AB
AB

AB
AB

>D> AP
AP
>D> AP
AP
>D> AP
AP
>D> AP
AP
>A> AP

CEFPODOXIME PROXETIL
FOR SUSPENSION;ORAL
CEFPODOXIME PROXETIL
SUN PHARM INDS LTD
TABLET;ORAL
CEFPODOXIME PROXETIL
SUN PHARM INDS LTD

CEFTAZIDIME
INJECTABLE;INJECTION
FORTAZ
+
CONCORDIA PHARMS INC
+
+
+
+
+
+
+
+
IGI LABS INC

1 -20

October

25MG
3.125MG
6.25MG
12.5MG
25MG

10

Sep
Sep
Sep
Sep
Sep

Dec
Dec
Dec
Apr

Apr
Dec
Apr
Dec
Apr

Jul
Jul
Jul
Jul
Jul
Jul
Jul
Jul
Jul

07,
05,
05,
05,
05,

27,
27,
27,
30,

29,
27,
29,
27,
25,

19,
19,
19,
19,
19,
19,
19,
19,
19,

2007
2007
2007
2007
2007

1991
1991
1991
1999

1993
1985
1993
1985
1988

1985
1985
1985
1985
1985
1985
1985
1985
1985

Jun
Apr
Apr
Apr
Apr

DISC
CAHN
CAHN
CAHN
CAHN

CAHN
CAHN
CAHN
CAHN

CAHN
CAHN
CAHN
CAHN
CAHN

CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT

>A> AP
>A> AP
>A> AP

2015

N 050578
N 050578
N 050578

002 Jul 19, 1985


003 Jul 19, 1985
004 Jul 19, 1985

Oct CAHN
Oct CAHN
Oct CAHN

N 050634
N 050634
N 050634
N 050634
N 050634
N 050634
N 050634
N 050634
N 050634

001
001
002
002
003
003
001
002
003

Oct
Jun
Oct
Jun
Oct
Jun
Oct
Oct
Oct

N 206829

001 Dec 19, 2014

Aug CAHN

A 065269

001 Feb 28, 2007

Jan CAHN

EQ 1GM BASE/VIAL
EQ 2GM BASE/VIAL
EQ 250MG BASE/VIAL

A 065268
A 065268
A 065245

001 Feb 28, 2007


002 Feb 28, 2007
001 Feb 15, 2006

Jan CAHN
Jan CAHN
Jul DISC

EQ 125MG BASE/5ML
EQ 250MG BASE/5ML

A 065323
A 065323

001 Feb 05, 2008


002 Feb 05, 2008

Apr CAHN
Apr CAHN

EQ
EQ
EQ
EQ
EQ

A 065190
A 065190
A 065118
A 065118
A 065118

001
002
001
002
003

Jul
Jul
Apr
Apr
Apr

EQ 1.5GM BASE/VIAL
EQ 7.5GM BASE/VIAL

A 064125
A 064124

002 May 30, 1997


001 May 30, 1997

Jan CAHN
Jan CAHN

EQ 1.5GM BASE/VIAL
EQ 7.5GM BASE/VIAL
ZINACEF IN PLASTIC CONTAINER
@ CONCORDIA PHARMS INC
EQ 15MG BASE/ML
+
EQ 30MG BASE/ML
INJECTABLE;INTRAMUSCULAR, INTRAVENOUS
CEFUROXIME SODIUM
FACTA FARMA
EQ 750MG BASE/VIAL
ZINACEF
+
CONCORDIA PHARMS INC EQ 750MG BASE/VIAL

N 050558
N 050558

003 Oct 19, 1983


004 Oct 23, 1986

Jun CAHN
Jun CAHN

N 050643
N 050643

001 Apr 28, 1989


002 Apr 28, 1989

Jun CAHN
Jun CAHN

A 064125

001 May 30, 1997

Jan CAHN

N 050558

002 Oct 19, 1983

Jun CAHN

A 204519
A 204519
A 204519
A 204519

001
002
003
004

Aug
Aug
Aug
Aug

1GM/VIAL
2GM/VIAL
6GM/VIAL

CEFTAZIDIME SODIUM
INJECTABLE;INJECTION
FORTAZ IN PLASTIC CONTAINER
@ CONCORDIA PHARMS INC EQ
@
EQ
+
EQ
+
EQ
+
EQ
+
EQ
@ IGI LABS INC
EQ
+
EQ
+
EQ

>D>
>D>
>D>
>A>
>A>
>A>

10MG
10MG
20MG
20MG
40MG
40MG
10MG
20MG
40MG

BASE/ML
BASE/ML
BASE/ML
BASE/ML
BASE/ML
BASE/ML
BASE/ML
BASE/ML
BASE/ML

CEFTOLOZANE SULFATE; TAZOBACTAM SODIUM


POWDER;IV (INFUSION)
ZERBAXA
+
CUBIST PHARMS LLC
EQ 1GM BASE/VIAL;EQ 0.5GM
BASE/VIAL

AP

AB
AB

AB
AB
AB
AB
AB

AP
AP
AP
AP

AB
AB

AB
AB
AB
AB

CEFTRIAXONE SODIUM
INJECTABLE;INJECTION
CEFTRIAXONE
FACTA FARMA
INJECTABLE;INTRAMUSCULAR,
CEFTRIAXONE
@ FACTA FARMA
@
@ FRESENIUS KABI USA
CEFUROXIME AXETIL
FOR SUSPENSION;ORAL
CEFUROXIME AXETIL
SUN PHARM INDS LTD
TABLET;ORAL
CEFUROXIME AXETIL
ANI PHARMS INC
SUN PHARM INDS LTD

CEFUROXIME SODIUM
INJECTABLE;INJECTION
CEFUROXIME SODIUM
FACTA FARMA

+
+

EQ 10GM BASE/VIAL
INTRAVENOUS

250MG
500MG
125MG
250MG
500MG

ZINACEF
CONCORDIA PHARMS INC

CELECOXIB
CAPSULE;ORAL
CELECOXIB
ALEMBIC PHARMS LTD

50MG
100MG
200MG
400MG

BASE
BASE
BASE
BASE
BASE

1 -21

October

INJECTABLE;INJECTION
FORTAZ
+
+
+

10

Apr
Apr
Apr
Apr
Apr
Apr
Apr
Apr
Apr

Oct
Oct
Apr
Apr
Apr

Aug
Aug
Aug
Aug

28,
28,
28,
28,
28,
28,
28,
28,
28,

18,
18,
25,
25,
25,

21,
21,
21,
21,

1989
1989
1989
1989
1989
1989
1989
1989
1989

2004
2004
2003
2003
2003

2015
2015
2015
2015

CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN

CAHN
CAHN
CAHN
CAHN
CAHN

NEWA
NEWA
NEWA
NEWA

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT

2015

50MG
100MG
200MG
50MG
100MG
200MG
400MG
100MG
200MG
400MG
100MG
200MG
400MG
50MG
100MG
200MG
400MG

A 204197
A 204197
A 204197
A 207446
A 207446
A 207446
A 207446
A 202240
A 202240
A 202240
A 078857
A 078857
A 078857
A 200562
A 200562
A 200562
A 200562

001
002
003
001
002
003
004
002
003
004
002
003
004
001
002
003
004

EQ 250MG BASE
EQ 500MG BASE

A 065007
A 065007

001 Sep 16, 1999


002 Sep 16, 1999

Apr CAHN

Apr CAHN

EQ 125MG BASE/5ML
EQ 250MG BASE/5ML

A 065081
A 065081

001 Jul 27, 2001


002 Jul 27, 2001

Apr CAHN

Apr CAHN

AA

CETIRIZINE HYDROCHLORIDE

SYRUP;ORAL

ZYRTEC

+
J AND J CONSUMER INC

5MG/5ML

N 020346

001 Sep 27, 1996

Aug CAHN

AP

CHLOROTHIAZIDE SODIUM

INJECTABLE;INJECTION

CHLOROTHIAZIDE SODIUM

SAGENT PHARMS

EQ 500MG BASE/VIAL

A 202462

001 May 29, 2015

May NEWA

N 206323

001 Jun 22, 2015

Jun NEWA

A 206438

001 Jan 27, 2015

Jan NEWA

N 204307

AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB

AB
AB

CIPLA LTD

LUPIN LTD

MYLAN PHARMS INC

WATSON LABS INC

CEPHALEXIN

CAPSULE;ORAL

CEPHALEXIN

SUN PHARM INDS LTD
FOR SUSPENSION;ORAL

CEPHALEXIN

@ SUN PHARM INDS LTD
@

CHLORPHENIRAMINE MALEATE; CODEINE PHOSPHATE



TABLET, EXTENDED RELEASE;ORAL

CODEINE PHOSPHATE AND CHLORPHENIRAMINE MALEATE

SPRIASO LLC
8MG;54.3MG

1 -22

October

CAPSULE;ORAL

CELECOXIB

APOTEX INC

10

Jun
Jun
Jun
Sep
Sep
Sep
Sep
Jun
Jun
Jun
Feb
Feb
Feb
Feb
Feb
Feb
Feb

02,
02,
02,
23,
23,
23,
23,
09,
09,
09,
11,
11,
11,
11,
11,
11,
11,

2015
2015
2015
2015
2015
2015
2015
2015
2015
2015
2015
2015
2015
2015
2015
2015
2015

May
May
May
Sep
Sep
Sep
Sep
May
May
May
Jan
Jan
Jan
Jan
Jan
Jan
Jan

NEWA

NEWA

NEWA

NEWA

NEWA

NEWA

NEWA

NEWA

NEWA

NEWA

NEWA

NEWA

NEWA

NEWA

NEWA

NEWA

NEWA

AA

CHLORPHENIRAMINE MALEATE; HYDROCODONE BITARTRATE



SOLUTION;ORAL

HYDROCODONE BITARTRATE AND CHLORPHENIRAMINE MALEATE

TRIS PHARMA INC
4MG/5ML;5MG/5ML
VITUZ

+
CYPRESS PHARM
4MG/5ML;5MG/5ML

001 Feb 20, 2013

Jan CFTG

AA

CHLORPHENIRAMINE MALEATE; HYDROCODONE BITARTRATE; PSEUDOEPHEDRINE HYDROCHLORIDE



SOLUTION;ORAL

HYDROCODONE BITARTRATE,CHLORPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE

COASTAL PHARMS
4MG/5ML;5MG/5ML;60MG/5ML
A 205657 001 Aug 03, 2015

Jul NEWA

AA

CHLORPHENIRAMINE POLISTIREX; CODEINE POLISTIREX



SUSPENSION, EXTENDED RELEASE;ORAL

TUZISTRA XR

+
TRIS PHARMA INC
EQ 2.8MG BASE/5ML;EQ 14.7MG
BASE/5ML

+
VERNALIS R AND D LTD
EQ 2.8MG BASE/5ML;EQ 14.7MG
BASE/5ML

CHLORPROMAZINE HYDROCHLORIDE

CONCENTRATE;ORAL

CHLORPROMAZINE HYDROCHLORIDE INTENSOL

@ CYCLE PHARMS LTD
30MG/ML
@
100MG/ML

N 207768

001 Apr 30, 2015

Apr NEWA

N 207768

001 Apr 30, 2015

Jun CAHN

A 088157
A 088158

001 Apr 27, 1983


001 Apr 27, 1983

Jun CAHN

Jun CAHN

October

2015

1 -23

A 083329

001

Feb CAHN

A 085331
A 085331
A 085331
A 085331
A 085331
A 080439
A 080439
A 080439
A 080439
A 080439

001
002
003
004
005
001
002
003
004
005

Jun
Jun
Jun
Jun
Jun
May
May
May
May
May

50MG
50MG
50MG

A 088651
A 089286
A 086831

001 May 30, 1985


001 Jul 21, 1986
001

Apr CAHN
Mar CMFD
Jun CTEC

15MG

N 019574

001 Dec 20, 1988

Jun DISC

CHOLESTYRAMINE
POWDER;ORAL
CHOLESTYRAMINE
@ ANI PHARMS INC
@

EQ 4GM RESIN/PACKET
EQ 4GM RESIN/SCOOPFUL

A 074554
A 074554

001 Oct 02, 1996


002 Oct 02, 1996

Aug CAHN
Aug CAHN

CHOLIC ACID
CAPSULE;ORAL
CHOLBAM
ASKLEPION PHARMS LLC
+
RTRX
+

50MG
250MG
50MG
250MG

N 205750
N 205750
N 205750
N 205750

001
002
001
002

Mar
Mar
Apr
Apr

CHOLINE C-11
INJECTABLE;INTRAVENOUS
CHOLINE C-11
+
MCPRF
+
UNIV TX MD ANDERSON

4-33.1mCi/ML
4-33.1mCi/ML
4-33.1mCi/ML

N 203155
N 203155
A 205690

001 Sep 12, 2012


001 Sep 12, 2012
001 Oct 29, 2015

Oct CFTG
Oct CFTG
Oct NEWA

AB
AB

CHOLINE FENOFIBRATE
CAPSULE, DELAYED RELEASE;ORAL
FENOFIBRIC ACID
ACTAVIS ELIZABETH
EQ 45MG FENOFIBRIC ACID
EQ 135MG FENOFIBRIC ACID

A 200920
A 200920

001 Oct 07, 2015


002 Oct 07, 2015

Sep NEWA
Sep NEWA

AT

CICLOPIROX
SOLUTION;TOPICAL
CICLOPIROX
APOTEX INC

8%

A 078172

001 Sep 18, 2007

Sep CMFD

AP

CIDOFOVIR
INJECTABLE;INJECTION
CIDOFOVIR
+
MYLAN INSTITUTIONAL

EQ 75MG BASE/ML

A 201276

001 Jun 27, 2012

May CRLD

A 074176

001 Jun 01, 1994

Apr CAHN

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT

INJECTABLE;INJECTION
CHLORPROMAZINE HYDROCHLORIDE
+
EUROHLTH INTL SARL
25MG/ML
TABLET;ORAL
CHLORPROMAZINE HYDROCHLORIDE
@ CYCLE PHARMS LTD
10MG
@
25MG
@
50MG
@
100MG
@
200MG
@ SANDOZ
10MG
@
25MG
@
50MG
@
100MG
@
200MG

AB
AB

>D>
>A> AP
>A> AP

CHLORTHALIDONE
TABLET;ORAL
CHLORTHALIDONE
@ G AND W LABS INC
MUTUAL PHARM
+
MYLAN
THALITONE
@ CITRON PHARMA LLC

CIMETIDINE HYDROCHLORIDE
SOLUTION;ORAL
CIMETIDINE HYDROCHLORIDE
@ G AND W LABS INC
EQ 300MG BASE/5ML

10

Mar
Mar
Mar
Mar

17,
17,
17,
17,

2015
2015
2015
2015

CAHN
CAHN
CAHN
CAHN
CAHN
DISC
DISC
DISC
DISC
DISC

NEWA
NEWA
CAHN
CAHN

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT

AP
AP
AP
AP

>D> AT
>A> AT

AB
AB
AB

2015

A 078062
A 078062

001 Apr 29, 2008


002 Apr 29, 2008

Apr CAHN
Apr CAHN

A 078024
A 078024

001 Mar 18, 2008


002 Mar 18, 2008

Apr CAHN
Apr CAHN

0.3% BASE
0.3% BASE

A 077689
A 077689

001 Dec 13, 2006


001 Dec 13, 2006

Oct CAHN
Oct CAHN

250MG BASE
500MG BASE
750MG BASE

A 075747
A 075747
A 075747

001 Jun 09, 2004


002 Jun 09, 2004
003 Jun 09, 2004

Apr CAHN
Apr CAHN
Apr CAHN

A 203183

001 Feb 26, 2015

Feb NEWA

A 203182
A 203182

001 Feb 26, 2015


002 Feb 26, 2015

Feb NEWA
Feb NEWA

A 206774

001 Aug 18, 2015

Aug NEWA

A 077048
A 077048
A 077048

001 Nov 16, 2004


002 Nov 16, 2004
003 Nov 16, 2004

Apr CAHN
Apr CAHN
Apr CAHN

A 065382
A 065382

001 Aug 30, 2007


002 Aug 30, 2007

Apr CAHN
Apr CAHN

A 203584
A 203584
A 065174
A 065174

001
002
001
002

Sep
Sep
Apr
Apr

A 202532
A 065154

001 Sep 15, 2015


001 May 18, 2005

Aug NEWA
Jan CRLD

A 062691

001 Dec 19, 1986

May DISC

N 050590

001 Apr 01, 1985

May DISC

N 050590

002 Apr 01, 1985

May DISC

N 050590

003 Aug 18, 1987

May DISC

N 050658

001 Dec 15, 1989

May DISC

CIPROFLOXACIN
INJECTABLE;INJECTION
CIPROFLOXACIN
CLARIS PHARMASERVICE

200MG/20ML (10MG/ML)
400MG/40ML (10MG/ML)
CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER
CLARIS PHARMASERVICE 200MG/100ML
400MG/200ML

CIPROFLOXACIN HYDROCHLORIDE
SOLUTION/DROPS;OPHTHALMIC
CIPROFLOXACIN HYDROCHLORIDE
NEXUS PHARMS
EQ
RISING PHARMS INC
EQ
TABLET;ORAL
CIPROFLOXACIN HYDROCHLORIDE
SUN PHARM INDS LTD
EQ
EQ
EQ

AP
AP

AP

CISPLATIN
INJECTABLE;INJECTION
CISPLATIN
ACCORD HLTHCARE

AB
AB
AB

CITALOPRAM HYDROBROMIDE
TABLET;ORAL
CITALOPRAM HYDROBROMIDE
G AND W LABS INC
EQ 10MG BASE
EQ 20MG BASE
EQ 40MG BASE

AB
AB

AB
AB
AB
AB

AB
AB

CLARITHROMYCIN
FOR SUSPENSION;ORAL
CLARITHROMYCIN
SUN PHARM INDS LTD

1 -24

October

CISATRACURIUM BESYLATE
INJECTABLE;INJECTION
CISATRACURIUM BESYLATE
FRESENIUS KABI USA
EQ 2MG BASE/ML
CISATRACURIUM BESYLATE PRESERVATIVE FREE
FRESENIUS KABI USA
EQ 2MG BASE/ML
EQ 10MG BASE/ML

AP

10

1MG/ML

125MG/5ML
250MG/5ML

TABLET;ORAL
CLARITHROMYCIN
HEC PHARM USA INC

250MG
500MG
SUN PHARM INDS LTD
250MG
500MG
TABLET, EXTENDED RELEASE;ORAL
CLARITHROMYCIN
LUPIN LTD
500MG
+
TEVA
500MG
CLAVULANATE POTASSIUM; TICARCILLIN DISODIUM
INJECTABLE;INJECTION
TIMENTIN
@ GLAXOSMITHKLINE
EQ 100MG BASE/VIAL;EQ 3GM
BASE/VIAL
@
EQ 100MG BASE/VIAL;EQ 3GM
BASE/VIAL
@
EQ 200MG BASE/VIAL;EQ 3GM
BASE/VIAL
@
EQ 1GM BASE/VIAL;EQ 30GM BASE/VIAL
TIMENTIN IN PLASTIC CONTAINER
@ GLAXOSMITHKLINE
EQ 100MG BASE/100ML;EQ 3GM
BASE/100ML

Sep
Sep
Sep
Sep

28,
28,
24,
24,

2015
2015
2004
2004

NEWA
NEWA
CAHN
CAHN

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT

CLEMASTINE FUMARATE
TABLET;ORAL
CLEMASTINE FUMARATE
@ ANI PHARMS INC

AB
AB
AB
AB

AP
AP
AP

AT

AB
AB

1.34MG

CLINDAMYCIN HYDROCHLORIDE
CAPSULE;ORAL
CLINDAMYCIN HYDROCHLORIDE
G AND W LABS INC
EQ
EQ
SUN PHARM INDS LTD
EQ
EQ
CLINDAMYCIN PHOSPHATE
INJECTABLE;INJECTION
CLINDAMYCIN PHOSPHATE
ALVOGEN INC

@ IGI LABS INC


SOLUTION;TOPICAL
CLINDAMYCIN PHOSPHATE
@ BOCA PHARMA LLC
VINTAGE PHARMS

EQ
EQ
EQ
EQ

1 -25

October

2015

A 073282

001 Jan 31, 1992

Jul CAHN

BASE
BASE
BASE
BASE

A 063029
A 063029
A 065061
A 065061

001
002
001
002

Sep
Aug
Feb
Feb

20,
05,
02,
02,

1989
2005
2001
2001

Apr
Apr
Apr
Apr

CAHN
CAHN
CAHN
CAHN

150MG
150MG
150MG
150MG

BASE/ML
BASE/ML
BASE/ML
BASE/ML

A 062800
A 062801
A 062943
A 062928

001
001
001
001

Jul
Jul
Sep
Feb

24,
24,
29,
13,

1987
1987
1988
1989

Sep
Sep
Sep
Mar

CAHN
CAHN
CAHN
CAHN

A 062944
A 203343

001 Jan 11, 1989


001 May 29, 2015

Jan CAHN
May NEWA

A 202564

001 Jun 12, 2015

Jun NEWA

N 050802

001 Nov 07, 2006

Jun CTEC

A 075430

001 May 26, 1999

May CRLD

A 074220

001 May 16, 1997

Jun CRLD

A 075368

001 Feb 15, 2000

May CRLD

A 074089

001 Feb 16, 1994

Feb CAHN

A 074331

001 Dec 15, 1995

Mar CMFD

N 018361

001 Mar 22, 1982

Jun DISC

A 090873
A 090873
A 090873

001 May 06, 2014


002 May 06, 2014
003 May 06, 2014

Mar CAHN
Mar CAHN
Mar CAHN

A 071783
A 071784
A 071785

001 Apr 05, 1988


001 Apr 05, 1988
001 Apr 05, 1988

May DISC
May DISC
May DISC

A 202792
A 203320

001 May 15, 2015


001 May 15, 2015

May NEWA
May NEWA

EQ 1% BASE
EQ 1% BASE

CLOBETASOL PROPIONATE
CREAM;TOPICAL
CLOBETASOL PROPIONATE (EMOLLIENT)
AB2
+
FOUGERA PHARMS
0.05%
CORMAX
AB1
+
HI TECH PHARMA
0.05%
GEL;TOPICAL
CLOBETASOL PROPIONATE
AB
+
FOUGERA PHARMS
0.05%
OINTMENT;TOPICAL
CLOBETASOL PROPIONATE
AB
G AND W LABS INC
0.05%
SOLUTION;TOPICAL
CLOBETASOL PROPIONATE
AT
G AND W LABS INC
0.05%

AB
AB
AB

150MG
300MG
150MG
300MG

CLINDAMYCIN PHOSPHATE; TRETINOIN


GEL;TOPICAL
CLINDAMYCIN PHOSPHATE AND TRETINOIN
ACTAVIS MID ATLANTIC 1.2%;0.025%
ZIANA
+
MEDICIS
1.2%;0.025%

CLOMIPHENE CITRATE
TABLET;ORAL
SEROPHENE
@ EMD SERONO

10

50MG

CLONIDINE
FILM, EXTENDED RELEASE;TRANSDERMAL
CLONIDINE
ACTAVIS LABS UT INC
0.1MG/24HR
0.2MG/24HR
0.3MG/24HR

CLONIDINE HYDROCHLORIDE
TABLET;ORAL
CLONIDINE HYDROCHLORIDE
@ DAVA PHARMS INC
0.1MG
@
0.2MG
@
0.3MG
TABLET, EXTENDED RELEASE;ORAL
CLONIDINE HYDROCHLORIDE
AB2
ACTAVIS ELIZABETH
0.1MG
AB1
0.1MG

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT

AB2
AB1
AB2
AB2
AB1
AB1
AB1
AB1
AB1
AB1
AB1

AB
AB
AB

AB
AB
AB
AB

AB
AB
AB
AB

October

2015

A 202792
A 202792
A 203320
A 203320
A 202983
A 202983
A 202983
A 202983

002
002
002
002
001
001
002
002

1 -26

TABLET, EXTENDED RELEASE;ORAL



CLONIDINE HYDROCHLORIDE

@
0.2MG
0.2MG
@
0.2MG
0.2MG
@ ANCHEN PHARMS
0.1MG
0.1MG
@
0.2MG
0.2MG
CLONIDINE HYDROCHLORIDE

ANCHEN PHARMS
0.1MG
@
0.2MG
0.2MG
KAPVAY

+
CONCORDIA PHARMS INC
0.1MG
0.1MG
+
0.1MG
@
0.2MG
+
0.2MG
0.2MG

A 202984
A 202984
A 202984

001 Sep 30, 2013


002 Sep 30, 2013
002 Sep 30, 2013

May CTEC

Aug DISC

May CTEC

N 022331
N 022331
N 022331
N 022331
N 022331
N 022331

003
003
003
004
004
004

Aug
Jun
May
Aug
Jun
May

CLORAZEPATE DIPOTASSIUM

TABLET;ORAL

CLORAZEPATE DIPOTASSIUM

SUN PHARM INDS LTD
3.75MG
7.5MG
15MG

A 076911
A 076911
A 076911

001 Sep 29, 2004


002 Sep 29, 2004
003 Sep 29, 2004

Apr CAHN

Apr CAHN

Apr CAHN

A 203807
A 203807

001 Sep 17, 2015


002 Sep 17, 2015

Sep NEWA

Sep NEWA

N 019758
N 019758

001 Sep 26, 1989


002 Sep 26, 1989

Aug CAHN

Aug CAHN

A 201824
A 201824

002 Sep 15, 2015


003 Sep 15, 2015

Aug NEWA

Aug NEWA

N 021590
N 021590

001 Feb 10, 2004


002 Feb 10, 2004

Aug CFTG

Aug CFTG

N 205395

001 Jan 29, 2015

Jan NEWA

CODEINE PHOSPHATE; PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE



SYRUP;ORAL

PROMETHAZINE HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE

AMNEAL PHARMS
10MG/5ML;5MG/5ML;6.25MG/5ML
A 200963 001 Aug 26, 2015

Aug NEWA

CODEINE SULFATE

SOLUTION;ORAL

CODEINE SULFATE

@ ROXANE

30MG/5ML

N 202245

001 Jun 30, 2011

Jan DISC

COLCHICINE

CAPSULE;ORAL

MITIGARE

HIKMA INTL PHARMS

0.6MG

N 204820

001 Sep 26, 2014

Jan CAHN

A 083734

001

Aug CAHN

CLOZAPINE

TABLET;ORAL

CLOZAPINE

ACTAVIS LABS FL INC

25MG
100MG

CLOZARIL

HERITAGE LIFE

25MG
+
100MG
TABLET, ORALLY DISINTEGRATING;ORAL

CLOZAPINE

MYLAN PHARMS INC
25MG
100MG
FAZACLO ODT

JAZZ PHARMS III
25MG
+
100MG
COBICISTAT; DARUNAVIR ETHANOLATE

TABLET;ORAL

PREZCOBIX

+
JANSSEN PRODS
150MG;EQ 800MG BASE

AA

10

COLCHICINE; PROBENECID

TABLET;ORAL

PROBENECID AND COLCHICINE

@ ANI PHARMS INC
0.5MG;500MG

May
May
May
May
Apr
Apr
Apr
Apr

Sep
Sep
Sep
Sep
Sep
Sep

15,
15,
15,
15,
02,
02,
02,
02,

28,
28,
28,
28,
28,
28,

2015
2015
2015
2015
2014
2014
2014
2014

2010
2010
2010
2010
2010
2010

Aug
May
Aug
May
Aug
May
Aug
May

DISC

NEWA

DISC

NEWA

DISC

CTEC

DISC

CTEC

CRLD

CRLD

CTEC

DISC

CRLD

CTEC

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT

10

October

2015

1 -27

COLISTIMETHATE SODIUM
INJECTABLE;INJECTION
COLISTIMETHATE SODIUM
XELLIA PHARMS APS

EQ 150MG BASE/VIAL

A 205356

001 May 29, 2015

May NEWA

CORTICOTROPIN
INJECTABLE;INJECTION
H.P. ACTHAR GEL
@ MALLINCKRODT ARD
+

40 UNITS/ML
80 UNITS/ML

N 008372
N 008372

006
008

Aug CAHN

Aug CAHN

CYANOCOBALAMIN
INJECTABLE;INJECTION
CYANOCOBALAMIN
@ EUROHLTH INTL SARL

1MG/ML

A 080515

002

Feb CAHN

AB
AB
AB
AB

CYCLOBENZAPRINE HYDROCHLORIDE
TABLET;ORAL
CYCLOBENZAPRINE HYDROCHLORIDE
ORIT LABS LLC
5MG
SUN PHARM INDS LTD
5MG
7.5MG
10MG

A 078218
A 078722
A 078722
A 078722

002
001
002
003

AA

CYPROHEPTADINE HYDROCHLORIDE
TABLET;ORAL
CYPROHEPTADINE HYDROCHLORIDE
MIRROR PHARMS LLC
4MG

A 205087

001 Sep 23, 2015

Sep NEWA

DABRAFENIB MESYLATE
CAPSULE;ORAL
TAFINLAR
NOVARTIS PHARMS CORP
+

EQ 50MG BASE
EQ 75MG BASE

N 202806
N 202806

001 May 29, 2013


002 May 29, 2013

Mar CAHN

Mar CAHN

DACLATASVIR DIHYDROCHLORIDE
TABLET;ORAL
DAKLINZA
BRISTOL-MYERS SQUIBB
+

EQ 30MG BASE
EQ 60MG BASE

N 206843
N 206843

001 Jul 24, 2015


002 Jul 24, 2015

Jul NEWA

Jul NEWA

7,500 IU/0.75ML
7,500 IU/0.75ML

N 020287
N 020287

008 Apr 04, 2002


008 Apr 04, 2002

Jun CAHN

Apr CAHN

2,500IU/0.2ML (12,500IU/ML)
5,000IU/0.2ML (25,000IU/ML)
7,500IU/0.3ML (25,000IU/ML)
10,000IU/0.4ML (25,000IU/ML)
10,000IU/ML (10,000IU/ML)
12,500IU/0.5ML (25,000IU/ML)
15,000IU/0.6ML (25,000IU/ML)
18,000IU/0.72ML (25,000IU/ML)
95,000IU/3.8ML (25,000IU/ML)
95,000IU/9.5ML (10,000IU/ML)
2,500IU/0.2ML (12,500IU/ML)
5,000IU/0.2ML (25,000IU/ML)
7,500IU/0.3ML (25,000IU/ML)
10,000IU/0.4ML (25,000IU/ML)
10,000IU/ML (10,000IU/ML)
12,500IU/0.5ML (25,000IU/ML)
15,000IU/0.6ML (25,000IU/ML)
18,000IU/0.72ML (25,000IU/ML)
95,000IU/3.8ML (25,000IU/ML)
95,000IU/9.5ML (10,000IU/ML)

N 020287
N 020287
N 020287
N 020287
N 020287
N 020287
N 020287
N 020287
N 020287
N 020287
N 020287
N 020287
N 020287
N 020287
N 020287
N 020287
N 020287
N 020287
N 020287
N 020287

001
003
005
002
004
009
010
011
006
007
001
003
005
002
004
009
010
011
006
007

Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Apr
Apr
Apr
Apr
Apr
Apr
Apr
Apr
Apr
Apr

AP

DALTEPARIN SODIUM
INJECTABLE;INJECTION
FRAGMIN
@ PFIZER INC
@ PHARMACIA AND UPJOHN
INJECTABLE;SUBCUTANEOUS
FRAGMIN
PFIZER INC

+
@
PHARMACIA AND UPJOHN

+
@

Jun
May
May
May

Dec
Mar
Apr
May
Jan
May
May
May
Apr
Apr
Dec
Mar
Apr
May
Jan
May
May
May
Apr
Apr

19,
12,
12,
12,

22,
18,
04,
01,
30,
01,
01,
01,
04,
04,
22,
18,
04,
01,
30,
01,
01,
01,
04,
04,

2015
2008
2008
2008

1994
1996
2002
2007
1998
2007
2007
2007
2002
2002
1994
1996
2002
2007
1998
2007
2007
2007
2002
2002

Jun
Apr
Apr
Apr

NEWA

CAHN

CAHN

CAHN

CAHN

CAHN

CAHN

CAHN

CAHN

CAHN

CAHN

CAHN

CAHN

CAHN

CAHN

CAHN

CAHN

CAHN

CAHN

CAHN

CAHN

CAHN

CAHN

CAHN

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT

AB
AB
AB

AB
AB
AB
AB

2015

A 076686
A 076686
A 076686

001 Oct 24, 2005


002 Oct 24, 2005
003 Oct 24, 2005

May CAHN
May CAHN
May CAHN

7.5MG BASE
15MG BASE

A 091190
A 091190

001 Mar 13, 2015


002 Mar 13, 2015

Mar NEWA
Mar NEWA

7.5MG BASE
15MG BASE

N 021513
N 021513

001 Dec 22, 2004


002 Dec 22, 2004

Mar CFTG
Mar CFTG

100MG
140MG

N 021986
N 021986

004 May 30, 2008


006 Oct 28, 2010

Sep CRLD
Sep CRLD

50MG/VIAL

N 021790

001 May 02, 2006

Jan CAHN

90MG
180MG
360MG

N 206910
N 206910
N 206910

001 Mar 30, 2015


002 Mar 30, 2015
003 Mar 30, 2015

Mar NEWA
Mar NEWA
Mar NEWA

100MG/ML

N 208030

001 Sep 09, 2015

Sep NEWA

DEMECLOCYCLINE HYDROCHLORIDE
TABLET;ORAL
DEMECLOCYCLINE HYDROCHLORIDE
EPIC PHARMA LLC
150MG
300MG

A 065447
A 065447

001 Aug 18, 2015


002 Aug 18, 2015

Aug NEWA
Aug NEWA

DEOXYCHOLIC ACID
SOLUTION;SUBCUTANEOUS
KYBELLA
+
KYTHERA BIOPHARMS

N 206333

001 Apr 29, 2015

Apr NEWA

DESIPRAMINE HYDROCHLORIDE
TABLET;ORAL
DESIPRAMINE HYDROCHLORIDE
ANI PHARMS INC
25MG
50MG
75MG
150MG

A 071803
A 071803
A 071803
A 071803

002
003
004
005

Sep
Sep
Sep
Sep

DESIRUDIN RECOMBINANT
INJECTABLE;SUBCUTANEOUS
IPRIVASK
+
VALEANT PHARMS NORTH

15MG/VIAL

N 021271

001 Apr 04, 2003

May CAHN

0.5MG/ML

N 021300

001 Sep 01, 2004

Jun CFTG

0.5MG/ML

A 202592

001 Jun 30, 2015

Jun NEWA

DARIFENACIN HYDROBROMIDE
TABLET, EXTENDED RELEASE;ORAL
DARIFENACIN HYDROBROMIDE
ANCHEN PHARMS
EQ
EQ
ENABLEX
WARNER CHILCOTT LLC
EQ
+
EQ
DASATINIB
TABLET;ORAL
SPRYCEL
+
BRISTOL MYERS SQUIBB

AP

DECITABINE
INJECTABLE;INTRAVENOUS
DACOGEN
+
OTSUKA PHARM CO LTD
DEFERASIROX
TABLET;ORAL
JADENU
NOVARTIS PHARMS CORP
+
DEFERIPRONE
SOLUTION;ORAL
FERRIPROX
+
APOPHARMA INC

AB
AB

AA
AA

25MG
50MG
100MG

DESLORATADINE
SOLUTION;ORAL
CLARINEX
+
MERCK SHARP DOHME
DESLORATADINE
TARO PHARM INDS

20MG/2ML (10MG/ML)

1 -28

October

DANTROLENE SODIUM
CAPSULE;ORAL
DANTROLENE SODIUM
ELITE LABS INC

10

Dec
Dec
Dec
May

08,
08,
08,
29,

1987
1987
1987
1997

CMS1
CMS1
CMS1
CMS1

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT

AB
AB
AB
AB

DESMOPRESSIN ACETATE
TABLET;ORAL
DDAVP
FERRING PHARMS INC
+
DESMOPRESSIN ACETATE
GLENMARK PHARMS LTD

10

2015

0.1MG
0.2MG

N 019955
N 019955

001 Sep 06, 1995


002 Sep 06, 1995

Jan CAHN
Jan CAHN

0.1MG
0.2MG

A 201831
A 201831

001 May 28, 2015


002 May 28, 2015

May NEWA
May NEWA

A 202226

001 Aug 12, 2015

Jul NEWA

N 021090

001 Dec 20, 2000

Aug CAHN

A 202789

001 Aug 12, 2015

Jul NEWA

A 075863

001 Apr 05, 2002

Apr CTEC

A 076681

001 Apr 30, 2015

Apr NEWA

0.05%

A 074027

001 Sep 28, 1992

May CMFD

0.25%
0.25%

A 205082
A 203234

001 Sep 04, 2015


001 Jun 12, 2015

Aug NEWA
Jun NEWA

0.25%

A 077770

001 Apr 20, 2015

Apr NEWA

50MG BASE
100MG BASE
50MG BASE
100MG BASE
50MG BASE
100MG BASE
50MG BASE
100MG BASE

A 204003
A 204003
A 204172
A 204172
A 204095
A 204095
A 204028
A 204028

001
002
001
002
001
002
001
002

Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun

50MG BASE
100MG BASE

N 021992
N 021992

001 Feb 29, 2008


002 Feb 29, 2008

Jun CFTG
Jun CFTG

A 203129
A 084282
A 087702

001 Sep 30, 2015


001
001 Sep 07, 1982

Sep NEWA
Mar CAHN
Feb CAHN

N 050065

002

Mar CAHN

N 050023

002

Mar CAHN

AB

DESOGESTREL; ETHINYL ESTRADIOL


TABLET;ORAL-28
BEKYREE
LUPIN LTD
0.15MG,N/A;0.02MG,0.01MG
CYCLESSA
+
ASPEN GLOBAL INC
0.1MG,0.125MG,0.15MG;0.025MG,0.025
MG,0.025MG
ISIBLOOM
SANDOZ INC
0.15MG;0.03MG
KARIVA
+
BARR
0.15MG,N/A;0.02MG,0.01MG
KIMIDESS
VINTAGE PHARMS
0.15MG,N/A;0.02MG,0.01MG

AB

DESONIDE
CREAM;TOPICAL
DESONIDE
TEVA PHARMS

AB
AB

AB
AB

AB
AB

AB

AB
AB
AB
AB
AB
AB
AB
AB
AB
AB

AP
AP

AT

AT

DESOXIMETASONE
CREAM;TOPICAL
DESOXIMETASONE
ACTAVIS MID ATLANTIC
VERSAPHARM INC
OINTMENT;TOPICAL
DESOXIMETASONE
PERRIGO NEW YORK

1 -29

October

DESVENLAFAXINE SUCCINATE
TABLET, EXTENDED RELEASE;ORAL
DESVENLAFAXINE SUCCINATE
ALEMBIC PHARMS LTD
EQ
EQ
LUPIN LTD
EQ
EQ
MYLAN PHARMS INC
EQ
EQ
SANDOZ INC
EQ
EQ
PRISTIQ
+
WYETH PHARMS INC
EQ
+
EQ

DEXAMETHASONE SODIUM PHOSPHATE


INJECTABLE;INJECTION
DEXAMETHASONE SODIUM PHOSPHATE
BD RX
EQ 4MG PHOSPHATE/ML
@ EUROHLTH INTL SARL
EQ 4MG PHOSPHATE/ML
+
EQ 10MG PHOSPHATE/ML
DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
OINTMENT;OPHTHALMIC
MAXITROL
+
ALCON LABS INC
0.1%;EQ 3.5MG BASE/GM;10,000
UNITS/GM
SUSPENSION/DROPS;OPHTHALMIC
MAXITROL
+
ALCON LABS INC
0.1%;EQ 3.5MG BASE/ML;10,000
UNITS/ML

Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun

29,
29,
29,
29,
29,
29,
29,
29,

2015
2015
2015
2015
2015
2015
2015
2015

NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT

AP
AP

>A>
>A>
>A>
>A>

AB
AB
AB
AB
AB
AB

AB
AB
AB

10

DEXMEDETOMIDINE HYDROCHLORIDE

INJECTABLE;INJECTION

DEXMEDETOMIDINE HYDROCHLORIDE

FRESENIUS KABI USA
EQ 200MCG BASE/2ML (EQ 100MCG
BASE/ML)

SUN PHARM INDS INC


EQ 200MCG BASE/2ML (EQ 100MCG
BASE/ML)

PRECEDEX

HOSPIRA
EQ 80MCG BASE/20ML (EQ 4MCG
BASE/ML)

SOLUTION;IV (INFUSION)

DEXMEDETOMIDINE HYDROCHLORIDE

+
HQ SPCLT PHARMA
EQ 1MG BASE/10ML (EQ 100MCG
BASE/ML)

EQ 400MCG BASE/4ML (EQ 100MCG


BASE/ML)

DEXMETHYLPHENIDATE HYDROCHLORIDE

CAPSULE, EXTENDED RELEASE;ORAL

DEXMETHYLPHENIDATE HYDROCHLORIDE

MYLAN PHARMS INC
5MG
10MG
15MG
40MG
WATSON LABS INC
5MG
10MG
TABLET;ORAL

DEXMETHYLPHENIDATE HYDROCHLORIDE

SUN PHARM INDS LTD
2.5MG
5MG
10MG

1 -30

October

2015

A 201072

001 Sep 18, 2015

Sep NEWA

A 202126

001 Aug 20, 2015

Aug NEWA

N 021038

004 Nov 14, 2014

Jan NEWA

N 206628

002 Oct 21, 2015

Oct NEWA

N 206628

001 Oct 21, 2015

Oct NEWA

A 204266
A 204266
A 204266
A 204266
A 079108
A 079108

001
002
003
007
001
002

Aug
Aug
Aug
Aug
Jul
Jul

A 201231
A 201231
A 201231

001 Sep 24, 2015


002 Sep 24, 2015
003 Sep 24, 2015

Aug
Aug
Aug
Aug
Aug
Aug

25,
25,
25,
25,
05,
05,

2015
2015
2015
2015
2015
2015

NEWA

NEWA

NEWA

NEWA

NEWA

NEWA

Sep NEWA

Sep NEWA

Sep NEWA

DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATE

INJECTABLE;INJECTION

PLASMA-LYTE 148 AND DEXTROSE 5% IN PLASTIC CONTAINER

@ BAXTER HLTHCARE
5GM/100ML;30MG/100ML;37MG/100ML;36 N 017451 001
Mar DISC

8MG/100ML;526MG/100ML;502MG/100ML

AP

AA

DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM



INJECTABLE;INJECTION

MD-76R

+
LIEBEL-FLARSHEIM
66%;10%
SOLUTION;ORAL, RECTAL

MD-GASTROVIEW

LIEBEL-FLARSHEIM
66%;10%
DICHLORPHENAMIDE

TABLET;ORAL

KEVEYIS

TARO

AT
AT

>D> AB
>A> AB

AA

50MG

DICLOFENAC SODIUM

GEL;TOPICAL

VOLTAREN

+
GLAXOSMITHKLINE CONS
1%
SOLUTION;TOPICAL

DICLOFENAC SODIUM

IGI LABS INC
1.5%
LUPIN LTD
1.5%
TABLET, EXTENDED RELEASE;ORAL

DICLOFENAC SODIUM

VALEANT INTL
100MG
VPNA
100MG
DIETHYLPROPION HYDROCHLORIDE

TABLET;ORAL

TENUATE

+
ACTAVIS LABS UT INC
25MG

N 019292

001 Sep 29, 1989

Feb CAHN

A 087388

001

Jan CAHN

N 011366

002 Aug 07, 2015

Aug NEWA

N 022122

001 Oct 17, 2007

Aug CAHN

A 202769
A 204132

001 Jul 08, 2015


001 Aug 20, 2015

Jun NEWA

Aug NEWA

A 075492
A 075492

001 Feb 11, 2000


001 Feb 11, 2000

Oct CAHN

Oct CAHN

N 011722

002

Mar CAHN

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT

AB

TABLET, EXTENDED RELEASE;ORAL


TENUATE DOSPAN
+
ACTAVIS LABS UT INC
75MG

October

2015

1 -31

N 012546

001

Mar CAHN

AB

DIFLORASONE DIACETATE
OINTMENT;TOPICAL
DIFLORASONE DIACETATE
VERSAPHARM INC

0.05%

A 206572

001 Jul 24, 2015

Jul NEWA

AB

DIFLUNISAL
TABLET;ORAL
DIFLUNISAL
HERITAGE PHARMA

500MG

A 202845

001 Mar 08, 2012

Mar CAHN

0.25MG/ML

A 083391

001

Feb CAHN

0.125MG
0.25MG
0.125MG
0.25MG

A 040282
A 040282
A 076363
A 076363

001
002
001
002

Dec
Dec
Jan
Jan

23,
23,
31,
31,

1999
1999
2003
2003

Jan
Jan
Feb
Feb

CTEC
CTEC
CMFD
CMFD

0.0625MG
0.125MG
0.1875MG
0.25MG
0.375MG
0.5MG

N 020405
N 020405
N 020405
N 020405
N 020405
N 020405

001
002
003
004
005
006

Sep
Sep
Sep
Sep
Sep
Sep

30,
30,
30,
30,
30,
30,

1997
1997
1997
1997
1997
1997

Apr
Apr
Apr
Apr
Apr
Apr

CAHN
CAHN
CAHN
CAHN
CAHN
CAHN

A 076151
A 076151
A 076151
A 076151
A 076151
A 076151
A 076151
A 076151

001
001
002
002
003
003
004
004

May
May
May
May
May
May
May
May

20,
20,
20,
20,
20,
20,
20,
20,

2004
2004
2004
2004
2004
2004
2004
2004

Oct
Oct
Oct
Oct
Oct
Oct
Oct
Oct

DISC
DISC
DISC
DISC
DISC
DISC
DISC
DISC

A 075124

001 Mar 18, 1998

Feb CRLD

N 020401
N 020401
N 020401
N 020401
N 020401
N 020401

001
002
003
004
005
006

Feb
Feb
Feb
Feb
Feb
Feb

A 078538

001 Dec 17, 2008

Jun CAHN

AP

AB
AB
AB
AB

DIGOXIN
INJECTABLE;INJECTION
DIGOXIN
EUROHLTH INTL SARL
TABLET;ORAL
DIGOXIN
MYLAN PHARMS INC
SUN PHARM INDS INC
LANOXIN
CONCORDIA PHARMS INC

AB
AB

+
@
@

>D>
>D>
>A>
>D>
>A>
>D>
>A>
>D>
>A>

10

AP

DILTIAZEM HYDROCHLORIDE
CAPSULE, EXTENDED RELEASE;ORAL
DILT-CD
APOTEX
120MG
@
120MG
180MG
@
180MG
240MG
@
240MG
300MG
@
300MG
DILTIAZEM HYDROCHLORIDE
+
MYLAN
240MG
TIAZAC
VALEANT PHARMS NORTH 120MG
180MG
240MG
300MG
360MG
+
420MG
INJECTABLE;INJECTION
DILTIAZEM HYDROCHLORIDE
EUROHLTH INTL SARL
5MG/ML

AP

DIPHENHYDRAMINE HYDROCHLORIDE
INJECTABLE;INJECTION
DIPHENHYDRAMINE HYDROCHLORIDE
+
EUROHLTH INTL SARL
50MG/ML

A 080817

002

Jun CAHN

AP

DIPYRIDAMOLE
INJECTABLE;INJECTION
DIPYRIDAMOLE
EUROHLTH INTL SARL

A 074521

001 Oct 18, 1996

Jun CAHN

AB3
AB3
AB3
AB3

AB2
AB4
AB4
AB4
AB4
AB4
AB4

5MG/ML

Sep
Sep
Sep
Sep
Sep
Oct

11,
11,
11,
11,
11,
16,

1995
1995
1995
1995
1995
1998

CAHN
CAHN
CAHN
CAHN
CAHN
CAHN

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT

AB
AB

AB
AB

AP
AP

AB
AB
>A> AB
>A> AB
AB
AB
AB

AP

AB

2015

A 203916
A 203916

001 Mar 04, 2015


002 Mar 04, 2015

Feb NEWA
Feb NEWA

DIVALPROEX SODIUM
TABLET, EXTENDED RELEASE;ORAL
DIVALPROEX SODIUM
AMNEAL PHARMS
EQ 250MG VALPROIC ACID
EQ 500MG VALPROIC ACID
@ G AND W LABS INC
EQ 500MG VALPROIC ACID

A 203730
A 203730
A 078700

001 May 29, 2015


002 May 29, 2015
001 Aug 03, 2009

May NEWA
May NEWA
Jul CAHN

DOBUTAMINE HYDROCHLORIDE
INJECTABLE;INJECTION
DOBUTAMINE HYDROCHLORIDE
@ IGI LABS INC
EQ 12.5MG BASE/ML

A 074098

001 Feb 21, 1995

Mar CAHN

A 203877
A 203877

001 Sep 16, 2015


002 Sep 16, 2015

Aug NEWA
Aug NEWA

DONEPEZIL HYDROCHLORIDE
TABLET;ORAL
DONEPEZIL HYDROCHLORIDE
HETERO LABS LTD V
5MG
10MG
LUPIN LTD
23MG
MYLAN PHARMS INC
23MG
SUN PHARM INDS LTD
5MG
10MG
23MG

A 203034
A 203034
A 202782
A 202656
A 076786
A 076786
A 204293

001
002
001
001
001
002
001

Jan
Jan
Oct
Oct
Apr
Apr
May

DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE


CAPSULE, EXTENDED RELEASE;ORAL
NAMZARIC
FOREST LABS LLC
10MG;14MG
+
10MG;28MG

N 206439
N 206439

001 Dec 23, 2014


002 Dec 23, 2014

Mar CAHN
Mar CAHN

DOPAMINE HYDROCHLORIDE
INJECTABLE;INJECTION
DOPAMINE HYDROCHLORIDE
@ IGI LABS INC
@
@
@
@
@
@
@

40MG/ML
40MG/ML
80MG/ML
80MG/ML
80MG/ML
160MG/ML
160MG/ML
160MG/ML

A 070087
N 018656
A 070089
A 070090
A 070091
A 070092
A 070093
A 070094

001
001
001
001
001
001
001
001

Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar

DOXAPRAM HYDROCHLORIDE
INJECTABLE;INJECTION
DOPRAM
+
EUROHLTH INTL SARL

20MG/ML

N 014879

001

Jun CAHN

EQ 100MG BASE
EQ 150MG BASE

A 070791
A 071669

005 May 13, 1986


001 Nov 09, 1987

Jan CRLD
Jan CRLD

5%

N 020126

001 Apr 01, 1994

Mar CAHN

DOCETAXEL
INJECTABLE;INJECTION
DOCETAXEL
TEVA PHARMS USA

DOXEPIN HYDROCHLORIDE
CAPSULE;ORAL
DOXEPIN HYDROCHLORIDE
+
MYLAN PHARMS INC
+
PAR PHARM
CREAM;TOPICAL
ZONALON
+
DELCOR ASSET CORP

250MG
500MG

20MG/ML (20MG/ML)
80MG/4ML (20MG/ML)

1 -32

October

DISULFIRAM
TABLET;ORAL
DISULFIRAM
MYLAN PHARMS INC

10

Jan
Jan
Oct
Oct
Nov
Nov
Jun

Oct
Jun
Oct
Oct
Oct
Oct
Oct
Oct

30,
30,
30,
22,
26,
26,
05,

23,
28,
23,
23,
23,
23,
23,
23,

2015
2015
2015
2015
2010
2010
2015

1985
1983
1985
1985
1985
1985
1985
1985

NEWA
NEWA
NEWA
NEWA
CAHN
CAHN
NEWA

CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT

AP

>D>
>D>
>D>
>D>
>D>
>D>
>D>
>A> AP
>A>
>A>
>A>
>A>
>A>
>A>
>A> AP
>A>

AB
AB
AB
AB
AB
AB

AB
AB
AB

AB
>A> AB

>A>
>A>
>A>
>A>
>A>

AB
AB
AB
AB
AB
AB
AB
AB

2015

A 203929

001 May 07, 2015

Apr NEWA

N 050629
N 050629

001 Dec 23, 1987


002 May 03, 1988

Oct CTNA
Oct CTNA

N 050467
N 050467
N 050467
N 050467

001
003 May 20, 1985
002
004 Jul 22, 1987

Oct
Oct
Oct
Oct

CTNA
CTNA
CTNA
CTNA

N 050629
N 050629
N 050467
N 050467
N 050467
N 050467
N 050629
N 050629
N 050629

001
001
001
003
002
004
003
002
002

Dec 23, 1987


Dec 23, 1987

Jul
Mar
May
May

22,
28,
03,
03,

1987
2011
1988
1988

Oct
Oct
Oct
Oct
Oct
Oct
Oct
Oct
Oct

CMFD
CTNA
CTNA
CTNA
CTNA
CTNA
NEWA
CMFD
CTNA

50MG BASE
75MG BASE
100MG BASE
50MG BASE
75MG BASE
100MG BASE

A 204446
A 204446
A 204446
A 065053
A 065053
A 065053

001
002
003
001
003
002

May
May
May
Nov
Sep
Nov

28,
28,
28,
22,
10,
22,

2015
2015
2015
2000
2003
2000

May
May
May
Apr
Apr
Apr

NEWA
NEWA
NEWA
CAHN
CAHN
CAHN

EQ 50MG BASE
EQ 75MG BASE
EQ 100MG BASE

A 065356
A 065356
A 065356

001 May 31, 2006


002 May 31, 2006
003 May 31, 2006

Apr CAHN
Apr CAHN
Apr CAHN

DOXYCYCLINE HYCLATE
INJECTABLE;INJECTION
DOXYCYCLINE
@ EUROHLTH INTL SARL
@

EQ 100MG BASE/VIAL
EQ 200MG BASE/VIAL

A 062450
A 062450

001 Oct 27, 1983


002 Oct 27, 1983

Jun CAHN
Jun CAHN

DROPERIDOL
INJECTABLE;INJECTION
DROPERIDOL
@ IGI LABS INC
@
@

2.5MG/ML
2.5MG/ML
2.5MG/ML

A 072019
A 072020
A 072021

001 Oct 19, 1988


001 Oct 19, 1988
001 Oct 19, 1988

Mar CAHN
Mar CAHN
Mar CAHN

DROSPIRENONE; ETHINYL ESTRADIOL


TABLET;ORAL
DROSPIRENONE AND ETHINYL ESTRADIOL
GLENMARK PHARMS LTD
3MG;0.02MG
JAI PHARMA LTD
3MG;0.02MG

A 204296
A 202594

001 Aug 17, 2015


001 Oct 22, 2015

Aug NEWA
Oct NEWA

DULOXETINE HYDROCHLORIDE
CAPSULE, DELAYED REL PELLETS;ORAL
DULOXETINE HYDROCHLORIDE
ALKEM LABS LTD
EQ 20MG
EQ 30MG
EQ 60MG
ANCHEN PHARMS
EQ 20MG
EQ 30MG
EQ 60MG
INVENTIA HLTHCARE
EQ 20MG
EQ 30MG

A 203197
A 203197
A 203197
A 090780
A 090780
A 090780
A 202336
A 202336

001
002
003
001
002
003
001
002

Aug
Aug
Aug
Oct
Oct
Oct
Oct
Oct

4MCG/2ML (2MCG/ML)

DOXORUBICIN HYDROCHLORIDE
INJECTABLE;INJECTION
ADRIAMYCIN PFS
@ PHARMACIA AND UPJOHN 2MG/ML
@
200MG/100ML
ADRIAMYCIN RDF
@ PHARMACIA AND UPJOHN
10MG/VIAL
@
20MG/VIAL
@
50MG/VIAL
@
150MG/VIAL
DOXORUBICIN HYDROCHLORIDE
+
PHARMACIA AND UPJOHN 2MG/ML
@
2MG/ML
@
10MG/VIAL
@
20MG/VIAL
@
50MG/VIAL
@
150MG/VIAL
150MG/75ML
+
200MG/100ML
@
200MG/100ML
DOXYCYCLINE
CAPSULE;ORAL
DOXYCYCLINE
NOVEL LABS INC

SUN PHARM INDS LTD

TABLET;ORAL
DOXYCYCLINE
SUN PHARM INDS LTD

EQ
EQ
EQ
EQ
EQ
EQ

BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE

1 -33

October

DOXERCALCIFEROL
INJECTABLE;INJECTION
DOXERCALCIFEROL
AKORN INC

10

May 20, 1985

Aug
Aug
Aug
Oct
Oct
Oct
Oct
Oct

26,
26,
26,
28,
28,
28,
28,
28,

2015
2015
2015
2015
2015
2015
2015
2015

NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT

>A> AB

AB
AB

ECONAZOLE NITRATE
CREAM;TOPICAL
ECONAZOLE NITRATE
FOUGERA PHARMS
+
PERRIGO NEW YORK
EDOXABAN TOSYLATE
TABLET;ORAL
SAVAYSA
DAIICHI SANKYO
+
EDROPHONIUM CHLORIDE
INJECTABLE;INJECTION
ENLON
+
MYLAN INSTITUTIONAL
ELTROMBOPAG OLAMINE
FOR SUSPENSION;ORAL
PROMACTA
+
NOVARTIS PHARMS CORP
TABLET;ORAL
PROMACTA
NOVARTIS PHARMS CORP

2015

A 202336

003 Oct 28, 2015

Oct NEWA

1%
1%

A 076075
A 076479

001 Nov 26, 2002


001 Jun 23, 2004

Mar CRLD
Mar CRLD

EQ 15MG BASE
EQ 30MG BASE
EQ 60MG BASE

N 206316
N 206316
N 206316

001 Jan 08, 2015


002 Jan 08, 2015
003 Jan 08, 2015

Jan NEWA
Jan NEWA
Jan NEWA

10MG/ML

A 088873

001 Aug 06, 1985

Mar CRLD

EQ 25MG ACID/PACKET

N 207027

001 Aug 24, 2015

Aug NEWA

EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ

N 022291
N 022291
N 022291
N 022291
N 022291
N 022291
N 022291
N 022291

004
001
002
002
003
003
005
005

Oct
Nov
Nov
Nov
Sep
Sep
Nov
Nov

20,
20,
20,
20,
08,
08,
16,
16,

2011
2008
2008
2008
2009
2009
2012
2012

Mar
Mar
May
Mar
May
Mar
May
Mar

CAHN
CAHN
CRLD
CAHN
CRLD
CAHN
CRLD
CAHN

+
+
+

May
May
May
May

27,
27,
27,
27,

2015
2015
2015
2015

Jul
Jul
May
May

CAHN
CAHN
NEWA
NEWA

12.5MG ACID
25MG ACID
50MG ACID
50MG ACID
75MG ACID
75MG ACID
100MG ACID
100MG ACID

ELUXADOLINE
TABLET;ORAL
VIBERZI
FOREST TOSARA LTD
+
FURIEX PHARMS
+

75MG
100MG
75MG
100MG

N 206940
N 206940
N 206940
N 206940

001
002
001
002

EMPAGLIFLOZIN; LINAGLIPTIN
TABLET;ORAL
GLYXAMBI
BOEHRINGER INGELHEIM
+

10MG;5MG
25MG;5MG

N 206073
N 206073

001 Jan 30, 2015


002 Jan 30, 2015

Jan NEWA
Jan NEWA

N 206111
N 206111
N 206111
N 206111

001
002
003
004

Aug
Aug
Aug
Aug

26,
26,
26,
26,

2015
2015
2015
2015

Aug
Aug
Aug
Aug

NEWA
NEWA
NEWA
NEWA

2.5MG
5MG
10MG
20MG
2.5MG
5MG
10MG
20MG

A 075496
A 075496
A 075459
A 075459
A 075556
A 075556
A 075556
A 075556

001
002
001
002
001
002
003
004

Aug
Aug
Aug
Aug
Aug
Aug
Aug
Aug

22,
22,
22,
22,
22,
22,
22,
22,

2000
2000
2000
2000
2000
2000
2000
2000

Mar
Mar
Mar
Mar
Apr
Apr
Apr
Apr

CMFD
CMFD
CMFD
CMFD
CAHN
CAHN
CAHN
CAHN

2.5MG

N 018998

005 Jul 26, 1988

EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE


TABLET;ORAL
SYNJARDY
BOEHRINGER INGELHEIM 5MG;500MG
5MG;1GM
12.5MG;500MG
+
12.5MG;1GM

AB
AB
AB
AB

AB

1 -34

October

CAPSULE, DELAYED REL PELLETS;ORAL


DULOXETINE HYDROCHLORIDE
EQ 60MG BASE

10

ENALAPRIL MALEATE
TABLET;ORAL
ENALAPRIL MALEATE
SANDOZ INC

@ SUN PHARM INDS LTD


@
@
@
VASOTEC
VALEANT PHARMS NORTH

Apr CAHN

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT

10

1 -35

October

2015

N 018998
N 018998
N 018998

001 Dec 24, 1985


002 Dec 24, 1985
003 Dec 24, 1985

Apr CAHN

Apr CAHN

Apr CAHN

AB
AB

ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE



TABLET;ORAL

ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE

G AND W LABS INC
5MG;12.5MG
10MG;25MG

A 075727
A 075727

001 Sep 18, 2001


002 Sep 18, 2001

Apr CAHN

Apr CAHN

AB

ENTACAPONE

TABLET;ORAL

ENTACAPONE

AUROBINDO PHARMA LTD

200MG

A 203437

001 Jun 19, 2015

Jun NEWA

0.5MG
1MG
0.5MG
1MG
0.5MG
1MG

A 206652
A 206652
A 206217
A 206217
A 205740
A 205740

001
002
001
002
001
002

Oct
Oct
Aug
Aug
Aug
Aug

TABLET;ORAL

VASOTEC

AB
AB
AB

>A> AB
>A> AB
AB
AB
AB
AB

>D>
>D>
>D>
>A>
>A>
>A>

AP
AP
AP
AP

AA

5MG
10MG
20MG

ENTECAVIR

TABLET;ORAL

ENTECAVIR

AMNEAL PHARMS
AUROBINDO PHARMA LTD
HETERO LABS LTD V

Nov
Nov
Aug
Aug
Aug
Aug

12,
12,
26,
26,
21,
21,

2015
2015
2015
2015
2015
2015

NEWA

NEWA

NEWA

NEWA

NEWA

NEWA

EPINEPHRINE

INJECTABLE;INTRAMUSCULAR, INTRAOCULAR, SUBCUTANEOUS

ADRENALIN

+
PAR STERILE PRODUCTS
EQ 1MG BASE/ML (EQ 1MG BASE/ML)
N 204200
INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS

ADRENALIN

+
PAR STERILE PRODUCTS
EQ 30MG BASE/30ML (EQ 1MG BASE/ML) N 204640

001 Dec 07, 2012

Jul CAIN

001 Dec 18, 2013

Jul CAIN

EPINEPHRINE HYDROCHLORIDE

SOLUTION;IV (INFUSION)

EPINEPHRINE

BELCHER PHARMS LLC
EQ 1MG BASE/ML
SOLUTION;IV (INFUSION), INTRAOCULAR

EPINEPHRINE

BELCHER PHARMS LLC
EQ 1MG BASE/ML (EQ 1MG BASE/ML)

N 205029

001 Jul 29, 2014

Oct CDFR

N 205029

001 Jul 29, 2014

Oct CDFR

EPINEPHRINE; LIDOCAINE HYDROCHLORIDE



INJECTABLE;INJECTION

LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE

@ EUROHLTH INTL SARL
0.01MG/ML;1%
@
0.01MG/ML;2%

A 080406
A 080406

001
002

Sep CAHN

Sep CAHN

EPROSARTAN MESYLATE; HYDROCHLOROTHIAZIDE



TABLET;ORAL

TEVETEN HCT

@ ABBVIE
600MG;12.5MG
@
600MG;25MG

N 021268
N 021268

001 Nov 01, 2001


002 Nov 01, 2001

Jun DISC

Jun DISC

2MG/ML
75MG/100ML

A 090854
A 091555

001 Jun 12, 2015


001 Jun 05, 2015

Jun NEWA

May NEWA

2MG/ML
75MG/100ML

N 020718
N 020718

001 May 18, 1998


002 May 18, 1998

Jun CTEC

May CFTG

50,000 IU

A 080704

001

Jan CAHN

EPTIFIBATIDE

INJECTABLE;INJECTION

EPTIFIBATIDE

TEVA PHARMS USA

+
+

INTEGRILIN

SCHERING

ERGOCALCIFEROL

CAPSULE;ORAL

VITAMIN D

BANNER LIFE SCIENCES

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT

2015

2MG

A 088337

001 Jun 08, 1984

Aug CAHN

EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ

25MG BASE
100MG BASE
150MG BASE
100MG BASE
100MG BASE
100MG BASE
150MG BASE
150MG BASE
150MG BASE

A 091002
A 091002
A 091002
A 091059
A 091059
A 091059
A 091059
A 091059
A 091059

001
002
003
002
002
002
003
003
003

Jun
Jun
Jun
Aug
Aug
Aug
Aug
Aug
Aug

11,
11,
11,
28,
28,
28,
28,
28,
28,

2014
2014
2014
2015
2015
2015
2015
2015
2015

Sep
Sep
Sep
Oct
Oct
Aug
Oct
Oct
Aug

DISC
DISC
DISC
DISC
DISC
NEWA
DISC
DISC
NEWA

>D> AB
>A>
AB
>D> AB
>A>
AB

EQ
EQ
EQ
EQ
EQ

25MG BASE
100MG BASE
100MG BASE
150MG BASE
150MG BASE

N 021743
N 021743
N 021743
N 021743
N 021743

001
002
002
003
003

Nov
Nov
Nov
Nov
Nov

18,
18,
18,
18,
18,

2004
2004
2004
2004
2004

Sep
Oct
Oct
Oct
Oct

CTEC
CTEC
CTEC
CTEC
CTEC

EQ 125MG BASE/5ML
EQ 250MG BASE/5ML

A 062169
A 062169

001 Oct 17, 1990


002 Oct 17, 1990

Apr CAHN
Apr CAHN

ERYTHROMYCIN ETHYLSUCCINATE
GRANULE;ORAL
ERYTHROMYCIN ETHYLSUCCINATE
@ ANI PHARMS INC
EQ 200MG BASE/5ML

A 062055

001

Jul CAHN

EQ 5MG BASE/5ML

A 203967

001 May 26, 2015

May NEWA

EQ
EQ
EQ
EQ
EQ
EQ

A 077550
A 077550
A 077550
A 078032
A 078032
A 078032

001
002
003
001
002
003

Apr
Apr
Apr
Aug
Aug
Aug

A 205520
A 201126

001 Jul 23, 2015


001 Feb 20, 2015

Jul NEWA
Feb NEWA

BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE

A 078279
A 078279
A 202784
A 202784
A 078003
A 078003
A 078936
A 078936
A 078936
A 078936
A 203636
A 203636

001
002
001
002
001
002
001
002
001
002
001
002

Sep
Sep
Sep
Sep
Jan
Jan
Jul
Jul
Sep
Sep
Oct
Oct

BASE

N 021153

001 Feb 20, 2001

ERLOTINIB HYDROCHLORIDE
TABLET;ORAL
ERLOTINIB HYDROCHLORIDE
@ MYLAN PHARMS INC
@
@
TEVA PHARMS USA
@

@
TARCEVA
OSI PHARMS

>D> AB
>A>
>D> AB
>A>

+
+
ERYTHROMYCIN ESTOLATE
SUSPENSION;ORAL
ERYTHROMYCIN ESTOLATE
@ G AND W LABS INC
@

AA

AB
AB
AB
AB
AB
AB

AP
AP

AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
>A> AB
>A> AB
AB

ESCITALOPRAM OXALATE
SOLUTION;ORAL
ESCITALOPRAM OXALATE
ANTRIM PHARMS LLC
TABLET;ORAL
ESCITALOPRAM OXALATE
MYLAN PHARMS INC

PRINSTON INC

ESMOLOL HYDROCHLORIDE
INJECTABLE;INJECTION
ESMOLOL HYDROCHLORIDE
AUROBINDO PHARMA LTD
LUITPOLD

5MG BASE
10MG BASE
20MG BASE
5MG BASE
10MG BASE
20MG BASE

10MG/ML
10MG/ML

ESOMEPRAZOLE MAGNESIUM
CAPSULE, DELAYED REL PELLETS;ORAL
ESOMEPRAZOLE MAGNESIUM
DR REDDYS LABS LTD
EQ 20MG
EQ 40MG
HETERO LABS LTD III
EQ 20MG
EQ 40MG
IVAX SUB TEVA PHARMS EQ 20MG
EQ 40MG
MYLAN LABS LTD
EQ 20MG
EQ 40MG
MYLAN PHARMS INC
EQ 20MG
EQ 40MG
TORRENT PHARMS LTD
EQ 20MG
EQ 40MG
NEXIUM
ASTRAZENECA PHARMS
EQ 20MG

1 -36

October

ERGOTAMINE TARTRATE
TABLET;SUBLINGUAL
ERGOSTAT
@ WATSON LABS INC

10

May
May
May
Aug
Aug
Aug

Sep
Sep
Sep
Sep
Jan
Jan
Aug
Aug
Aug
Aug
Oct
Oct

14,
14,
14,
28,
28,
28,

25,
25,
21,
21,
26,
26,
02,
03,
02,
03,
19,
19,

2015
2015
2015
2015
2015
2015

2015
2015
2015
2015
2015
2015
2015
2015
2015
2015
2015
2015

NEWA
NEWA
NEWA
NEWA
NEWA
NEWA

NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
CAHN
CAHN
NEWA
NEWA

Jan CFTG

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT

AB

AP

ESOMEPRAZOLE SODIUM

INJECTABLE;INTRAVENOUS

ESOMEPRAZOLE SODIUM

ACCORD HLTHCARE

2015

N 021153

002 Feb 20, 2001

Jan CFTG

A 205379

001 Sep 25, 2015

Sep NEWA

N 202342
N 202342

001 Aug 06, 2013


002 Aug 06, 2013

Aug CPOT

Aug CPOT

N 020655
N 020655
N 020655
N 020655

004
001
002
003

Mar
Mar
Mar
Mar

N 203752

005 Sep 23, 2014

Jan NEWA

A 040275
A 040275
A 040275
A 040275
A 040275
A 040275

001
002
003
001
002
003

Oct
Oct
Oct
Oct
Oct
Oct

A 205256

001 May 29, 2015

May DISC

1MG
2MG
3MG

A 202929
A 202929
A 202929

001 Jan 30, 2015


002 Jan 30, 2015
003 Jan 30, 2015

Jan NEWA

Jan NEWA

Jan NEWA

EQ 50MG BASE/VIAL

N 016093

001

Jul CFTG

EQ 50MG BASE/VIAL

A 205473

001 Jul 29, 2015

Jul NEWA

A 075095
A 075095

001 Nov 30, 1999


002 Nov 30, 1999

Jan CMFD

Jan CMFD

A 203163

001 Feb 23, 2015

Feb NEWA

A 202791
A 203164
A 079218

001 Apr 09, 2015


001 Jun 12, 2015
001 Jun 06, 2011

Mar NEWA
Jun NEWA
Mar CTEC

A 073594

001 Dec 13, 1993

Aug CRLD

N 018782

001 Jul 21, 1982

Aug DISC

A 201088

001 May 21, 2015

May NEWA

EQ 40MG BASE/VIAL

ESOMEPRAZOLE STRONTIUM

CAPSULE, DELAYED RELEASE;ORAL

ESOMEPRAZOLE STRONTIUM

HANMI PHARM CO LTD
24.65MG
+
49.3MG

BX
BX
BX
BX

>A>
>A>
>A>
>D>
>D>
>D>

AB
AB
AB

ESTRADIOL

FILM, EXTENDED RELEASE;TRANSDERMAL

ALORA

ACTAVIS LABS UT INC
0.025MG/24HR
0.05MG/24HR
0.075MG/24HR
0.1MG/24HR
MINIVELLE

NOVEN
0.025MG/24HR
TABLET;ORAL

ESTRADIOL

@ EPIC PHARMA INC
0.5MG
@
1MG
@
2MG
@ HERITAGE PHARMS INC
0.5MG
@
1MG
@
2MG
TABLET;VAGINAL

ESTRADIOL

@ AMNEAL PHARMS
10MCG
ESZOPICLONE

TABLET;ORAL

ESZOPICLONE

MACLEODS PHARMS LTD

AP

ETHACRYNATE SODIUM

INJECTABLE;INJECTION

EDECRIN

+
ATON
ETHACRYNATE SODIUM

PAR STERILE PRODUCTS

AB
AB

ETHAMBUTOL HYDROCHLORIDE

TABLET;ORAL

ETHAMBUTOL HYDROCHLORIDE

VERSAPHARM INC
100MG
400MG

AP

ETHINYL ESTRADIOL; LEVONORGESTREL



TABLET;ORAL

ASHLYNA
AB
GLENMARK GENERICS
0.03MG,0.01MG;0.15MG,N/A
LEVONORGESTREL AND ETHINYL ESTRADIOL
AB
GLENMARK GENERICS
0.02MG;0.09MG
AB
GLENMARK PHARMS LTD
0.03MG;0.15MG
AB
+
WATSON LABS
0.02MG;0.09MG
TABLET;ORAL-28
LEVORA 0.15/30-28
AB
+
WATSON LABS
0.03MG;0.15MG
NORDETTE-28
@ TEVA BRANDED PHARM
0.03MG;0.15MG
VIENVA
AB1
SANDOZ INC
0.02MG;0.1MG

1 -37

October

CAPSULE, DELAYED REL PELLETS;ORAL



NEXIUM

+
EQ 40MG BASE

10

Apr
Dec
Dec
Dec

Dec
Dec
Dec
Dec
Dec
Dec

05,
20,
20,
20,

29,
29,
29,
29,
29,
29,

2002
1996
1996
1996

1998
1998
1998
1998
1998
1998

CAHN

CAHN

CAHN

CAHN

CAHN

CAHN

CAHN

CAHN

CAHN

CAHN

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT

AB

10

ETHINYL ESTRADIOL; NORELGESTROMIN



FILM, EXTENDED RELEASE;TRANSDERMAL

XULANE

+
MYLAN TECHNOLOGIES
0.035MG/24HR;0.15MG/24HR

ETHINYL ESTRADIOL; NORETHINDRONE



TABLET;ORAL-21

BREVICON 21-DAY

@ ACTAVIS LABS UT INC
0.035MG;0.5MG
NORINYL 1+35 21-DAY

AB
ACTAVIS LABS UT INC
0.035MG;1MG
TRI-NORINYL 21-DAY

@ ACTAVIS LABS UT INC
0.035MG,0.035MG,0.035MG;0.5MG,1MG,
0.5MG

TABLET;ORAL-28

BREVICON 28-DAY

AB
ACTAVIS LABS UT INC
0.035MG;0.5MG
NORETHINDRONE AND ETHINYL ESTRADIOL

AB
FAMY CARE LTD
0.035MG;0.4MG
AB
+
JAI PHARMA LTD
0.035MG;0.4MG
>A> AB
0.035MG;0.5MG
>A> AB
0.035MG;1MG
+
0.05MG;1MG
NORINYL 1+35 28-DAY

AB
ACTAVIS LABS UT INC
0.035MG;1MG
OVCON-35

@ WARNER CHILCOTT LLC
0.035MG;0.4MG
TRI-NORINYL 28-DAY

AB
+
ACTAVIS LABS UT INC
0.035MG,0.035MG,0.035MG;0.5MG,1MG,
0.5MG

>A>
>A> AB
AB
AB
AB
AB
AB
AB

>A> AB
>A> AB
AB
AB
AB
AB

AB

A 200910
001 Apr 16, 2014

Feb CRLD

N 017566
001

Mar CAHN

N 017565
001

Feb CAHN

N 018977
001 Apr 13, 1984

Feb CAHN

N 017743
001

Mar CAHN

A 200897

A 200897

A 200488

A 200489

A 203006

ETHINYL ESTRADIOL; NORGESTREL



TABLET;ORAL-28

LOW-OGESTREL-28

WATSON LABS
0.03MG;0.3MG

001
001
001
001
001

May
May
Oct
Oct
Aug

11,
11,
21,
21,
05,

2015

2015

2015

2015

2013

Apr
Jul
Oct
Oct
Jul

NEWA

CRLD

NEWA

NEWA

CTEC

N 017565
002

Feb CAHN

N 017716
001

Jul DISC

N 018977
002 Apr 13, 1984

Feb CAHN

ETHINYL ESTRADIOL; NORETHINDRONE ACETATE



TABLET;ORAL

BLISOVI 24 FE

LUPIN LTD
0.02MG;1MG
A 091398

FEMHRT

WARNER CHILCOTT LLC
0.0025MG;0.5MG
N 021065

LARIN 24 FE

NOVAST LABS LTD
0.02MG;1MG
A 202994

NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL

+
BARR LABS INC
0.005MG;1MG
A 076221

GLENMARK GENERICS
0.0025MG;0.5MG
A 203038

0.005MG;1MG
A 203038

NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE

+
AMNEAL PHARMS
0.02MG;1MG
A 078267

ETHINYL ESTRADIOL; NORGESTIMATE

TABLET;ORAL-28

NORGESTIMATE AND ETHINYL ESTRADIOL

HAUPT PHARMA
0.035MG,0.035MG,0.035MG;0.18MG,0.2
15MG,0.25MG

0.035MG;0.25MG
JAI PHARMA LTD
0.025MG,0.025MG,0.025MG;0.18MG,0.2
15MG,0.25MG

OC PHARMA
0.035MG;0.035MG;0.035MG;0.18MG;0.2
15MG;0.25MG

0.035MG;0.25MG
TRI-LO-ESTARYLLA

SANDOZ INC
0.025MG,0.025MG,0.025MG;0.18MG,0.2
15MG,0.25MG

1 -38

October
2015

001 Oct 28, 2015


Oct NEWA

001 Jan 14, 2005


Mar CTEC

001 Feb 18, 2015


Feb NEWA

001 Nov 06, 2009



001 Apr 02, 2015

002 Apr 02, 2015

Mar CTEC

Mar NEWA

Mar NEWA

001 Sep 01, 2009


Jan CRLD

A 203870
001 Nov 12, 2015

Oct NEWA

A 203865
001 Oct 27, 2015

A 202132
001 Sep 09, 2015

Oct NEWA

Aug NEWA

A 200383
001 Apr 07, 2015

Mar NEWA

A 200384
001 Apr 07, 2015

Mar NEWA

A 091232
001 Jun 29, 2015

Jun NEWA

A 075288
002 Jul 28, 1999

Feb CMFD

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT

AB
AB

AP

AB
AB

>A> AB
>A> AB

AB
AB
AB
AB
AB
AB

AB
AB

AB
AB
AB
AB
AB
AB

October

2015

1 -39

250MG
250MG

A 040430
A 200892

001 Oct 28, 2002


001 Sep 25, 2012

Jan CAHN
Sep CAHN

ETODOLAC
TABLET;ORAL
ETODOLAC
@ LEHIGH VALLEY

400MG

A 074927

001 Oct 30, 1997

Sep CAHN

ETONOGESTREL
IMPLANT;IMPLANTATION
IMPLANON
@ ORGANON USA INC

68MG/IMPLANT

N 021529

001 Jul 17, 2006

Jun DISC

10MG
10MG

A 078560
A 078560

001 Jun 26, 2015


001 Jun 26, 2015

Jun DISC
Jun NEWA

10MG
10MG

N 021445
N 021445

001 Oct 25, 2002


001 Oct 25, 2002

Jun CTEC
Jun CFTG

A 075488
A 075799

001 Apr 16, 2001


001 Apr 30, 2002

Jun CAHN
Sep CAHN

A 075486

001 Apr 16, 2001

Jun CAHN

20MG
40MG

N 019462
N 019462

001 Oct 15, 1986


002 Oct 15, 1986

Feb CAHN
Feb CAHN

400MG
600MG

A 202284
A 202284

001 Nov 04, 2015


002 Nov 04, 2015

Oct NEWA
Oct NEWA

FELODIPINE
TABLET, EXTENDED RELEASE;ORAL
FELODIPINE
ORCHID HLTHCARE
2.5MG
5MG
10MG
SUN PHARM INDS LTD
2.5MG
5MG
10MG

A 203032
A 203032
A 203032
A 091200
A 091200
A 091200

001
002
003
001
002
003

May
May
May
Apr
Apr
Apr

43MG
130MG

A 201748
A 201748

001 Oct 31, 2014


002 Oct 31, 2014

Apr CAHN
Apr CAHN

54MG
160MG
54MG
107MG
160MG
48MG
145MG

A 204019
A 204019
A 076635
A 076635
A 076635
A 090715
A 090715

001
002
001
002
003
001
002

Aug
Aug
Apr
Apr
Apr
Aug
Aug

AB

AP

ETHOSUXIMIDE
CAPSULE;ORAL
ETHOSUXIMIDE
BANNER LIFE SCIENCES
HERITAGE PHARMS INC

EZETIMIBE
TABLET;ORAL
EZETIMIBE
@ GLENMARK PHARMS LTD

AB

10

+
+

ZETIA
MSD INTL GMBH

FAMOTIDINE
INJECTABLE;INJECTION
FAMOTIDINE
+
EUROHLTH INTL SARL
@
FAMOTIDINE PRESERVATIVE
+
EUROHLTH INTL SARL
TABLET;ORAL
PEPCID
VALEANT PHARMS NORTH
+
FELBAMATE
TABLET;ORAL
FELBAMATE
COREPHARMA

FENOFIBRATE
CAPSULE;ORAL
FENOFIBRATE
SUN PHARM INDS LTD
TABLET;ORAL
FENOFIBRATE
LUPIN LTD
SUN PHARM INDS LTD

VALEANT PHARMS NORTH

10MG/ML
10MG/ML
FREE
10MG/ML

May
May
May
Dec
Dec
Dec

Aug
Aug
Oct
Oct
Oct
Apr
Apr

21,
21,
21,
13,
13,
13,

17,
17,
31,
31,
31,
05,
05,

2015
2015
2015
2013
2013
2013

2015
2015
2005
2005
2005
2012
2012

NEWA
NEWA
NEWA
CAHN
CAHN
CAHN

NEWA
NEWA
CAHN
CAHN
CAHN
CAHN
CAHN

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT

2015

N 022418
N 022418

001 Aug 14, 2009


002 Aug 14, 2009

Jun CAHN
Jun CAHN

A 076709

004 Aug 20, 2007

Mar CAHN

A 077154

005 Jun 11, 2015

Jun NEWA

A 076709

001 Aug 20, 2007

Mar CAHN

A 076709

002 Aug 20, 2007

Mar CAHN

A 076709

003 Aug 20, 2007

Mar CAHN

N 022266
N 022266
N 022266
N 022266
N 022266

001
002
003
004
005

Mar
Mar
Mar
Mar
Mar

N 019101

001 Jul 11, 1984

Feb CAHN

FENTANYL HYDROCHLORIDE
SYSTEM;IONTOPHORESIS, TRANSDERMAL
IONSYS
@ THE MEDICINES CO
10.8MCG
+
EQ 40MCG BASE/ACTIVATION

N 021338
N 021338

001 May 22, 2006


001 May 22, 2006

Apr CAHN
Jun CMFD

FERRIC CITRATE
TABLET;ORAL
AURYXIA
+
KERYX BIOPHARMS

N 205874

001 Sep 05, 2014

Jan CTNA

FERRIC PYROPHOSPHATE CITRATE


SOLUTION;IV (INFUSION)
TRIFERIC
+
ROCKWELL MEDICAL INC 27.2MG IRON/5ML (5.44MG IRON/ML)
272MG IRON/50ML (5.44MG IRON/ML)

N 206317
N 206317

001 Jan 23, 2015


002 Sep 04, 2015

Jan NEWA
Oct NEWA

FIDAXOMICIN
TABLET;ORAL
DIFICID
+
CUBIST PHARMS LLC

200MG

N 201699

001 May 27, 2011

Aug CAHN

50MG
100MG
150MG
50MG
100MG
150MG
50MG
100MG
150MG

A 075882
A 075882
A 075882
A 202821
A 202821
A 202821
A 076421
A 076421
A 076421

001
002
003
001
002
003
001
002
003

Apr
Apr
Apr
Jun
Jun
Jun
Apr
Apr
Apr

35MG
105MG

AB

FENTANYL
FILM, EXTENDED RELEASE;TRANSDERMAL
FENTANYL-100
ACTAVIS LABS UT INC
100MCG/HR
FENTANYL-12
MALLINCKRODT INC
12.5MCG/HR
FENTANYL-25
ACTAVIS LABS UT INC
25MCG/HR
FENTANYL-50
ACTAVIS LABS UT INC
50MCG/HR
FENTANYL-75
ACTAVIS LABS UT INC
75MCG/HR

AP

FENTANYL CITRATE
FILM;BUCCAL
ONSOLIS
@ BIODELIVERY SCI INTL EQ 0.2MG BASE
@
EQ 0.4MG BASE
@
EQ 0.6MG BASE
@
EQ 0.8MG BASE
@
EQ 1.2MG BASE
INJECTABLE;INJECTION
FENTANYL CITRATE PRESERVATIVE FREE
+
EUROHLTH INTL SARL
EQ 0.05MG BASE/ML

AB
AB
AB
AB

>A>

AB
AB
AB
AB
AB
AB
AB
AB
AB

FLECAINIDE ACETATE
TABLET;ORAL
FLECAINIDE ACETATE
ANI PHARMS INC

AUROBINDO PHARMA LTD

SUN PHARM INDS LTD

EQ 210MG IRON

1 -40

October

FENOFIBRIC ACID
TABLET;ORAL
FIBRICOR
TRIBUTE PHARMS INTL
+

10

Jul
Jul
Jul
Jul
Jul

Oct
Oct
Oct
Jul
Jul
Jul
Mar
Mar
Mar

16,
16,
16,
16,
16,

28,
28,
28,
08,
08,
08,
28,
28,
28,

2009
2009
2009
2009
2009

2002
2002
2002
2015
2015
2015
2003
2003
2003

CAHN
CAHN
CAHN
CAHN
CAHN

CAHN
CAHN
CAHN
NEWA
NEWA
NEWA
CAHN
CAHN
CAHN

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT

FLIBANSERIN

TABLET;ORAL

ADDYI

+
SPROUT PHARMS

AB
AB

AP
AP
AP
AP

AP
AP

AB
AB
AB
AB

>A> AP
AP
>A> AP
AP
AP

>D>
>A> AP
AP

AP
AP

FLUCONAZOLE

FOR SUSPENSION;ORAL

FLUCONAZOLE

SUN PHARM INDS LTD

10

100MG

N 022526
001 Aug 18, 2015

Aug NEWA

50MG/5ML

200MG/5ML

A 076332
001 Jul 29, 2004
A 076332
002 Jul 29, 2004

Apr CAHN

Apr CAHN

A 077988
001 May 26, 2010
A 077988
002 May 26, 2010

Apr CAHN

Apr CAHN

A 077947
001 May 26, 2010
A 077947
002 May 26, 2010

Apr CAHN

Apr CAHN

A 077909

A 077909

A 077909

A 077909

003
003
001
002

Apr
Apr
May
May

20,
20,
26,
26,

2015
2015
2010
2010

Apr
Apr
Apr
Apr

NEWA

CAHN

CAHN

CAHN

A 078423

A 078423

A 078423

A 078423

001
002
003
004

Mar
Mar
Mar
Mar

07,
07,
07,
07,

2011
2011
2011
2011

May
May
May
May

CMFD

CMFD

CMFD

CMFD

20-300mCi/ML

20-300mCi/ML

4-40mCi/ML

20-300mCi/ML

20-300mCi/ML

20-500mCi/ML

10-100mCi/ML

4-500mCi/ML

4-40mCi/ML

4-40mCi/ML

20-300mCi/ML

A 203778

A 203591

A 204759

A 203904

A 204472

A 204546

A 203771

A 203911

A 203811

A 203811

A 204531

001
001
001
001
001
001
001
001
001
001
001

Oct
Aug
Oct
Apr
Sep
Apr
Aug
Apr
Jun
Jun
Jul

30,
31,
27,
23,
11,
07,
31,
22,
27,
27,
17,

2015
2015
2015
2015
2015
2015
2015
2015
2013
2013
2015

Oct
Aug
Oct
Apr
Aug
Mar
Aug
Apr
Oct
Oct
Jul

NEWA

NEWA

NEWA

NEWA

NEWA

NEWA

NEWA

NEWA

CTEC

CTEC

NEWA

0.5MG/5ML (0.1MG/ML)

1MG/10ML (0.1MG/ML)

0.5MG/5ML (0.1MG/ML)

1MG/10ML (0.1MG/ML)

A 076755

A 076755

A 076787

A 076787

002
001
002
001

Oct
Oct
Oct
Oct

12,
12,
12,
12,

2004
2004
2004
2004

Apr
Apr
Jun
Jun

CAHN

CAHN

CAHN

CAHN

0.01%

A 091514
001 Jun 25, 2015

Jun NEWA

0.01%

A 206422
001 Sep 02, 2015

Aug NEWA

INJECTABLE;INJECTION

FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER

CLARIS PHARMASERVICE
200MG/100ML (2MG/ML)

400MG/200ML (2MG/ML)

FLUCONAZOLE IN SODIUM CHLORIDE 0.9%



CLARIS PHARMASERVICE
200MG/100ML (2MG/ML)

400MG/200ML (2MG/ML)

FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER



CLARIS PHARMASERVICE
100MG/50ML (2MG/ML)

100MG/50ML (2MG/ML)

200MG/100ML (2MG/ML)

400MG/200ML (2MG/ML)

TABLET;ORAL

FLUCONAZOLE

HARRIS PHARM
50MG

100MG

150MG

200MG

FLUDEOXYGLUCOSE F-18

INJECTABLE;INTRAVENOUS

FLUDEOXYGLUCOSE F18

3D IMAGING DRUG
IBA MOLECULAR N AM
KETTERING MEDCTR
METHODIST HOSP RES
MIPS CRF
PRECISION NUCLEAR
QUEEN HAMAMATSU PET
SPECTRON MRC LLC
+
UCLA BIOMEDICAL
+
UNIV MICHIGAN
FLUMAZENIL

INJECTABLE;INJECTION

FLUMAZENIL

@ CLARIS PHARMASERVICE
@
EUROHLTH INTL SARL

1 -41

-
October
2015

AT

FLUOCINOLONE ACETONIDE

OIL;TOPICAL

FLUOCINOLONE ACETONIDE

VERSAPHARM INC
SOLUTION;TOPICAL

FLUOCINOLONE ACETONIDE

GAVIS PHARMS LLC

AB

FLUOCINONIDE

GEL;TOPICAL

FLUOCINONIDE

G AND W LABS INC

0.05%

A 072537
001 Feb 07, 1989

Apr CAHN

FLUOROURACIL

CREAM;TOPICAL

CARAC

+
VALEANT PHARMS NORTH
+

0.5%

0.5%

N 020985
001 Oct 27, 2000
N 020985
001 Oct 27, 2000

Apr CFTG

Feb CAHN

AT

AB

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT

AB

2015

0.5%

A 203122

001 Apr 20, 2015

Apr NEWA

4%

N 022259

001 Sep 18, 2015

Sep NEWA

A 076287
A 076287
A 078045
A 078045
A 077469
A 077469
A 204597
A 204597
A 204597
A 076990

001
002
002
002
001
002
001
002
003
001

Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Apr

0.05%
0.05%

N 012806
N 012806

001
001

Jun CRLD
May CMFD

0.004MG/SQ CM

N 016455

001

Mar CAHN

50MG
50MG
100MG
100MG

N 018766
N 018766
N 018766
N 018766

002
002
003
003

100MG
100MG

A 074358
A 074358

002 Jun 20, 1994


002 Jun 20, 1994

Oct CRLD
Oct CRLD

FLUTICASONE FUROATE; VILANTEROL TRIFENATATE


POWDER;INHALATION
BREO ELLIPTA
GLAXO GRP LTD
0.2MG/INH;EQ 0.025MG BASE/INH

N 204275

002 Apr 30, 2015

Apr NEWA

FLUTICASONE PROPIONATE
CREAM;TOPICAL
FLUTICASONE PROPIONATE
PERRIGO NEW YORK
+

A 076793
A 076793

001 May 14, 2004


001 May 14, 2004

Oct CRLD
Oct CRLD

A 202458

001 Sep 11, 2015

Aug NEWA

N 021192

001 Oct 06, 2000

Aug CFTG

A 075897
A 075898
A 075897
A 075898
A 075897
A 075898

001
001
002
002
003
003

Jul
Jul
Jul
Jul
Jul
Jul

FLUOXETINE HYDROCHLORIDE
CAPSULE;ORAL
FLUOXETINE HYDROCHLORIDE
@ ANI PHARMS INC
EQ 10MG BASE
@
EQ 20MG BASE
+
MYLAN
EQ 20MG BASE
EQ 20MG BASE
@ SANDOZ
EQ 10MG BASE
@
EQ 20MG BASE
AB1
SCIEGEN PHARMS INC
EQ 10MG BASE
AB1
EQ 20MG BASE
AB
EQ 40MG BASE
AB
SUN PHARM INDS LTD
EQ 40MG BASE
FLURANDRENOLIDE
OINTMENT;TOPICAL
CORDRAN
+
AQUA PHARMS
TAPE;TOPICAL
CORDRAN
+
ACTAVIS LABS UT INC

>D>
>D> AB
>A>
>D> AB
>A>
>D> AB
>A> AB

>D> AB
>A> AB

AB
AB

AB

FLURBIPROFEN
TABLET;ORAL
ANSAID
PHARMACIA AND UPJOHN
@
+
@
FLURBIPROFEN
MYLAN
+

0.05%
0.05%

FLUVASTATIN SODIUM
TABLET, EXTENDED RELEASE;ORAL
FLUVASTATIN SODIUM
MYLAN PHARMS INC
80MG
LESCOL XL
+
NOVARTIS
80MG
FLUVOXAMINE MALEATE
TABLET;ORAL
FLUVOXAMINE MALEATE
ANI PHARMS INC
@

AB
@
AB
@

25MG
25MG
50MG
50MG
100MG
100MG

1 -42

October

CREAM;TOPICAL
FLUOROURACIL
SPEAR PHARMS INC
TOLAK
+
HILL DERMACEUTICALS

10

May
May
Nov
Nov
Nov
Nov
Mar
Mar
Mar
Dec

Oct
Oct
Oct
Oct

Jan
Mar
Jan
Mar
Jan
Mar

20,
20,
17,
17,
17,
17,
16,
16,
16,
13,

31,
31,
31,
31,

25,
12,
25,
12,
25,
12,

2008
2008
2008
2008
2008
2008
2015
2015
2015
2004

1988
1988
1988
1988

2001
2001
2001
2001
2001
2001

Oct
Oct
Oct
Oct

DISC
DISC
CRLD
CTEC
DISC
DISC
NEWA
NEWA
NEWA
CAHN

DISC
DISC
DISC
DISC

CAHN
CAHN
CAHN
CAHN
CAHN
CAHN

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT

10

1 -43

October

2015

A 091145
A 204418

001 Jul 12, 2013


001 Jul 28, 2015

Aug CAHN
Jul NEWA

AA
AA

FOLIC ACID
TABLET;ORAL
FOLIC ACID
AIPING PHARM INC
NUVO PHARM INC

AB
AB

FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE


TABLET;ORAL
FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE
SUN PHARM INDS LTD
10MG;12.5MG
20MG;12.5MG

A 076739
A 076739

001 Dec 17, 2004


002 Dec 17, 2004

Apr CAHN
Apr CAHN

FUROSEMIDE
INJECTABLE;INJECTION
FUROSEMIDE
@ IGI LABS INC
@

10MG/ML
10MG/ML

A 070095
A 070096

001 Sep 09, 1985


001 Sep 09, 1985

Mar CAHN
Mar CAHN

100MG
300MG
400MG

A 076606
A 076606
A 076606

001 Oct 07, 2005


002 Oct 07, 2005
003 Oct 07, 2005

Apr CAHN
Apr CAHN
Apr CAHN

600MG
800MG

A 078782
A 078782

001 Jul 21, 2011


002 Jul 21, 2011

Jun DISC
Jun DISC

N 020937
N 020937
N 020937
N 020937
N 020975

001
002
003
004
001

Dec
Dec
Dec
Dec
Dec

08,
08,
08,
08,
08,

1999
1999
1999
1999
1999

Feb
Feb
Feb
Feb
Feb

CAHN
CAHN
CAHN
CAHN
CAHN

N 020976
N 020976
N 020976
N 020976

002
003
004
001

Dec
Dec
Dec
Dec

08,
08,
08,
08,

1999
1999
1999
1999

Feb
Feb
Feb
Feb

CAHN
CAHN
CAHN
CAHN

AB
AB
AB

GABAPENTIN
CAPSULE;ORAL
GABAPENTIN
SUN PHARM INDS LTD

TABLET;ORAL
GABAPENTIN
@ HIKMA PHARMS
@

1MG
1MG

GADOVERSETAMIDE
INJECTABLE;INJECTION
OPTIMARK
+
LIEBEL-FLARSHEIM
1654.5MG/5ML (330.9MG/ML)
+
3309MG/10ML (330.9MG/ML)
+
4963.5MG/15ML (330.9MG/ML)
+
6618MG/20ML (330.9MG/ML)
+
16.545GM/50ML (330.9MG/ML)
OPTIMARK IN PLASTIC CONTAINER
+
LIEBEL-FLARSHEIM
3309MG/10ML (330.9MG/ML)
+
4963.5MG/15ML (330.9MG/ML)
+
6618MG/20ML (330.9MG/ML)
+
9927MG/30ML (330.9MG/ML)

AB

AB
AB

AP
AP

GEFITINIB
TABLET;ORAL
IRESSA
+
ASTRAZENECA PHARMS

250MG

N 206995

001 Jul 13, 2015

Jul NEWA

GEMFIBROZIL
TABLET;ORAL
GEMFIBROZIL
AUROBINDO PHARMA LTD

600MG

A 202726

001 Sep 16, 2015

Aug NEWA

EQ 320MG BASE

N 021158

001 Apr 04, 2003

Jun CFTG

EQ 320MG BASE

A 090466

001 Jun 15, 2015

Jun NEWA

20MG/ML

N 020622

002 Feb 12, 2002

Mar CFTG

20MG/ML

A 090218

001 Apr 16, 2015

Mar NEWA

GEMIFLOXACIN MESYLATE
TABLET;ORAL
FACTIVE
+
LG LIFE SCIENCES
GEMIFLOXACIN MESYLATE
ORCHID HLTHCARE
GLATIRAMER ACETATE
INJECTABLE;SUBCUTANEOUS
COPAXONE
+
TEVA PHARMS USA
GLATOPA
SANDOZ INC

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT

2015

A 078952
A 078952
A 078952

001 Aug 01, 2013


002 Aug 01, 2013
003 Aug 01, 2013

Apr DISC
Apr DISC
Apr DISC

A 074387
A 074497
A 074387
A 074497
A 074497
A 074497

001
001
002
002
001
002

Aug
Oct
Aug
Oct
Oct
Oct

A 202298
A 202298
A 202298

001 May 19, 2015


002 May 19, 2015
003 May 19, 2015

May NEWA
May NEWA
May NEWA

N 201849

001 May 08, 2015

May NEWA

1.25MG
2.5MG
5MG

N 017532
N 017532
N 017532

001 May 01, 1984


002 May 01, 1984
003 May 01, 1984

Sep CFTG
Sep CFTG
Sep CFTG

1.25MG
2.5MG
5MG
1.25MG
1.25MG
2.5MG
2.5MG
5MG
5MG
1.25MG
2.5MG
5MG
1.25MG
2.5MG
5MG

A 077537
A 077537
A 077537
A 076257
A 206079
A 076257
A 206079
A 076257
A 206079
A 090937
A 090937
A 090937
A 074388
A 074388
A 074388

001
002
003
001
001
002
002
003
003
001
002
003
001
002
003

Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep

GLYBURIDE; METFORMIN HYDROCHLORIDE


TABLET;ORAL
GLUCOVANCE
BRISTOL MYERS SQUIBB 1.25MG;250MG
@
1.25MG;250MG

N 021178
N 021178

001 Jul 31, 2000


001 Jul 31, 2000

Oct DISC
Oct DISC

GLYCEROL PHENYLBUTYRATE
LIQUID;ORAL
RAVICTI
+
HORIZON THERAPS INC

1.1GM/ML

N 203284

001 Feb 01, 2013

May CAHN

0.2MG/ML

N 017558

001

Jun CAHN

15.6MCG/INH

N 207923

001 Oct 29, 2015

Oct NEWA

1MG

A 040844

001 Aug 18, 2009

Apr CAHN

1MG
2MG
4MG

GLIPIZIDE
TABLET;ORAL
GLIPIZIDE
@ ANI PHARMS INC
>A> AB
>A> AB
>D> AB
>D> AB

AB
AB
AB

5MG
5MG
@
10MG
10MG
IVAX SUB TEVA PHARMS
5MG
10MG
TABLET, EXTENDED RELEASE;ORAL
GLIPIZIDE
MYLAN PHARMS INC
2.5MG
5MG
10MG

GLUCAGON HYDROCHLORIDE
POWDER;INTRAMUSCULAR, INTRAVENOUS
GLUCAGON
+
FRESENIUS KABI USA
EQ 1MG BASE/VIAL
GLYBURIDE
TABLET;ORAL
DIABETA
AB2
SANOFI AVENTIS US
AB2
AB2
+
GLYBURIDE
AB1
AUROBINDO PHARMA
AB1
AB1
AB1
COREPHARMA
AB2
AB1
AB2
AB1
AB2
AB1
HERITAGE PHARMS INC
AB1
AB1
AB1
TEVA
AB1
AB1
+

>D> AB
>A>

AP
>A>
>A>
>A>

AA

GLYCOPYRROLATE
INJECTABLE;INJECTION
ROBINUL
+
EUROHLTH INTL SARL
POWDER;INHALATION
SEEBRI
+
NOVARTIS PHARMS CORP
TABLET;ORAL
GLYCOPYRROLATE
SUN PHARM INDS LTD

1 -44

October

GLIMEPIRIDE
TABLET;ORAL
GLIMEPIRIDE
@ HIKMA PHARMS
@
@

10

Mar
Aug
Mar
Aug
Aug
Aug

Oct
Oct
Oct
Jun
Sep
Jun
Sep
Jun
Sep
Feb
Feb
Feb
Aug
Aug
Aug

04,
31,
04,
31,
31,
31,

18,
18,
18,
27,
30,
27,
30,
27,
30,
28,
28,
28,
29,
29,
29,

1996
1995
1996
1995
1995
1995

2007
2007
2007
2002
2015
2002
2015
2002
2015
2011
2011
2011
1995
1995
1995

CAHN
CAHN
CAHN
CAHN
CAHN
CAHN

CTEC
CTEC
CTEC
CTEC
NEWA
CTEC
NEWA
CTEC
NEWA
CTEC
CTEC
CTEC
CTEC
CTEC
CTEC

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT

10

1 -45

October
2015

TABLET;ORAL

GLYCOPYRROLATE

AA
>A>
>A>
>A>
>A>

2MG
GLYCOPYRROLATE ; INDACATEROL MALEATE

POWDER;INHALATION

UTIBRON

+
NOVARTIS PHARMS CORP
15.6MCG/INH;27.5MCG/INH

AP
AP

AP
AP

GRANISETRON HYDROCHLORIDE

INJECTABLE;INJECTION

GRANISETRON HYDROCHLORIDE

BANNER LIFE SCIENCES
EQ 0.1MG BASE/ML (EQ 0.1MG
BASE/ML)

EQ 4MG BASE/4ML (EQ 1MG BASE/ML)


@ CLARIS PHARMASERVICE
EQ 1MG BASE/ML (EQ 1MG BASE/ML)
@
EQ 4MG BASE/4ML (EQ 1MG BASE/ML)
EUROHLTH INTL SARL
EQ 4MG BASE/4ML (EQ 1MG BASE/ML)
GRANISETRON HYDROCHLORIDE PRESERVATIVE FREE

BANNER LIFE SCIENCES
EQ 1MG BASE/ML (EQ 1MG BASE/ML)

AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB

Apr CAHN

N 207930
001 Oct 29, 2015

Oct NEWA

A 078863
001 Jun 30, 2008

Jan CAHN

A 078880

A 078198

A 078198

A 077177

Jan
Apr
Apr
Jun

001
001
002
001

Jun
Jun
Jun
Dec

30,
30,
30,
31,

2008

2008

2008

2007

CAHN

CAHN

CAHN

CAHN

A 078863
002 Jun 30, 2008

Jan CAHN

N 022424
001 May 14, 2015

N 022424
001 May 14, 2015

May NEWA

Sep CAHN

GUAIFENESIN; HYDROCODONE BITARTRATE; PSEUDOEPHEDRINE HYDROCHLORIDE



SOLUTION;ORAL

HYCOFENIX

+
MIKART INC
200MG/5ML;2.5MG/5ML;30MG/5ML
N 022279
001 May 14, 2015

May NEWA

GUANFACINE HYDROCHLORIDE

TABLET, EXTENDED RELEASE;ORAL

GUANFACINE HYDROCHLORIDE

IMPAX LABS INC
EQ 1MG
EQ 2MG
EQ 3MG
EQ 4MG
MYLAN PHARMS INC
EQ 1MG
EQ 2MG
EQ 3MG
EQ 4MG
SANDOZ INC
EQ 1MG
EQ 2MG
EQ 3MG
EQ 4MG
TEVA PHARMS USA
EQ 1MG
EQ 2MG
EQ 3MG
EQ 4MG
TWI PHARMS INC
EQ 1MG
EQ 2MG
EQ 3MG
EQ 4MG

GUAIFENESIN; HYDROCODONE BITARTRATE



SOLUTION;ORAL

FLOWTUSS

MIKART INC
200MG/5ML;2.5MG/5ML
MISSION PHARMACAL CO
200MG/5ML;2.5MG/5ML

>A>
>A>
>A>
>A>

A 040844
002 Aug 18, 2009

BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE

A 202238

A 202238

A 202238

A 202238

A 202578

A 202578

A 202578

A 202578

A 202568

A 202568

A 202568

A 202568

A 201382

A 201382

A 201382

A 201382

A 201408

A 201408

A 201408

A 201408

001
002
003
004
001
002
003
004
001
002
003
004
001
002
003
004
001
002
003
004

Oct
Oct
Oct
Oct
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun

20,
20,
20,
20,
02,
02,
02,
02,
03,
03,
03,
03,
02,
02,
02,
02,
02,
02,
02,
02,

2015

2015

2015

2015

2015

2015

2015

2015

2015

2015

2015

2015

2015

2015

2015

2015

2015

2015

2015

2015

Oct
Oct
Oct
Oct
May
May
May
May
May
May
May
May
May
May
May
May
May
May
May
May

NEWA

NEWA

NEWA

NEWA

NEWA

NEWA

NEWA

NEWA

NEWA

NEWA

NEWA

NEWA

NEWA

NEWA

NEWA

NEWA

NEWA

NEWA

NEWA

NEWA

001
001
001
001
001
001

Feb
Feb
Feb
May
May
Feb

17,
17,
17,
12,
12,
17,

1987

1987

1987

1987

1987

1987

May
Jun
Jun
Jun
May
Jun

CAHN

CAHN

CAHN

CAHN

CAHN

CAHN

HALOPERIDOL

TABLET;ORAL

HALOPERIDOL

@ CYCLE PHARMS LTD
@
@
@
@
@ ROXANE

0.5MG
1MG
5MG
10MG
20MG
2MG

A 071128

A 071129

A 071131

A 071132

A 071133

A 071130

HALOPERIDOL LACTATE

CONCENTRATE;ORAL

HALOPERIDOL INTENSOL

@ CYCLE PHARMS LTD

EQ 2MG BASE/ML

A 072045
001 Apr 12, 1988

May CAHN

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT

INJECTABLE;INJECTION
HALOPERIDOL
@ CLARIS PHARMASERVICE
@

AP

AP

AP

AP
AP
AP

AB

AB
AB
AB
AB
AB
AB

HEPARIN SODIUM
INJECTABLE;INJECTION
HEPARIN SODIUM
@ EUROHLTH INTL SARL
+
@
@
@
+
@
@
@
+
@
@

HYDROCHLOROTHIAZIDE
CAPSULE;ORAL
HYDROCHLOROTHIAZIDE
@ SUN PHARM INDS INC
MICROZIDE
+
ACTAVIS LABS UT INC

2015

EQ 5MG BASE/ML
EQ 5MG BASE/ML

A 076791
A 076828

001 Aug 25, 2004


001 Aug 25, 2004

Apr CAHN
May CAHN

1,000 UNITS/ML
1,000 UNITS/ML
2,500 UNITS/ML
5,000 UNITS/ML
5,000 UNITS/0.5ML
5,000 UNITS/ML
5,000 UNITS/0.5ML
7,500 UNITS/ML
10,000 UNITS/ML
10,000 UNITS/ML
15,000 UNITS/ML
20,000 UNITS/ML

N 017007
N 017037
N 017007
N 017007
N 017007
N 017037
N 017037
N 017007
N 017007
N 017037
N 017007
N 017007

001
001
007
002
010
002
013 Apr 07, 1986
003
004
003
005
006

Aug
Jun
Aug
Aug
Aug
Jun
Jun
Aug
Aug
Jun
Aug
Aug

A 040730
A 040136
A 203110

001 Apr 21, 2009


001 Jun 30, 1997
001 Jun 29, 2015

Feb CRLD
Feb CRLD
Jun NEWA

A 040858
A 040858
A 040858
A 040858

001
002
003
004

Sep
Sep
Sep
Sep

12.5MG

A 090651

001 Apr 07, 2014

Aug DISC

12.5MG

N 020504

001 Dec 27, 1996

Feb CAHN

A 076007
A 076007
A 076007

001 Jul 01, 2002


002 Jul 01, 2002
003 Jul 01, 2002

Apr CAHN
Apr CAHN
Apr CAHN

N 019888
N 019888
N 019888

003 Nov 18, 1993


001 Sep 20, 1990
002 Jul 20, 1989

Feb CAHN
Feb CAHN
Feb CAHN

N 021956
N 021956
N 021956

001 Aug 28, 2006


002 Aug 28, 2006
003 Aug 28, 2006

Jun CAHN
Jun CAHN
Jun CAHN

N 018031
N 018031

001
001

Oct DISC
Oct DISC

A 070704
A 072042
A 070705
A 072043
A 070947
A 070947

001
001
001
001
002
002

HYDROCHLOROTHIAZIDE; LISINOPRIL
TABLET;ORAL
LISINOPRIL AND HYDROCHLOROTHIAZIDE
SUN PHARM INDS LTD
12.5MG;10MG
12.5MG;20MG
25MG;20MG
ZESTORETIC
ALVOGEN IPCO SARL
12.5MG;10MG
+
12.5MG;20MG
+
25MG;20MG
HYDROCHLOROTHIAZIDE; METOPROLOL SUCCINATE
TABLET, EXTENDED RELEASE;ORAL
DUTOPROL
CONCORDIA PHARMS INC 12.5MG;EQ 25MG TARTRATE
12.5MG;EQ 50MG TARTRATE
+
12.5MG;EQ 100MG TARTRATE

>D>
>D> AB
>A>

AB
AB
>D> AB
>A> AB

HYDROCHLOROTHIAZIDE; PROPRANOLOL HYDROCHLORIDE


TABLET;ORAL
INDERIDE-40/25
+
WYETH PHARMS INC
25MG;40MG
@
25MG;40MG
PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
@ ANI PHARMS INC
25MG;40MG
25MG;40MG
@
25MG;80MG
25MG;80MG
MYLAN
25MG;40MG
+
25MG;40MG

1 -46

October

HYDRALAZINE HYDROCHLORIDE
INJECTABLE;INJECTION
HYDRALAZINE HYDROCHLORIDE
+
AKORN
20MG/ML
LUITPOLD
20MG/ML
X-GEN PHARMS INC
20MG/ML
TABLET;ORAL
HYDRALAZINE HYDROCHLORIDE
@ HERITAGE PHARMS INC
10MG
@
25MG
@
50MG
@
100MG

10

Feb
Feb
Feb
Feb

Oct
Mar
Oct
Mar
Mar
Mar

26,
26,
26,
26,

01,
14,
01,
14,
04,
04,

2010
2010
2010
2010

1986
1988
1986
1988
1987
1987

Jul
Aug
Jul
Aug
Oct
Oct

CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN

CAHN
CAHN
CAHN
CAHN

CAHN
CAHN
CAHN
CAHN
CRLD
CRLD

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT

2015

HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE


TABLET;ORAL
QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
SUN PHARM INDS LTD
12.5MG;EQ 10MG BASE
12.5MG;EQ 20MG BASE
25MG;EQ 20MG BASE

A 078211
A 078211
A 078211

001 Mar 04, 2009


002 Mar 04, 2009
003 Mar 04, 2009

Apr CAHN
Apr CAHN
Apr CAHN

>A> AB
>A> AB
>A> AB

HYDROCHLOROTHIAZIDE; TELMISARTAN
TABLET;ORAL
TELMISARTAN AND HYDROCHLOROTHIAZIDE
MACLEODS PHARMS LTD
12.5MG;40MG
12.5MG;80MG
25MG;80MG

A 204169
A 204169
A 204169

001 Nov 02, 2015


002 Nov 02, 2015
003 Nov 02, 2015

Oct NEWA
Oct NEWA
Oct NEWA

A 074970

001 Jan 06, 1998

Aug CAHN

AB

HYDROCHLOROTHIAZIDE; TRIAMTERENE
CAPSULE;ORAL
TRIAMTERENE AND HYDROCHLOROTHIAZIDE
@ ANI PHARMS INC
25MG;37.5MG
TABLET;ORAL
TRIAMTERENE AND HYDROCHLOROTHIAZIDE
ANI PHARMS INC
50MG;75MG

A 073467

001 Jan 31, 1996

Aug CAHN

HYDROCODONE BITARTRATE
CAPSULE, EXTENDED RELEASE;ORAL
ZOHYDRO ER
+
FERRIMILL LTD
10MG
15MG
20MG
30MG
40MG
50MG
+
PERNIX IRELAND PAIN
10MG
15MG
20MG
30MG
40MG
50MG
TABLET, EXTENDED RELEASE;ORAL
HYSINGLA
+
PURDUE PHARMA LP
20MG

N 202880
N 202880
N 202880
N 202880
N 202880
N 202880
N 202880
N 202880
N 202880
N 202880
N 202880
N 202880

001
002
003
004
005
006
001
002
003
004
005
006

Apr
Apr
Apr
Apr
Apr
Apr
Jun
Jun
Jun
Jun
Jun
Jun

N 206627

001 Nov 20, 2014

Mar CRLD

A 040879

001 Aug 20, 2010

Mar CAHN

A 085982

001

Apr DISC

A 083365
A 083365
A 083365

002 Feb 23, 2015


003 Feb 23, 2015
001

Feb NEWA
Feb NEWA
Feb CMFD

HYDROCORTISONE ACETATE
POWDER;FOR RX COMPOUNDING
HYDROCORTISONE ACETATE
@ X GEN PHARMS
100%

A 085981

001

Apr DISC

HYDROCORTISONE VALERATE
CREAM;TOPICAL
HYDROCORTISONE VALERATE
@ G AND W LABS INC
0.2%

A 074489

001 Aug 12, 1998

Apr CAHN

N 060613

001

Jun CMS2

AT

AB
AB
AB

AT

HYDROCORTISONE
CREAM;TOPICAL
HYDROCORTISONE
RISING PHARMS INC
2.5%
POWDER;FOR RX COMPOUNDING
HYDRO-RX
@ X GEN PHARMS
100%
TABLET;ORAL
HYDROCORTISONE
HIKMA INTL PHARMS
5MG
10MG
20MG

HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE



SUSPENSION/DROPS;OTIC

CORTISPORIN

+
CITRON PHARMA LLC
1%;EQ 3.5MG BASE/ML;10,000
UNITS/ML

1 -47

October

AB
AB
AB

10

Oct
Oct
Oct
Oct
Oct
Oct
Oct
Oct
Oct
Oct
Oct
Oct

25,
25,
25,
25,
25,
25,
25,
25,
25,
25,
25,
25,

2013
2013
2013
2013
2013
2013
2013
2013
2013
2013
2013
2013

CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT

>D>
>A>

AB
AB
AB

AB

AB
AB
AB
AB
AB
AB
AB
AB
AB

AB
AB

>A> AP
AP

AB
AB
AB

HYDROMORPHONE HYDROCHLORIDE
INJECTABLE;INJECTION
DILAUDID-HP
+
PURDUE PHARM PRODS
250MG/VIAL
@
250MG/VIAL
TABLET, EXTENDED RELEASE;ORAL
HYDROMORPHONE HYDROCHLORIDE
PADDOCK LLC
8MG
12MG
16MG

10

1 -48

October

2015

N 019034
N 019034

002 Aug 04, 1994


002 Aug 04, 1994

Oct DISC
Oct DISC

A 204278
A 204278
A 204278

001 Apr 06, 2015


002 Apr 06, 2015
003 Apr 06, 2015

Mar NEWA
Mar NEWA
Mar NEWA

HYDROXOCOBALAMIN
INJECTABLE;INJECTION
CYANOKIT
@ SERB SAS
+

2.5GM/VIAL (5GM/KIT)
5GM/VIAL (5GM/KIT)

N 022041
N 022041

002 Dec 15, 2006


001 Apr 08, 2011

Apr CAHN
Apr CAHN

HYDROXYCHLOROQUINE SULFATE
TABLET;ORAL
PLAQUENIL
+
CONCORDIA PHARMS INC

200MG

N 009768

001

Jun CAHN

HYDROXYPROGESTERONE CAPROATE
INJECTABLE;INJECTION
HYDROXYPROGESTERONE CAPROATE
@ ACTAVIS LABS UT INC
125MG/ML
@
250MG/ML
+
MCGUFF
250MG/ML

N 017439
N 017439
A 200271

001
002
001 Aug 24, 2015

Mar CAHN
Mar CAHN
Aug NEWA

HYDROXYZINE HYDROCHLORIDE
TABLET;ORAL
HYDROXYZINE HYDROCHLORIDE
ELITE LABS INC
10MG
25MG
50MG
HERITAGE PHARMA
10MG
25MG
50MG
MIKAH PHARMA
10MG
25MG
50MG
@ MUTUAL PHARM
10MG
@
25MG
@
50MG
@ WATSON LABS
10MG
@
25MG
@
50MG

A 040600
A 040602
A 040604
A 204279
A 204279
A 204279
A 040600
A 040602
A 040604
A 089381
A 089382
A 089383
A 088348
A 088349
A 088350

001
001
001
001
002
003
001
001
001
001
001
001
001
001
001

Jun
Jun
Jun
Mar
Mar
Mar
Mar
Mar
Mar
Jul
Jul
Jul
Jul
Jul
Jul

EQ 25MG HYDROCHLORIDE
EQ 50MG HYDROCHLORIDE

A 201507
A 201507

001 Jun 03, 2013


002 Jun 03, 2013

Mar CAHN
Mar CAHN

EQ 3MG BASE/3ML
EQ 3MG BASE/3ML

A 204222
A 205332

001 Oct 16, 2015


001 Aug 19, 2015

Oct NEWA
Aug NEWA

400MG
600MG
800MG
300MG
400MG
600MG
800MG

A 091625
A 091625
A 091625
A 071230
A 071231
A 071232
A 072004

001
002
003
001
001
001
001

Aug
Aug
Aug
Jul
Jul
Jul
Jul

HYDROXYZINE PAMOATE
CAPSULE;ORAL
HYDROXYZINE PAMOATE
HERITAGE PHARMA

IBANDRONATE SODIUM
INJECTABLE;INTRAVENOUS
IBANDRONATE SODIUM
APOTEX INC
AUROBINDO PHARMA LTD
IBUPROFEN
TABLET;ORAL
IBUPROFEN
GRANULES INDIA LTD

@ VINTAGE PHARMS
@
@
@

Dec
Dec
Dec
Aug
Aug
Aug
Dec
Dec
Dec
May
May
May
Sep
Sep
Sep

Sep
Sep
Sep
Oct
Oct
Oct
Nov

28,
28,
28,
20,
20,
20,
28,
28,
28,
19,
19,
19,
15,
15,
15,

15,
15,
15,
22,
22,
22,
18,

2004
2004
2004
2014
2014
2014
2004
2004
2004
1986
1986
1986
1983
1983
1983

2015
2015
2015
1986
1986
1986
1987

CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CMFD
CMFD
CMFD
DISC
DISC
DISC
DISC
DISC
DISC

NEWA
NEWA
NEWA
DISC
DISC
DISC
DISC

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT

2015

1MG
2MG
4MG
6MG
8MG
10MG
12MG

N 022192
N 022192
N 022192
N 022192
N 022192
N 022192
N 022192

001
002
003
004
005
006
007

AB

5%

A 200481

001 Apr 18, 2011

Apr CAHN

AB

1.25MG
1.25MG
2.5MG
2.5MG

A 074299
A 074498
A 074299
A 074498

002
002
001
001

Jul
Jul
Jul
Jul

INDOMETHACIN
CAPSULE, EXTENDED RELEASE;ORAL
INDOMETHACIN
JUBILANT GENERICS
75MG

A 202706

001 Oct 05, 2015

Sep NEWA

INGENOL MEBUTATE
GEL;TOPICAL
PICATO
+
LEO PHARMA AS

0.015%

N 202833

001 Jan 23, 2012

May CRLD

INSULIN DEGLUDEC
SOLUTION;SUBCUTANEOUS
TRESIBA
NOVO NORDISK INC
+

300 UNITS/3ML (100 UNITS/ML)


600 UNITS/3ML (200 UNITS/ML)

N 203314
N 203314

001 Sep 25, 2015


002 Sep 25, 2015

Sep NEWA
Sep NEWA

INSULIN GLARGINE RECOMBINANT


SOLUTION;SUBCUTANEOUS
TOUJEO SOLOSTAR
+
SANOFI US SERVICES
300 UNITS/ML (300 UNITS/ML)

N 206538

001 Feb 25, 2015

Feb NEWA

INSULIN LISPRO RECOMBINANT


SOLUTION;SUBCUTANEOUS
HUMALOG KWIKPEN
+
ELI LILLY AND CO

200 UNITS/ML

N 205747

001 May 26, 2015

May NEWA

INSULIN RECOMBINANT HUMAN


POWDER;INHALATION
AFREZZA
SANOFI AVENTIS

12 UNITS/INH

N 022472

003 Apr 17, 2015

Apr NEWA

IOHEXOL
FOR SOLUTION;ORAL
ORALTAG
INTERPHARMA PRAHA AS

9.7GM/BOT

N 205383

001 Mar 26, 2015

Mar NEWA

51%

A 074679

001 Apr 02, 1997

Jan DISC

61%

A 074679

002 Apr 02, 1997

Jan DISC

76%

A 074679

003 Apr 02, 1997

Jan DISC

41%

N 018735

006 Jul 07, 1987

Feb CTEC

IMIQUIMOD
CREAM;TOPICAL
IMIQUIMOD
G AND W LABS INC
INDAPAMIDE
TABLET;ORAL
INDAPAMIDE
ANI PHARMS INC
@

AB
@

AB

IOPAMIDOL
INJECTABLE;INJECTION
IOPAMIDOL-250
@ FRESENIUS KABI USA
IOPAMIDOL-300
@ FRESENIUS KABI USA
IOPAMIDOL-370
@ FRESENIUS KABI USA
ISOVUE-200
+
BRACCO

1 -49

October

ILOPERIDONE
TABLET;ORAL
FANAPT
+
VANDA PHARMS INC

10

May
May
May
May
May
May
May

Apr
Feb
Jul
Oct

06,
06,
06,
06,
06,
06,
06,

29,
12,
27,
31,

2009
2009
2009
2009
2009
2009
2009

1996
1998
1995
1996

Jan
Jan
Jan
Jan
Jan
Jan
Jan

CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN

CAHN
CAHN
CAHN
CAHN

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT

AP
AP

INJECTABLE;INJECTION
ISOVUE-250
+
BRACCO
+
ISOVUE-300
+
BRACCO
ISOVUE-370
+
BRACCO
SCANLUX-300
MYLAN INSTITUTIONAL
SCANLUX-370
MYLAN INSTITUTIONAL
IOTHALAMATE MEGLUMINE
INJECTABLE;INJECTION
CONRAY
+
LIEBEL-FLARSHEIM
CONRAY 30
+
LIEBEL-FLARSHEIM
CONRAY 43
+
LIEBEL-FLARSHEIM
SOLUTION;INTRAVESICAL
CYSTO-CONRAY II
LIEBEL-FLARSHEIM
IOVERSOL
INJECTABLE;INJECTION
OPTIRAY 160
@ LIEBEL-FLARSHEIM
OPTIRAY 240
+
LIEBEL-FLARSHEIM
@
OPTIRAY 300
+
LIEBEL-FLARSHEIM
+
OPTIRAY 320
+
LIEBEL-FLARSHEIM
@
+
@
OPTIRAY 350
+
LIEBEL-FLARSHEIM
+

>D>
>A>

AB
AB
AB

IRBESARTAN
TABLET;ORAL
IRBESARTAN
JUBILANT GENERICS

2015

51%
51%

N 018735
N 020327

007 Jul 06, 1992


002 Oct 12, 1994

Feb CTEC
Feb CTEC

61%

N 020327

003 Oct 12, 1994

Feb CTEC

76%

N 020327

004 Oct 12, 1994

Feb CTEC

61%

A 090394

001 Jun 18, 2010

Aug CAHN

76%

A 090394

002 Jun 18, 2010

Aug CAHN

60%

N 013295

001

Feb CAHN

30%

N 016983

001

Feb CAHN

43%

N 013295

002

Feb CAHN

17.2%

N 017057

002

Feb CAHN

34%

N 019710

003 Dec 30, 1988

Feb CAHN

51%
51%

N 019710
N 020923

002 Dec 30, 1988


001 May 28, 1998

Feb CAHN
Feb CAHN

64%
64%

N 019710
N 020923

004 Jan 22, 1992


004 May 13, 1999

Feb CAHN
Feb CAHN

68%
68%
68%
68%

N 019710
N 020923
N 020923
N 020923

001
002
002
002

Feb
Oct
Oct
Feb

74%
74%

N 019710
N 020923

005 Jan 22, 1992


003 May 28, 1998

Feb CAHN
Feb CAHN

N 018905

002 Jul 26, 1985

May DISC

A 203534
A 203534
A 203534

001 Feb 23, 2015


002 Feb 23, 2015
003 Feb 23, 2015

Feb NEWA
Feb NEWA
Feb NEWA

N 207793

001 Oct 22, 2015

Oct NEWA

N 017441

001

Mar CAHN

75MG
150MG
300MG

IRINOTECAN HYDROCHLORIDE
INJECTABLE, LIPOSOMAL;IV (INFUSION)
ONIVYDE
+
MERRIMACK PHARMS
EQ 43MG BASE/10ML (EQ 4.3MG
BASE/ML)

>A>
>A>

BP

IRON DEXTRAN
INJECTABLE;INJECTION
INFED
+
ACTAVIS LABS UT INC

EQ 50MG IRON/ML

1 -50

October

IOXAGLATE MEGLUMINE; IOXAGLATE SODIUM


INJECTABLE;INJECTION
HEXABRIX
@ GUERBET
39.3%;19.6%

10

Dec
May
May
May

30,
29,
29,
29,

1988
1998
1998
1998

CAHN
CMFD
CMFD
CAHN

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT

2015

186MG

N 207500

001 Mar 06, 2015

Mar NEWA

372MG

N 207501

001 Mar 06, 2015

Mar NEWA

AB

5MG
40MG

N 012093
N 012093

007 Jul 29, 1988


001 Jul 29, 1988

Feb CAHN
Feb CAHN

25MG
35MG

N 021951
N 021951

005 Aug 15, 2014


006 Aug 15, 2014

Feb NEWA
Feb NEWA

30MG

A 076485

004 Aug 25, 2015

Aug NEWA

10MG
20MG
30MG
40MG

A 076041
A 076041
A 076503
A 076041

001
002
001
003

Apr
Apr
Apr
Apr

30MG

A 202099

004 Feb 23, 2015

Feb NEWA

2.5MG
5MG

A 077169
A 077169

001 Apr 24, 2006


002 Apr 24, 2006

Mar CAHN
Mar CAHN

10MG/ML

A 205573

001 Oct 30, 2015

Oct NEWA

10MG/ML
10MG/ML

N 020657
N 020657

001 Feb 21, 1997


001 Feb 21, 1997

Oct CFTG
Oct CFTG

IVABRADINE HYDROCHLORIDE
TABLET;ORAL
CORLANOR
AMGEN INC
+

EQ 5MG BASE
EQ 7.5MG BASE

N 206143
N 206143

001 Apr 15, 2015


002 Apr 15, 2015

Apr NEWA
Apr NEWA

IVACAFTOR
GRANULE;ORAL
KALYDECO
VERTEX PHARMS INC
+

50MG/PACKET
75MG/PACKET

N 207925
N 207925

001 Mar 17, 2015


002 Mar 17, 2015

Mar NEWA
Mar NEWA

IVACAFTOR; LUMACAFTOR
TABLET;ORAL
ORKAMBI
+
VERTEX PHARMS INC

125MG;200MG

N 206038

001 Jul 02, 2015

Jul NEWA

IXABEPILONE
INJECTABLE;IV (INFUSION)
IXEMPRA KIT
+
R-PHARM US LLC
+

15MG/VIAL
45MG/VIAL

N 022065
N 022065

001 Oct 16, 2007


002 Oct 16, 2007

Jun CAHN
Jun CAHN

ISOSORBIDE DINITRATE
TABLET;ORAL
ISORDIL
VALEANT PHARMS NORTH
+
ISOTRETINOIN
CAPSULE;ORAL
ABSORICA
RANBAXY

AB
AB
AB
AB
AB
AB

AB
AB

>A>
>A> AA
>D>
>A> AA

MYORISAN
DOUGLAS PHARMS
SOTRET
SUN PHARM INDS LTD

ZENATANE
DR REDDYS LABS LTD
ISRADIPINE
CAPSULE;ORAL
ISRADIPINE
ELITE LABS INC

ITRACONAZOLE
SOLUTION;ORAL
ITRACONAZOLE
AMNEAL PHARMS
SPORANOX
+
JANSSEN PHARMS
+

1 -51

October

ISAVUCONAZONIUM SULFATE
CAPSULE;ORAL
CRESEMBA
+
ASTELLAS
POWDER;IV (INFUSION)
CRESEMBA
+
ASTELLAS

10

Dec
Dec
Jun
Dec

24,
24,
20,
24,

2002
2002
2003
2002

CAHN
CAHN
CAHN
CAHN

October

2015

1 -52

EQ 75MG BASE/2ML
EQ 500MG BASE/2ML
EQ 1GM BASE/3ML

A 062324
A 062324
A 062324

001
002
003

Jun CAHN
Jun CAHN
Jun CAHN

15MG/ML
30MG/ML
15MG/ML
30MG/ML
15MG/ML
30MG/ML

A 203242
A 203242
A 075631
A 075631
A 075772
A 075772

001
002
002
001
001
002

15.75MG/SPRAY

N 022382

001 May 14, 2010

Jan CAHN

N 205388

001 May 30, 2014

Feb CPOT

A 076051

001 Jul 05, 2002

Apr CAHN

A 075215
A 075215
A 075215

001 Jul 29, 1999


002 Jul 29, 1999
003 Jul 29, 1999

Jan CMFD
Jan CMFD
Jan CMFD

A 203762

001 Mar 27, 2015

Mar NEWA

LAMIVUDINE; RALTEGRAVIR POTASSIUM


TABLET;ORAL
DUTREBIS
@ MERCK SHARP DOHME
150MG;EQ 300MG BASE
+
150MG;EQ 300MG BASE

N 206510
N 206510

001 Feb 06, 2015


001 Feb 06, 2015

Aug DISC
Feb NEWA

AB
AB
AB

LAMIVUDINE; ZIDOVUDINE
TABLET;ORAL
LAMIVUDINE AND ZIDOVUDINE
HETERO LABS LTD III
150MG;300MG
STRIDES ARCOLAB LTD
150MG;300MG
STRIDES PHARMA
150MG;300MG

A 079124
A 079128
A 079128

001 Sep 17, 2015


001 May 13, 2015
001 May 13, 2015

Aug NEWA
Apr NEWA
Aug CAHN

A 078134
A 078134
A 078134
A 078134

001
002
003
004

Apr
Apr
Apr
Apr

19,
19,
19,
19,

2011
2011
2011
2011

May
May
May
May

DISC
DISC
DISC
DISC

AB
AB
AB
AB

LAMOTRIGINE
TABLET;ORAL
LAMOTRIGINE
@ HIKMA PHARMS
25MG
@
100MG
@
150MG
@
200MG
TABLET, ORALLY DISINTEGRATING;ORAL
LAMOTRIGINE
PAR PHARM
25MG
50MG
100MG
200MG

A 204158
A 204158
A 204158
A 204158

001
002
003
004

Oct
Oct
Oct
Oct

27,
27,
27,
27,

2015
2015
2015
2015

Oct
Oct
Oct
Oct

NEWA
NEWA
NEWA
NEWA

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT

KANAMYCIN SULFATE
INJECTABLE;INJECTION
KANAMYCIN
@ EUROHLTH INTL SARL
@
@

AP
AP

KETOROLAC TROMETHAMINE
INJECTABLE;INJECTION
KETOROLAC TROMETHAMINE
BD RX
@ CLARIS PHARMASERVICE
@
@ EUROHLTH INTL SARL
@
SPRAY, METERED;NASAL
SPRIX
+
EGALET US INC

KETOROLAC TROMETHAMINE; PHENYLEPHRINE HYDROCHLORIDE


SOLUTION;IRRIGATION
OMIDRIA
+
OMEROS
EQ 4.24MG BASE/ML;EQ 12.4MG
BASE/ML

>A>
>A>
>A>
>A>

AB
AB
AB

LABETALOL HYDROCHLORIDE
INJECTABLE;INJECTION
LABETALOL HYDROCHLORIDE
@ CLARIS PHARMASERVICE 5MG/ML
TABLET;ORAL
LABETALOL HYDROCHLORIDE
MUTUAL PHARM
100MG
200MG
300MG

AA

LACTULOSE
SOLUTION;ORAL, RECTAL
LACTULOSE
BIO-PHARM INC

10GM/15ML

10

Oct
Oct
Jun
Jun
Jul
Jul

07,
07,
29,
29,
21,
21,

2015
2015
2001
2001
2004
2004

Sep
Sep
Apr
Apr
Jun
Jun

NEWA
NEWA
CAHN
CAHN
CAHN
CAHN

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT

AP

AA

AB
AB
AB
AB
AB
AB

AP
AP
AP
AP
AP
AP
AP
AP
AP

AT

AB
AB

October

2015

1 -53

LAPATINIB DITOSYLATE
TABLET;ORAL
TYKERB
+
NOVARTIS PHARMS CORP

EQ 250MG BASE

N 022059

001 Mar 13, 2007

Mar CAHN

LENVATINIB MESYLATE
CAPSULE;ORAL
LENVIMA
EISAI INC
+

EQ 4MG BASE
EQ 10MG BASE

N 206947
N 206947

001 Feb 13, 2015


002 Feb 13, 2015

Feb NEWA
Feb NEWA

500MG/5ML (100MG/ML)

A 090876

001 Aug 13, 2015

Jul NEWA

100MG/ML

A 201157

001 Jun 04, 2015

May NEWA

N 207958
N 207958
N 207958
N 207958

001
002
003
004

Jul
Jul
Jul
Jul

31,
31,
31,
31,

2015
2015
2015
2015

Jul
Jul
Jul
Jul

NEWA
NEWA
NEWA
NEWA

A 202958
A 202167
A 202167
A 201464
A 201464
A 203468
A 203468

001
001
002
001
002
001
002

Feb
Sep
Sep
May
May
May
May

25,
04,
04,
25,
25,
21,
21,

2015
2015
2015
2012
2012
2015
2015

Feb
Aug
Aug
Aug
Aug
May
May

NEWA
NEWA
NEWA
CAHN
CAHN
NEWA
NEWA

A 075881

001 Mar 29, 2001

Apr DISC

A 203027
A 201653

001 Feb 13, 2015


001 Jun 26, 2015

Feb NEWA
Jun NEWA

A 091436
A 078577
A 078577

001 Jun 05, 2013


001 Aug 12, 2015
002 Aug 12, 2015

Apr CAHN
Jul NEWA
Jul NEWA

A 091397
A 091397
A 091397
A 078579
A 078579
A 078579

001
002
003
001
002
003

Apr
Apr
Apr
Aug
Aug
Aug

A 077700

001 Dec 20, 2010

Jul CRLD

N 021199

001 Aug 18, 2000

Jul DISC

A 203613
A 203613

001 Jun 19, 2015


002 Jun 19, 2015

Jun NEWA
Jun NEWA

LEVETIRACETAM
INJECTABLE;IV (INFUSION)
LEVETIRACETAM
FRESENIUS KABI USA
SOLUTION;ORAL
LEVETIRACETAM
PHARM ASSOC
TABLET;ORAL
SPRITAM
APRECIA PHARMS CO

250MG
500MG
750MG
1GM
TABLET, EXTENDED RELEASE;ORAL
LEVETIRACETAM
APOTEX INC
1GM
DEXCEL PHARMA
500MG
750MG
PHARMADAX INC
500MG
750MG
PRINSTON INC
500MG
750MG

LEVOCARNITINE
INJECTABLE;INJECTION
LEVOCARNITINE
@ TEVA PHARMS USA

AB
AB

10

200MG/ML

LEVOCETIRIZINE DIHYDROCHLORIDE
TABLET;ORAL
LEVOCETIRIZINE DIHYDROCHLORIDE
APOTEX INC
5MG
SUN PHARM INDS LTD
5MG
LEVOFLOXACIN
INJECTABLE;INJECTION
LEVOFLOXACIN
CLARIS PHARMASERVICE
HOSPIRA INC

EQ 500MG/20ML (EQ 25MG/ML)


EQ 500MG/20ML (EQ 25MG/ML)
EQ 750MG/30ML (EQ 25MG/ML)
LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER
CLARIS PHARMASERVICE EQ 250MG/50ML (EQ 5MG/ML)
EQ 500MG/100ML (EQ 5MG/ML)
EQ 750MG/150ML (EQ 5MG/ML)
HOSPIRA INC
EQ 250MG/50ML (EQ 5MG/ML)
EQ 500MG/100ML (EQ 5MG/ML)
EQ 750MG/150ML (EQ 5MG/ML)
SOLUTION/DROPS;OPHTHALMIC
LEVOFLOXACIN
+
NEXUS PHARMS
0.5%
QUIXIN
@ SANTEN
0.5%
TABLET;ORAL
LEVOFLOXACIN
JUBILANT GENERICS
250MG
500MG

Aug
Aug
Aug
Sep
Sep
Sep

08,
08,
08,
03,
03,
03,

2013
2013
2013
2015
2015
2015

CAHN
CAHN
CAHN
NEWA
NEWA
NEWA

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT

>A> AP

2015

BASE/17.5ML (EQ 10MG

A 203576

001 Oct 20, 2015

Oct NEWA

BASE/25ML (EQ 10MG

A 203576

002 Oct 20, 2015

Oct NEWA

BASE/25ML (EQ 10MG

A 203563

002 Mar 09, 2015

Feb NEWA

BASE/17.5ML (EQ 10MG

A 203563

001 Mar 09, 2015

Oct CTEC

BASE/17.5ML (EQ 10MG

A 203563

001 Mar 09, 2015

Oct CTEC

BASE/17.5ML (EQ 10MG

A 203563

001 Mar 09, 2015

Feb NEWA

BASE/25ML (EQ 10MG

A 203563

002 Mar 09, 2015

Oct CTEC

BASE/25ML (EQ 10MG

A 203563

002 Mar 09, 2015

Oct CTEC

BASE/25ML (EQ 10MG

A 203563

002 Mar 09, 2015

Mar CRLD

LEVONORGESTREL
INTRAUTERINE DEVICE;INTRAUTERINE
LILETTA
MEDICINES360
52MG

N 206229

001 Feb 26, 2015

Feb NEWA

LEVORPHANOL TARTRATE
TABLET;ORAL
LEVORPHANOL TARTRATE
+
SENTYNL THERAPS INC

2MG

A 074278

001 Mar 31, 2000

Apr CAHN

5%
5%

A 206297
A 080210

001 Aug 07, 2015


001

Jul NEWA
Sep CAHN

5%
5%

A 200675
A 202346

001 Aug 23, 2012


001 Aug 07, 2015

Mar CAHN
Jul NEWA

A 080407
A 080407
A 091564

001
002
001 Aug 14, 2015

Mar CAHN
Mar CAHN
Aug NEWA

A 084625
A 084625

001
002

Feb CAHN
Feb CAHN

2%

A 080429

001

Jan CAHN

2%

A 081318

001 Apr 29, 1993

Apr CAHN

LIDOCAINE; PRILOCAINE
CREAM;TOPICAL
EMLA
+
ACTAVIS LABS UT INC

2.5%;2.5%

N 019941

001 Dec 30, 1992

Feb CAHN

LINACLOTIDE
CAPSULE;ORAL
LINZESS
FOREST LABS LLC
+

145MCG
290MCG

N 202811
N 202811

001 Aug 30, 2012


002 Aug 30, 2012

Mar CAHN
Mar CAHN

>A> AP
SANDOZ
>D>

SANDOZ INC

>A> AP

>D>

>A> AP

+
+

AT

AB
AB

AP

AB

LIDOCAINE
OINTMENT;TOPICAL
LIDOCAINE
AMNEAL PHARMS
@ BELMORA LLC
PATCH;TOPICAL
LIDOCAINE
ACTAVIS LABS UT INC
MYLAN TECHNOLOGIES
LIDOCAINE HYDROCHLORIDE
INJECTABLE;INJECTION
LIDOCAINE HYDROCHLORIDE
@ EUROHLTH INTL SARL
@
LUITPOLD
LIDOCAINE HYDROCHLORIDE
@ EUROHLTH INTL SARL
@
JELLY;TOPICAL
ANESTACON
@ BANNER LIFE SCIENCES
LIDOCAINE HYDROCHLORIDE
@ G AND W LABS INC

EQ 175MG
BASE/ML)
EQ 250MG
BASE/ML)
EQ 250MG
BASE/ML)
EQ 175MG
BASE/ML)
EQ 175MG
BASE/ML)
EQ 175MG
BASE/ML)
EQ 250MG
BASE/ML)
EQ 250MG
BASE/ML)
EQ 250MG
BASE/ML)

1%
2%
1%
PRESERVATIVE FREE
1%
2%

1 -54

October

LEVOLEUCOVORIN CALCIUM
SOLUTION;IV (INFUSION)
LEVOLEUCOVORIN CALCIUM
MYLAN TEORANTA

10

October

2015

1 -55

EQ 300MG BASE/ML

N 050317

001

May CFTG

EQ 300MG BASE/ML

A 201746

001 Jun 04, 2015

May NEWA

100MG/5ML

A 200068

001 Jun 03, 2015

May NEWA

100MG/5ML

N 021132

001 Apr 18, 2000

May CFTG

(2MG/ML)
(2MG/ML)
(2MG/ML)
(2MG/ML)
PLASTIC CONTAINER
(2MG/ML)

A 205442
A 200904
A 200904
A 200222

001
001
002
001

Jun
Jul
Jul
May

N 206473

001 Jun 18, 2015

Jun NEWA

(2MG/ML)
(2MG/ML)
(2MG/ML)
(2MG/ML)

N 021131
N 021131
N 021131
N 021131

001
001
002
003

Jul
May
May
May

A 078061

001 May 18, 2015

May NEWA

N 021130

002 Apr 18, 2000

May CFTG

2.5MG
5MG
10MG
20MG
30MG
40MG

A 075944
A 075944
A 075944
A 075944
A 075944
A 075944

001
002
003
004
006
005

Jul
Jul
Jul
Jul
Feb
Jul

01,
01,
01,
01,
11,
01,

2002
2002
2002
2002
2003
2002

Apr
Apr
Apr
Apr
Apr
Apr

CAHN

CAHN

CAHN

CAHN

CAHN

CAHN

2.5MG
5MG
10MG
20MG
30MG
40MG

N 019777
N 019777
N 019777
N 019777
N 019777
N 019777

005
001
002
003
006
004

Apr
May
May
May
Jan
May

29,
19,
19,
19,
20,
19,

1993
1988
1988
1988
1999
1988

Feb
Feb
Feb
Feb
Feb
Feb

CAHN

CAHN

CAHN

CAHN

CAHN

CAHN

LITHIUM CARBONATE
TABLET, EXTENDED RELEASE;ORAL
LITHIUM CARBONATE
ALEMBIC PHARMS LTD
300MG
@ HIKMA INTL PHARMS
450MG
UNIQUE PHARM LABS
300MG

A 204445
A 076490
A 204779

001 Jun 10, 2015


001 Jun 17, 2003
001 Jul 27, 2015

May NEWA

Feb DISC

Jul NEWA

EQ 30MG BASE
EQ 40MG BASE
EQ 60MG BASE

N 203858
N 203858
N 203858

004 Apr 23, 2015


005 Apr 23, 2015
006 Apr 23, 2015

Apr NEWA

Apr NEWA

Apr NEWA

5MG

N 017588

004 Dec 19, 2014

Jan NEWA

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT

AP
AP

AB
AB

AP
AP
AP
AP

AP

AP

AB
AB

AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB

AB
AB

LINCOMYCIN HYDROCHLORIDE
INJECTABLE;INJECTION
LINCOCIN
+
PHARMACIA AND UPJOHN
LINCOMYCIN
X-GEN PHARMS INC
LINEZOLID
FOR SUSPENSION;ORAL
LINEZOLID
ROXANE
ZYVOX
+
PHARMACIA AND UPJOHN
SOLUTION;IV (INFUSION)
LINEZOLID
HOSPIRA INC
SANDOZ INC

600MG/300ML
200MG/100ML
600MG/300ML
TEVA PHARMS
600MG/300ML
LINEZOLID IN SODIUM CHLORIDE 0.9% IN
+
HOSPIRA INC
600MG/300ML
ZYVOX
PHARMACIA AND UPJOHN
200MG/100ML
200MG/100ML
400MG/200ML
+
600MG/300ML
TABLET;ORAL
LINEZOLID
TEVA PHARMS USA
600MG
ZYVOX
+
PHARMACIA AND UPJOHN
600MG

LISINOPRIL
TABLET;ORAL
LISINOPRIL
SUN PHARM INDS LTD

ZESTRIL
ALVOGEN IPCO SARL

LOMITAPIDE MESYLATE
CAPSULE;ORAL
JUXTAPID
AEGERION

LOMUSTINE
CAPSULE;ORAL
GLEOSTINE
CORDEN PHARMA

10

Jul
Jul
Jul
Jun

Apr
Apr
Apr
Apr

07,
16,
16,
27,

18,
18,
18,
18,

2015
2015
2015
2012

2000
2000
2000
2000

NEWA

NEWA

NEWA

CDFR

CTEC

CDFR

NEWA

NEWA

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT

AB

AP
AP

>A>
>A>
>A>
>D>
>D>
>D>

AB
AB
AB
AB
AB
AB
AB
AB
AB

AB
AB
AB
>A> AB
>A> AB
>A> AB
AB
AB
AB

October

2015

1 -56

LOPERAMIDE HYDROCHLORIDE
CAPSULE;ORAL
IMODIUM
@ J AND J CONSUMER INC
+

2MG
2MG

N 017690
N 017694

001
001

Jul CAHN
Jul CAHN

LOPINAVIR; RITONAVIR
CAPSULE;ORAL
KALETRA
@ ABBVIE

133.3MG;33.3MG

N 021226

001 Sep 15, 2000

Jun DISC

2MG/ML
4MG/ML

N 018140
N 018140

001
002

Jun CAHN
Jun CAHN

0.5MG
1MG
2MG
0.5MG
1MG
2MG
0.5MG
1MG
2MG

A 077396
A 077396
A 077396
A 077396
A 077396
A 077396
A 076045
A 076045
A 076045

001
002
003
001
002
003
001
002
003

Dec
Dec
Dec
Dec
Dec
Dec
Aug
Aug
Aug

13,
13,
13,
13,
13,
13,
29,
29,
29,

2006
2006
2006
2006
2006
2006
2001
2001
2001

Oct
Oct
Oct
Oct
Oct
Oct
Apr
Apr
Apr

CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN

25MG
50MG
100MG
25MG
50MG
100MG
25MG
50MG
100MG

A 203835
A 203835
A 203835
A 203030
A 203030
A 203030
A 091129
A 091129
A 091129

001
002
003
001
002
003
001
002
003

Aug
Aug
Aug
Oct
Oct
Oct
Oct
Oct
Oct

12,
12,
12,
14,
14,
14,
06,
06,
06,

2015
2015
2015
2015
2015
2015
2010
2010
2010

Jul
Jul
Jul
Oct
Oct
Oct
Feb
Feb
Feb

NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
CMFD
CMFD
CMFD

N 021316
N 021316
N 021316
N 021316

001
002
003
004

Jun
Jun
Jun
Jun

26,
26,
26,
26,

2002
2002
2002
2002

May
May
May
May

CAHN
CAHN
CAHN
CAHN

EQ 25MG BASE/ML

N 017658

001

Mar CAHN

EQ 50MG BASE/ML

N 018039

001

Mar CAHN

EQ
EQ
EQ
EQ

5MG BASE
10MG BASE
25MG BASE
50MG BASE

A 076868
A 076868
A 076868
A 076868

001
002
003
004

EQ
EQ
EQ
EQ

5MG BASE
10MG BASE
25MG BASE
50MG BASE

N 017525
N 017525
N 017525
N 017525

001
002
003
004

LORAZEPAM
INJECTABLE;INJECTION
ATIVAN
+
EUROHLTH INTL SARL
+
TABLET;ORAL
LORAZEPAM
ANI PHARMS INC

IVAX SUB TEVA PHARMS

SUN PHARM INDS LTD

LOSARTAN POTASSIUM
TABLET;ORAL
LOSARTAN POTASSIUM
HETERO LABS LTD V

UNICHEM LABS LTD

WATSON LABS

LOVASTATIN
TABLET, EXTENDED RELEASE;ORAL
ALTOPREV
@ COVIS PHARMA SARL
10MG
20MG
40MG
+
60MG
LOXAPINE HYDROCHLORIDE
CONCENTRATE;ORAL
LOXITANE C
@ ACTAVIS LABS UT INC
INJECTABLE;INJECTION
LOXITANE IM
@ ACTAVIS LABS UT INC

AB
AB
AB
AB

10

LOXAPINE SUCCINATE
CAPSULE;ORAL
LOXAPINE SUCCINATE
ELITE LABS INC

LOXITANE
@ ACTAVIS LABS UT INC
@
@
@

Aug
Aug
Aug
Aug

04,
04,
04,
04,

2005
2005
2005
2005

May
May
May
May

CAHN
CAHN
CAHN
CAHN

Mar
Mar
Mar
Mar

CAHN
CAHN
CAHN
CAHN

October

2015

1 -57

EQ 10MG BASE
EQ 25MG BASE
EQ 50MG BASE

N 017525
N 017525
N 017525

006

007

008

Mar CAHN

Mar CAHN

Mar CAHN

8.5ML

N 021746

001 Mar 06, 2012


May DISC

MAGNESIUM ACETATE TETRAHYDRATE; POTASSIUM ACETATE; SODIUM CHLORIDE



INJECTABLE;INJECTION

PLASMA-LYTE 56 IN PLASTIC CONTAINER

@ BAXTER HLTHCARE
32MG/100ML;128MG/100ML;234MG/100ML N 019047

001 Jun 15, 1984


Mar DISC

MAGNESIUM SULFATE

SOLUTION;INTRAMUSCULAR, INTRAVENOUS

MAGNESIUM SULFATE

EXELA PHARMA SCS LLC
5GM/10ML (500MG/ML)
+
FRESENIUS KABI USA
5GM/10ML (500MG/ML)
+
HOSPIRA
5GM/10ML (500MG/ML)
HOSPIRA INC
10GM/20ML (500MG/ML)

A 206039
N 019316
A 075151
A 202411

001
001
001
001

Apr
Apr
Apr
Apr

MAGNESIUM SULFATE

SOLUTION;INTRAMUSCULAR, INTRAVENOUS

MAGNESIUM SULFATE

+
FRESENIUS KABI USA
1GM/2ML (500MG/ML)

N 019316

002 Sep 08, 1986


RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT

TABLET;ORAL

LOXITANE

@ ACTAVIS LABS UT INC
@
@
LUCINACTANT

SUSPENSION;INTRATRACHEAL

SURFAXIN

@ DISCOVERY LABS

AP
AP
AP

10

Dec
Sep
Apr
May

18,
08,
25,
14,

2014

1986

2000

2015

MAGNESIUM SULFATE; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; POTASSIUM SULFATE; SODIUM

BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE



SOLUTION;ORAL

SUCLEAR

@ BRAINTREE LABS
1.6GM/BOT,3.13GM/BOT,17.5GM/BOT,N/ N 203595 001 Jan 18, 2013

A,N/A,N/A,N/A;N/A,N/A,N/A,210GM,0.

74GM,2.86GM,5.6GM

>A>
>A>
>A>
>A>

AA
AA
AA

CDFR

CPOT

CDFR

NEWA

Apr NEWA

Aug DISC

MANNITOL

INJECTABLE;INJECTION

MANNITOL 25%

@ IGI LABS INC
@

12.5GM/50ML
12.5GM/50ML

A 089239
A 089240

001 May 06, 1987



001 May 06, 1987

Mar CAHN

Mar CAHN

MECLIZINE HYDROCHLORIDE

TABLET;ORAL

MECLIZINE HYDROCHLORIDE

@ ANI PHARMS INC
@
@ VINTAGE PHARMS
@

12.5MG
25MG
12.5MG
25MG

A 084975
A 084657
A 040179
A 040179

001

001

001 Jan 30, 1997

002 Jan 30, 1997

Aug
Aug
Jun
Jun

MELOXICAM

CAPSULE;ORAL

VIVLODEX

IROKO PHARMS LLC
+

5MG
10MG

N 207233
N 207233

001 Oct 22, 2015



002 Oct 22, 2015

Oct NEWA

Oct NEWA

N 022525
N 022525
N 022525
N 022525

001
002
003
004

Mar
Mar
Mar
Mar

A 202790
A 204033

001 Oct 13, 2015



001 Oct 13, 2015

Sep NEWA

Sep NEWA

N 021627
N 021627

001 Apr 18, 2005



001 Apr 18, 2005

Sep CFTG

Mar CAHN

MEMANTINE HYDROCHLORIDE

CAPSULE, EXTENDED RELEASE;ORAL

NAMENDA XR

FOREST LABS LLC
7MG
14MG
21MG
+
28MG
SOLUTION;ORAL

MEMANTINE HYDROCHLORIDE

MACLEODS PHARMS LTD
2MG/ML
SILARX PHARMS INC
2MG/ML
NAMENDA

+
FOREST LABS LLC
2MG/ML
+
2MG/ML

Jun
Jun
Jun
Jun

21,
21,
21,
21,

2010

2010

2010

2010

CAHN

CAHN

DISC

DISC

CAHN

CAHN

CAHN

CAHN

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT

>D>
>D> AB
AB
>D> AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
>A> AB
>A> AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB

AP
AP
AP
AP

2015

A 090058
A 090058
A 090058
A 090058

001
001
002
002

May
May
May
May

05,
05,
05,
05,

2010
2010
2010
2010

Oct
Mar
Oct
Mar

CTNA
CMFD
CTNA
CMFD

A 200891
A 200891
A 090041
A 090041
A 203175
A 203175
A 090048
A 090048
A 091585
A 091585
A 090051
A 090051
A 202840
A 202840
A 079225
A 079225
A 079225
A 079225
A 079225
A 079225
A 090058
A 090058
A 090052
A 090052
A 200155
A 200155
A 200022
A 200022
A 090043
A 090043
A 090073
A 090073

001
002
001
002
001
002
001
002
001
002
001
002
001
002
001
001
001
002
002
002
001
002
001
002
001
002
001
002
001
002
001
002

Oct
Oct
Apr
Apr
Oct
Oct
Apr
Apr
Oct
Oct
Apr
Apr
Oct
Oct
Jan
Jan
Jan
Jan
Jan
Jan
May
May
Oct
Oct
Oct
Oct
Oct
Oct
Jul
Jul
Sep
Sep

13,
13,
10,
10,
13,
13,
14,
14,
13,
13,
10,
10,
13,
13,
30,
30,
30,
30,
30,
30,
05,
05,
25,
25,
13,
13,
13,
13,
31,
31,
04,
04,

2015
2015
2015
2015
2015
2015
2010
2010
2015
2015
2015
2015
2015
2015
2015
2015
2015
2015
2015
2015
2010
2010
2011
2011
2015
2015
2015
2015
2015
2015
2015
2015

Sep
Sep
Mar
Mar
Sep
Sep
Jun
Jun
Sep
Sep
Mar
Mar
Sep
Sep
Jun
Mar
Jan
Jun
Mar
Jan
Oct
Oct
May
May
Sep
Sep
Sep
Sep
Jul
Jul
Aug
Aug

NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
CMFD
CMFD
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
CMFD
DISC
NEWA
CMFD
DISC
NEWA
CTNA
CTNA
CMFD
CMFD
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA

N 021487
N 021487

001 Oct 16, 2003


002 Oct 16, 2003

Mar CAHN
Mar CAHN

MENOTROPINS (FSH;LH)
INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS
REPRONEX
@ FERRING
75 IU/VIAL;75 IU/VIAL

N 021047

001 Aug 27, 1999

May DISC

MEPERIDINE HYDROCHLORIDE
INJECTABLE;INJECTION
MEPERIDINE HYDROCHLORIDE
EUROHLTH INTL SARL
25MG/ML
50MG/ML
75MG/ML
100MG/ML
@ IGI LABS INC
25MG/ML
@
50MG/ML
@
50MG/ML
@
50MG/ML
@
75MG/ML
@
100MG/ML
@
100MG/ML
@
100MG/ML

A 080445
A 080445
A 080445
A 080445
A 089781
A 089782
A 089783
A 089784
A 089785
A 089786
A 089787
A 089788

001
002
003
004
001
001
001
001
001
001
001
001

Feb
Feb
Feb
Feb
May
Mar
Mar
Mar
Mar
Mar
Mar
Mar

MEPERIDINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE


INJECTABLE;INJECTION
MEPERGAN
@ EUROHLTH INTL SARL
25MG/ML;25MG/ML

N 011730

001

5MG
5MG
10MG
10MG

MEMANTINE HYDROCHLORIDE
ALEMBIC PHARMS LTD
5MG
10MG
AMNEAL PHARMS
5MG
10MG
AUROBINDO PHARMA LTD 5MG
10MG
DR REDDYS LABS LTD
5MG
10MG
JUBILANT GENERICS
5MG
10MG
LUPIN LTD
5MG
10MG
MACLEODS PHARMS LTD
5MG
10MG
MYLAN PHARMS INC
5MG
@
5MG
5MG
10MG
@
10MG
10MG
SUN PHARMA GLOBAL
5MG
10MG
TEVA PHARMS
5MG
10MG
TORRENT PHARMS LTD
5MG
10MG
UNICHEM LABS LTD
5MG
10MG
UPSHER SMITH
5MG
10MG
WOCKHARDT LTD
5MG
10MG
NAMENDA
FOREST LABS LLC
5MG
+
10MG

1 -58

October

TABLET;ORAL
MEMANTINE
SUN PHARMA GLOBAL

10

Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar

31,
31,
31,
31,
31,
31,
31,
31,

1989
1989
1989
1989
1989
1989
1989
1989

CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN

Jun CAHN

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT

10

AB

>D>
>D>
>A>

2015

N 202106
N 202106

001 Apr 30, 2015


002 Apr 30, 2015

Apr NEWA

Apr NEWA

N 022301

001 Oct 31, 2008

Jul CAHN

A 076841

001 Sep 30, 2004

Aug CAHN

N 021252
N 021252

001 Jan 05, 2001


002 Nov 05, 2004

Aug CAHN

Aug CAHN

N 019651
N 019651

001 Jan 31, 1992


001 Jan 31, 1992

Oct DISC

Oct DISC

0.1MG;2MG

N 013625

004

Mar CAHN

0.05MG;1MG

N 013625

002

Mar CAHN

0.05MG;1MG

N 016659

001

Mar CAHN

0.4%
0.6%
0.4%
0.6%

A 071786
A 070804
A 075586
A 075586

001
001
001
002

10MG/5ML
10MG/5ML

A 072761
A 073034

001 Feb 27, 1992


001 Aug 30, 1991

Apr CAHN

Apr CAHN

400MG
640MG

A 040486
N 022503

001 Feb 27, 2015


001 Jun 01, 2015

Feb NEWA

Jun NEWA

500MG/5ML

N 021591

001 Sep 11, 2003

Apr CAHN

A 204802
A 204802

001 Nov 05, 2015


002 Nov 05, 2015

Oct NEWA

Oct NEWA

N 022386
N 022386

001 Jun 23, 2008


002 Jun 23, 2008

Jun CFTG

Jun CFTG

A 200624
A 200624

001 Jul 15, 2015


002 Jul 15, 2015

Jun NEWA

Jun NEWA

MESALAMINE
CAPSULE, EXTENDED RELEASE;ORAL
APRISO
+
VALEANT PHARMS INTL
375MG
ENEMA;RECTAL
MESALAMINE
G AND W LABS INC
4GM/60ML
SUPPOSITORY;RECTAL
CANASA
@ FOREST LABS LLC
500MG
+
1GM
TABLET, DELAYED RELEASE;ORAL
ASACOL
+
WARNER CHILCOTT LLC
400MG
@
400MG
MESTRANOL; NORETHINDRONE
TABLET;ORAL-20
NORINYL
@ ACTAVIS LABS UT INC
TABLET;ORAL-21
NORINYL 1+50 21-DAY
@ ACTAVIS LABS UT INC
TABLET;ORAL-28
NORINYL 1+50 28-DAY
+
ACTAVIS LABS UT INC
METAPROTERENOL SULFATE
SOLUTION;INHALATION
METAPROTERENOL SULFATE
@ MYLAN SPECLT
@
@ WOCKHARDT
@
SYRUP;ORAL
METAPROTERENOL SULFATE
@ G AND W LABS INC
@
METAXALONE
TABLET;ORAL
METAXALONE
COREPHARMA

METFORMIN HYDROCHLORIDE
SOLUTION;ORAL
RIOMET
+
SUN PHARM INDS LTD

>A> AB
>A> AB

AB
AB
AB
AB

1 -59

October

MEROPENEM
POWDER;IV (INFUSION)
MEROPENEM AND SODIUM CHLORIDE IN DUPLEX CONTAINER
B BRAUN MEDICAL INC
500MG/VIAL
1GM/VIAL

METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE


TABLET;ORAL
PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE
MACLEODS PHARMS LTD
500MG;EQ 15MG BASE
850MG;EQ 15MG BASE
METFORMIN HYDROCHLORIDE; REPAGLINIDE
TABLET;ORAL
PRANDIMET
NOVO NORDISK INC
500MG;1MG
+
500MG;2MG
REPAGLINIDE AND METFORMIN HYDROCHLORIDE
LUPIN LTD
500MG;1MG
500MG;2MG

Aug
Aug
May
May

05,
17,
30,
30,

1988
1987
2002
2002

Apr
Apr
Apr
Apr

DISC

DISC

DISC

DISC

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT

2015

N 021410
N 021410
N 021410
N 021410

002
003
004
005

Oct
Oct
Aug
Aug

10,
10,
25,
25,

2002
2002
2003
2003

May
May
May
May

DISC
DISC
DISC
DISC

A 077337
A 077337
A 077337
A 077337

001
002
004
003

May
May
May
May

07,
07,
07,
07,

2014
2014
2014
2014

May
May
May
May

CTEC
CTEC
CRLD
CTEC

AA
AA
AA
AA

A 203502
A 203502
A 090065
A 090065

001
002
001
002

Aug
Aug
Aug
Aug

31,
31,
18,
18,

2015
2015
2015
2015

Aug
Aug
Aug
Aug

NEWA
NEWA
NEWA
NEWA

AB
AB

5MG
10MG

A 040734
A 040734

001 Dec 14, 2007


002 Dec 14, 2007

Mar CAHN
Mar CAHN

1GM/10ML (100MG/ML)

N 011790

001

Jun CAHN

METHADONE HYDROCHLORIDE
TABLET;ORAL
METHADONE HYDROCHLORIDE
AUROLIFE PHARMA LLC
5MG
10MG
COREPHARMA
5MG
10MG
METHIMAZOLE
TABLET;ORAL
METHIMAZOLE
HERITAGE PHARMA

1 -60

October

METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE


TABLET;ORAL
AVANDAMET
@ SB PHARMCO
500MG;EQ 2MG BASE
@
500MG;EQ 4MG BASE
@
1GM;EQ 2MG BASE
@
1GM;EQ 4MG BASE
ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE
TEVA
500MG;EQ 2MG BASE
500MG;EQ 4MG BASE
+
1GM;EQ 4MG BASE
1GM;EQ 2MG BASE

10

AP

METHOCARBAMOL
SOLUTION;IM-IV
ROBAXIN
+
EUROHLTH INTL SARL

AP

METHOTREXATE SODIUM
INJECTABLE;INJECTION
METHOTREXATE PRESERVATIVE FREE
FRESENIUS KABI USA
EQ 25MG BASE/ML

A 040265

001 Feb 26, 1999

May CMFD

AB

METHOXSALEN
CAPSULE;ORAL
METHOXSALEN
ACTAVIS INC

A 202603

001 Jun 09, 2015

May NEWA

N 205831
N 205831
N 205831
N 205831
N 205831
N 205831
N 205831

001
002
003
004
005
006
007

Apr
Apr
Apr
Apr
Apr
Apr
Apr

17,
17,
17,
17,
17,
17,
17,

2015
2015
2015
2015
2015
2015
2015

Apr
Apr
Apr
Apr
Apr
Apr
Apr

NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA

A 203583
A 203583
A 203583
A 203583
A 203583
A 203583

001
002
003
004
005
006

Sep
Sep
Sep
Sep
Sep
Sep

29,
29,
29,
29,
29,
29,

2015
2015
2015
2015
2015
2015

Sep
Sep
Sep
Sep
Sep
Sep

NEWA
NEWA
NEWA
NEWA
NEWA
NEWA

N 021284
N 021284

003 Jun 05, 2002


005 Oct 27, 2014

Feb CRLD
Feb CRLD

A 204602
A 204602

001 Aug 14, 2015


002 Aug 14, 2015

Aug NEWA
Aug NEWA

A 207416
A 207416
A 207416

001 Sep 22, 2015


002 Sep 22, 2015
003 Sep 22, 2015

Sep NEWA
Sep NEWA
Sep NEWA

AB2
AB2
AB2
AB2
AB2
AB2
AB1

AA
AA

AB
AB
AB

10MG

METHYLPHENIDATE HYDROCHLORIDE
CAPSULE, EXTENDED RELEASE;ORAL
APTENSIO XR
RHODES PHARMS
10MG
15MG
20MG
30MG
40MG
50MG
+
60MG
METHYLPHENIDATE HYDROCHLORIDE
MALLINCKRODT INC
10MG
20MG
30MG
40MG
50MG
60MG
RITALIN LA
NOVARTIS
40MG
+
60MG
SOLUTION;ORAL
METHYLPHENIDATE HYDROCHLORIDE
NOVEL LABS INC
5MG/5ML
10MG/5ML
TABLET;ORAL
METHYLPHENIDATE HYDROCHLORIDE
ASCENT PHARMS INC
5MG
10MG
20MG

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT

AB
AB
AB
AB
AB
AB

AB
AB
AB

AB
AB

AP

AP

AB
AB
AB
AB

>A>
>A>
>A>
>D>
>D>
>D>

2015

N 021475
N 021475
N 021475

001 Apr 15, 2003


002 Apr 15, 2003
003 Apr 15, 2003

Feb CFTG
Feb CFTG
Feb CFTG

A 204115
A 204115
A 204115

001 Feb 25, 2015


002 Feb 25, 2015
003 Feb 25, 2015

Feb NEWA
Feb NEWA
Feb NEWA

A 075629

001 May 09, 2000

May CTEC

A 207488
A 207488

001 Jun 09, 2015


002 Jun 09, 2015

May NEWA
May NEWA

10MG

A 204851

001 Sep 21, 2015

Sep NEWA

10MG

A 083976

001

Sep CTEC

1MG/ML

A 078950

001 Apr 29, 2013

Apr CAHN

37.5MG
75MG

A 076704
A 076704

004 Mar 18, 2015


005 Mar 18, 2015

Mar NEWA
Mar NEWA

1%

N 020743

001 Sep 26, 1997

Feb CAHN

1.3%

N 205223

001 Mar 24, 2014

Feb CAHN

1.3%

N 205223

001 Mar 24, 2014

Feb CTNA

500MG/100ML
CONTAINER
500MG/100ML

N 018907

001 Mar 30, 1984

Aug CAHN

A 078084

001 Mar 31, 2008

Apr CAHN

250MG
500MG
250MG
500MG

A 205245
A 205245
A 203974
A 203974

001
002
001
002

Sep
Sep
May
May

23,
23,
29,
29,

2015
2015
2015
2015

Sep
Sep
May
May

NEWA
NEWA
NEWA
NEWA

MEXILETINE HYDROCHLORIDE
CAPSULE;ORAL
MEXILETINE HYDROCHLORIDE
@ IDT AUSTRALIA LTD
@
@
@ SANDOZ
@
@

150MG
200MG
250MG
150MG
200MG
250MG

A 074450
A 074450
A 074450
A 074450
A 074450
A 074450

001
002
003
001
002
003

May
May
May
May
May
May

16,
16,
16,
16,
16,
16,

1996
1996
1996
1996
1996
1996

Oct
Oct
Oct
Oct
Oct
Oct

CAHN
CAHN
CAHN
CAHN
CAHN
CAHN

MICONAZOLE
TABLET;BUCCAL
ORAVIG
+
DARA BIOSCIENCES

50MG

N 022404

001 Apr 16, 2010

2.5MG
5MG
+
10MG
METHYLPHENIDATE HYDROCHLORIDE
NOVEL LABS INC
2.5MG
5MG
10MG
TABLET, EXTENDED RELEASE;ORAL
METHYLIN ER
MALLINCKRODT INC
10MG
METHYLPHENIDATE HYDROCHLORIDE
ABHAI
10MG
20MG
METHYLTESTOSTERONE
CAPSULE;ORAL
METHYLTESTOSTERONE
IMPAX LABS INC
TESTRED
+
VALEANT PHARM INTL
METOPROLOL TARTRATE
INJECTABLE;INJECTION
METOPROLOL TARTRATE
CLARIS PHARMASERVICE
TABLET;ORAL
METOPROLOL TARTRATE
MYLAN

METRONIDAZOLE
CREAM;TOPICAL
NORITATE
+
VALEANT PHARMS NORTH
GEL;VAGINAL
METRONIDAZOLE
+
ACTAVIS LABS UT INC
NUVESSA
+
ACTAVIS LABS UT INC
INJECTABLE;INJECTION
METRONIDAZOLE
@ EUROHLTH INTL SARL
METRONIDAZOLE IN PLASTIC
CLARIS PHARMASERVICE
TABLET;ORAL
METRONIDAZOLE
APPCO PHARMA LLC
AUROBINDO PHARMA LTD

1 -61

October

TABLET, CHEWABLE;ORAL
METHYLIN
MALLINCKRODT

10

Apr CAHN

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT

AP
AP

AA

AB
AA
AB
AA
AB
AA
AB
AA
AB
AA
AB
AA

AP
AP
AP

AB
AB
AB
AB
AB
AB

AB
AB
AB
AB
AB
AB

AB
AB
AB
AB

MIGLITOL
TABLET;ORAL
GLYSET
PHARMACIA AND UPJOHN

+
+
MIGLITOL
ORIENT PHARMA CO LTD

MILRINONE LACTATE
INJECTABLE;INJECTION
MILRINONE LACTATE
BEDFORD
EUROHLTH INTL SARL
@
+
HIKMA FARMACEUTICA

2015

A 075637
A 075637
A 075243
A 075243
A 075263
A 078141
A 078511
A 078141
A 078511

001
002
001
002
001
001
001
002
002

A 076058

001 Mar 15, 2002

Apr CAHN

25MG
25MG
50MG
50MG
100MG
100MG

N 020682
N 020682
N 020682
N 020682
N 020682
N 020682

001
001
002
002
003
003

Dec
Dec
Dec
Dec
Dec
Dec

18,
18,
18,
18,
18,
18,

1996
1996
1996
1996
1996
1996

Mar
Feb
Mar
Feb
Mar
Feb

CTEC
CFTG
CTEC
CFTG
CTEC
CFTG

25MG
25MG
50MG
50MG
100MG
100MG

A 203965
A 203965
A 203965
A 203965
A 203965
A 203965

001
001
002
002
003
003

Feb
Feb
Feb
Feb
Feb
Feb

24,
24,
24,
24,
24,
24,

2015
2015
2015
2015
2015
2015

Mar
Feb
Mar
Feb
Mar
Feb

CTEC
NEWA
CTEC
NEWA
CTEC
NEWA

A 075660
A 075530
A 075852
A 077966

001
001
001
001

May
May
May
Dec

28,
28,
28,
03,

2002
2002
2002
2010

Jan
Jun
Sep
Jan

CRLD
CAHN
CAHN
CRLD

A 065062
A 065062
A 065062
A 065062
A 065062
A 065062

001
002
003
001
002
003

Nov
Nov
Nov
Nov
Nov
Nov

30,
30,
30,
30,
30,
30,

2000
2000
2000
2000
2000
2000

Apr
Apr
Apr
Jun
Jun
Jun

CAHN
CAHN
CAHN
CAHN
CAHN
CAHN

N 201922
N 201922
N 201922
N 201922
N 201922

001
002
003
004
005

Jul
Jul
Jul
Jul
Jul

11,
11,
11,
11,
11,

2012
2012
2012
2012
2012

Apr
Apr
Apr
Apr
Apr

CAHN
CAHN
CAHN
CAHN
CAHN

A 065156
A 065156
A 065156
A 065156
A 065156
A 065156

001
002
003
001
002
003

Jan
Jan
Jan
Jan
Jan
Jan

06,
06,
06,
06,
06,
06,

2004
2004
2004
2004
2004
2004

Apr
Apr
Apr
Jun
Jun
Jun

CAHN
CAHN
CAHN
CAHN
CAHN
CAHN

A 090422
A 091118
A 091118
A 091118

003
001
004
005

Aug
Sep
Sep
Sep

13,
25,
25,
25,

2009
2014
2014
2014

Sep
Apr
Apr
Apr

CRLD
CAHN
CAHN
CAHN

EQ
EQ
EQ
EQ

1MG
1MG
1MG
1MG

BASE/ML
BASE/ML
BASE/ML
BASE/ML

MINOCYCLINE HYDROCHLORIDE
CAPSULE;ORAL
MINOCYCLINE HYDROCHLORIDE
SUN PHARM INDS LTD
EQ 50MG BASE
EQ 75MG BASE
EQ 100MG BASE
TORRENT PHARMA INC
EQ 50MG BASE
EQ 75MG BASE
EQ 100MG BASE
CAPSULE, EXTENDED RELEASE;ORAL
XIMINO
@ SUN PHARM INDS LTD
EQ 45MG BASE
@
EQ 67.5MG BASE
@
EQ 90MG BASE
@
EQ 112.5MG BASE
@
EQ 135MG BASE
TABLET;ORAL
MINOCYCLINE HYDROCHLORIDE
SUN PHARM INDS LTD
EQ 50MG BASE
EQ 75MG BASE
EQ 100MG BASE
TORRENT PHARMA INC
EQ 50MG BASE
EQ 75MG BASE
EQ 100MG BASE
TABLET, EXTENDED RELEASE;ORAL
MINOCYCLINE HYDROCHLORIDE
+
SANDOZ
EQ 135MG BASE
SUN PHARM INDS LTD
EQ 45MG BASE
EQ 80MG BASE
EQ 90MG BASE

1 -62

October

MIDAZOLAM HYDROCHLORIDE
INJECTABLE;INJECTION
MIDAZOLAM HYDROCHLORIDE
@ CLARIS PHARMASERVICE EQ 1MG BASE/ML
@
EQ 5MG BASE/ML
EUROHLTH INTL SARL
EQ 1MG BASE/ML
EQ 5MG BASE/ML
@ IGI LABS INC
EQ 5MG BASE/ML
@ WOCKHARDT
EQ 1MG BASE/ML
@
EQ 1MG BASE/ML
@
EQ 5MG BASE/ML
@
EQ 5MG BASE/ML
SYRUP;ORAL
MIDAZOLAM HYDROCHLORIDE
SUN PHARM INDS LTD
EQ 2MG BASE/ML

10

Oct
Oct
Jun
Jun
Jun
May
Nov
May
Nov

31,
31,
20,
20,
26,
30,
10,
30,
10,

2000
2000
2000
2000
2000
2008
2008
2008
2008

Apr
Apr
Jun
Jun
Apr
Mar
Mar
Mar
Mar

CAHN
CAHN
CAHN
CAHN
CAHN
DISC
DISC
DISC
DISC

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT

AB
AB

AB
AB

MIVACURIUM CHLORIDE

SOLUTION;INTRAVENOUS

MIVACRON

ABBVIE
+

2015

A 091118
A 091118

006 Sep 25, 2014


008 Sep 25, 2014

Apr CAHN

Apr CAHN

N 050808
N 050808
N 050808

008 Aug 27, 2010


007 Aug 27, 2010
005 Jul 23, 2009

Sep CRLD

Sep CRLD

Sep CRLD

EQ 10MG BASE/5ML (EQ 2MG BASE/ML)


N 020098
EQ 20MG BASE/10ML (EQ 2MG BASE/ML) N 020098

004 Jan 22, 1992


005 Jan 22, 1992

Jan NEWA

Jan NEWA

A 090453
A 090453
A 090453

001 Mar 20, 2015


002 Mar 20, 2015
003 Mar 20, 2015

Mar NEWA

Mar NEWA

Mar NEWA

EQ 4MG BASE/PACKET

A 203438

001 Jul 31, 2015

Jul NEWA

EQ
EQ
EQ
EQ

10MG
10MG
10MG
10MG

A 203432
A 204604
A 201522
A 204290

001
001
001
001

Jul
Sep
Aug
Oct

31,
04,
03,
08,

2015
2015
2012
2015

Jul
Aug
Mar
Sep

NEWA

NEWA

CAHN

NEWA

EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ

4MG
5MG
4MG
5MG
4MG
5MG
4MG
5MG
4MG
5MG
4MG
5MG

A 203328
A 203328
A 205695
A 205695
A 204093
A 204093
A 203795
A 203795
A 200405
A 200405
A 203582
A 203582

001
002
001
002
001
002
001
002
001
002
001
002

Jul
Jul
Nov
Nov
May
May
Feb
Feb
Aug
Aug
Mar
Mar

31,
31,
05,
05,
22,
22,
27,
27,
03,
03,
12,
12,

2015
2015
2015
2015
2015
2015
2015
2015
2012
2012
2015
2015

Jul
Jul
Oct
Oct
May
May
Feb
Feb
Mar
Mar
Feb
Feb

NEWA

NEWA

NEWA

NEWA

NEWA

NEWA

NEWA

NEWA

CAHN

CAHN

NEWA

NEWA

N 021260
N 021260
N 021260
N 021260
N 021260
N 021260

001
005
002
006
003
004

Mar
Dec
Mar
Dec
Mar
Mar

20,
18,
20,
18,
20,
20,

2002
2008
2002
2008
2002
2002

Sep
Sep
Sep
Sep
Sep
Sep

DISC

DISC

DISC

DISC

DISC

DISC

N 020616
N 020616
N 020616
N 020616
N 020616
N 020616
N 020616
N 020616
N 020616
N 020616
N 020616
N 020616
N 020616
N 020616

008
001
004
009
009
002
005
010
010
006
003
011
012
007

Apr
Jul
Mar
Jul
Jul
Jul
Mar
Jul
Jul
Oct
Jul
Jul
Jul
Feb

20,
03,
09,
09,
09,
03,
09,
09,
09,
27,
03,
09,
09,
27,

2007
1996
2001
2012
2012
1996
2001
2012
2012
2006
1996
2012
2012
2007

Mar
Mar
Mar
May
Mar
Mar
Mar
May
Mar
Mar
Mar
Mar
Mar
Mar

CAHN

CAHN

CAHN

CTEC

CAHN

CAHN

CAHN

CTEC

CAHN

CAHN

CAHN

CAHN

CAHN

CAHN

MOLINDONE HYDROCHLORIDE

TABLET;ORAL

MOLINDONE HYDROCHLORIDE

COREPHARMA
5MG
10MG
+
25MG

AB

AB
AB
AB
AB

AB
AB
>A> AB
>A> AB
AB
AB
AB
AB
AB
AB
AB
AB

AB1
AB1
AB1
AB1
AB1
AB1
AB1
AB1
AB1

AB1

MONTELUKAST SODIUM

GRANULE;ORAL

MONTELUKAST SODIUM

AJANTA PHARMA LTD
TABLET;ORAL

MONTELUKAST SODIUM

AJANTA PHARMA LTD
AMNEAL PHARMS
KREMERS URBAN PHARMS
UNICHEM LABS LTD
TABLET, CHEWABLE;ORAL

MONTELUKAST SODIUM

AJANTA PHARMA LTD
ANBISON LAB CO LTD
HETERO LABS LTD V
JUBILANT GENERICS
KREMERS URBAN PHARMS
MACLEODS PHARMS LTD

MORPHINE SULFATE

CAPSULE, EXTENDED RELEASE;ORAL

AVINZA

@ KING PHARMS LLC
30MG
@
45MG
@
60MG
@
75MG
@
90MG
@
120MG
KADIAN

+
ACTAVIS LABS UT INC
10MG
20MG
30MG
40MG
40MG
50MG
60MG
70MG
70MG
80MG
+
100MG
130MG
150MG
+
200MG

BASE
BASE
BASE
BASE

BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE

1 -63

October

TABLET, EXTENDED RELEASE;ORAL



MINOCYCLINE HYDROCHLORIDE

EQ 105MG BASE
EQ 135MG BASE
SOLODYN

MEDICIS
EQ 55MG BASE
EQ 80MG BASE
+
EQ 115MG BASE

10

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT

AB1
AB1

AP
AP

AP
AP
AP
AP
AP
AP

AA
AA
>A> AA

>A>
>A>
>A>
>A>
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB

AT2
AT1
AT2
AT1
AT
AT1

AB

>D> AB
>A>

10

CAPSULE, EXTENDED RELEASE;ORAL



MORPHINE SULFATE

ACTAVIS ELIZABETH
30MG
45MG
60MG
75MG
90MG
+
120MG
TEVA PHARMS USA
40MG
70MG
INJECTABLE;INJECTION
DURAMORPH PF
+
EUROHLTH INTL SARL
0.5MG/ML
+
1MG/ML
INFUMORPH
+
EUROHLTH INTL SARL
10MG/ML
+
25MG/ML
MORPHINE SULFATE
EUROHLTH INTL SARL
4MG/ML
8MG/ML
10MG/ML
+
HOSPIRA INC
4MG/ML
+
8MG/ML
+
10MG/ML
SOLUTION;ORAL
MORPHINE SULFATE
TRIS PHARMA INC
10MG/5ML
100MG/5ML
VINTAGE PHARMS LLC
20MG/5ML
TABLET, EXTENDED RELEASE;ORAL
MORPHABOND
IDT
15MG
30MG
60MG
+
100MG
MORPHINE SULFATE
ACTAVIS ELIZABETH
15MG
30MG
60MG
100MG
200MG
SUN PHARM INDS LTD
15MG
30MG
60MG
100MG
200MG
MOXIFLOXACIN HYDROCHLORIDE
SOLUTION;IV (INFUSION)
MOXIFLOXACIN HYDROCHLORIDE
+
FRESENIUS KABI USA
EQ 400MG BASE/250ML (EQ 1.6MG
BASE/ML)
SOLUTION/DROPS;OPHTHALMIC
MOXEZA
+
ALCON PHARMS LTD
EQ 0.5% BASE
MOXIFLOXACIN HYDROCHLORIDE
LUPIN LTD
EQ 0.5% BASE
EQ 0.5% BASE
WATSON LABS INC
EQ 0.5% BASE
EQ 0.5% BASE
VIGAMOX
+
ALCON PHARMS LTD
EQ 0.5% BASE
TABLET;ORAL
MOXIFLOXACIN HYDROCHLORIDE
MYLAN PHARMS INC
EQ 400MG BASE
MYCOPHENOLATE MOFETIL
CAPSULE;ORAL
MYCOPHENOLATE MOFETIL
DR REDDYS LABS LTD
@

250MG
250MG

1 -64

October

2015

A 079040
A 079040
A 079040
A 079040
A 079040
A 079040
A 202718
A 202718

001
002
003
004
005
006
007
008

N 018565
N 018565

001 Sep 18, 1984


002 Sep 18, 1984

Jun CAHN
Jun CAHN

N 018565
N 018565

003 Jul 19, 1991


004 Jul 19, 1991

Jun CAHN
Jun CAHN

A 205758
A 205758
A 205758
N 202515
N 202515
N 202515

001
002
003
002
003
004

May
May
May
May
May
May

A 203518
A 203518
A 202310

001 May 12, 2015


002 May 12, 2015
001 Oct 30, 2015

May NEWA
May NEWA
Oct NEWA

N 206544
N 206544
N 206544
N 206544

001
002
003
004

Oct
Oct
Oct
Oct

02,
02,
02,
02,

2015
2015
2015
2015

Oct
Oct
Oct
Oct

NEWA
NEWA
NEWA
NEWA

A 203849
A 203849
A 203849
A 203849
A 203849
A 078761
A 078761
A 078761
A 078761
A 078761

001
002
003
004
005
001
002
003
004
005

Apr
Apr
Apr
Apr
Apr
May
May
May
May
May

06,
06,
06,
06,
06,
11,
11,
11,
11,
11,

2015
2015
2015
2015
2015
2012
2012
2012
2012
2012

Mar
Mar
Mar
Mar
Mar
Apr
Apr
Apr
Apr
Apr

NEWA
NEWA
NEWA
NEWA
NEWA
CAHN
CAHN
CAHN
CAHN
CAHN

N 205572

001 Apr 03, 2015

Apr NEWA

N 022428

001 Nov 19, 2010

May CFTG

A 202867
A 204079
A 202525
A 202525

001
001
001
001

May
May
May
Feb

N 021598

001 Apr 15, 2003

May CTEC

A 204635

001 Aug 31, 2015

Aug NEWA

A 091315
A 091315

001 Oct 27, 2011


001 Oct 27, 2011

Oct DISC
Oct DISC

Jan
Jan
Jan
Jan
Jan
Jan
Jun
Jun

May
May
May
Nov
Nov
Nov

Sep
May
Mar
Mar

16,
16,
16,
16,
16,
16,
03,
03,

21,
21,
21,
14,
14,
14,

04,
28,
06,
06,

2013
2013
2013
2013
2013
2013
2015
2015

2015
2015
2015
2011
2011
2011

2014
2015
2015
2015

Sep
Sep
Sep
Sep
Sep
Sep
May
May

CTEC
CTEC
CTEC
CTEC
CTEC
CTEC
NEWA
NEWA

NEWA
NEWA
NEWA
CFTG
CFTG
CFTG

CTEC
NEWA
CTEC
NEWA

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT

>D>
>D>
>D>
>D>
>D>
>A>
>A>
>A>
>A>
>A>

2015

20MG
40MG
80MG
120MG
160MG
20MG
40MG
80MG
120MG
160MG

N 018063
N 018063
N 018063
N 018063
N 018063
N 018063
N 018063
N 018063
N 018063
N 018063

005 Oct 28, 1986


001
002
003
004
005 Oct 28, 1986
001
002
003
004

Oct
Oct
Oct
Oct
Oct
Oct
Oct
Oct
Oct
Oct

40MG
80MG

A 201893
A 201893

001 Sep 16, 2015


002 Sep 16, 2015

Aug NEWA
Aug NEWA

NALBUPHINE HYDROCHLORIDE
INJECTABLE;INJECTION
NALBUPHINE HYDROCHLORIDE
@ IGI LABS INC
@
@
@
@
@

10MG/ML
10MG/ML
10MG/ML
20MG/ML
20MG/ML
20MG/ML

A 072070
A 072071
A 072072
A 072073
A 072074
A 072075

001
001
001
001
001
001

Mar
Mar
Mar
Mar
Mar
Mar

NALMEFENE HYDROCHLORIDE
INJECTABLE;INJECTION
REVEX
@ EUROHLTH INTL SARL
@

EQ 0.1MG BASE/ML
EQ 1MG BASE/ML

N 020459
N 020459

001 Apr 17, 1995


002 Apr 17, 1995

Jun CAHN
Jun CAHN

0.4MG/ML

A 070299

001 Sep 24, 1986

Mar CAHN

0.02MG/ML
0.02MG/ML
0.02MG/ML
0.02MG/ML
0.4MG/ML
0.4MG/ML
0.4MG/ML
0.4MG/ML
0.4MG/ML
1MG/ML
1MG/ML
1MG/ML

A 072082
A 072083
A 072084
A 072085
A 072086
A 072087
A 072088
A 072089
A 072090
A 072091
A 072092
A 072093

001
001
001
001
001
001
001
001
001
001
001
001

Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar
Mar

0.02MG/ML
0.4MG/ML
1MG/ML

N 016636
N 016636
N 016636

002
001
003 Jun 14, 1982

Aug CAHN
Aug CAHN
Aug CAHN

AB

NALOXONE HYDROCHLORIDE; PENTAZOCINE HYDROCHLORIDE


TABLET;ORAL
NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE
SUN PHARM INDS LTD
EQ 0.5MG BASE;EQ 50MG BASE

A 075523

001 Mar 17, 2000

Apr CAHN

AB

NAPROXEN
SUSPENSION;ORAL
NAPROSYN
+
PEDIAPHARM INC

N 018965

001 Mar 23, 1987

Apr CAHN

N 020353
N 020353
N 020353

001 Jan 05, 1996


002 Jan 05, 1996
003 Jan 05, 1996

Oct CAHN
Oct CAHN
Oct CAHN

AB
AB
AB

+
@
@

AB
AB
AB

AB
AB

US WORLD MEDS LLC


+
@
@
NADOLOL
ORION CORP ORION

NALOXONE HYDROCHLORIDE
INJECTABLE;INJECTION
NALOXONE
@ EUROHLTH INTL SARL
NALOXONE HYDROCHLORIDE
@ IGI LABS INC
@
@
@
@
@
@
@
@
@
@
@
NARCAN
@ ADAPT
@
@

>D> AB
>D> AB
>D>

25MG/ML

NAPROXEN SODIUM
TABLET, EXTENDED RELEASE;ORAL
NAPRELAN
ALMATICA PHARMA INC
EQ 375MG BASE
EQ 500MG BASE
+
EQ 750MG BASE

1 -65

October

NADOLOL
TABLET;ORAL
CORGARD
KING PHARMS

10

Apr
Apr
Apr
Apr
Apr
Apr

Apr
Apr
Apr
Apr
Apr
Apr
Apr
Apr
Apr
Apr
Apr
Apr

10,
10,
10,
10,
10,
10,

11,
11,
11,
11,
11,
11,
11,
11,
11,
11,
11,
11,

1989
1989
1989
1989
1989
1989

1989
1989
1989
1989
1989
1989
1989
1989
1989
1989
1989
1989

CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN

CAHN
CAHN
CAHN
CAHN
CAHN
CAHN

CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT

>A> AB
>A> AB
>A>

AB
AB
AB
AB

AB
AB
AB
AB
AB

2015

N 020353
N 020353
N 020353

001 Jan 05, 1996


002 Jan 05, 1996
003 Jan 05, 1996

Oct CAHN
Oct CAHN
Oct CAHN

NAPROXEN SODIUM; SUMATRIPTAN SUCCINATE


TABLET;ORAL
TREXIMET
PERNIX IRELAND LTD
60MG;EQ 10MG BASE

N 021926

002 May 14, 2015

Jun NEWA

NEBIVOLOL HYDROCHLORIDE
TABLET;ORAL
NEBIVOLOL HYDROCHLORIDE
@ ALKEM LABS LTD
EQ
EQ
@
EQ
EQ
@
EQ
EQ
@
EQ
EQ
@ AMERIGEN PHARMS LTD
EQ
EQ
@
EQ
EQ
@
EQ
EQ
@
EQ
EQ
@ INDCHEMIE HEALTH
EQ
EQ
@
EQ
EQ
@
EQ
EQ
@
EQ
EQ

A 203741
A 203741
A 203741
A 203741
A 203741
A 203741
A 203741
A 203741
A 203659
A 203659
A 203659
A 203659
A 203659
A 203659
A 203659
A 203659
A 203828
A 203828
A 203828
A 203828
A 203828
A 203828
A 203828
A 203828

001
001
002
002
003
003
004
004
001
001
002
002
003
003
004
004
001
001
002
002
003
003
004
004

Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Apr
Apr
Apr
Apr
Apr
Apr
Apr
Apr
Jul
Jul
Jul
Jul
Jul
Jul
Jul
Jul

24,
24,
24,
24,
24,
24,
24,
24,
16,
16,
16,
16,
16,
16,
16,
16,
29,
29,
29,
29,
29,
29,
29,
29,

2015
2015
2015
2015
2015
2015
2015
2015
2015
2015
2015
2015
2015
2015
2015
2015
2015
2015
2015
2015
2015
2015
2015
2015

Jun
Jun
Jun
Jun
Jun
Jun
Jun
Jun
Apr
Mar
Apr
Mar
Apr
Mar
Apr
Mar
Jul
Jul
Jul
Jul
Jul
Jul
Jul
Jul

DISC
NEWA
DISC
NEWA
DISC
NEWA
DISC
NEWA
DISC
NEWA
DISC
NEWA
DISC
NEWA
DISC
NEWA
DISC
NEWA
DISC
NEWA
DISC
NEWA
DISC
NEWA

50MG
100MG
150MG
200MG
250MG
50MG
100MG
150MG
200MG
250MG

A 076072
A 076072
A 076072
A 076072
A 076072
A 076409
A 076409
A 076409
A 076409
A 076409

001
002
003
004
005
001
002
003
004
005

Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep
Sep

16,
16,
16,
16,
16,
16,
16,
16,
16,
16,

2003
2003
2003
2003
2003
2003
2003
2003
2003
2003

Apr
Apr
Apr
Apr
Apr
Apr
Apr
Apr
Apr
Apr

CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN

250MG/50ML (5MG/ML)

N 021877

001 Oct 28, 2005

Mar CAHN

NEOSTIGMINE METHYLSULFATE
SOLUTION;INTRAVENOUS
NEOSTIGMINE METHYLSULFATE
FRESENIUS KABI USA
5MG/10ML (0.5MG/ML)
10MG/10ML (1MG/ML)

N 203629
N 203629

001 Jan 08, 2015


002 Jan 08, 2015

Jan NEWA
Jan NEWA

NEVIRAPINE
TABLET, EXTENDED RELEASE;ORAL
NEVIRAPINE
ALVOGEN MALTA
100MG
100MG
400MG
ALVOGEN PINE BROOK
400MG
400MG
CIPLA LTD
400MG

A 204621
A 204621
A 204621
A 204621
A 204621
A 206448

002
002
001
001
001
001

Oct
Oct
Oct
Oct
Jun
Oct

NEFAZODONE HYDROCHLORIDE
TABLET;ORAL
NEFAZODONE HYDROCHLORIDE
@ IDT AUSTRALIA LTD
@
@
@
@
SUN PHARM INDS LTD

NELARABINE
INJECTABLE;IV (INFUSION)
ARRANON
+
NOVARTIS PHARMS CORP

>A>
>A>
>A>
>D>

AB
AB
AB
AB
AB
>A> AB

2.5MG BASE
2.5MG BASE
5MG BASE
5MG BASE
10MG BASE
10MG BASE
20MG BASE
20MG BASE
2.5MG BASE
2.5MG BASE
5MG BASE
5MG BASE
10MG BASE
10MG BASE
20MG BASE
20MG BASE
2.5MG BASE
2.5MG BASE
5MG BASE
5MG BASE
10MG BASE
10MG BASE
20MG BASE
20MG BASE

1 -66

October

TABLET, EXTENDED RELEASE;ORAL


NAPRELAN
ALVOGEN MALTA
EQ 375MG BASE
EQ 500MG BASE
+
EQ 750MG BASE

10

Nov
Nov
Jul
Jul
Jul
Oct

09,
09,
10,
10,
10,
15,

2015
2015
2015
2015
2015
2015

NEWA
CAHN
CAHN
CAHN
NEWA
NEWA

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT

10

October

2015

1 -67

A 206271

001 Nov 09, 2015

Oct NEWA

>D>
>A> AB

TABLET, EXTENDED RELEASE;ORAL


NEVIRAPINE
MYLAN PHARMS INC
100MG
VIRAMUNE XR
BOEHRINGER INGELHEIM
100MG
100MG

N 201152
N 201152

002 Nov 08, 2012


002 Nov 08, 2012

Oct CFTG

Oct CFTG

AB
AB

NIACIN
TABLET, EXTENDED RELEASE;ORAL
NIACIN
AMNEAL PHARMS
500MG
1GM

A 203578
A 203578

001 Jul 24, 2015


002 Jul 24, 2015

Jul NEWA

Jul NEWA

A 202644
A 202644

001 Apr 25, 2013


002 Apr 25, 2013

Mar CAHN

Mar CAHN

A 075289
A 075289

002 Feb 06, 2001


001 Sep 27, 2000

Aug CAHN

Aug CAHN

>A> AB

AB
AB

AB2
AB2

AB
AB

NIFEDIPINE
CAPSULE;ORAL
NIFEDIPINE
HERITAGE PHARMA

10MG
20MG
TABLET, EXTENDED RELEASE;ORAL
NIFEDIPINE
VALEANT PHARMS NORTH
30MG
60MG

NILUTAMIDE
TABLET;ORAL
NILANDRON
@ CONCORDIA PHARMS INC
+

50MG
150MG

N 020169
N 020169

001 Sep 19, 1996


002 Apr 30, 1999

Apr CAHN

Apr CAHN

NIMODIPINE
CAPSULE;ORAL
NIMODIPINE
+
BANNER LIFE SCIENCES
SOFGEN PHARMS

30MG
30MG

A 076740
A 201832

001 Jan 17, 2008


001 Jul 24, 2015

Jan CAHN

Jul NEWA

NINTEDANIB ESYLATE
CAPSULE;ORAL
OFEV
BOEHRINGER INGELHEIM
+

EQ 100MG BASE
EQ 150MG BASE

N 205832
N 205832

001 Oct 15, 2014


002 Oct 15, 2014

Mar CAIN

Mar CAIN

NITRIC OXIDE
GAS;INHALATION
INOMAX
@ INO

100PPM

N 020845

002 Dec 23, 1999

Jun DISC

N 016620
N 016620
N 016620
N 016620
N 016620
N 016620
N 016620

003
003
001
002
003
001
002

Oct
Jun
Oct
Oct
Oct
Oct
Oct

A 091095
A 091095
A 091095

001 Jun 18, 2015


002 Jun 18, 2015
003 Jun 18, 2015

Jun NEWA

Jun NEWA

Jun NEWA

A 202250

001 Jul 08, 2015

Jun NEWA

AB
AB
AB

NITROFURANTOIN, MACROCRYSTALLINE
CAPSULE;ORAL
MACRODANTIN
ALVOGEN INC
25MG
25MG
50MG
+
100MG
ALVOGEN MALTA
25MG
50MG
+
100MG
NITROFURANTOIN
ACTAVIS LABS FL INC
25MG
50MG
100MG

AB

NITROFURANTOIN; NITROFURANTOIN, MACROCRYSTALLINE


CAPSULE;ORAL
NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)
WATSON LABS INC
75MG;25MG

>D> AB
AB
>D> AB
>D> AB
>A> AB
>A> AB
>A> AB

CAHN

CTEC

CAHN

CAHN

CAHN

CAHN

CAHN

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT

October

2015

1 -68

NORETHINDRONE
TABLET;ORAL-28
NOR-QD
AB1
+
ACTAVIS LABS UT INC

0.35MG

N 017060

001

Mar CAHN

NORGESTREL
TABLET;ORAL
OVRETTE
@ LABORATOIRE HRA

0.075MG

N 017031

001

Jun CAHN

100,000 UNITS/GM

A 061966

001

Jun CMFD

100,000 UNITS/ML
100,000 UNITS/ML

A 062349
A 062776

001 Jul 14, 1982


001 Dec 17, 1987

Apr CAHN
Apr CAHN

A 062367

001 May 28, 1985

Mar CMFD

A 062733

001 Mar 09, 1987

Mar CMFD

A 076093

003 Sep 02, 2003

Jul CMFD

A 202295
A 202295
A 202295
A 202295
A 202295
A 202295
A 077301

001
002
003
004
005
006
001

Oct
Oct
Oct
Oct
Oct
Oct
Apr

20,
20,
20,
20,
20,
20,
29,

2015
2015
2015
2015
2015
2015
2015

Oct
Oct
Oct
Oct
Oct
Oct
Apr

NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA

A 203044
A 203044
A 203044
A 203044
A 202937
A 202937
A 202937
A 202937

001
002
003
004
001
002
003
004

Feb
Feb
Feb
Feb
Mar
Mar
Mar
Mar

20,
20,
20,
20,
02,
02,
02,
02,

2015
2015
2015
2015
2015
2015
2015
2015

Feb
Feb
Feb
Feb
Feb
Feb
Feb
Feb

NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA

N 206162

001 Dec 19, 2014

Jan CTNA

N 206756

001 May 21, 2015

May NEWA

A 090848

001 Jul 13, 2015

Jun NEWA

N 021545

001 Dec 22, 2004

Jun CFTG

AT

AA

NYSTATIN
CREAM;TOPICAL
NYSTATIN
G AND W LABS INC
SUSPENSION;ORAL
NYSTATIN
G AND W LABS INC
@

AT

NYSTATIN; TRIAMCINOLONE ACETONIDE


CREAM;TOPICAL
MYKACET
G AND W LABS INC
100,000 UNITS/GM;0.1%
OINTMENT;TOPICAL
MYKACET
G AND W LABS INC
100,000 UNITS/GM;0.1%

AB

OFLOXACIN
TABLET;ORAL
OFLOXACIN
LARKEN LABS

AT

>A>
>A>
>A>
>A>
>A>
>A>

10

AB
AB
AB
AB
AB
AB
AB

AB
AB
AB
AB
AB
AB
AB
AB

400MG

OLANZAPINE
TABLET;ORAL
OLANZAPINE
ALKEM LABS LTD

2.5MG
5MG
7.5MG
10MG
15MG
20MG
IVAX PHARMS INC
20MG
TABLET, ORALLY DISINTEGRATING;ORAL
OLANZAPINE
MACLEODS PHARMS LTD
5MG
10MG
15MG
20MG
ORCHID HLTHCARE
5MG
10MG
15MG
20MG

OLAPARIB
CAPSULE;ORAL
LYNPARZA
ASTRAZENECA PHARMS

50MG

OLODATEROL HYDROCHLORIDE; TIOTROPIUM BROMIDE


SPRAY, METERED;INHALATION
STIOLTO RESPIMAT
+
BOEHRINGER INGELHEIM EQ 0.0025MG BASE/INH;EQ 0.0025MG
BASE/INH

AT
AT

OLOPATADINE HYDROCHLORIDE
SOLUTION/DROPS;OPHTHALMIC
OLOPATADINE HYDROCHLORIDE
BARR LABS INC
EQ 0.2% BASE
PATADAY
+
ALCON PHARMS LTD
EQ 0.2% BASE

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT

AB
AB
AB
AB

2015

N 206276

001 Jan 30, 2015

Jan NEWA

OMBITASVIR; PARITAPREVIR; RITONAVIR



TABLET;ORAL

TECHNIVIE

+
ABBVIE INC
12.5MG;75MG;50MG
+
12.5MG;75MG;50MG

N 207931
N 207931

001 Jul 24, 2015


001 Jul 25, 2015

Aug CMS1

Jul NEWA

OMEPRAZOLE

CAPSULE, DELAYED REL PELLETS;ORAL

OMEPRAZOLE

AUROBINDO PHARMA USA
10MG
20MG
40MG
LUPIN LTD
40MG

A 203270
A 203270
A 203270
A 202384

001
002
003
001

Aug
Aug
Aug
Aug

AB
AB

A 078602
A 078602

001 Feb 24, 2011


002 Feb 24, 2011

Apr CAHN

Apr CAHN

AB
AB

N 020781
N 020781

001 Jan 27, 1999


002 Jan 27, 1999

Mar CAHN

Mar CAHN

A 206846
A 078288
A 077365

001 Jul 13, 2015


001 Feb 22, 2013
001 Dec 26, 2006

Jun NEWA

Apr CAHN

Jun CAHN

A 078287
A 077541
A 078014

001 Feb 22, 2013


001 Dec 26, 2006
001 Mar 21, 2008

Apr CAHN

Jun CAHN

Jan DISC

N 020007

001 Jan 04, 1991

Mar CAHN

N 020007

003 Dec 10, 1993

Mar CAHN

N 020605

001 Jan 24, 1997

Mar CAHN

N 020103
N 020103
N 020103

001 Dec 31, 1992


002 Dec 31, 1992
003 Aug 27, 1999

Mar CAHN
Mar CAHN
Mar CAHN

30MG/ML
30MG/ML

N 013055
N 013055

001
001

Apr CAHN
Mar DISC

30MG/ML

A 040484

001 May 24, 2006

Mar CRLD

OXACILLIN SODIUM
CAPSULE;ORAL
OXACILLIN SODIUM
@ ANI PHARMS INC
@

EQ 250MG BASE
EQ 500MG BASE

A 062222
A 062222

001
002

Aug CAHN
Aug CAHN

OXANDROLONE
TABLET;ORAL
OXANDRIN
GEMINI LABS LLC
+

2.5MG
10MG

N 013718
N 013718

001
002 Nov 05, 2001

Aug CAHN
Aug CAHN

ONDANSETRON

TABLET, ORALLY DISINTEGRATING;ORAL

ONDANSETRON

SUN PHARM INDS LTD
4MG
8MG
ZOFRAN ODT

NOVARTIS PHARMS CORP
4MG
+
8MG

AB
AB
AB

ONDANSETRON HYDROCHLORIDE

INJECTABLE;INJECTION

ONDANSETRON HYDROCHLORIDE

ACCORD HLTHCARE
EQ 2MG BASE/ML
CLARIS PHARMASERVICE
EQ 2MG BASE/ML
EUROHLTH INTL SARL
EQ 2MG BASE/ML
ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE

CLARIS PHARMASERVICE
EQ 2MG BASE/ML
EUROHLTH INTL SARL
EQ 2MG BASE/ML
@ TARO PHARMS IRELAND
EQ 2MG BASE/ML
ZOFRAN

+
NOVARTIS PHARMS CORP
EQ 2MG BASE/ML
ZOFRAN PRESERVATIVE FREE

+
NOVARTIS PHARMS CORP EQ 2MG BASE/ML
SOLUTION;ORAL
ZOFRAN
+
NOVARTIS PHARMS CORP EQ 4MG BASE/5ML
TABLET;ORAL
ZOFRAN
NOVARTIS PHARMS CORP EQ 4MG BASE
EQ 8MG BASE
+
EQ 24MG BASE

AP

ORPHENADRINE CITRATE
INJECTABLE;INJECTION
NORFLEX
@ IGI LABS INC
@ MEDICIS
ORPHENADRINE CITRATE
+
AKORN

AP
AP
AP
AP
AP

AP
AP

AA

AB
AB

1 -69

October

SOLUTION/DROPS;OPHTHALMIC

PAZEO

+
ALCON RES LTD
EQ 0.7% BASE

10

Aug
Aug
Aug
Aug

19,
19,
19,
25,

2015
2015
2015
2015

NEWA

NEWA

NEWA

NEWA

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT

AB

AB

OXCARBAZEPINE

SUSPENSION;ORAL

OXCARBAZEPINE

SUN PHARM INDS LTD

OXYBUTYNIN CHLORIDE

GEL;TRANSDERMAL

GELNIQUE

+
ACTAVIS LABS UT INC

AB
AB

AA
AA
AA

2015

A 078734

001 Jun 26, 2009

Apr CAHN

N 021351

002 Feb 26, 2003

Mar CAHN

N 202513

001 Dec 07, 2011

Mar CAHN

10%(100MG/PACKET)

N 022204

001 Jan 27, 2009

Mar CAHN

5MG
5MG

A 202773
A 204752

001 Aug 17, 2015


001 Aug 24, 2015

Aug NEWA

Aug NEWA

5MG/5ML
100MG/5ML
5MG/5ML

A 204979
A 204603
A 206456

001 Jun 01, 2015


001 Apr 29, 2015
001 Jun 16, 2015

May NEWA

Apr NEWA

Jun NEWA

5MG
7.5MG
5MG
7.5MG
5MG
7.5MG

N 202080
N 202080
N 202080
N 202080
N 202080
N 202080

001
002
001
002
001
002

Jun
Jun
Jun
Jun
Jun
Jun

17,
17,
17,
17,
17,
17,

2011
2011
2011
2011
2011
2011

Mar
Mar
May
May
Jul
Jul

CTNA

CTNA

CAHN

CAHN

CAHN

CAHN

A 076636
A 202662
A 202662
A 202662
A 202662
A 077712
A 077712

003
001
002
003
004
004
005

Apr
Sep
Sep
Sep
Sep
Apr
Apr

07,
22,
22,
22,
22,
13,
13,

2015
2015
2015
2015
2015
2015
2015

Mar
Sep
Sep
Sep
Sep
Mar
Mar

NEWA

NEWA

NEWA

NEWA

NEWA

NEWA

NEWA

A 203506
A 203506
A 203506
A 203506
A 203506
A 203506
A 203506

001
002
003
004
005
006
007

Apr
Apr
Apr
Apr
Apr
Apr
Apr

24,
24,
24,
24,
24,
24,
24,

2015
2015
2015
2015
2015
2015
2015

Apr
Apr
Apr
Apr
Apr
Apr
Apr

NEWA

NEWA

NEWA

NEWA

NEWA

NEWA

NEWA

OXYBUTYNIN

FILM, EXTENDED RELEASE;TRANSDERMAL

OXYTROL

+
ACTAVIS LABS UT INC
3.9MG/24HR
GEL, METERED;TRANSDERMAL

GELNIQUE 3%

+
ACTAVIS LABS UT INC
3%

OXYCODONE HYDROCHLORIDE

CAPSULE;ORAL

OXYCODONE HYDROCHLORIDE

AVANTHI INC
NOVEL LABS INC
SOLUTION;ORAL

OXYCODONE HYDROCHLORIDE

ANI PHARMS INC
NOVEL LABS INC
WOCKHARDT BIO AG
TABLET;ORAL

OXAYDO

ACURA PHARMS INC
EGALET LTD
EGALET US INC

OXYCODONE HYDROCHLORIDE

ACTAVIS ELIZABETH
5MG
EPIC PHARMA LLC
5MG
10MG
15MG
30MG
VINTAGE PHARMS
10MG
20MG

AB
AB
AB
AB
AB
AB
AB

AB
AB
AB
AB
AB
AB
AB

OXYMORPHONE HYDROCHLORIDE

TABLET, EXTENDED RELEASE;ORAL

OXYMORPHONE HYDROCHLORIDE

SUN PHARM INDS LTD
5MG
7.5MG
10MG
15MG
20MG
30MG
40MG

AP
AP

OXYTOCIN

INJECTABLE;INJECTION

OXYTOCIN

+
EUROHLTH INTL SARL
+
PALBOCICLIB

CAPSULE;ORAL

IBRANCE

PFIZER INC
+

1 -70

October

300MG/5ML

10

10USP UNITS/ML (10USP UNITS/ML)


N 018243
100USP UNITS/10ML (10USP UNITS/ML) N 018243

001
002 Jan 10, 2007

Feb CAHN

Feb CAHN

75MG
100MG
125MG

001 Feb 03, 2015


002 Feb 03, 2015
003 Feb 03, 2015

Feb NEWA

Feb NEWA

Feb NEWA

N 207103
N 207103
N 207103

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT

AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB

AP
AP

AP
AP
AP

2015

N 021999
N 021999
N 021999
N 021999

006
001
002
003

Aug
Dec
Dec
Dec

26,
19,
19,
19,

2008
2006
2006
2006

Jul
Jul
Jul
Jul

CFTG
CFTG
CFTG
CFTG

A 202645
A 202645
A 202645
A 202645
A 203802
A 203802
A 203802
A 203802

001
002
003
004
001
002
003
004

Aug
Aug
Aug
Aug
Sep
Sep
Sep
Sep

03,
03,
03,
03,
24,
24,
24,
24,

2015
2015
2015
2015
2015
2015
2015
2015

Jul
Jul
Jul
Jul
Sep
Sep
Sep
Sep

NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA

PALIPERIDONE PALMITATE
SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR
INVEGA TRINZA
JANSSEN PHARMS
273MG/0.875ML (273MG/0.875ML)
410MG/1.315ML (311.79MG/ML)
546MG/1.75ML (312MG/ML)
+
819MG/2.625ML (312MG/ML)

N 207946
N 207946
N 207946
N 207946

001
002
003
004

May
May
May
May

18,
18,
18,
18,

2015
2015
2015
2015

May
May
May
May

NEWA
NEWA
NEWA
NEWA

PALONOSETRON HYDROCHLORIDE
INJECTABLE;INTRAVENOUS
ALOXI
+
HELSINN HLTHCARE

N 021372

002 Feb 29, 2008

Sep CFTG

N 021372

001 Jul 25, 2003

Sep CFTG

A 202521

001 Oct 13, 2015

Sep NEWA

A 090713

002 Oct 13, 2015

Sep NEWA

A 090713

001 Oct 13, 2015

Sep NEWA

1MG/ML
2MG/ML
2MG/ML
2MG/ML

A 072210
A 072211
A 072212
A 072213

001
001
001
001

Mar
Mar
Mar
Mar

10MG
15MG
20MG

N 205353
N 205353
N 205353

001 Feb 23, 2015


002 Feb 23, 2015
003 Feb 23, 2015

Feb NEWA
Feb NEWA
Feb NEWA

N 205353
N 205353
N 205353
N 205353
N 205353
N 205353

001
001
002
002
003
003

Mar
Mar
Mar
Mar
Mar
Mar

A 090296

001 Jul 14, 2015

Jun NEWA

A 078281

001 Jan 20, 2011

Mar CAHN

PALIPERIDONE

TABLET, EXTENDED RELEASE;ORAL

INVEGA
JANSSEN PHARMS
1.5MG
3MG
+
6MG
9MG
PALIPERIDONE
ACTAVIS LABS FL INC
1.5MG
3MG
6MG
9MG
MYLAN PHARMS INC
1.5MG
3MG
6MG
9MG

EQ 0.075MG BASE/1.5ML (EQ 0.05MG


BASE/ML)
+
EQ 0.25MG BASE/5ML (EQ 0.05MG
BASE/ML)
PALONOSETRON HYDROCHLORIDE
SANDOZ INC
EQ 0.25MG BASE/5ML (EQ 0.05MG
BASE/ML)
TEVA PHARMS USA
EQ 0.075MG BASE/1.5ML (EQ 0.05MG
BASE/ML)
EQ 0.25MG BASE/5ML (EQ 0.05MG
BASE/ML)

PANOBINOSTAT
CAPSULE;ORAL
FARYDAK
NOVARTIS PHARMS CORP
+
PANOBINOSTAT LACTATE
CAPSULE;ORAL
FARYDAK
NOVARTIS PHARMS CORP

+
+

AB

EQ
EQ
EQ
EQ
EQ
EQ

10MG
10MG
15MG
15MG
20MG
20MG

BASE
BASE
BASE
BASE
BASE
BASE

PANTOPRAZOLE SODIUM
INJECTABLE;IV (INFUSION)
PANTOPRAZOLE SODIUM
SANDOZ INC
EQ 40MG BASE/VIAL
TABLET, DELAYED RELEASE;ORAL
PANTOPRAZOLE SODIUM
KREMERS URBAN PHARMS EQ 20MG BASE

1 -71

October

PANCURONIUM BROMIDE
INJECTABLE;INJECTION
PANCURONIUM BROMIDE
@ IGI LABS INC
@
@
@

AP

10

Mar
Mar
Mar
Mar

Feb
Feb
Feb
Feb
Feb
Feb

31,
31,
31,
31,

23,
23,
23,
23,
23,
23,

1988
1988
1988
1988

2015
2015
2015
2015
2015
2015

CAHN
CAHN
CAHN
CAHN

CAIN
CPOT
CAIN
CPOT
CAIN
CPOT

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT

2015

A 078281
A 200794
A 200794

002 Jan 20, 2011


001 May 02, 2012
002 May 02, 2012

Mar CAHN
Apr CAHN
Apr CAHN

1MCG
2MCG
4MCG

A 202539
A 202539
A 202539

001 Mar 27, 2014


002 Mar 27, 2014
003 Mar 27, 2014

Jan CAHN
Jan CAHN
Jan CAHN

EQ 8.4GM BASE/PACKET
EQ 16.8GM BASE/PACKET
EQ 25.2GM BASE/PACKET

N 205739
N 205739
N 205739

001 Oct 21, 2015


002 Oct 21, 2015
003 Oct 21, 2015

Oct NEWA
Oct NEWA
Oct NEWA

EQ 200MG BASE
EQ 400MG BASE
EQ 400MG BASE

N 022465
N 022465
N 022465

001 Oct 19, 2009


002 Oct 19, 2009
002 Oct 19, 2009

Mar CAHN
Aug DISC
Mar CAHN

A 075028

001 Jul 20, 1998

Feb CAHN

A 088021

001 Sep 21, 1982

Jan DISC

N 018074

001

Jan CTEC

AB

PHENOXYBENZAMINE HYDROCHLORIDE
CAPSULE;ORAL
DIBENZYLINE
+
CONCORDIA PHARMS INC 10MG

N 008708

001

Jun CAHN

AA

PHENTERMINE HYDROCHLORIDE
CAPSULE;ORAL
PHENTERMINE HYDROCHLORIDE
MIKAH PHARMA LLC
37.5MG

A 040228

001 Jun 19, 1997

Jun CMFD

PHENYLEPHRINE HYDROCHLORIDE
SOLUTION/DROPS;OPHTHALMIC
PHENYLEPHRINE HYDROCHLORIDE
+
AKORN INC
2.5%
2.5%
+
10%
10%
+
PARAGON BIOTECK
2.5%

N 207926
N 207926
N 207926
N 207926
N 203510

001
001
002
002
001

Sep
Jan
Sep
Jan
Sep

AA

PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE


SYRUP;ORAL
PROMETH VC PLAIN
+
G AND W LABS INC
5MG/5ML;6.25MG/5ML

A 088761

001 Nov 08, 1984

Jul CAHN

A 040759
A 040732

001 Dec 18, 2007


001 Jan 30, 2008

Jun DISC
Jun DISC

AB

PHENYTOIN SODIUM
CAPSULE;ORAL
EXTENDED PHENYTOIN SODIUM
@ WOCKHARDT
30MG EXTENDED
@ WOCKHARDT USA
100MG EXTENDED
PHENYTOIN SODIUM
AUROBINDO PHARMA LTD 100MG EXTENDED

A 204309

001 Jun 10, 2015

May NEWA

AB
AB
AB

AB
AB
AB
>A>
>A>
>A>
>A>
>A>
>A>

PARICALCITOL
CAPSULE;ORAL
PARICALCITOL
BANNER LIFE SCIENCES

PATIROMER SORBITEX CALCIUM


POWDER;ORAL
VELTASSA
RELYPSA INC
+
PAZOPANIB HYDROCHLORIDE
TABLET;ORAL
VOTRIENT
+
NOVARTIS PHARMS CORP
@

AB

PENTOXIFYLLINE
TABLET, EXTENDED RELEASE;ORAL
PENTOXIFYLLINE
VALEANT PHARMS
400MG
PHENDIMETRAZINE TARTRATE
CAPSULE, EXTENDED RELEASE;ORAL
BONTRIL
@ VALEANT
105MG
PHENDIMETRAZINE TARTRATE
+
SANDOZ
105MG

1 -72

October

TABLET, DELAYED RELEASE;ORAL



PANTOPRAZOLE SODIUM
EQ 40MG BASE
SUN PHARM INDS LTD
EQ 20MG BASE
EQ 40MG BASE

10

Jan
Jan
Jan
Jan
Mar

15,
15,
15,
15,
21,

2015
2015
2015
2015
2013

CRLD
NEWA
CRLD
NEWA
CRLD

October

2015

1 -73

50MG/ML

A 084307

001

Feb CAHN

1MG/0.5ML
10MG/ML

N 012223
N 012223

002
001

Apr CAHN
Apr CAHN

N 018796

001 Oct 01, 1984

Aug DISC

A 076746

001 Nov 16, 2004

Mar CAHN

1MG
2MG

N 017473
N 017473

003 Aug 27, 1997


001 Jul 31, 1984

Sep CFTG
Sep CFTG

1MG
2MG

A 204521
A 204521

001 Sep 28, 2015


002 Sep 28, 2015

Sep NEWA
Sep NEWA

5MG
5MG
5MG
10MG
10MG
10MG

A 073661
A 073687
A 074123
A 073661
A 073687
A 074123

001
001
001
002
002
002

Apr
Apr
Apr
Apr
Apr
Apr

PIRBUTEROL ACETATE
AEROSOL, METERED;INHALATION
MAXAIR
@ MEDICIS
EQ 0.2MG BASE/INH

N 020014

001 Nov 30, 1992

Jan DISC

PIRFENIDONE
CAPSULE;ORAL
ESBRIET
+
GENENTECH INC

267MG

N 022535

001 Oct 15, 2014

Feb CAHN

10MG
20MG

A 074116
A 074118

001 Jun 15, 1993


001 Jun 15, 1993

May CAHN
May CAHN

0.5%

N 020529

001 Mar 13, 1997

Feb CAHN

0.5%

N 019795

001 Dec 13, 1990

Jan CAHN

0.5%

A 090184

001 Jul 21, 2010

May CAHN

A 064211

001 Apr 13, 1998

Jan CAHN

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT

AP

INJECTABLE;INJECTION
PHENYTOIN SODIUM
+
EUROHLTH INTL SARL
PHYTONADIONE
INJECTABLE;INJECTION
AQUAMEPHYTON
@ IGI LABS INC
@

AB

AB
AB
AB
AB

PILOCARPINE HYDROCHLORIDE
GEL;OPHTHALMIC
PILOPINE HS
@ ALCON
4%
TABLET;ORAL
PILOCARPINE HYDROCHLORIDE
ELAN PHARMA INTL LTD 5MG
PIMOZIDE
TABLET;ORAL
ORAP
TEVA
+
PIMOZIDE
PAR PHARM

PINDOLOL
TABLET;ORAL
PINDOLOL
@ G AND W LABS INC
@
@
@
@
@

AB
AB

10

PIROXICAM
CAPSULE;ORAL
PIROXICAM
MYLAN PHARMS INC

AT

PODOFILOX
GEL;TOPICAL
CONDYLOX
+
ACTAVIS LABS UT INC
SOLUTION;TOPICAL
CONDYLOX
+
ACTAVIS LABS UT INC
PODOFILOX
BAUSCH AND LOMB INC

AT

POLYMYXIN B SULFATE; TRIMETHOPRIM SULFATE


SOLUTION/DROPS;OPHTHALMIC
TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE
ALCON RES LTD
10,000 UNITS/ML;EQ 1MG BASE/ML

AT

Oct
Feb
Apr
Oct
Feb
Apr

31,
26,
17,
31,
26,
17,

1993
1993
1997
1993
1993
1997

CAHN
CAHN
CAHN
CAHN
CAHN
CAHN

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT

PONATINIB HYDROCHLORIDE
TABLET;ORAL
ICLUSIG
ARIAD

AB
AB

AB1
AB2
AB2
>A> AB2
>A> AB2

EQ 30MG BASE

POTASSIUM CHLORIDE
CAPSULE, EXTENDED RELEASE;ORAL
KLOR-CON
UPSHER SMITH
8MEQ
10MEQ
FOR SOLUTION;ORAL
POTASSIUM CHLORIDE
PHARMA RES SOFTWARE
20MEQ
TABLET, EXTENDED RELEASE;ORAL
POTASSIUM CHLORIDE
ADARE PHARMS INC
20MEQ
MYLAN PHARMS INC
8MEQ
10MEQ
PADDOCK LLC
8MEQ
10MEQ

10

1 -74

October

2015

N 203469

003 Apr 23, 2015

Apr NEWA

A 203106
A 203106

001 Jul 10, 2015


002 Jul 10, 2015

Jun NEWA

Jun NEWA

N 208019

001 Aug 19, 2015

Aug NEWA

A 076368
A 204662
A 204662
A 205993
A 205993

001
001
002
001
002

Jul
Feb
Feb
Oct
Oct

A 090781

006 Sep 11, 2015

Aug NEWA

A 203354
A 203354
A 203354
A 203354
A 203354

001
002
003
004
005

Jul
Jul
Jul
Jul
Jul

Aug
Aug
Aug
Nov
Nov

18,
21,
21,
05,
05,

2004
2014
2014
2015
2015

CAHN

CPOT

CPOT

NEWA

NEWA

AB
AB
AB
AB
AB

PRAMIPEXOLE DIHYDROCHLORIDE
TABLET;ORAL
PRAMIPEXOLE DIHYDROCHLORIDE
GLENMARK GENERICS
0.75MG
TABLET, EXTENDED RELEASE;ORAL
PRAMIPEXOLE DIHYDROCHLORIDE
DR REDDYS LABS LTD
0.375MG
0.75MG
1.5MG
3MG
4.5MG

AB

PREDNICARBATE
OINTMENT;TOPICAL
DERMATOP
+
VALEANT PHARMS NORTH

0.1%

N 019568

001 Sep 23, 1991

Apr CAHN

PREDNISONE
TABLET;ORAL
PREDNISONE
@ HIKMA PHARMS

1MG

A 040890

001 Nov 01, 2010

Aug DISC

25MG
50MG
75MG
100MG
150MG
200MG
225MG
300MG

N 021446
N 021446
N 021446
N 021446
N 021446
N 021446
N 021446
N 021446

001
002
003
004
005
006
007
008

Apr
Apr
Apr
Apr
Apr
Apr
Apr
Apr

A 089219
A 089221

001 Jul 01, 1986


001 Jul 01, 1986

Jun CAHN

Jun CAHN

A 089369
A 089370
A 089371

001 Aug 14, 1987


001 Jan 09, 1987
001 Aug 14, 1987

Jun CAHN

Jun CAHN

Jun CAHN

AB

PREGABALIN
CAPSULE;ORAL
LYRICA
PF PRISM CV

PROCAINAMIDE HYDROCHLORIDE
CAPSULE;ORAL
PROCAINAMIDE HYDROCHLORIDE
@ IDT AUSTRALIA LTD
250MG
@
500MG
TABLET, EXTENDED RELEASE;ORAL
PROCAINAMIDE HYDROCHLORIDE
@ IDT AUSTRALIA LTD
250MG
@
500MG
@
750MG

Aug
Aug
Aug
Aug
Aug

Dec
Dec
Dec
Dec
Dec
Dec
Dec
Dec

07,
07,
07,
07,
07,

30,
30,
30,
30,
30,
30,
30,
30,

2015
2015
2015
2015
2015

2004
2004
2004
2004
2004
2004
2004
2004

NEWA

NEWA

NEWA

NEWA

NEWA

CTEC

CTEC

CTEC

CTEC

CTEC

CTEC

CTEC

CTEC

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT

AP

AB
AB

AO

PROGESTERONE

CAPSULE;ORAL

PROGESTERONE

BANNER LIFE SCIENCES
GEL;VAGINAL

CRINONE

ACTAVIS LABS UT INC
+
INJECTABLE;INJECTION

PROGESTERONE

+
ACTAVIS LABS UT INC

2015

A 089903

001 Aug 29, 1989

Feb CAHN

100MG
200MG

A 200900
A 200900

001 Aug 16, 2013


002 Aug 16, 2013

Jan CAHN

Jan CAHN

4%
8%

N 020701
N 020701

001 Jul 31, 1997


002 Jul 31, 1997

Feb CAHN

Feb CAHN

50MG/ML

N 017362

002

Mar CAHN

A 083312
A 083312

001
002

Jun CAHN

Jun CAHN

N 010926
N 010926

002
001

Apr CAHN

Apr CAHN

A 040673
A 040673
A 040673

001 Mar 05, 2008


002 Mar 05, 2008
003 Mar 05, 2008

Mar CAHN

Mar CAHN

Mar CAHN

A 202688
A 202688
A 202688

001 Aug 24, 2015


002 Aug 24, 2015
003 Aug 24, 2015

Aug NEWA

Aug NEWA

Aug NEWA

A 040512
A 040512
A 205650

002 Jul 20, 2005


001 Oct 08, 2003
001 Jun 22, 2015

Aug CAHN

Aug CAHN

Jun NEWA

AB
AB
AB

PROMETHAZINE HYDROCHLORIDE

INJECTABLE;INJECTION

PROMETHAZINE HYDROCHLORIDE

+
EUROHLTH INTL SARL
25MG/ML
+
50MG/ML
SUPPOSITORY;RECTAL

PHENERGAN

@ DELCOR ASSET CORP
12.5MG
@
25MG
TABLET;ORAL

PROMETHAZINE HYDROCHLORIDE

HERITAGE PHARMA
12.5MG
25MG
50MG

AB
AB
AB

PROPAFENONE HYDROCHLORIDE

CAPSULE, EXTENDED RELEASE;ORAL

PROPAFENONE HYDROCHLORIDE

WATSON LABS INC
225MG
325MG
425MG

AP
AP

AB

AB
AB
AB

AB
AB
AB

1 -75

October

PROCHLORPERAZINE EDISYLATE

INJECTABLE;INJECTION

PROCHLORPERAZINE EDISYLATE

+
EUROHLTH INTL SARL
EQ 5MG BASE/ML

10

PYRIDOSTIGMINE BROMIDE

TABLET;ORAL

PYRIDOSTIGMINE BROMIDE

@ ANI PHARMS INC
30MG
@
60MG
ZYDUS PHARMS USA INC
60MG
TABLET, EXTENDED RELEASE;ORAL

MESTINON
+
VALEANT PHARMS LLC
180MG
PYRIDOSTIGMINE BROMIDE
ALVOGEN INC
180MG
IMPAX LABS INC
180MG

N 011665

001

Jun CFTG

A 204737
A 203184

001 Jun 26, 2015


001 Sep 15, 2015

Jun NEWA
Aug NEWA

PYRIMETHAMINE
TABLET;ORAL
DARAPRIM
+
TURING PHARMS AG

25MG

N 008578

001

Aug CAHN

QUAZEPAM
TABLET;ORAL
DORAL
@ SCIECURE PHARMA INC

15MG

N 018708

001 Dec 27, 1985

Jun DISC

EQ
EQ
EQ
EQ

N 020639
N 020639
N 020639
N 020639

001
007
002
004

May
May
May
May

QUETIAPINE FUMARATE
TABLET;ORAL
SEROQUEL
+
ASTRAZENECA PHARMS

25MG BASE
50MG BASE
100MG BASE
150MG BASE

Sep
Oct
Sep
Dec

26,
04,
26,
20,

1997
2005
1997
1998

CAHN
CAHN
CAHN
CAHN

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT

10

1 -76

October

2015

N 020639
N 020639
N 020639

003 Sep 26, 1997


005 Jul 26, 2000
006 Oct 04, 2005

May CAHN
May CAHN
May CAHN

A 076607
A 076607
A 076607
A 076607

001
002
003
004

Apr
Apr
Apr
Apr

A 088431

001 Jan 06, 1984

Jun CAHN

A 083640
A 085632

001
001

Jun CAHN
Jun CAHN

A 040045

001 Jun 30, 1994

Apr CAHN

A 203729
A 203112
A 204372

001 Jul 15, 2015


001 Apr 24, 2015
001 Jul 22, 2015

Jun NEWA
Apr NEWA
Jul NEWA

TABLET;ORAL
SEROQUEL
AB
AB
AB

AB
AB
AB
AB

EQ 200MG BASE
EQ 300MG BASE
EQ 400MG BASE

QUINAPRIL HYDROCHLORIDE
TABLET;ORAL
QUINAPRIL HYDROCHLORIDE
SUN PHARM INDS LTD
EQ
EQ
EQ
EQ

5MG BASE
10MG BASE
20MG BASE
40MG BASE

QUINIDINE GLUCONATE
TABLET, EXTENDED RELEASE;ORAL
QUINIDINE GLUCONATE
@ CYCLE PHARMS LTD
324MG
QUINIDINE SULFATE
TABLET;ORAL
QUINIDINE SULFATE
@ CYCLE PHARMS LTD
200MG
@
300MG
TABLET, EXTENDED RELEASE;ORAL
QUINIDINE SULFATE
+
G AND W LABS INC
300MG

Dec
Dec
Dec
Dec

15,
15,
15,
15,

2004
2004
2004
2004

CAHN
CAHN
CAHN
CAHN

AB
AB
AB

QUININE SULFATE
CAPSULE;ORAL
QUININE SULFATE
AMNEAL PHARMS
LUPIN LTD
RICONPHARMA LLC

AB

RABEPRAZOLE SODIUM
TABLET, DELAYED RELEASE;ORAL
RABEPRAZOLE SODIUM
AMNEAL PHARMS
20MG

A 204179

001 Jul 31, 2015

Jul NEWA

AB
AB

RALOXIFENE HYDROCHLORIDE
TABLET;ORAL
RALOXIFENE HYDROCHLORIDE
AUROBINDO PHARMA LTD 60MG
WATSON LABS INC
60MG

A 204310
A 200825

001 Aug 28, 2015


001 Jan 21, 2015

Aug NEWA
Jan NEWA

AB

RAMELTEON
TABLET;ORAL
RAMELTEON
ACTAVIS LABS FL INC

A 091610

001 Aug 19, 2015

Aug NEWA

N 019090

001 Oct 19, 1984

Jun CAHN

A 075439
A 075439

001 Apr 19, 2000


002 Apr 19, 2000

Apr CAHN
Apr CAHN

A 091517
A 091517
A 091517

001 Apr 24, 2015


002 Apr 24, 2015
003 Apr 24, 2015

Apr NEWA
Apr NEWA
Apr NEWA

AP

AB
AB
AB

324MG
324MG
324MG

8MG

RANITIDINE HYDROCHLORIDE
INJECTABLE;INJECTION
ZANTAC
+
CONCORDIA PHARMS INC
EQ 25MG BASE/ML
TABLET;ORAL
RANITIDINE HYDROCHLORIDE
@ SUN PHARM INDS LTD
EQ 150MG BASE
@
EQ 300MG BASE
REPAGLINIDE
TABLET;ORAL
REPAGLINIDE
STANDARD CHEM PHARM

0.5MG
1MG
2MG

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT

RIBAVIRIN

CAPSULE;ORAL

REBETOL

@ MERCK SHARP DOHME

200MG

10

1 -77

October

2015

N 020903

001 Jun 03, 1998

Jun DISC

N 022560

001 Oct 08, 2010

May CFTG

A 203217

001 May 18, 2015

May NEWA

Apr
Apr
Apr
Apr
Apr

AB

RISEDRONATE SODIUM

TABLET, DELAYED RELEASE;ORAL

ATELVIA

+
WARNER CHILCOTT LLC
35MG
RISEDRONATE SODIUM

TEVA PHARMS USA
35MG

AB
AB
AB
AB
AB

RISPERIDONE

TABLET, ORALLY DISINTEGRATING;ORAL

RISPERIDONE

SUN PHARM INDS LTD
0.5MG
1MG
2MG
3MG
4MG

A 077542
A 077542
A 077542
A 078474
A 078474

001
002
003
001
002

RIVAROXABAN

TABLET;ORAL

XARELTO

JANSSEN PHARMS

N 022406

001 Jul 01, 2011

Apr CRLD

N 022083
N 022083
N 022083

001 Jul 06, 2007


002 Jul 06, 2007
005 Aug 31, 2012

Aug CFTG
Aug CFTG
Aug CFTG

A 204403
A 204403
A 204403
A 204403
A 204403
A 204403

001
002
003
001
002
003

Sep
Sep
Aug
Sep
Sep
Aug

03,
03,
31,
03,
03,
31,

2015
2015
2015
2015
2015
2015

Aug
Aug
Aug
Aug
Aug
Aug

NEWA
NEWA
NEWA
CAHN
CAHN
CAHN

A 090879
A 090879
A 090879
A 090879

001
002
003
004

Jun
Jun
Jun
Jun

10,
10,
10,
10,

2015
2015
2015
2015

May
May
May
May

NEWA
NEWA
NEWA
NEWA

A 203334
A 203334

001 Oct 16, 2015


002 Oct 16, 2015

Oct NEWA
Oct NEWA

50MG/5ML (10MG/ML)
100MG/10ML (10MG/ML)

A 091458
A 091458

001 Jul 28, 2010


002 Jul 28, 2010

Aug CAHN
Aug CAHN

ROFLUMILAST
TABLET;ORAL
DALIRESP
+
ASTRAZENECA PHARMS

500MCG

N 022522

001 Feb 28, 2011

Mar CAHN

ROLAPITANT HYDROCHLORIDE
TABLET;ORAL
VARUBI
+
TESARO INC

EQ 90MG BASE

N 206500

001 Sep 01, 2015

Sep NEWA

AB

AB
AB
AB
AB
AB
AB
AB
AB
AB

AB
AB
AB
AB

>A> AB
>A> AB

AP
AP

10MG

RIVASTIGMINE

FILM, EXTENDED RELEASE;TRANSDERMAL

EXELON
NOVARTIS
4.6MG/24HR
+
9.5MG/24HR
13.3MG/24HR
RIVASTIGMINE
ALVOGEN INC
4.6MG/24HR
9.5MG/24HR
13.3MG/24HR
ALVOGEN PINE BROOK
4.6MG/24HR
9.5MG/24HR
13.3MG/24HR
RIVASTIGMINE TARTRATE
CAPSULE;ORAL
RIVASTIGMINE TARTRATE
ORCHID HLTHCARE

EQ
EQ
EQ
EQ

1.5MG BASE
3MG BASE
4.5MG BASE
6MG BASE

RIZATRIPTAN BENZOATE
TABLET, ORALLY DISINTEGRATING;ORAL
RIZATRIPTAN BENZOATE
JUBILANT GENERICS
EQ 5MG BASE
EQ 10MG BASE
ROCURONIUM BROMIDE
INJECTABLE;INJECTION
ROCURONIUM BROMIDE
SAGENT PHARMS

Aug
Aug
Aug
Aug
Aug

06,
06,
06,
06,
06,

2010
2010
2010
2010
2010

CAHN

CAHN

CAHN

CAHN

CAHN

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT

AB
AB
AB
AB
AB
AB
AB

SACUBITRIL; VALSARTAN
TABLET;ORAL
ENTRESTO
NOVARTIS PHARMS CORP
+
SAPROPTERIN DIHYDROCHLORIDE
POWDER;ORAL
KUVAN
BIOMARIN PHARM

>A>

AB
AB
AB

2015

A 077460
A 077460
A 077460
A 077460
A 077460
A 077460
A 077460

001
002
003
004
005
006
007

24MG;26MG
49MG;51MG
97MG;103MG

N 207620
N 207620
N 207620

001 Jul 07, 2015


002 Jul 07, 2015
003 Jul 07, 2015

Jul NEWA
Jul NEWA
Jul NEWA

500MG/PACKET

N 205065

002 Oct 27, 2015

Oct NEWA

A 078830
A 078830

001 Jan 30, 2015


001 Jan 30, 2015

Mar CAHN
Jan NEWA

N 017874

001

Jan CFTG

A 074537
A 074744
A 074756

001 Aug 02, 1996


001 Jan 27, 1997
001 Nov 25, 1998

Apr CAHN
Apr CAHN
Apr CAHN

A 077864
A 077864
A 077864
A 077977
A 077977
A 077977
A 077977
A 077977

001
002
003
001
002
003
004
005

May
May
May
Apr
Apr
Apr
Apr
Apr

100%

A 203793

001 Nov 03, 2015

Oct NEWA

EQ 10MG BASE/12.5ML (EQ 0.8MG


BASE/ML)

N 022473

001 Nov 18, 2009

Mar CFTG

EQ 10MG BASE/12.5ML (EQ 0.8MG


BASE/ML)

A 203988

001 Apr 01, 2015

Mar NEWA

4MG
8MG

N 022206
N 022206

001 Oct 08, 2008


002 Oct 08, 2008

Mar CAHN
Mar CAHN

0.25MG BASE
0.5MG BASE
1MG BASE
2MG BASE
3MG BASE
4MG BASE
5MG BASE

SCOPOLAMINE
FILM, EXTENDED RELEASE;TRANSDERMAL
SCOPOLAMINE
PERRIGO PHARMS CO
1MG/72HR
PERRIGO R AND D
1MG/72HR
TRANSDERM SCOP
+
NOVARTIS
1MG/72HR
SELEGILINE HYDROCHLORIDE
TABLET;ORAL
SELEGILINE HYDROCHLORIDE
@ G AND W LABS INC
5MG
@
5MG
@
5MG

AB
AB
AB

SERTRALINE HYDROCHLORIDE
TABLET;ORAL
SERTRALINE HYDROCHLORIDE
@ HIKMA PHARMS
@
@
SUN PHARM INDS LTD

>A> AN

SEVOFLURANE
LIQUID;INHALATION
SEVOFLURANE
SHANGHAI HENGRUI

AP

SILDENAFIL CITRATE
SOLUTION;INTRAVENOUS
REVATIO
+
PFIZER

AP

SILDENAFIL CITRATE
AUROBINDO PHARMA LTD

SILODOSIN
CAPSULE;ORAL
RAPAFLO
+
ACTAVIS LABS UT INC

EQ
EQ
EQ
EQ
EQ
EQ
EQ
EQ

25MG BASE
50MG BASE
100MG BASE
25MG BASE
50MG BASE
100MG BASE
150MG BASE
200MG BASE

1 -78

October

ROPINIROLE HYDROCHLORIDE
TABLET;ORAL
ROPINIROLE HYDROCHLORIDE
G AND W LABS INC
EQ
EQ
EQ
EQ
EQ
EQ
EQ

10

May
May
May
May
May
May
May

Aug
Aug
Aug
Feb
Feb
Feb
Feb
Feb

05,
05,
05,
05,
05,
05,
19,

10,
10,
10,
06,
06,
06,
06,
06,

2008
2008
2008
2008
2008
2008
2008

2009
2009
2009
2007
2007
2007
2007
2007

Apr
Apr
Apr
Apr
Apr
Apr
Apr

CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN

DISC
DISC
DISC
CAHN
CAHN
CAHN
CAHN
CAHN

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT

>A>
>A>
>A>
>A>
>A>
>D>
>D>
>D>
>D>
>D>

AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB

AP

AB

>A> AP
AP
AP
AP
AP
AP
AP
>A> AP
AP

AA
AA

2015

A 078034
A 078034
A 078034
A 078034
A 078034
A 078034
A 078034
A 078034
A 078034
A 078034
A 076285
A 076285
A 076285
A 076285
A 076285

001
002
003
004
005
001
002
003
004
005
001
002
003
004
005

A 201850

001 Jan 20, 2012

Feb CAHN

A 201833

001 Sep 24, 2013

Feb CAHN

N 021569
N 021569
N 021569
N 021569

001
002
001
002

Feb
Feb
Feb
Feb

SODIUM FERRIC GLUCONATE COMPLEX


INJECTABLE;INJECTION
SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSE
EUROHLTH INTL SARL
62.5MG/5ML

A 078215

001 Mar 31, 2011

Jun CAHN

SODIUM FLUORIDE F-18


INJECTABLE;INTRAVENOUS
SODIUM FLUORIDE F-18
3D IMAGING DRUG
CARDINAL HEALTH 414
HOT SHOTS NM LLC
IBA MOLECULAR N AM
MIPS CRF
PRECISION NUCLEAR
SPECTRON MRC LLC
TRIAD ISOTOPES INC
UNIV UTAH CYCLOTRON

10-200mCi/ML
10-200mCi/ML
10-200mCi/ML
10-200mCi/ML
10-200mCi/ML
10-200mCi/ML
10-200mCi/ML
10-200mCi/ML
10-200mCi/ML

A 203777
A 203780
A 204530
A 203592
A 204517
A 204542
A 203912
A 203968
A 204497

001
001
001
001
001
001
001
001
001

Oct
Jul
Jul
Aug
Jul
Feb
Apr
Oct
Apr

SODIUM IODIDE I-123


CAPSULE;ORAL
SODIUM IODIDE I 123
+
CARDINAL HEALTH 418
+
@

100uCi
200uCi
400uCi

N 018671
N 018671
N 018671

001 May 27, 1982


002 May 27, 1982
003 May 27, 1982

Apr CAHN
Apr CAHN
Apr CAHN

N 016692

001

Sep DISC

N 020004

001 Apr 21, 1992

Sep CTEC

A 040905

002 Apr 03, 2015

Mar NEWA

N 011287

001

Apr CAHN

BLU CARIBE

SUN PHARM INDS LTD

5MG
10MG
20MG
40MG
80MG
5MG
10MG
20MG
40MG
80MG
5MG
10MG
20MG
40MG
80MG

SODIUM CHLORIDE
INJECTABLE;INJECTION
SODIUM CHLORIDE 0.9%
EUROHLTH INTL SARL
9MG/ML
SODIUM CHLORIDE 0.9%
EUROHLTH INTL SARL
9MG/ML
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
+
LIEBEL-FLARSHEIM
45MG/50ML (9MG/ML)
112.5MG/125ML (9MG/ML)
+
405MG/50ML (9MG/ML)
1012.5MG/125ML (9MG/ML)

SODIUM LACTATE
INJECTABLE;INJECTION
SODIUM LACTATE 0.167 MOLAR IN PLASTIC CONTAINER
@ BAXTER HLTHCARE
1.87GM/100ML
SODIUM LACTATE 1/6 MOLAR IN PLASTIC CONTAINER
B BRAUN
1.87GM/100ML

AA

SODIUM POLYSTYRENE SULFONATE


POWDER;ORAL, RECTAL
KALEXATE
KVK TECH
15GM/BOT
KAYEXALATE
+
CONCORDIA PHARMS INC 453.6GM/BOT

1 -79

October

SIMVASTATIN
TABLET;ORAL
SIMVASTATIN
BIOCON LIMITED

10

Dec
Dec
Dec
Dec
Dec
Dec
Dec
Dec
Dec
Dec
Dec
Dec
Dec
Dec
Jun

Jul
Jul
Jul
Jul

Oct
Jul
Jul
Aug
Jul
Feb
Apr
Oct
Apr

20,
20,
20,
20,
20,
20,
20,
20,
20,
20,
20,
20,
20,
20,
23,

27,
27,
27,
27,

19,
30,
29,
18,
21,
27,
22,
23,
20,

2006
2006
2006
2006
2006
2006
2006
2006
2006
2006
2006
2006
2006
2006
2006

2006
2006
2006
2006

2015
2015
2015
2015
2015
2015
2015
2015
2015

Oct
Oct
Oct
Oct
Oct
Oct
Oct
Oct
Oct
Oct
Apr
Apr
Apr
Apr
Apr

CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN
CAHN

CAHN
CAHN
CPOT
CPOT

NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT

2015

20MG/2ML (10MG/ML)

A 040541

001 Nov 12, 2004

Jul CRLD

30MG/3ML

N 021148

011 Jan 23, 2015

Jan NEWA

30MG/3ML
30MG/3ML
30MG/3ML

N 021148
N 021148
N 021148

007 Mar 10, 2009


007 Mar 10, 2009
007 Mar 10, 2009

Jul DISC
Mar CMFD
Jan DISC

5MG/VIAL
10MG/VIAL
10MG/VIAL

N 020168
N 020168
N 020168

001 Nov 17, 1993


002 Nov 17, 1993
002 Nov 17, 1993

Jun DISC
Jun DISC
Mar CTEC

10MG/2ML (5MG/ML)

N 020522

001 Dec 29, 1995

Jun DISC

5MG/2ML (2.5MG/ML)
10MG/2ML (5MG/ML)
20MG/2ML (10MG/ML)

N 020522
N 020522
N 020522

003 Jan 03, 2008


005 Jan 03, 2008
004 Jan 03, 2008

Jun CTNA
Jun NEWA
Jun CTNA

20MG/2ML (10MG/ML)

N 020522

006 Jan 03, 2008

Jun NEWA

5MG/VIAL
10MG/VIAL
10MG/VIAL

N 019774
N 019774
N 019774

002 Jan 04, 2002


003 Mar 07, 2012
003 Mar 07, 2012

Mar CTNA
Apr CRLD
Mar NEWA

EQ 200MG BASE

N 205266

001 Jul 24, 2015

Jul NEWA

150MG/10ML (15MG/ML)

N 022306

001 Jul 02, 2009

Apr CAHN

80MG
120MG
160MG
240MG
320MG

N 019865
N 019865
N 019865
N 019865
N 019865

001
005
002
003
004

Mar
Mar
Mar
Mar
Mar

STERILE WATER FOR INJECTION


LIQUID;N/A
STERILE WATER FOR INJECTION
EUROHLTH INTL SARL
100%

A 206369

001 Sep 02, 2015

Aug NEWA

SUCCINYLCHOLINE CHLORIDE
INJECTABLE;INJECTION
QUELICIN PRESERVATIVE FREE
@ HOSPIRA
100MG/ML

N 008845

004

Jun DISC

AB

SUCRALFATE
TABLET;ORAL
SUCRALFATE
MYLAN PHARMS INC

1GM

A 074415

001 Jun 08, 1998

May CAHN

AP

SUFENTANIL CITRATE
INJECTABLE;INJECTION
SUFENTANIL CITRATE
EUROHLTH INTL SARL

EQ 0.05MG BASE/ML

A 074413

001 Dec 15, 1995

Jun CAHN

SOMATROPIN RECOMBINANT
INJECTABLE;INJECTION
NORDITROPIN FLEXPRO
NOVO NORDISK INC
NORDITROPIN NORDIFLEX
@ NOVO NORDISK INC
@
NUTROPIN
@ GENENTECH
@
BX

BX
BX
BX

+
NUTROPIN AQ
@ GENENTECH
NUTROPIN AQ NUSPIN
+
GENENTECH
+
+
NUTROPIN AQ PEN
+
GENENTECH
ZOMACTON
+
FERRING
+
SONIDEGIB PHOSPHATE
CAPSULE;ORAL
ODOMZO
+
NOVARTIS PHARMS CORP

SOTALOL HYDROCHLORIDE
SOLUTION;INTRAVENOUS
SOTALOL HYDROCHLORIDE
+
ALTATHERA PHARMS LLC
TABLET;ORAL
BETAPACE
AB1
COVIS PHARMA SARL
AB1
AB1
+
AB1
@

AP

1 -80

October

SODIUM TETRADECYL SULFATE


INJECTABLE;INJECTION
SOTRADECOL
+
MYLAN INSTITUTIONAL

10

Oct
Apr
Oct
Oct
Oct

30,
20,
30,
30,
30,

1992
1994
1992
1992
1992

CAHN
CAHN
CAHN
CAHN
CAHN

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT

AB
>D>
>D> AT
>A>
>D> AT
>A>

AT

>A>
>D>

AB
AB
AB

2015

10%

N 019931

001 Dec 23, 1996

Mar CAHN

10%
10%

A 080021
A 080021

001
001

Oct DISC
Oct DISC

10%
10%

A 080029
A 080029

001
001

Oct CRLD
Oct CRLD

10%

A 040215

001 May 25, 1999

Mar CMFD

SULFAMETHOXAZOLE; TRIMETHOPRIM
SUSPENSION;ORAL
SULFAMETHOXAZOLE AND TRIMETHOPRIM
@ ANI PHARMS INC
200MG/5ML;40MG/5ML

A 070028

001 Jun 02, 1987

Jul CAHN

SULFANILAMIDE
CREAM;VAGINAL
SULFANILAMIDE
@ G AND W LABS INC

15%

A 088718

001 Sep 19, 1985

Apr CAHN

SULFISOXAZOLE
TABLET;ORAL
SULFISOXAZOLE
@ ANI PHARMS INC
@ IVAX SUB TEVA PHARMS

500MG
500MG

A 080142
A 080142

001
001

Oct CAHN
Oct CAHN

SULINDAC
TABLET;ORAL
SULINDAC
@ ANI PHARMS INC
@

150MG
200MG

A 072972
A 072973

001 Feb 28, 1992


001 Feb 28, 1992

Aug CAHN
Aug CAHN

EQ
EQ
EQ
EQ
EQ
EQ

A 076976
A 076976
A 076976
A 076554
A 076554
A 076572

001
002
003
001
002
001

Sep
Sep
Sep
Apr
Apr
Apr

N 206406
N 206406
N 206406

001 Jul 10, 2015


002 Jul 10, 2015
003 Jul 10, 2015

Jul NEWA
Jul NEWA
Jul NEWA

N 203794

001 Oct 15, 2012

May CAHN

N 022304
N 022304
N 022304

001 Nov 20, 2008


002 Nov 20, 2008
003 Nov 20, 2008

May CAHN
May CAHN
May CAHN

N 200533
N 200533
N 200533
N 200533
N 200533

001
002
003
004
005

May
May
May
May
May

SUMATRIPTAN SUCCINATE
TABLET;ORAL
SUMATRIPTAN SUCCINATE
@ SANDOZ
@
@
SUN PHARM INDS LTD

25MG BASE
50MG BASE
100MG BASE
25MG BASE
50MG BASE
100MG BASE

TACROLIMUS
TABLET, EXTENDED RELEASE;ORAL
ENVARSUS XR
VELOXIS PHARMS INC
EQ 0.75MG BASE
EQ 1MG BASE
+
EQ 4MG BASE
TAPENTADOL HYDROCHLORIDE
SOLUTION;ORAL
NUCYNTA
+
DEPOMED INC
TABLET;ORAL
NUCYNTA
DEPOMED INC

EQ 20MG BASE/ML

EQ 50MG BASE
EQ 75MG BASE
+
EQ 100MG BASE
TABLET, EXTENDED RELEASE;ORAL
NUCYNTA ER
DEPOMED INC
EQ 50MG BASE
EQ 100MG BASE
EQ 150MG BASE
EQ 200MG BASE
+
EQ 250MG BASE

1 -81

October

SULFACETAMIDE SODIUM
LOTION;TOPICAL
KLARON
+
VALEANT PHARMS NORTH
OINTMENT;OPHTHALMIC
CETAMIDE
+
ALCON
@
SULFACETAMIDE SODIUM
PERRIGO CO TENNESSEE
+
SOLUTION/DROPS;OPHTHALMIC
SULFACETAMIDE SODIUM
AKORN

10

Aug
Aug
Aug
Aug
Aug
Feb

Aug
Aug
Aug
Aug
Aug

10,
10,
10,
10,
10,
09,

25,
25,
25,
25,
25,

2009
2009
2009
2009
2009
2009

2011
2011
2011
2011
2011

DISC
DISC
DISC
CAHN
CAHN
CAHN

CAHN
CAHN
CAHN
CAHN
CAHN

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT

TEDIZOLID PHOSPHATE
POWDER;IV (INFUSION)
SIVEXTRO
+
CUBIST PHARMS LLC
TABLET;ORAL
SIVEXTRO
+
CUBIST PHARMS LLC
TELAPREVIR
TABLET;ORAL
INCIVEK
@ VERTEX PHARMS

AB
AB
AB
AB
AB
AB
>A> AB
>A> AB
>A> AB

AB
AB
AB
AB

AB
AB
AB
AB
AB
AB

AB
AB

TELMISARTAN
TABLET;ORAL
TELMISARTAN
AMNEAL PHARMS

AUROBINDO PHARMA LTD

INVENTIA HLTHCARE

TEMAZEPAM
CAPSULE;ORAL
TEMAZEPAM
VINTAGE PHARMS

TEMOZOLOMIDE
CAPSULE;ORAL
TEMOZOLOMIDE
AMNEAL PHARMS

TERBINAFINE
GEL;TOPICAL
LAMISIL
@ GLAXOSMITHKLINE CONS

2015

200MG/VIAL

N 205436

001 Jun 20, 2014

Sep CAHN

200MG

N 205435

001 Jun 20, 2014

Sep CAHN

375MG

N 201917

001 May 23, 2011

Jan DISC

20MG
40MG
80MG
20MG
40MG
80MG
20MG
40MG
80MG

A 204415
A 204415
A 204415
A 206511
A 206511
A 206511
A 205150
A 205150
A 205150

001
002
003
001
002
003
001
002
003

Sep
Sep
Sep
Sep
Sep
Sep
Oct
Oct
Oct

08,
08,
08,
03,
03,
03,
30,
30,
30,

2015
2015
2015
2015
2015
2015
2015
2015
2015

Aug
Aug
Aug
Aug
Aug
Aug
Oct
Oct
Oct

NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA
NEWA

7.5MG
15MG
22.5MG
30MG

A 201781
A 201781
A 201781
A 201781

001
002
003
004

Jun
Jun
Jun
Jun

04,
04,
04,
04,

2015
2015
2015
2015

May
May
May
May

NEWA
NEWA
NEWA
NEWA

5MG
20MG
100MG
140MG
180MG
250MG

A 203691
A 203691
A 203691
A 203691
A 203691
A 203691

001
002
003
004
005
006

May
May
May
May
May
May

08,
08,
08,
08,
08,
08,

2015
2015
2015
2015
2015
2015

Apr
Apr
Apr
Apr
Apr
Apr

NEWA
NEWA
NEWA
NEWA
NEWA
NEWA

A 091612

001 Mar 18, 2015

Mar NEWA

N 021356

001 Oct 26, 2001

Mar CFTG

N 020846

001 Apr 29, 1998

Aug CAHN

N 020749

001 Oct 17, 1997

Aug CAHN

A 078229

001 Jul 02, 2007

Feb DISC

A 077553

001 Mar 09, 2007

Sep CMFD

1%

TERBINAFINE HYDROCHLORIDE
SOLUTION;TOPICAL
LAMISIL
@ GLAXOSMITHKLINE CONS
1%
TABLET;ORAL
TERBINAFINE HYDROCHLORIDE
@ WOCKHARDT
EQ 250MG BASE

AB

TERCONAZOLE
SUPPOSITORY;VAGINAL
TERCONAZOLE
TARO

80MG

1 -82

October

TENOFOVIR DISOPROXIL FUMARATE


TABLET;ORAL
TENOFOVIR DISOPROXIL FUMARATE
TEVA PHARMS USA
300MG
VIREAD
+
GILEAD SCIENCES INC
300MG

10

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT

TESTOSTERONE

GEL;TRANSDERMAL

ANDROGEL

AB1
ABBVIE
AB1
+
TESTIM

AB2
+
AUXILIUM PHARMS
TESTOSTERONE

@ ACTAVIS LABS UT INC
@
AB1
AB1
BX
ANI PHARMS INC
BX
AB1
PAR PHARM
AB1
AB1
PERRIGO ISRAEL
AB1
VOGELXO

AB2
UPSHER SMITH
GEL, METERED;TRANSDERMAL

ANDROGEL

AB
+
ABBVIE
FORTESTA

AB
+
ENDO PHARMS
TESTOSTERONE

AB
ACTAVIS LABS UT INC
AB
AB
PERRIGO ISRAEL

AB
AB

TETRABENAZINE

TABLET;ORAL

TETRABENAZINE

SUN PHARMA GLOBAL
XENAZINE

VALEANT PHARMS NORTH

AB
AB

AB

AB
AB

+
+

October

1 -83

2015

25MG/2.5GM PACKET

50MG/5GM PACKET

N 021015
001 Feb 28, 2000
N 021015
002 Feb 28, 2000

Jan CTEC

Jan CTEC

50MG/5GM PACKET

N 021454
001 Oct 31, 2002

Jan CTEC

1% (2.5GM/PACKET)

1% (5GM/PACKET)

25MG/2.5GM PACKET

50MG/5GM PACKET

25MG/2.5GM PACKET

50MG/5GM PACKET

25MG/2.5GM PACKET

50MG/5GM PACKET

25MG/2.5GM PACKET

50MG/5GM PACKET

A 076737

A 076737

A 076737

A 076737

N 202763

N 202763

A 076744

A 076744

N 203098

N 203098

Mar
Mar
Jul
Jul
May
May
Aug
Aug
Jan
Jan

50MG/5GM PACKET

N 204399
002 Jun 04, 2014

Jan CTEC

1.62% (20.25MG/1.25GM ACTUATION)

N 022309
001 Apr 29, 2011

Jul CFTG

10MG/0.5GM ACTUATION

N 021463
001 Dec 29, 2010

Jul CFTG

10MG/0.5GM ACTUATION

12.5MG/1.25GM ACTUATION

1.62% (20.25MG/1.25GM ACTUATION)


A 204571
001 Aug 05, 2015
A 076737
003 Mar 09, 2015
A 204268
001 Aug 04, 2015

Jul NEWA

Aug NEWA

Jul NEWA

12.5MG

25MG

A 206129
001 Aug 17, 2015
A 206129
002 Aug 17, 2015

Aug NEWA

Aug NEWA

12.5MG

12.5MG

25MG

25MG

N 021894

N 021894

N 021894

N 021894

Aug
Feb
Aug
Feb

TETRACYCLINE HYDROCHLORIDE

CAPSULE;ORAL

ACHROMYCIN V

+
HERITAGE PHARMS INC
500MG

TETRACYCLINE HYDROCHLORIDE

@ CHARTWELL CIENCA
250MG

@
500MG

@ IVAX SUB TEVA PHARMS
250MG

@
500MG

THEOPHYLLINE

TABLET;ORAL

THEOLAIR

@ MEDICIS
125MG

@
250MG

TABLET, EXTENDED RELEASE;ORAL

THEOPHYLLINE

MYLAN PHARMS INC
400MG

+
600MG

THIOTEPA

INJECTABLE;INJECTION

THIOTEPA

+
EUROHLTH INTL SARL

10

15MG/VIAL

001
002
001
002
001
002
001
002
002
003

001
001
002
002

Jan
Jan
Jan
Jan
Feb
Feb
May
May
Jan
Jan

Aug
Aug
Aug
Aug

27,
27,
27,
27,
14,
14,
23,
23,
31,
31,

15,
15,
15,
15,

2006
2006
2006
2006
2012
2012
2007
2007
2013
2013

2008
2008
2008
2008

CAHN

CAHN

CMFD

CMFD

CAHN

CAHN

CMFD

CMFD

CTEC

CTEC

CFTG

CAHN

CFTG

CAHN

N 050278
001

Apr CRLD

A 062752

A 062752

A 060704

A 060704

Sep
Sep
Apr
Apr

001 Aug 12, 1988


002 Aug 12, 1988
001
002

CAHN

CAHN

DISC

DISC

A 086399
001
A 086399
002

Mar DISC

Mar DISC

A 040595
001 Apr 21, 2006
A 040560
002 Apr 21, 2006

May CAHN

May CAHN

A 075547
001 Apr 02, 2001

May CRLD

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT

2015

60MG

N 022433

002 Sep 03, 2015

Sep NEWA

AP

50MG/VIAL

A 091620

001 May 27, 2015

May NEWA

AP

50MG/VIAL

N 021821

001 Jun 15, 2005

May CFTG

BASE

N 021516

001 Jun 04, 2004

Apr CFTG

BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE
BASE

A 074466
A 074516
A 074262
A 204936
A 074776
A 077259
A 075163
A 074747
A 078771

001
001
001
001
001
002
001
001
002

Apr
Apr
Apr
Apr
Apr
Apr
Apr
Apr
Apr

BASE

N 018086

002

Apr CTEC

A 203808
A 203808

001 Aug 04, 2015


002 Aug 04, 2015

Jul NEWA
Jul NEWA

TIOTROPIUM BROMIDE
SPRAY, METERED;INHALATION
SPIRIVA RESPIMAT
BOEHRINGER INGELHEIM EQ 0.00125MG BASE/INH

N 021936

002 Sep 15, 2015

Sep NEWA

TIPIRACIL HYDROCHLORIDE; TRIFLURIDINE


TABLET;ORAL
LONSURF
TAIHO ONCOLOGY
EQ 6.14MG BASE;15MG
+
EQ 8.19MG BASE;20MG

N 207981
N 207981

001 Sep 22, 2015


002 Sep 22, 2015

Sep NEWA
Sep NEWA

N 205433

001 Dec 02, 2014

Feb CTEC

A 205501

001 Jul 13, 2015

Jun NEWA

N 050541

001

Mar CAHN

A 063119
A 063120
A 063121
A 063122

001
001
001
001

Oct
Oct
Oct
Oct

31,
31,
31,
31,

1994
1994
1994
1994

Mar
Mar
Mar
Mar

CAHN
CAHN
CAHN
CAHN

A 065120
A 065120
A 063116
A 063116

001
001
001
001

Nov
Nov
May
May

29,
29,
18,
18,

2002
2002
1992
1992

Jul
Jul
Jul
Jul

CTEC
CRLD
DISC
CTNA

TIGECYCLINE
INJECTABLE;IV (INFUSION)
TIGECYCLINE
SANDOZ INC
TYGACIL
+
PF PRISM CV

TIMOLOL MALEATE
SOLUTION/DROPS;OPHTHALMIC
ISTALOL
AT2
+
BAUSCH AND LOMB
EQ 0.5%
TIMOLOL MALEATE
AT1
AKORN
EQ 0.5%
AT1
EQ 0.5%
AT1
ALCON RES LTD
EQ 0.5%
AT2
APOTEX INC
EQ 0.5%
AT1
BAUSCH AND LOMB
EQ 0.5%
AT1
FDC LTD
EQ 0.5%
AT1
HI TECH PHARMA
EQ 0.5%
AT1
PACIFIC PHARMA
EQ 0.5%
AT1
WOCKHARDT
EQ 0.5%
TIMOPTIC
AT1
+
ATON
EQ 0.5%

AB
AB

AN
AN

AT

AP
AP

TINIDAZOLE
TABLET;ORAL
TINIDAZOLE
EDENBRIDGE PHARMS

250MG
500MG

TOBRAMYCIN
SOLUTION;INHALATION
KITABIS PAK
PULMOFLOW INC
300MG/5ML
TOBRAMYCIN
AMNEAL PHARMS
300MG/5ML
SOLUTION/DROPS;OPHTHALMIC
TOBREX
+
ALCON LABS INC
0.3%
TOBRAMYCIN SULFATE
INJECTABLE;INJECTION
TOBRAMYCIN SULFATE
@ IGI LABS INC
EQ 10MG BASE/ML
@
EQ 40MG BASE/ML
@
EQ 40MG BASE/ML
@
EQ 40MG BASE/ML
TOBRAMYCIN SULFATE (PHARMACY BULK)
+
FRESENIUS KABI USA
EQ 40MG BASE/ML
+
EQ 40MG BASE/ML
@ HOSPIRA
EQ 40MG BASE/ML
EQ 40MG BASE/ML

1 -84

October

TICAGRELOR
TABLET;ORAL
BRILINTA
ASTRAZENECA LP

10

Mar
Mar
Apr
Apr
Mar
Apr
Sep
Mar
Sep

25,
25,
28,
17,
25,
30,
10,
25,
28,

1997
1997
1995
2015
1997
2008
2002
1997
2009

CTEC
CTEC
CTEC
NEWA
CTEC
CTEC
CTEC
CTEC
CTEC

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT

TOLAZAMIDE
TABLET;ORAL
TOLAZAMIDE
@ G AND W LABS INC
@
@

AB
AB

TOLCAPONE
TABLET;ORAL
TASMAR
+
VALEANT PHARMS LLC
TOLCAPONE
PAR PHARM INC
TOLMETIN SODIUM
TABLET;ORAL
TOLMETIN SODIUM
@ G AND W LABS INC
@

AB
AB

AB
AB
AB
AB

AB
AB
AB

TOPIRAMATE
TABLET;ORAL
TOPIRAMATE
SUN PHARM INDS LTD

@ WOCKHARDT USA
@
@
@
TOPIRAMATE
@ HIKMA PHARMS
@
@
@

AP
AP

TOPOTECAN HYDROCHLORIDE
CAPSULE;ORAL
HYCAMTIN
NOVARTIS PHARMS CORP
+
INJECTABLE;INJECTION
HYCAMTIN
+
NOVARTIS PHARMS CORP
TOPOTECAN HYDROCHLORIDE
CHEM WERTH INC
TORSEMIDE
INJECTABLE;INJECTION
TORSEMIDE
@ EUROHLTH INTL SARL
@
@ LUITPOLD
@

2015

100MG
250MG
500MG

N 018894
N 018894
N 018894

001 Nov 02, 1984


002 Nov 02, 1984
003 Nov 02, 1984

Apr CAHN
Apr CAHN
Apr CAHN

100MG

N 020697

001 Jan 29, 1998

Mar CFTG

100MG

A 204584

001 Mar 26, 2015

Mar NEWA

EQ 600MG BASE
EQ 600MG BASE

A 074399
A 074729

001 Mar 28, 1996


001 Feb 27, 1997

May CAHN
Apr CAHN

A 203016
A 203016

001 Aug 11, 2015


002 Aug 11, 2015

Jul NEWA
Jul NEWA

A 077006
A 077006
A 203409
A 203409

001
002
001
002

Feb
Feb
Aug
Aug

23,
23,
31,
31,

2015
2015
2015
2015

Feb
Feb
Aug
Aug

NEWA
NEWA
NEWA
NEWA

25MG
100MG
200MG
25MG
50MG
100MG
200MG

A 076327
A 076327
A 076327
A 090353
A 090353
A 090353
A 090353

001
002
003
001
002
003
004

Mar
Mar
Mar
Sep
Sep
Sep
Sep

27,
27,
27,
01,
01,
01,
01,

2009
2009
2009
2010
2010
2010
2010

Apr
Apr
Apr
Apr
Apr
Apr
Apr

CAHN
CAHN
CAHN
DISC
DISC
DISC
DISC

25MG
50MG
100MG
200MG

A 091185
A 091185
A 091185
A 091185

001
002
003
004

Nov
Nov
Nov
Nov

25,
25,
25,
25,

2013
2013
2013
2013

May
May
May
May

DISC
DISC
DISC
DISC

EQ 0.25MG BASE
EQ 1MG BASE

N 020981
N 020981

001 Oct 11, 2007


002 Oct 11, 2007

Mar CAHN
Mar CAHN

EQ 4MG BASE/VIAL

N 020671

001 May 28, 1996

Mar CAHN

EQ 4MG BASE/VIAL

A 201166

001 Aug 08, 2012

May CAHN

20MG/2ML
50MG/5ML
20MG/2ML
50MG/5ML

A 078007
A 078007
A 090656
A 090656

001
002
001
002

Jan
Jan
Jan
Jan

(10MG/ML)
(10MG/ML)
(10MG/ML)
(10MG/ML)

1 -85

October

TOLTERODINE TARTRATE
CAPSULE, EXTENDED RELEASE;ORAL
TOLTERODINE TARTRATE
TORRENT PHARMS LTD
2MG
4MG
TABLET;ORAL
TOLTERODINE TARTRATE
IVAX SUB TEVA PHARMS 1MG
2MG
MACLEODS PHARMS LTD
1MG
2MG

10

Jun
Jun
Apr
Apr

11,
11,
21,
21,

2008
2008
2010
2010

DISC
DISC
DISC
DISC

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT

>A>
>A>
>A>
>A>

TRABECTEDIN
POWDER;IV (INFUSION)
YONDELIS
+
JANSSEN PRODS

2015

N 207953

001 Oct 23, 2015

Oct NEWA

A 205702

001 Sep 25, 2015

Sep NEWA

A 204421
A 204421
A 204421

001 Oct 20, 2015


002 Oct 20, 2015
003 Oct 20, 2015

Oct NEWA
Oct NEWA
Oct NEWA

N 204114
N 204114
N 204114

001 May 29, 2013


002 May 29, 2013
003 May 29, 2013

Mar CAHN
Mar CAHN
Mar CAHN

100MG/ML

A 091596

001 Mar 02, 2012

Apr CMFD

650MG

A 205133

001 Sep 21, 2015

Sep NEWA

EQ 10MG BASE

N 012342

003 Aug 16, 1985

Jun CAHN

N 204822

001 May 15, 2014

Jul DISC

N 021994

001 Sep 21, 2006

Jun CTEC

A 203431

001 Jul 10, 2015

Jun NEWA

50MG
100MG
150MG
300MG

N 018207
N 018207
N 018207
N 018207

001
002
003 Mar 25, 1985
004 Nov 07, 1988

May
May
May
May

0.02%
0.05%

N 021108
N 019963

001 Aug 31, 2000


001 Dec 29, 1995

Apr CAHN
Apr CAHN

0.1%

N 017340

001

Apr CAHN

0.05%

N 022070

001 Jul 26, 2007

Jul CTEC

0.05%

A 207955

001 Aug 13, 2015

Jul NEWA

TRAMADOL HYDROCHLORIDE
TABLET;ORAL
TRAMADOL HYDROCHLORIDE
AB
MACLEODS PHARMS LTD
50MG
TABLET, EXTENDED RELEASE;ORAL
TRAMADOL HYDROCHLORIDE
>A> AB1
AUROBINDO PHARMA LTD 100MG
>A> AB1
200MG
>A> AB1
300MG
TRAMETINIB DIMETHYL SULFOXIDE
TABLET;ORAL
MEKINIST
NOVARTIS PHARMS CORP EQ 0.5MG NON-SOLVATED PARENT
EQ 1MG NON-SOLVATED PARENT
+
EQ 2MG NON-SOLVATED PARENT

AB

TRANEXAMIC ACID
INJECTABLE;INJECTION
TRANEXAMIC ACID
FRESENIUS KABI USA
TABLET;ORAL
TRANEXAMIC ACID
MYLAN

AB

TRANYLCYPROMINE SULFATE
TABLET;ORAL
PARNATE
+
CONCORDIA PHARMS INC

AP

AT
AT

TRAVOPROST
SOLUTION/DROPS;OPHTHALMIC
IZBA
@ ALCON LABS INC
0.003%
TRAVATAN Z
+
ALCON PHARMS LTD
0.004%
TRAVOPROST
APOTEX INC
0.004%
TRAZODONE HYDROCHLORIDE
TABLET;ORAL
DESYREL
@ PRAGMA PHARMS LLC
@
@
@

TRETINOIN
CREAM;TOPICAL
RENOVA
+
VALEANT PHARMS NORTH
AB2
+
RETIN-A
AB
+
VALEANT PHARMS NORTH
GEL;TOPICAL
ATRALIN
AB
+
DOW PHARM
TRETINOIN
AB
SPEAR PHARMS INC

1 -86

October

1MG/VIAL

10

CAHN
CAHN
CAHN
CAHN

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT

AT
AT
AT
AT

AT

AT
AT
AT
AT

AT
AT
AT

2015

A 089797
A 089798

001 May 31, 1991


001 May 31, 1991

Apr CMFD
Apr CMFD

A 088042
A 088042

002 Mar 25, 2015


003 Mar 25, 2015

Mar NEWA
Mar NEWA

A 089129

001 Aug 14, 1986

Mar CMFD

N 011600
N 011600

003
001

Mar CMFD
Mar CMFD

A 089795
A 089796

001 Dec 23, 1988


001 Dec 23, 1988

Aug CMFD
Aug CMFD

N 012104
N 012104

001
001

Mar CFTG
Aug CAHN

A 205782

001 Apr 13, 2015

Mar NEWA

50MG
100MG

N 013174
N 013174

001
002

Apr CAHN
Apr CAHN

EQ 50MG BASE
EQ 100MG BASE

N 016792
N 016792

002
003 Sep 15, 1982

Jun CRLD
Jun CRLD

TRIPLE SULFA (SULFABENZAMIDE;SULFACETAMIDE;SULFATHIAZOLE)


CREAM;VAGINAL
VAGILIA
@ G AND W LABS INC
3.7%;2.86%;3.42%

A 088821

001 Nov 09, 1987

Jul CAHN

TRIPTORELIN PAMOATE
INJECTABLE;INTRAMUSCULAR
TRELSTAR
+
ACTAVIS LABS UT INC
+
+

N 020715
N 021288
N 022437

001 Jun 15, 2000


001 Jun 29, 2001
001 Mar 10, 2010

Jan CAHN
Jan CAHN
Jan CAHN

N 022103

001 Aug 03, 2007

May DISC

A 091289
A 091289
A 091635

001 Oct 12, 2012


001 Oct 12, 2012
001 Apr 29, 2015

Jun CRLD
May CRLD
Apr NEWA

N 021595

001 May 28, 2004

May DISC

A 091575
A 091575

001 Aug 13, 2010


001 Aug 13, 2010

Jun CRLD
May CRLD

N 021214
N 021214

001 Aug 03, 2000


001 Aug 03, 2000

May CAHN
Jan CAHN

TRIAMTERENE
CAPSULE;ORAL
DYRENIUM
CONCORDIA PHARMS INC
+

AB
AB

AB
AB
AB

AB
AB

TRIMIPRAMINE MALEATE
CAPSULE;ORAL
SURMONTIL
+
ODYSSEY PHARMS

EQ 3.75MG BASE/VIAL
EQ 11.25MG BASE/VIAL
EQ 22.5MG BASE/VIAL

TROSPIUM CHLORIDE
CAPSULE, EXTENDED RELEASE;ORAL
SANCTURA XR
@ ALLERGAN
60MG
TROSPIUM CHLORIDE
ACTAVIS LABS FL INC
60MG
+
60MG
SANDOZ INC
60MG
TABLET;ORAL
SANCTURA
@ ALLERGAN
20MG
TROSPIUM CHLORIDE
GLENMARK GENERICS
20MG
+
20MG
UNOPROSTONE ISOPROPYL
SOLUTION/DROPS;OPHTHALMIC
RESCULA
+
R-TECH UENO LTD
0.15%
+
SUCAMPO PHARMA LLC
0.15%

1 -87

October

TRIAMCINOLONE ACETONIDE
CREAM;TOPICAL
TRIAMCINOLONE ACETONIDE
G AND W LABS
0.025%
0.1%
TRIDERM
CROWN LABS
0.025%
0.5%
LOTION;TOPICAL
TRIAMCINOLONE ACETONIDE
G AND W LABS INC
0.1%
OINTMENT;TOPICAL
KENALOG
DELCOR ASSET CORP
0.025%
0.1%
TRIAMCINOLONE ACETONIDE
G AND W LABS
0.025%
0.1%
SPRAY;TOPICAL
KENALOG
+
RANBAXY
0.147MG/GM
+
SUN PHARM INDS LTD
0.147MG/GM
TRIAMCINOLONE ACETONIDE
PERRIGO UK FINCO
0.147MG/GM

10

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT

10

October

2015

1 -88

URIDINE TRIACETATE
GRANULE;ORAL
XURIDEN
+
WELLSTAT THERAP

2GM/PACKET

N 208169

001 Sep 04, 2015

Sep NEWA

AB

URSODIOL
CAPSULE;ORAL
ACTIGALL
@ ACTAVIS LABS UT INC
+

150MG
300MG

N 019594
N 019594

001 Dec 31, 1987


002 Dec 31, 1987

Mar CAHN
Mar CAHN

AB
AB
AB
AB

VALACYCLOVIR HYDROCHLORIDE
TABLET;ORAL
VALACYCLOVIR HYDROCHLORIDE
HETERO LABS LTD V
EQ
EQ
SUN PHARM INDS LTD
EQ
EQ

A 203047
A 203047
A 076588
A 076588

001
002
001
002

Mar
Mar
Apr
Apr

A 073484

001 Jun 29, 1993

Jan CAHN

N 022152
N 022152
N 022152

001 Jul 29, 2008


002 Jul 29, 2008
003 Jul 29, 2008

Jan CAHN
Jan CAHN
Jan CAHN

A 204821
A 204821
A 204821
A 204821

001
002
003
004

May
May
May
May

125MG BASE
250MG BASE

A 090439
A 090439

001 Jan 28, 2015


002 Jan 28, 2015

Jan NEWA
Jan NEWA

500MG BASE/VIAL
1GM BASE/VIAL
2GM BASE/VIAL
5GM BASE/VIAL
10GM BASE/VIAL

A 062682
A 062682
A 062682
A 062682
A 062682

001
002
003
004
005

Jun
Jun
Jun
Jun
Jun

500MG BASE/VIAL
1GM BASE/VIAL

A 091377
A 091377

001 Sep 09, 2015


002 Sep 09, 2015

Aug NEWA
Aug NEWA

N 200179

001 Jun 17, 2010

Apr CFTG

A 203689

001 Apr 22, 2015

Apr NEWA

A 090071
A 090071
A 090071

001 Apr 15, 2011


002 Apr 15, 2011
003 Apr 15, 2011

Feb CAHN
Feb CAHN
Feb CAHN

A 202036
A 202036
A 202036

001 May 28, 2015


002 May 28, 2015
003 May 28, 2015

May NEWA
May NEWA
May NEWA

AB

AB
AB
AB
AB

AB
AB

AP
AP

AB
AB

AB
AB
AB

AB
AB
AB

500MG BASE
1GM BASE
500MG BASE
1GM BASE

VALPROIC ACID
CAPSULE;ORAL
VALPROIC ACID
BANNER LIFE SCIENCES 250MG
CAPSULE, DELAYED RELEASE;ORAL
STAVZOR
@ BANNER LIFE SCIENCES 125MG
@
250MG
@
500MG
VALSARTAN
TABLET;ORAL
VALSARTAN
PRINSTON INC

40MG
80MG
160MG
320MG

VANCOMYCIN HYDROCHLORIDE
CAPSULE;ORAL
VANCOMYCIN HYDROCHLORIDE
LUPIN LTD
EQ
EQ
INJECTABLE;INJECTION
VANCOLED
@ EUROHLTH INTL SARL
EQ
@
EQ
@
EQ
@
EQ
@
EQ
VANCOMYCIN HYDROCHLORIDE
XELLIA PHARMS APS
EQ
EQ

VARDENAFIL HYDROCHLORIDE
TABLET, ORALLY DISINTEGRATING;ORAL
STAXYN
+
BAYER HLTHCARE
10MG
VARDENAFIL HYDROCHLORIDE
WATSON LABS INC
10MG
VENLAFAXINE HYDROCHLORIDE
CAPSULE, EXTENDED RELEASE;ORAL
VENLAFAXINE HYDROCHLORIDE
VALEANT PHARMS NORTH
EQ 37.5MG BASE
EQ 75MG BASE
EQ 150MG BASE
TABLET;ORAL
VENLAFAXINE HYDROCHLORIDE
YAOPHARMA CO LTD
EQ 25MG BASE
EQ 37.5MG BASE
EQ 50MG BASE

Apr
Apr
Jan
Jan

Jun
Jun
Jun
Jun

Jul
Mar
May
May
May

08,
08,
31,
31,

09,
09,
09,
09,

22,
30,
11,
11,
11,

2015
2015
2007
2007

2015
2015
2015
2015

1986
1988
1988
1988
1988

NEWA
NEWA
CAHN
CAHN

NEWA
NEWA
NEWA
NEWA

CAHN
CAHN
CAHN
CAHN
CAHN

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT

2015

A 202036
A 202036

004 May 28, 2015


005 May 28, 2015

May NEWA
May NEWA

N 019614
N 019614
N 019614
N 019614

001
003
002
004

Apr
Apr
Apr
Apr

N 020943
N 020943
N 020943

001 Nov 25, 1998


002 Nov 25, 1998
003 Nov 25, 1998

Apr CAHN
Apr CAHN
Apr CAHN

N 018925

001 Mar 30, 1984

Aug CAHN

N 018485

001

Apr CAHN

N 018593
N 018593
N 018593

003 Nov 23, 1987


001 Mar 08, 1982
002 Mar 08, 1982

Apr CAHN
Apr CAHN
Apr CAHN

A 071881

002 Oct 14, 2015

Oct NEWA

15MG/VIAL

N 021119

001 Apr 12, 2000

Mar CAHN

10MG
20MG
40MG

N 022567
N 022567
N 022567

001 Jan 21, 2011


002 Jan 21, 2011
003 Jan 21, 2011

Mar CAHN
Mar CAHN
Mar CAHN

EQ 10MG BASE/ML

A 075992

001 Jun 10, 2003

Sep CAHN

50MG
200MG

A 203503
A 203503

001 Sep 02, 2015


002 Sep 02, 2015

Aug NEWA
Aug NEWA

AB
AB

ZAFIRLUKAST
TABLET;ORAL
ACCOLATE
PAR PHARM INC
+

10MG
20MG

N 020547
N 020547

003 Sep 17, 1999


001 Sep 26, 1996

Feb CAHN
Feb CAHN

AP
AP
AP
AP

ZOLEDRONIC ACID
INJECTABLE;IV (INFUSION)
ZOLEDRONIC ACID
FRESENIUS KABI USA
HOSPIRA INC
MYLAN LABS LTD
USV NORTH AMERICA

EQ
EQ
EQ
EQ

A 091516
A 090621
A 202650
A 202923

001
001
001
001

Apr
Mar
Jul
Mar

AB
AB

AB
AB
AB

AB
AB
AB

>A> AB

VERAPAMIL HYDROCHLORIDE
CAPSULE, EXTENDED RELEASE;ORAL
VERELAN
RECRO GAINESVILLE
120MG
180MG
240MG
+
360MG
VERELAN PM
RECRO GAINESVILLE
100MG
200MG
+
300MG
INJECTABLE;INJECTION
CALAN
@ EXELA PHARMA SCS LLC 2.5MG/ML
ISOPTIN
@ MT ADAMS
2.5MG/ML
TABLET;ORAL
ISOPTIN
@ MT ADAMS
40MG
@
80MG
@
120MG
VERAPAMIL HYDROCHLORIDE
HERITAGE PHARMS INC
40MG
VERTEPORFIN
INJECTABLE;INJECTION
VISUDYNE
+
VALEANT LUXEMBOURG
VILAZODONE HYDROCHLORIDE
TABLET;ORAL
VIIBRYD
+
FOREST LABS LLC

AP

AB
AB

VINORELBINE TARTRATE
INJECTABLE;INJECTION
VINORELBINE TARTRATE
EUROHLTH INTL SARL
VORICONAZOLE
TABLET;ORAL
VORICONAZOLE
GLENMARK PHARMS LTD

4MG
4MG
4MG
4MG

BASE/5ML
BASE/5ML
BASE/5ML
BASE/5ML

1 -89

October

TABLET;ORAL
VENLAFAXINE HYDROCHLORIDE
EQ 75MG BASE
EQ 100MG BASE

10

May
Jan
May
May

Apr
Mar
Mar
Sep

29,
09,
29,
10,

23,
19,
04,
04,

1990
1992
1990
1996

2015
2015
2013
2014

CAHN
CAHN
CAHN
CAHN

NEWA
NEWA
CAHN
CPOT

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT

AB
AB
AB
AB

AB
AB
>A> AB
>A> AB

AB
AB

AB
AB
AB
AB

AB
AB
AB

2015

A 204232
A 204232
A 203772
A 203772

001
002
001
002

Sep
Sep
Sep
Sep

30,
30,
30,
30,

2015
2015
2015
2015

Sep
Sep
Sep
Sep

NEWA
NEWA
NEWA
NEWA

A 202956
A 202956
A 204336
A 204336

001
002
001
002

Sep
Sep
Oct
Oct

17,
17,
22,
22,

2015
2015
2015
2015

Sep
Sep
Oct
Oct

NEWA
NEWA
NEWA
NEWA

5MG/SPRAY

N 022196

001 Dec 19, 2008

Sep CAHN

5MG
10MG
5MG
10MG

A 078129
A 078129
A 078055
A 078055

001
002
001
002

Mar
Mar
Apr
Apr

1.75MG
3.5MG

N 022328
N 022328

001 Nov 23, 2011


002 Nov 23, 2011

May CFTG
May CFTG

1.75MG
3.5MG

A 204299
A 204299

001 Jun 03, 2015


002 Jun 03, 2015

May NEWA
May NEWA

25MG
50MG
100MG

A 077813
A 077813
A 077813

001 Aug 16, 2006


002 Aug 16, 2006
003 Aug 16, 2006

Jan CAHN
Jan CAHN
Jan CAHN

2.5MG
5MG
MACLEODS PHARMS LTD
2.5MG
5MG
TABLET, ORALLY DISINTEGRATING;ORAL
ZOLMITRIPTAN
JUBILANT GENERICS
2.5MG
5MG
MACLEODS PHARMS LTD
2.5MG
5MG

ZOLPIDEM TARTRATE
SPRAY, METERED;ORAL
ZOLPIMIST
+
AMHERST PHARMS LLC
TABLET;ORAL
ZOLPIDEM TARTRATE
@ HIKMA
@
SUN PHARM INDS LTD
TABLET;SUBLINGUAL
INTERMEZZO
PURDUE PHARMA
+
ZOLPIDEM TARTRATE
NOVEL LABS INC

ZONISAMIDE
CAPSULE;ORAL
ZONISAMIDE
BANNER LIFE SCIENCES

1 -90

October

ZOLMITRIPTAN
TABLET;ORAL
ZOLMITRIPTAN
ALEMBIC PHARMS LTD

10

Apr
Apr
Apr
Apr

30,
30,
23,
23,

2008
2008
2007
2007

DISC
DISC
CAHN
CAHN

OTC DRUG PRODUCT LIST

35TH

OTC DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT

10

EDITION

-

2 -1

October

2015

N 017756
N 017756

002
001

Aug CAHN

Aug CAHN

ACETAMINOPHEN

SUPPOSITORY;RECTAL

TYLENOL

@ J AND J CONSUMER INC
120MG
@
650MG
TABLET, EXTENDED RELEASE;ORAL

ACETAMINOPHEN

SUN PHARM INDS LTD
650MG
@
650MG
TYLENOL

+
J AND J CONSUMER INC
650MG
+
650MG

A 078569
A 090205

001 Dec 14, 2011


001 Nov 18, 2009

Apr CAHN

Apr CAHN

N 019872
N 019872

001 Jun 08, 1994


002 Jan 11, 2001

Aug CAHN

Aug CAHN

AVOBENZONE; OCTINOXATE; OXYBENZONE



LOTION;TOPICAL

SHADE UVAGUARD

+
BAYER HEALTHCARE LLC
3%;7.5%;3%

N 020045

001 Dec 07, 1992

Mar CAHN

BUDESONIDE

SPRAY, METERED;NASAL

RHINOCORT ALLERGY

+
ASTRAZENECA PHARMS

0.032MG/SPRAY

N 020746

003 Mar 23, 2015

Mar NEWA

BUTENAFINE HYDROCHLORIDE

CREAM;TOPICAL

LOTRIMIN ULTRA

+
BAYER HEALTHCARE LLC

1%

N 021307

001 Dec 07, 2001

Mar CAHN

N 020958

001 Oct 16, 2000

Aug CAHN

N 022429
N 022429

001 Jul 23, 2009


004 Jul 23, 2009

Jan CAHN

Jan CAHN

N 022429
N 022429

003 Jul 23, 2009


002 Jul 23, 2009

Jan CAHN

Jan CAHN

N 022155

002 Nov 16, 2007

Aug CAHN

N 022155

001 Nov 16, 2007

Aug CAHN

A 090760
A 090760
A 077498
A 077498

001
003
001
002

Jul
Jul
Apr
Apr

A 077498
A 077498

003 Dec 27, 2007


004 Dec 27, 2007

Apr CAHN

Apr CAHN

A 090760
A 090760

002 Aug 05, 2015


004 Aug 05, 2015

Jul NEWA

Jul NEWA

N 019835
N 019835

003 Nov 16, 2007


004 Nov 16, 2007

Aug CAHN

Aug CAHN

N 019835
N 019835

005 Nov 16, 2007


006 Nov 16, 2007

Aug CAHN

Aug CAHN

A 091116
A 091116
A 078692

001 Feb 19, 2015


002 Feb 19, 2015
001 Feb 14, 2008

Feb NEWA

Feb NEWA

Feb CTNA

CALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE



TABLET, CHEWABLE;ORAL

PEPCID COMPLETE

+
J AND J CONSUMER INC
800MG;10MG;165MG
CETIRIZINE HYDROCHLORIDE

CAPSULE;ORAL

CETIRIZINE HYDROCHLORIDE ALLERGY

BANNER LIFE SCIENCES
5MG
+
10MG
CETIRIZINE HYDROCHLORIDE HIVES RELIEF

BANNER LIFE SCIENCES
5MG
+
10MG
SYRUP;ORAL

CHILDREN'S ZYRTEC ALLERGY

+
J AND J CONSUMER INC
5MG/5ML
CHILDREN'S ZYRTEC HIVES RELIEF

+
J AND J CONSUMER INC
5MG/5ML
TABLET;ORAL

CETIRIZINE HYDROCHLORIDE ALLERGY

AUROBINDO PHARMA LTD
5MG
10MG
SUN PHARM INDS LTD
5MG
10MG
CETIRIZINE HYDROCHLORIDE HIVES

SUN PHARM INDS LTD
5MG
10MG
CETIRIZINE HYDROCHLORIDE HIVES RELIEF

AUROBINDO PHARMA LTD
5MG
10MG
ZYRTEC ALLERGY

J AND J CONSUMER INC
5MG
+
10MG
ZYRTEC HIVES RELIEF

J AND J CONSUMER INC
5MG
+
10MG
TABLET, CHEWABLE;ORAL

CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY

JUBILANT GENERICS
5MG
10MG
SANDOZ
5MG

Aug
Aug
Dec
Dec

05,
05,
27,
27,

2015
2015
2007
2007

NEWA

NEWA

CAHN

CAHN

OTC DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT

2015

A 078692

002 Feb 14, 2008

Feb CTNA

A 091116
A 091116

003 Feb 19, 2015


004 Feb 19, 2015

Feb NEWA
Feb NEWA

N 021621
N 021621

003 Nov 16, 2007


004 Nov 16, 2007

Aug CAHN
Aug CAHN

N 021621
N 021621

005 Nov 16, 2007


006 Nov 16, 2007

Aug CAHN
Aug CAHN

A 205490

001 Sep 02, 2015

Aug NEWA

N 022578

001 Sep 03, 2010

Aug CAHN

CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE


TABLET, EXTENDED RELEASE;ORAL
ZYRTEC-D 12 HOUR
+
J AND J CONSUMER INC 5MG;120MG

N 021150

002 Nov 09, 2007

Aug CAHN

CHLORPHENIRAMINE MALEATE
TABLET, EXTENDED RELEASE;ORAL
CHLOR-TRIMETON
@ BAYER HEALTHCARE LLC 8MG
+
12MG

N 007638
N 007638

001
002

Mar CAHN
Mar CAHN

CHLORPHENIRAMINE MALEATE; PSEUDOEPHEDRINE SULFATE


TABLET, EXTENDED RELEASE;ORAL
CHLOR-TRIMETON
+
BAYER HEALTHCARE LLC 8MG;120MG

N 018397

001

Mar CAHN

CLEMASTINE FUMARATE
TABLET;ORAL
CLEMASTINE FUMARATE
@ ANI PHARMS INC

A 073282

002 Dec 03, 1992

Jul CAHN

N 018052

002 Nov 30, 1990

Mar CAHN

N 020574

001 Nov 24, 1998

Mar CAHN

N 020289

002 Apr 26, 1993

Mar CAHN

N 017717

002 Nov 30, 1990

Mar CAHN

A 091070
A 091070

001 Aug 31, 2015


002 Aug 31, 2015

Aug NEWA
Aug NEWA

A 090397

001 Nov 22, 2010

Jan CAHN

10MG
20MG

A 090283
A 090283

001 Nov 17, 2009


002 Nov 17, 2009

Apr CAHN
Apr CAHN

10MG

N 020325

001 Apr 28, 1995

Jul CAHN

1.34MG

CLOTRIMAZOLE
CREAM;VAGINAL
GYNE-LOTRIMIN
+
BAYER HEALTHCARE LLC 1%
GYNE-LOTRIMIN 3
+
BAYER HEALTHCARE LLC 2%
CREAM, TABLET;TOPICAL, VAGINAL
GYNE-LOTRIMIN COMBINATION PACK
+
BAYER HEALTHCARE LLC 1%,100MG
TABLET;VAGINAL
GYNE-LOTRIMIN
+
BAYER HEALTHCARE LLC 100MG
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
TABLET, EXTENDED RELEASE;ORAL
GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE
ACTAVIS LABS FL INC
30MG;600MG
60MG;1.2GM
DIPHENHYDRAMINE HYDROCHLORIDE; IBUPROFEN
CAPSULE;ORAL
IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE
BANNER LIFE SCIENCES 25MG;EQ 200MG FREE ACID AND
POTASSIUM SALT
FAMOTIDINE
TABLET;ORAL
FAMOTIDINE
SUN PHARM INDS LTD
PEPCID AC
J AND J CONSUMER INC

2 -2

October

TABLET, CHEWABLE;ORAL
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY
+
10MG
CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF
JUBILANT GENERICS
5MG
10MG
CHILDREN'S ZYRTEC ALLERGY
@ J AND J CONSUMER INC
5MG
@
10MG
CHILDREN'S ZYRTEC HIVES RELIEF
@ J AND J CONSUMER INC
5MG
@
10MG
TABLET, ORALLY DISINTEGRATING;ORAL
CETIRIZINE HYDROCHLORIDE ALLERGY
PAR PHARM INC
10MG
ZYRTEC ALLERGY
+
J AND J CONSUMER INC 10MG

10

OTC DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT

2015

20MG

N 020325

002 Sep 23, 2003

Jul CAHN

10MG

N 020902

001 Aug 05, 1999

Aug CAHN

10MG
20MG

N 020801
N 020801

001 Sep 24, 1998


002 Dec 17, 2007

Aug CAHN
Aug CAHN

A 204507
A 204507

002 Sep 16, 2015


003 Sep 16, 2015

Aug NEWA
Aug NEWA

A 204507
A 204507

004 Sep 16, 2015


005 Sep 16, 2015

Aug NEWA
Aug NEWA

FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE


TABLET, EXTENDED RELEASE;ORAL
FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE
SUN PHARMA GLOBAL
60MG;120MG
A 090818

001 Jan 29, 2015

Jan NEWA

GUAIFENESIN
TABLET, EXTENDED RELEASE;ORAL
GUAIFENESIN
ACTAVIS LABS FL INC
1.2GM

A 091009

002 Sep 03, 2015

Aug NEWA

GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE


TABLET, EXTENDED RELEASE;ORAL
GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE
ACTAVIS LABS FL INC
600MG;60MG
1.2GM;120MG

A 091071
A 091071

001 May 27, 2015


002 May 27, 2015

May NEWA
May NEWA

IBUPROFEN
CAPSULE;ORAL
IBUPROFEN
BANNER LIFE SCIENCES

EQ 200MG FREE ACID AND POTASSIUM


SALT

A 078682

001 Mar 24, 2009

Jan CAHN

200MG

N 021472

001 Oct 18, 2002

Jan CAHN

100MG/5ML

N 020516

001 Jun 16, 1995

Aug CAHN

40MG/ML

N 020603

001 Jun 10, 1996

Aug CAHN

200MG
200MG
200MG
200MG

A 071144
A 072901
A 072903
A 071144

001
001
001
001

Oct
Aug
Aug
Oct

100MG

N 020602

001 Jun 10, 1996

Aug CAHN

200MG

N 019012

003 Dec 17, 1990

Aug CAHN

200MG

N 019012

004 Feb 25, 2000

Aug CAHN

200MG
200MG

N 019012
N 019012

001 May 18, 1984


002 Jul 29, 1987

Aug CAHN
Aug CAHN

50MG

N 020601

001 Nov 15, 1996

Aug CAHN

100MG

N 020601

003 Nov 15, 1996

Aug CAHN

FEXOFENADINE HYDROCHLORIDE
TABLET;ORAL
FEXOFENADINE HYDROCHLORIDE ALLERGY
SCIEGEN PHARMS INC
60MG
180MG
FEXOFENADINE HYDROCHLORIDE HIVES
SCIEGEN PHARMS INC
60MG
180MG

>A>

>D>

MIDOL LIQUID GELS


+
BANNER LIFE SCIENCES
SUSPENSION;ORAL
CHILDREN'S MOTRIN
+
J AND J CONSUMER INC
SUSPENSION/DROPS;ORAL
CHILDREN'S MOTRIN
+
J AND J CONSUMER INC
TABLET;ORAL
IBUPROFEN
@ ANI PHARMS INC
@
@
@ IVAX SUB TEVA PHARMS
JUNIOR STRENGTH MOTRIN
J AND J CONSUMER INC
MOTRIN IB
+
J AND J CONSUMER INC
MOTRIN MIGRAINE PAIN
+
J AND J CONSUMER INC
NUPRIN
@ J AND J CONSUMER INC
@
TABLET, CHEWABLE;ORAL
CHILDREN'S MOTRIN
J AND J CONSUMER INC
JUNIOR STRENGTH MOTRIN
+
J AND J CONSUMER INC

2 -3

October

TABLET;ORAL
PEPCID AC
+
PEPCID AC
J AND J CONSUMER INC
TABLET, CHEWABLE;ORAL
PEPCID AC
@ J AND J CONSUMER INC
+

10

Jan
Dec
Dec
Jan

20,
19,
19,
20,

1987
1991
1991
1987

CAHN
CAHN
CAHN
CAHN

OTC DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT

2015

A 206581

001 Aug 03, 2015

Jul NEWA

N 021128

001 Aug 01, 2000

Aug CAHN

N 019899

001 Dec 31, 1992

Aug CAHN

KETOTIFEN FUMARATE
SOLUTION/DROPS;OPHTHALMIC
ALAWAY
BAUSCH AND LOMB
EQ 0.035% BASE

N 021996

002 Feb 11, 2015

Feb NEWA

LEVONORGESTREL
TABLET;ORAL
LEVONORGESTREL
LOTUS PHARM CO LTD
OC PHARMA

1.5MG
1.5MG

A 202246
A 202380

001 Jun 05, 2015


001 May 29, 2015

May NEWA
May NEWA

1MG
2MG

N 021855
N 021855

001 Aug 04, 2005


002 Aug 04, 2005

Jan CAHN
Jan CAHN

1MG/5ML

N 019487

001 Mar 01, 1988

Aug CAHN

1MG/7.5ML

N 019487

002 Jul 08, 2004

Aug CAHN

2MG

N 019860

001 Nov 22, 1989

Aug CAHN

2MG

N 020448

001 Jul 24, 1997

Aug CAHN

N 021140

001 Nov 30, 2000

Aug CAHN

A 077500

001 Sep 06, 2006

Apr CAHN

N 020606

001 Jun 26, 1996

Aug CAHN

10MG

N 021952

001 Jun 16, 2008

Mar CAHN

1MG/ML

N 020641

002 Nov 27, 2002

Mar CAHN

1MG/ML

N 020641

003 Nov 19, 2003

Mar CAHN

1MG/ML

A 201865

001 Jul 31, 2015

Jul NEWA

10MG

A 076134

001 Aug 18, 2003

Apr CAHN

5MG

N 021891

001 Aug 23, 2006

Mar CAHN

EQ 200MG BASE

IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE


SUSPENSION;ORAL
CHILDREN'S MOTRIN COLD
+
J AND J CONSUMER INC 100MG/5ML;15MG/5ML
TABLET;ORAL
SINE-AID IB
J AND J CONSUMER INC 200MG;30MG

LOPERAMIDE HYDROCHLORIDE
CAPSULE;ORAL
LOPERAMIDE HYDROCHLORIDE
BANNER LIFE SCIENCES
+
SOLUTION;ORAL
IMODIUM A-D
+
J AND J CONSUMER INC
SUSPENSION;ORAL
IMODIUM A-D
+
J AND J CONSUMER INC
TABLET;ORAL
IMODIUM A-D
+
J AND J CONSUMER INC
TABLET, CHEWABLE;ORAL
IMODIUM A-D EZ CHEWS
+
J AND J CONSUMER INC

LOPERAMIDE HYDROCHLORIDE; SIMETHICONE


TABLET;ORAL
IMODIUM MULTI-SYMPTOM RELIEF
+
J AND J CONSUMER INC
2MG;125MG
LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE
SUN PHARM INDS LTD
2MG;125MG
TABLET, CHEWABLE;ORAL
IMODIUM MULTI-SYMPTOM RELIEF
+
J AND J CONSUMER INC 2MG;125MG
LORATADINE
CAPSULE;ORAL
CLARITIN
+
BAYER HEALTHCARE LLC
SYRUP;ORAL
CLARITIN
+
BAYER HEALTHCARE LLC
CLARITIN HIVES RELIEF
@ BAYER HEALTHCARE LLC
LORATADINE
TARO
TABLET;ORAL
LORATADINE
SUN PHARM INDS LTD
TABLET, CHEWABLE;ORAL
CHILDREN'S CLARITIN
+
BAYER HEALTHCARE LLC

2 -4

October

IBUPROFEN SODIUM
TABLET;ORAL
IBUPROFEN SODIUM
PERRIGO R AND D

10

OTC DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT

2015

N 021993

001 Dec 12, 2006

Mar CAHN

A 077153

001 Apr 11, 2007

Apr CAHN

N 019670

002 Nov 27, 2002

Mar CAHN

N 020470

002 Nov 27, 2002

Mar CAHN

A 076557

001 Sep 22, 2004

Apr CAHN

EQ 200MG BASE

N 021920

001 Feb 17, 2006

Jan CAHN

EQ 200MG BASE

A 091183

001 May 20, 2011

Apr CAHN

EQ 2MG BASE
EQ 4MG BASE

A 076880
A 077850

001 Feb 18, 2009


001 Feb 18, 2009

Mar DISC
Mar DISC

A 204152

001 Jul 30, 2015

Jul NEWA

N 022281

001 Dec 01, 2009

Mar CAHN

N 022283

001 Jun 17, 2013

Mar CAHN

N 018471

001 May 30, 1986

Mar CAHN

N 022015

001 Oct 06, 2006

Mar CAHN

A 202071

001 Dec 28, 2012

Jan CAHN

A 077442

001 Sep 28, 2005

Apr CAHN

N 020021

002 Dec 15, 1992

Aug CAHN

A 075132
A 078884

001 Jan 14, 2000


001 Jul 31, 2008

Apr CAHN
Jan DISC

LORATADINE; PSEUDOEPHEDRINE SULFATE


TABLET, EXTENDED RELEASE;ORAL
CLARITIN-D
+
BAYER HEALTHCARE LLC 5MG;120MG
CLARITIN-D 24 HOUR
+
BAYER HEALTHCARE LLC
10MG;240MG
LORATADINE AND PSEUDOEPHEDRINE SULFATE
SUN PHARM INDS LTD
10MG;240MG
NAPROXEN SODIUM
CAPSULE;ORAL
NAPROXEN SODIUM
+
BANNER LIFE SCIENCES
TABLET;ORAL
NAPROXEN SODIUM
SUN PHARM INDS LTD
NICOTINE POLACRILEX
GUM, CHEWING;BUCCAL
NICOTINE POLACRILEX
@ IVAX SUB TEVA PHARMS
@

OMEPRAZOLE MAGNESIUM
TABLET, DELAYED RELEASE;ORAL
OMEPRAZOLE MAGNESIUM
PERRIGO R AND D
EQ 20MG BASE
OMEPRAZOLE; SODIUM BICARBONATE
CAPSULE;ORAL
ZEGERID OTC
+
BAYER HEALTHCARE LLC 20MG;1.1GM
FOR SUSPENSION;ORAL
ZEGERID OTC
+
BAYER HEALTHCARE LLC 20MG/PACKET;1.68GM/PACKET
OXYMETAZOLINE HYDROCHLORIDE
SOLUTION/DROPS;OPHTHALMIC
OCUCLEAR
BAYER HEALTHCARE LLC 0.025%
POLYETHYLENE GLYCOL 3350
FOR SOLUTION;ORAL
MIRALAX
+
BAYER HEALTHCARE LLC
17GM/SCOOPFUL
POLYETHYLENE GLYCOL 3350
RARITAN PHARMS INC
17GM/SCOOPFUL
PSEUDOEPHEDRINE HYDROCHLORIDE
TABLET, EXTENDED RELEASE;ORAL
PSEUDOEPHEDRINE HYDROCHLORIDE
SUN PHARM INDS LTD
120MG
SUDAFED 24 HOUR
+
J AND J CONSUMER INC 240MG
RANITIDINE HYDROCHLORIDE
TABLET;ORAL
RANITIDINE HYDROCHLORIDE
@ SUN PHARM INDS LTD
EQ 75MG BASE
@ WOCKHARDT
EQ 75MG BASE

2 -5

October

TABLET, ORALLY DISINTEGRATING;ORAL


CLARITIN REDITABS
+
BAYER HEALTHCARE LLC 5MG
LORATADINE REDIDOSE
SUN PHARM INDS LTD
10MG

10

3-1
DRUG PRODUCTS WITH APPROVAL UNDER SECTION 505 OF THE ACT
ADMINISTERED BY THE CENTER FOR BIOLOGICS EVALUATION AND RESEARCH LIST
CUMULATIVE SUPPLEMENT NUMBER 10 OCTOBER 2015

NO OCTOBER 2015 APPROVALS

4-1

ORPHAN PRODUCT DESIGNATIONS AND APPROVALS LIST

The list of List of Orphan Designations and Approvals is available at:


http://www.fda.gov/orphan/designat/list.htm

5-1
DRUG PRODUCTS WHICH MUST DEMONSTRATE IN VIVO BIOAVAILABILITY
ONLY IF PRODUCT FAILS TO ACHIEVE ADEQUATE DISSOLUTION

NO OCTOBER 2015 ADDITIONS

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST - 35TH EDITION

A - 1

PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 10 - October 2015
See List footnote for information regarding List content
APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY

EXPIRATION

DATE

ABACAVIR SULFATE - ZIAGEN


N 020977 001

D-147

Mar 23, 2018

ABACAVIR SULFATE - ZIAGEN


N 020978 001

D-147

Mar 23, 2018

ABACAVIR SULFATE; DOLUTEGRAVIR SODIUM; LAMIVUDINE - TRIUMEQ


N 205551 001
6417191
Mar 28, 2016
DP U-1572
6417191*PED
Sep 28, 2016
ABACAVIR SULFATE; LAMIVUDINE - EPZICOM
N 021652 001
6417191
Mar 28, 2016
6417191*PED
Sep 28, 2016

DP U-257

ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE - XARTEMIS XR


N 204031 001
8980319
Dec 21, 2030
8992975
May 16, 2032
9050335
May 16, 2032

DP
DP
DP

ACLIDINIUM BROMIDE - TUDORZA PRESSAIR


N 202450 001
9056100
Jul 07, 2020

DP U-1263

ACYCLOVIR; HYDROCORTISONE - XERESE


N 022436 001
7223387
7223387

Jul 24, 2021


Jul 24, 2021

DP U-1006
DP U-1484

ADAPALENE; BENZOYL PEROXIDE - EPIDUO


N 022320 001
8936800
Dec 23, 2022

DP U-1078

ADAPALENE; BENZOYL PEROXIDE - EPIDUO FORTE


N 207917 001
8445543
Jul 12, 2027
8703820
Mar 12, 2023
8729127
Mar 12, 2023
8785420
Dec 23, 2022
8909305
Dec 23, 2022
8936800
Dec 23, 2022

U-1078
U-1078
U-1078
U-1078
U-1078
DP U-1078

NP

Jul 15, 2018

ALBUTEROL SULFATE - PROAIR RESPICLICK


N 205636 001
6446627
Dec
6701917
Jun
6718972
Jun
6748947
Jun
6871646
Jun
7540282
May
8006690
Jun
8651103
Mar

DP
DP
DP
DP
DP
DP
DP
DP

NP

Mar 12, 2018

18,
23,
23,
23,
23,
06,
23,
26,

2017
2021
2021
2021
2021
2023
2021
2028

ALBUTEROL SULFATE; IPRATROPIUM BROMIDE - COMBIVENT RESPIMAT


N 021747 001
8733341
Dec 16, 2029
DP
9027967
Mar 31, 2027
DP
ALCAFTADINE - LASTACAFT
N 022134 001 >A> 8664215

Dec 23, 2027

ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE - OSENI


N 022426 001
8637079
Jun 04, 2029
DP
ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE - OSENI
N 022426 002
8637079
Jun 04, 2029
DP

U-1493

A - 2

PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 10 - October 2015
See List footnote for information regarding List content
APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY

EXPIRATION

DATE

ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE - OSENI


N 022426 003
8637079
Jun 04, 2029
DP
ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE - OSENI
N 022426 004
8637079
Jun 04, 2029
DP
ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE - OSENI
N 022426 005
8637079
Jun 04, 2029
DP
ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE - OSENI
N 022426 006
8637079
Jun 04, 2029
DP
ALVIMOPAN - ENTEREG
N 021775 001
8946262

Feb 12, 2030

U-1655

AMBRISENTAN - LETAIRIS
N 022081 001 >A> 8377933

Dec 11, 2027

U-1754

>A> I-716

Oct 02, 2018

AMBRISENTAN - LETAIRIS
N 022081 002 >A> 8377933

Dec 11, 2027

U-1754

>A> I-716

Oct 02, 2018

AMOXICILLIN - MOXATAG
N 050813 001
8778924

Dec 08, 2026

AMPHETAMINE - DYANAVEL XR
N 208147 001 >A> 8062667
>A> 8597684
>A> 8747902
>A> 8883217

Mar
Mar
Mar
Mar

29,
15,
15,
15,

2029
2027
2027
2027

>A> NP

Oct 19, 2018

APIXABAN - ELIQUIS
N 202155 001
6967208
6967208
6967208
6967208
6967208
6967208
6967208
6967208
6967208

Feb
Feb
Feb
Feb
Feb
Feb
Feb
Feb
Feb

03,
03,
03,
03,
03,
03,
03,
03,
03,

2023
2023
2023
2023
2023
2023
2023
2023
2023

DS
DS
DS
DS
DS
DS
DS
DS
DS

DP
DP
DP
DP
DP
DP
DP
DP
DP

U-1167
U-1200
U-1301
U-1302
U-1323
U-1501
U-1502
U-1729
U-1730

APIXABAN - ELIQUIS
N 202155 002
6413980
6413980
6413980
6967208
6967208
6967208
6967208

Dec
Dec
Dec
Feb
Feb
Feb
Feb

22,
22,
22,
03,
03,
03,
03,

2019
2019
2019
2023
2023
2023
2023

DS
DS
DS
DS
DS
DS
DS

DP
DP
DP
DP
DP
DP
DP

U-1200
U-1301
U-1302
U-1200
U-1301
U-1302
U-1323

APREMILAST - OTEZLA
N 205437 001
9018243
9018243

Mar 19, 2023


Mar 19, 2023

U-1505
U-1595

APREMILAST - OTEZLA
N 205437 002
9018243
9018243

Mar 19, 2023


Mar 19, 2023

U-1505
U-1595

APREMILAST - OTEZLA
N 205437 003
9018243
9018243

Mar 19, 2023


Mar 19, 2023

U-1505
U-1595

DS DP U-897

DP
DP
DP
DP

A - 3

PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 10 - October 2015
See List footnote for information regarding List content
APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY

EXPIRATION

DATE

APREPITANT - EMEND

N 021549 001
6096742
6096742
6096742
8258132
8258132

Jul
Jul
Jul
Sep
Sep

01,
01,
01,
26,
26,

2018
2018
2018
2027
2027

DS DP U-745
DS DP U-1743

DS DP U-1744

DP U-901

DP U-1743

NPP

Aug 28, 2018

APREPITANT - EMEND

N 021549 002
6096742
6096742
6096742
8258132
8258132

Jul
Jul
Jul
Sep
Sep

01,
01,
01,
26,
26,

2018
2018
2018
2027
2027

DS DP U-745
DS DP U-1743

DS DP U-1744

DP U-901

DP U-1743

NPP

Aug 28, 2018

APREPITANT - EMEND

N 021549 003
6096742
6096742
6096742
8258132
8258132

Jul
Jul
Jul
Sep
Sep

01,
01,
01,
26,
26,

2018
2018
2018
2027
2027

DS DP U-745
DS DP U-1743

DS DP U-1744

DP U-901

DP U-1743

NPP

Aug 28, 2018

ARIPIPRAZOLE - ABILIFY

N 021436 001
9089567
9125939

Jan 28, 2022


Jul 28, 2026

U-543
U-1749

ODE

Dec 12, 2021


ARIPIPRAZOLE - ABILIFY

N 021436 002
9089567
9125939

Jan 28, 2022


Jul 28, 2026

U-543
U-1749

ODE

Dec 12, 2021


ARIPIPRAZOLE - ABILIFY

N 021436 003
9089567
9125939

Jan 28, 2022


Jul 28, 2026

U-543
U-1749

ODE

Dec 12, 2021


ARIPIPRAZOLE - ABILIFY

N 021436 004
9089567
9125939

Jan 28, 2022


Jul 28, 2026

U-543
U-1749

ODE

Dec 12, 2021


ARIPIPRAZOLE - ABILIFY

N 021436 005
9089567
9125939

Jan 28, 2022


Jul 28, 2026

U-543
U-1749

ODE

Dec 12, 2021


ARIPIPRAZOLE - ABILIFY

N 021436 006
9089567
9125939

Jan 28, 2022


Jul 28, 2026

U-543
U-1749

ODE

Dec 12, 2021


ARIPIPRAZOLE - ABILIFY

N 021713 001
5006528
5006528
5006528*PED
6977257
6977257*PED

Oct
Oct
Apr
Apr
Oct

ODE

Dec 12, 2021


ARIPIPRAZOLE - ABILIFY

N 021729 002
9089567
9125939

Jan 28, 2022


Jul 28, 2026

U-543
U-1749

ODE

Dec 12, 2021


ARIPIPRAZOLE - ABILIFY

N 021729 003
9089567
9125939

Jan 28, 2022


Jul 28, 2026

U-543
U-1749

ODE

Dec 12, 2021


20,
20,
20,
24,
24,

2014
2014
2015

2022
2022

DS DP U-543
DS DP U-761

DP

A - 4

PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 10 - October 2015
See List footnote for information regarding List content
APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

ARIPIPRAZOLE - ABILIFY
N 021729 004

ODE

Dec 12, 2021

ARIPIPRAZOLE - ABILIFY
N 021729 005

ODE

Dec 12, 2021

ODE

Dec 12, 2021

ARIPIPRAZOLE - ABILIFY
N 021866 001
5006528
5006528
5006528*PED

Oct 20, 2014


Oct 20, 2014
Apr 20, 2015

ARIPIPRAZOLE - ABILIFY MAINTENA KIT


N 202971 001
5006528
Oct 20, 2014
5006528
Oct 20, 2014
5006528*PED
Apr 20, 2015
8030313
Oct 19, 2024
8030313
Oct 19, 2024
8338427
Mar 15, 2025
8338427
Mar 15, 2025
8338428
Aug 06, 2023
8338428
Aug 06, 2023
8399469
Jun 29, 2025
8759351
Aug 06, 2023
8759351
Aug 06, 2023
8993761
Sep 25, 2022
9089567
Jan 28, 2022
ARIPIPRAZOLE - ABILIFY MAINTENA KIT
N 202971 002
5006528
Oct 20, 2014
5006528
Oct 20, 2014
5006528*PED
Apr 20, 2015
8030313
Oct 19, 2024
8030313
Oct 19, 2024
8338427
Mar 15, 2025
8338427
Mar 15, 2025
8338428
Aug 06, 2023
8338428
Aug 06, 2023
8399469
Jun 29, 2025
8759351
Aug 06, 2023
8759351
Aug 06, 2023
8993761
Sep 25, 2022
9089567
Jan 28, 2022
ARIPIPRAZOLE - ABILIFY MAINTENA KIT
N 202971 003
5006528
Oct 20, 2014
5006528
Oct 20, 2014
5006528*PED
Apr 20, 2015
8030313
Oct 19, 2024
8030313
Oct 19, 2024
8338427
Mar 15, 2025
8338427
Mar 15, 2025
8338428
Aug 06, 2023
8338428
Aug 06, 2023
8399469
Jun 29, 2025
8759351
Aug 06, 2023
8759351
Aug 06, 2023
8993761
Sep 25, 2022
9089567
Jan 28, 2022
ARIPIPRAZOLE - ABILIFY MAINTENA KIT

N 202971 004
5006528
Oct 20, 2014
5006528
Oct 20, 2014
5006528*PED
Apr 20, 2015

8030313
Oct 19, 2024
8030313
Oct 19, 2024

DS DP U-543
DS DP U-763

DS DP U-543
DS DP U-1632

DP
DP
DP
DP

U-543
U-1632
U-543
U-1633
U-543
U-1633

DS
DP U-1530
DP U-1633
DS
U-543

DS DP U-543
DS DP U-1632

DP
DP
DP
DP

U-543
U-1632
U-543
U-1633
U-543
U-1633

DS
DP U-1530
DP U-1633
DS
U-543

DS DP U-543
DS DP U-1632

DP
DP
DP
DP

U-543
U-1632
U-543
U-1633
U-543
U-1633

DS
DP U-1530
DP U-1633
DS
U-543

DS DP U-543

DS DP U-1632

U-543

U-1632

A - 5

PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 10 - October 2015
See List footnote for information regarding List content
APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

ARIPIPRAZOLE - ABILIFY MAINTENA KIT



N 202971 004
8338427
Mar 15, 2025
8338427
Mar 15, 2025
8338428
Aug 06, 2023
8338428
Aug 06, 2023
8399469
Jun 29, 2025
8759351
Aug 06, 2023
8759351
Aug 06, 2023
8993761
Sep 25, 2022
9089567
Jan 28, 2022

PATENT
CODES

DP
DP
DP
DP

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY

EXPIRATION

DATE

U-543

U-1633

U-543

U-1633

DS

DP U-1530

DP U-1633

DS

U-543

ARIPIPRAZOLE LAUROXIL - ARISTADA



N 207533 001 >A> 8431576
>A> 8796276
>A> 9034867

Oct 26, 2030


Jun 24, 2030
Nov 07, 2032

DS

ARIPIPRAZOLE LAUROXIL - ARISTADA



N 207533 002 >A> 8431576
>A> 8796276
>A> 9034867

Oct 26, 2030


Jun 24, 2030
Nov 07, 2032

DS

ARIPIPRAZOLE LAUROXIL - ARISTADA



N 207533 003 >A> 8431576
>A> 8796276
>A> 9034867

Oct 26, 2030


Jun 24, 2030
Nov 07, 2032

DS

ASENAPINE MALEATE - SAPHRIS



N 022117 001
5763476
5763476*PED
7741358
7741358*PED
8022228
8022228*PED

Jun
Dec
Apr
Oct
Apr
Oct

09,
09,
06,
06,
06,
06,

2020
2020
2026
2026
2026
2026

ASENAPINE MALEATE - SAPHRIS



N 022117 002
5763476
5763476*PED
7741358
7741358*PED
8022228
8022228*PED

Jun
Dec
Apr
Oct
Apr
Oct

09,
09,
06,
06,
06,
06,

2020
2020
2026
2026
2026
2026

ASPIRIN - ASPIRIN

N 203697 001
9101637
9101637
9101637

Mar 23, 2022


Mar 23, 2022
Mar 23, 2022

ATAZANAVIR SULFATE - REYATAZ



N 021567 001
5849911
5849911*PED
6087383
6087383*PED

Jun
Dec
Dec
Jun

20,
20,
21,
21,

2017
2017

2018
2019

DS DP U-167

ATAZANAVIR SULFATE - REYATAZ



N 021567 002
5849911
5849911*PED
6087383
6087383*PED

Jun
Dec
Dec
Jun

20,
20,
21,
21,

2017
2017

2018
2019

DS DP U-167

ATAZANAVIR SULFATE - REYATAZ



N 021567 003
5849911
5849911*PED
6087383
6087383*PED

Jun
Dec
Dec
Jun

20,
20,
21,
21,

2017
2017

2018
2019

DS DP U-167

>A> NCE

Oct 05, 2020


>A> NCE

Oct 05, 2020


>A> NCE

Oct 05, 2020


U-543

DP U-543

U-543

DP U-543

U-543

DP U-543

DP U-326
DS DP U-1064

M-158
NPP
PED
PED

Mar
Mar
Sep
Sep

17,
17,
17,
17,

2018

2018

2018

2018

M-158
NPP
PED
PED

Mar
Mar
Sep
Sep

17,
17,
17,
17,

2018

2018

2018

2018

DS DP

DP U-326
DS DP U-1064
DS DP

U-1731

U-1732

U-1733

DS DP

DS DP

DS DP

A - 6

PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 10 - October 2015
See List footnote for information regarding List content
APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

ATAZANAVIR SULFATE - REYATAZ


N 021567 003
5849911
5849911*PED
6087383
6087383*PED

Jun
Dec
Dec
Jun

20,
20,
21,
21,

2017
2017
2018
2019

DS DP U-167

ATAZANAVIR SULFATE - REYATAZ


N 021567 004
5849911
5849911*PED
6087383
6087383*PED

Jun
Dec
Dec
Jun

20,
20,
21,
21,

2017
2017
2018
2019

DS DP U-167

ATAZANAVIR SULFATE - REYATAZ


N 206352 001
5849911
5849911*PED
6087383
6087383*PED

Jun
Dec
Dec
Jun

20,
20,
21,
21,

2017
2017
2018
2019

DS DP U-167

ATAZANAVIR SULFATE; COBICISTAT - EVOTAZ


N 206353 001
5849911
Jun 20, 2017
5849911*PED
Dec 20, 2017
6087383
Dec 21, 2018
6087383*PED
Jun 21, 2019
8148374
Sep 03, 2029
AVIBACTAM SODIUM; CEFTAZIDIME - AVYCAZ
N 206494 001
7112592
Feb
7612087
Nov
8178554
Jul
8471025
Aug
8835455
Oct
8969566
Jun

24,
12,
24,
12,
08,
15,

2022
2026
2021
2031
2030
2032

AZELAIC ACID - FINACEA


N 207071 001
6730288
7700076
8435498
8722021
8900554

08,
18,
01,
24,
24,

2019
2027
2024
2023
2023

Sep
Sep
Mar
Oct
Oct

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

DS DP

DS DP

DS DP

NP
NPP
PED
PED

Jun
Sep
Dec
Mar

02,
24,
02,
24,

2017
2018
2017
2019

NP

Jul 29, 2018

NPP
NPP

Feb 20, 2018


Feb 20, 2018

NPP

Feb 20, 2018

DS DP U-167
DS DP
DS DP U-1279

DS DP U-282
DP
DS DP U-282
DS
DP
DS

DP
DP
U-1727
DP
DP

AZELASTINE HYDROCHLORIDE - ASTEPRO


N 022203 001

AZELASTINE HYDROCHLORIDE; FLUTICASONE PROPIONATE - DYMISTA


N 202236 001
8163723
Aug 29, 2023
U-77
8163723
Aug 29, 2023
U-81
8163723
Aug 29, 2023
U-644
8163723
Aug 29, 2023
U-707
8163723
Aug 29, 2023
U-1667
AZILSARTAN KAMEDOXOMIL - EDARBI
N 200796 001
9066936

Mar 26, 2028

DP

AZILSARTAN KAMEDOXOMIL - EDARBI


N 200796 002
9066936

Mar 26, 2028

DP

AZILSARTAN KAMEDOXOMIL; CHLORTHALIDONE - EDARBYCLOR


N 202331 001
9066936
Mar 26, 2028

DP

AZILSARTAN KAMEDOXOMIL; CHLORTHALIDONE - EDARBYCLOR


N 202331 002
9066936
Mar 26, 2028

DP

A - 7

PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 10 - October 2015
See List footnote for information regarding List content
APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE - ACANYA



N 050819 001
8895070
Jun 03, 2029
9078870
Jun 03, 2029

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY

EXPIRATION

DATE

U-124

DP

BESIFLOXACIN HYDROCHLORIDE - BESIVANCE



N 022308 001
8937062
Nov 13, 2029

U-80

BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE - ENSTILAR



N 207589 001 >A> 6753013
Jun 10, 2031
>A> 9119781
Jun 10, 2031

DP U-1761
DP U-1761

>A> NP

BEXAROTENE - TARGRETIN

N 021055 001
BIMATOPROST - LUMIGAN

N 022184 001
8933120
8933127

Mar 16, 2025


Mar 16, 2025

BIMATOPROST - LATISSE

N 022369 001
7351404
7388029
8541466
8986715

May
Jan
Jan
Jan

25,
21,
31,
15,

2024
2022
2021
2023

BORTEZOMIB - VELCADE

N 021602 001
5780454
5780454*PED
6713446
6713446*PED
6958319
6958319*PED

May
Nov
Jan
Jul
Jan
Jul

03,
03,
25,
25,
25,
25,

2017
2017
2022
2022
2022
2022

BREXPIPRAZOLE - REXULTI

N 205422 001
7888362
8349840
8618109

Feb 23, 2027


Apr 12, 2026
Apr 12, 2026

DS

BREXPIPRAZOLE - REXULTI

N 205422 002
7888362
8349840
8618109

Feb 23, 2027


Apr 12, 2026
Apr 12, 2026

DS

BREXPIPRAZOLE - REXULTI

N 205422 003
7888362
8349840
8618109

Feb 23, 2027


Apr 12, 2026
Apr 12, 2026

DS

BREXPIPRAZOLE - REXULTI

N 205422 004
7888362
8349840
8618109

Feb 23, 2027


Apr 12, 2026
Apr 12, 2026

DS

BREXPIPRAZOLE - REXULTI

N 205422 005
7888362
8349840
8618109

Feb 23, 2027


Apr 12, 2026
Apr 12, 2026

DS

Oct 16, 2018


M-164

Jul 29, 2018


D-141
D-142
I-695
M-139
M-165
ODE
PED
PED
PED
PED
PED
PED

Oct
Oct
Oct
Aug
Sep
Oct
Feb
Apr
Apr
Apr
Mar
Apr

NCE

Jul 10, 2020


NCE

Jul 10, 2020


NCE

Jul 10, 2020


NCE

Jul 10, 2020


NCE

Jul 10, 2020


DP

DP

U-939
U-938
U-1217

U-1217

DS DP
DS DP
DS DP

Y

Y

08,
08,
08,
08,
14,
08,
08,
08,
08,
08,
14,
08,

2017

2017

2017

2017

2018

2021

2018

2018

2018

2018

2019

2022

DP U-1529

U-543

DP U-1529

U-543

DP U-1529

U-543

DP U-1529

U-543

DP U-1529

U-543

A - 8

PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 10 - October 2015
See List footnote for information regarding List content
APPL/PROD

NO

PATENT

EXPIRATION
DATE

PATENT NO

BREXPIPRAZOLE - REXULTI

N 205422 006
7888362

8349840

8618109

Feb 23, 2027


Apr 12, 2026
Apr 12, 2026

PATENT

CODES

DS

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

NCE

EXCLUSIVITY
EXPIRATION
DATE

Jul 10, 2020

DP U-1529

U-543

BRIMONIDINE TARTRATE; BRINZOLAMIDE - SIMBRINZA



N 204251 001
9044484
Oct 30, 2030

DP

BROMFENAC SODIUM - PROLENSA



N 203168 001 >A> 9144609

Jan 16, 2024

DP

BROMOCRIPTINE MESYLATE - CYCLOSET



N 020866 001
8877708

Jun 07, 2030

DP U-1706

BUDESONIDE - UCERIS

N 203634 001
9132093

Sep 07, 2031

DP

BUDESONIDE - UCERIS

N 205613 001
5914122

Dec 19, 2015

DP

BUPRENORPHINE HYDROCHLORIDE - BELBUCA



N 207932 001

>A> NP

Oct 23, 2018

BUPRENORPHINE HYDROCHLORIDE - BELBUCA



N 207932 002

>A> NP

Oct 23, 2018

BUPRENORPHINE HYDROCHLORIDE - BELBUCA



N 207932 003

>A> NP

Oct 23, 2018

BUPRENORPHINE HYDROCHLORIDE - BELBUCA



N 207932 004

>A> NP

Oct 23, 2018

BUPRENORPHINE HYDROCHLORIDE - BELBUCA



N 207932 005

>A> NP

Oct 23, 2018

BUPRENORPHINE HYDROCHLORIDE - BELBUCA



N 207932 006

>A> NP

Oct 23, 2018

BUPRENORPHINE HYDROCHLORIDE - BELBUCA



N 207932 007

>A> NP

Oct 23, 2018

BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE - ZUBSOLV



N 204242 001
8470361
May 22, 2030
DP U-1425

8940330
Sep 18, 2032
DP

I-713

Aug 10, 2018

BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE - ZUBSOLV



N 204242 002
8470361
May 22, 2030
DP U-1425

8940330
Sep 18, 2032
DP

I-713

Aug 10, 2018

BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE - ZUBSOLV



N 204242 003
8470361
May 22, 2030
DP U-1425

8940330
Sep 18, 2032
DP

I-713

Aug 10, 2018

BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE - ZUBSOLV



N 204242 004
8470361
May 22, 2030
DP U-1425

8940330
Sep 18, 2032
DP

I-713

Aug 10, 2018

I-713

Aug 10, 2018

BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE - ZUBSOLV



N 204242 005
8454996
Sep 24, 2019
U-1421

8470361
May 22, 2030
DP U-1425

8658198
Dec 03, 2027
DP U-1494

A - 9

PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 10 - October 2015
See List footnote for information regarding List content
APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY

EXPIRATION

DATE

BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE - ZUBSOLV



N 204242 005
8940330
Sep 18, 2032
DP

BUPROPION HYDROCHLORIDE; NALTREXONE
N 200063 001
8916195
9107837
>A> 9125868

HYDROCHLORIDE - CONTRAVE

Feb 02, 2030
U-1639

Jun 04, 2027
U-1639

Nov 08, 2027
U-1585

CALCIUM ACETATE - PHOSLO GELCAPS



N 021160 003
6875445

Jul 30, 2021

CALCIUM ACETATE - PHOSLYRA



N 022581 001
9089528

Jul 20, 2027

DP

U-1469

CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM PHOSPHATE

- PHOXILLUM BK 4/2.5 IN PLASTIC CONTAINER

N 207026 001
ODE
Jan 13, 2022

CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM PHOSPHATE

- PHOXILLUM B22K 4/0 IN PLASTIC CONTAINER

N 207026 002
ODE
Jan 13, 2022

CANGRELOR - KENGREAL

N 204958 001
6114313
6130208
8680052
8759316

Dec
Jun
Mar
May

11,
29,
09,
13,

2017
2018
2033
2029

DP U-1715
DP U-1715

U-1715

U-1715

NCE

Jun 22, 2020


CARBIDOPA; LEVODOPA - RYTARY



N 203312 001
7094427
8377474
8377474
8454998
8454998
8454998
8454998
8454998
8557283
8557283
9089607
9089607
9089608

May
Dec
Dec
Dec
Dec
Dec
Dec
Dec
Dec
Dec
Dec
Dec
Dec

29,
26,
26,
26,
26,
26,
26,
26,
26,
26,
26,
26,
26,

2022
2028
2028
2028
2028
2028
2028
2028
2028
2028
2028
2028
2028

DP U-1645
DP U-219

DP U-1645

DP U-219

DP U-1645

DP U-1646

DP U-1647

DP U-1649

DP U-219

DP U-1645

DP U-1645

DP U-1720

DP

NDF

Jan 07, 2018


CARBIDOPA; LEVODOPA - RYTARY



N 203312 002
7094427
8377474
8377474
8454998
8454998
8454998
8454998
8454998
8557283
8557283
9089607
9089607
9089608

May
Dec
Dec
Dec
Dec
Dec
Dec
Dec
Dec
Dec
Dec
Dec
Dec

29,
26,
26,
26,
26,
26,
26,
26,
26,
26,
26,
26,
26,

2022
2028
2028
2028
2028
2028
2028
2028
2028
2028
2028
2028
2028

DP U-1645
DP U-219

DP U-1645

DP U-219

DP U-1645

DP U-1646

DP U-1647

DP U-1649

DP U-219

DP U-1645

DP U-1645

DP U-1720

DP

NDF

Jan 07, 2018


CARBIDOPA; LEVODOPA - RYTARY



N 203312 003
7094427
8377474
8377474
8454998
8454998

May
Dec
Dec
Dec
Dec

29,
26,
26,
26,
26,

2022
2028
2028
2028
2028

DP
DP
DP
DP
DP

NDF

Jan 07, 2018


U-1645
U-219

U-1645

U-219

U-1645

A - 10

PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 10 - October 2015
See List footnote for information regarding List content
APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

CARBIDOPA; LEVODOPA - RYTARY



N 203312 003
8454998
8454998
8454998
8557283
8557283
9089607
9089607
9089608

Dec
Dec
Dec
Dec
Dec
Dec
Dec
Dec

26,
26,
26,
26,
26,
26,
26,
26,

2028
2028
2028
2028
2028
2028
2028
2028

DP U-1646

DP U-1647

DP U-1649

DP U-219

DP U-1645

DP U-1645

DP U-1720

DP

CARBIDOPA; LEVODOPA - RYTARY



N 203312 004
7094427
8377474
8377474
8454998
8454998
8454998
8454998
8454998
8557283
8557283
9089607
9089607
9089608

May
Dec
Dec
Dec
Dec
Dec
Dec
Dec
Dec
Dec
Dec
Dec
Dec

29,
26,
26,
26,
26,
26,
26,
26,
26,
26,
26,
26,
26,

2022
2028
2028
2028
2028
2028
2028
2028
2028
2028
2028
2028
2028

DP U-1645
DP U-219

DP U-1645

DP U-219

DP U-1645

DP U-1646

DP U-1647

DP U-1649

DP U-219

DP U-1645

DP U-1645

DP U-1720

DP

CARBIDOPA; LEVODOPA - DUOPA



N 203952 001

CARFILZOMIB - KYPROLIS

N 202714 001

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY

EXPIRATION

DATE

NDF

Jan 07, 2018


NP
ODE

Jan 09, 2018



Jan 09, 2022

I-712

Jul 24, 2018


CARIPRAZINE HYDROCHLORIDE - VRAYLAR



N 204370 001 >A> 7737142
Mar 27, 2027
>A> 7943621
Dec 16, 2028

DS DP U-1750
DS DP

NCE

Sep 17, 2020

CARIPRAZINE HYDROCHLORIDE - VRAYLAR



N 204370 002 >A> 7737142
Mar 27, 2027
>A> 7943621
Dec 16, 2028

DS DP U-1750
DS DP

NCE

Sep 17, 2020

CARIPRAZINE HYDROCHLORIDE - VRAYLAR



N 204370 003 >A> 7737142
Mar 27, 2027
>A> 7943621
Dec 16, 2028

DS DP U-1750
DS DP

NCE

Sep 17, 2020

CARIPRAZINE HYDROCHLORIDE - VRAYLAR



N 204370 004 >A> 7737142
Mar 27, 2027
>A> 7943621
Dec 16, 2028

DS DP U-1750
DS DP

NCE

Sep 17, 2020

CEFTAROLINE FOSAMIL - TEFLARO



N 200327 001
6417175

Apr 11, 2022

DS DP U-1676

CEFTAROLINE FOSAMIL - TEFLARO



N 200327 002
6417175

Apr 11, 2022

DS DP U-1676

PC

Jun 02, 2015


CEFTOLOZANE SULFATE; TAZOBACTAM SODIUM - ZERBAXA



N 206829 001
8968753
Mar 14, 2034
8968753
Mar 14, 2034
CELECOXIB - CELECOXIB

A 076898 002

U-1672

U-1673

A - 11

PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 10 - October 2015
See List footnote for information regarding List content
APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY

EXPIRATION

DATE

CELECOXIB - CELECOXIB

A 076898 003

PC

Jun 02, 2015


CELECOXIB - CELECOXIB

A 076898 004

PC

Jun 02, 2015


CELECOXIB - CELECOXIB

A 078857 002

PC

Jun 02, 2015


CELECOXIB - CELECOXIB

A 078857 003

PC

Jun 02, 2015


CELECOXIB - CELECOXIB

A 078857 004

PC

Jun 02, 2015


CELECOXIB - CELECOXIB

A 200562 002

PC

Jun 02, 2015


CELECOXIB - CELECOXIB

A 200562 003

PC

Jun 02, 2015


CELECOXIB - CELECOXIB

A 200562 004

PC

Jun 02, 2015


CHLORPHENIRAMINE MALEATE; CODEINE PHOSPHATE - CODEINE PHOSPHATE AND CHLORPHENIRAMINE MALEATE



N 206323 001
6248363
Nov 23, 2019
DP U-1716

6383471
Apr 06, 2019
DP U-1716

9066942
Jan 03, 2032
U-1716

>A> 9107921
Jan 03, 2032
DP

CHLORPHENIRAMINE POLISTIREX; CODEINE POLISTIREX - TUZISTRA XR

N 207768 001
8062667
Mar 29, 2029
DP

8790700
Mar 15, 2027
DP

CHOLIC ACID - CHOLBAM

N 205750 001

ODE

Mar 17, 2022


CHOLIC ACID - CHOLBAM



N 205750 002

ODE

Mar 17, 2022


PC

Jul 01, 2015


CICLESONIDE - ALVESCO

N 021658 002
8371292

Feb 01, 2028

U-1355

CICLESONIDE - ALVESCO

N 021658 003
8371292

Feb 01, 2028

U-1355

CICLESONIDE - OMNARIS

N 022004 001
8371292

Feb 01, 2028

U-1356

CICLESONIDE - ZETONNA

N 202129 001
8371292

Feb 01, 2028

U-1357

CIPROFLOXACIN; DEXAMETHASONE - CIPRODEX



N 021537 001 >A> 9149486
Sep 13, 2022

DP U-1578

CLOBETASOL PROPIONATE - CLOBETASOL PROPIONATE



A 090898 001

A - 12

PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 10 - October 2015
See List footnote for information regarding List content
APPL/PROD
NO

PATENT NO

CLOBETASOL PROPIONATE - OLUX E



N 022013 001
8962000

PATENT
EXPIRATION
DATE

PATENT
CODES

Aug 31, 2025

COBICISTAT; DARUNAVIR ETHANOLATE - PREZCOBIX



N 205395 001
5843946
Dec 01, 2015
5843946*PED
Jun 01, 2016

7470506
Jun 23, 2019
7470506*PED
Dec 23, 2019

7700645
Dec 26, 2026
7700645*PED
Jun 26, 2027

8148374
Sep 03, 2029
8518987
Feb 16, 2024
8518987*PED
Aug 16, 2024

8597876
Jun 23, 2019
8597876*PED
Dec 23, 2019

RE42889
Oct 19, 2016
RE42889*PED
Apr 19, 2017

RE43596
May 09, 2017
RE43596*PED
Nov 09, 2017

RE43802
Oct 19, 2016
RE43802*PED
Apr 19, 2017

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY

EXPIRATION

DATE

DP U-1410

DP U-1660

U-1660

DS DP

DS DP U-1660

DS DP

U-1660

DP

DS DP

U-1660

COBICISTAT; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE - STRIBILD



N 203100 001
8981103
Oct 26, 2026
DS DP

I-704

Dec 17, 2017


COLCHICINE - MITIGARE

N 204820 001
8927607

Aug 22, 2033

CRIZOTINIB - XALKORI

N 202570 001
7230098

Aug 26, 2025

DS

M-163

Sep 14, 2018


CRIZOTINIB - XALKORI

N 202570 002
7230098

Aug 26, 2025

DS

M-163

Sep 14, 2018


CROFELEMER - FULYZAQ

N 202292 001
8962680

Oct 31, 2031

CYANOCOBALAMIN - NASCOBAL

N 021642 001
7229636
7879349
8003353
8940714

Aug
Aug
Aug
Feb

CYSTEAMINE BITARTRATE - PROCYSBI



N 203389 001 >A> 9173851

Jun 17, 2034

DP

NPP

Aug 14, 2018


CYSTEAMINE BITARTRATE - PROCYSBI



N 203389 002 >A> 9173851

Jun 17, 2034

DP

NPP

Aug 14, 2018


01,
01,
01,
26,

2024
2024
2024
2024

U-1020

U-1319

DP U-817

DP U-1152

U-817

U-1152

DABIGATRAN ETEXILATE MESYLATE - PRADAXA



N 022512 001 >A> 9034822
Jan 20, 2031

U-1759

DABIGATRAN ETEXILATE MESYLATE - PRADAXA



N 022512 002 >A> 9034822
Jan 20, 2031

U-1759

DABRAFENIB MESYLATE - TAFINLAR



N 202806 001
8703781

Oct 15, 2030

DS DP U-1713

DABRAFENIB MESYLATE - TAFINLAR



N 202806 002
8703781

Oct 15, 2030

DS DP U-1713

A - 13

PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 10 - October 2015
See List footnote for information regarding List content
APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY

EXPIRATION

DATE

DACLATASVIR DIHYDROCHLORIDE - DAKLINZA



N 206843 001
8329159
Apr 13, 2028
8629171
Jun 13, 2031
8642025
Aug 11, 2027
8642025
Aug 11, 2027
8900566
Aug 08, 2027
8900566
Aug 08, 2027

DS
DS DP U-1724

DS DP U-1724

DS DP U-1725

U-1724

U-1725

NCE

Jul 24, 2020


DACLATASVIR DIHYDROCHLORIDE - DAKLINZA



N 206843 002
8329159
Apr 13, 2028
8629171
Jun 13, 2031
8642025
Aug 11, 2027
8642025
Aug 11, 2027
8900566
Aug 08, 2027
8900566
Aug 08, 2027

DS
DS DP U-1724

DS DP U-1724

DS DP U-1725

U-1724

U-1725

NCE

Jul 24, 2020


DANTROLENE SODIUM - RYANODEX



N 205579 001

ODE

Jul 22, 2021


DAPAGLIFLOZIN PROPANEDIOL - FARXIGA



N 202293 001

M-157

Mar 11, 2018


DAPAGLIFLOZIN PROPANEDIOL - FARXIGA



N 202293 002

M-157

Mar 11, 2018


DEFERASIROX - EXJADE

N 021882 001

ODE

Jan 23, 2020


DEFERASIROX - EXJADE

N 021882 002

ODE

Jan 23, 2020


DEFERASIROX - EXJADE

N 021882 003

ODE

Jan 23, 2020


DASABUVIR SODIUM ; OMBITASVIR; PARITAPREVIR; RITONAVIR - VIEKIRA PAK (COPACKAGED)

N 206619 001
6037157
Jun 26, 2016
U-1635

6703403
Jun 26, 2016
U-1635

7148359
Jul 19, 2019
DP

7364752
Nov 10, 2020
DP

8188104
May 17, 2029
DS DP U-1636

8268349
Aug 25, 2024
DP

8399015
Aug 25, 2024
DP

8420596
Apr 10, 2031
DS DP

8466159
Sep 04, 2032
U-1637

8492386
Sep 04, 2032
U-1637

8501238
Sep 17, 2028
DS DP U-1636

8642538
Sep 10, 2029
DS DP U-1638

8680106
Sep 04, 2032
U-1637

8685984
Sep 04, 2032
U-1637

8686026
Jun 09, 2031
DP

8691938
Apr 13, 2032
DS DP

9006387
Jun 10, 2030
U-1687

9044480
Apr 10, 2031
U-1638

>A> 9139536
Nov 09, 2028
U-1753

DEFERASIROX - JADENU

N 206910 001
6465504
6596750

Apr 05, 2019


Jun 24, 2017

DS DP

DS
U-735

DEFERASIROX - JADENU

N 206910 002
6465504
6596750

Apr 05, 2019


Jun 24, 2017

DS DP

DS
U-735

A - 14

PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 10 - October 2015
See List footnote for information regarding List content
APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

DEFERASIROX - JADENU
N 206910 003
6465504
6596750

Apr 05, 2019


Jun 24, 2017

DS DP
DS
U-735

DEFERIPRONE - FERRIPROX
N 021825 001
7049328

Jun 28, 2021

U-735

DEFERIPRONE - FERRIPROX
N 208030 001
7049328
8703156

Jun 28, 2021


Oct 29, 2029

U-735
DP U-735

DEOXYCHOLIC ACID - KYBELLA


N 206333 001
7622130
7754230
8101593
8242294
8298556
8367649
8461140
8546367
8653058
8846066
8883770

Dec
Dec
Mar
May
Aug
Mar
Feb
Feb
Mar
Feb
Feb

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY

EXPIRATION

DATE

NCE
ODE

Oct 14, 2016


Oct 14, 2016

DESMOPRESSIN ACETATE - DESMOPRESSIN ACETATE


A 200653 001

PC

May 16, 2015

DESMOPRESSIN ACETATE - DESMOPRESSIN ACETATE


A 200653 002

PC

May 16, 2015

10,
10,
02,
16,
03,
02,
21,
21,
02,
08,
21,

2027
2027
2030
2028
2025
2030
2028
2028
2030
2025
2028

DESONIDE - VERDESO
N 021978 001
8962000

Aug 31, 2025

DESVENLAFAXINE SUCCINATE - PRISTIQ


N 021992 003
6673838
6673838
8269040

Mar 01, 2022


Mar 01, 2022
Jul 05, 2027

DEXAMETHASONE - OZURDEX
N 022315 001
8043628
8088407
9012437

Oct 20, 2020


Oct 20, 2020
Oct 20, 2020

DEXLANSOPRAZOLE - DEXILANT
N 022287 001
9011926
>A> 9145389

Feb 24, 2026


Jun 15, 2020

DEXLANSOPRAZOLE - DEXILANT
N 022287 002
8784885
8784885
8784885
8784885*PED
9011926
>A> 9145389

Oct
Oct
Oct
Apr
Feb
Jun

15,
15,
15,
15,
24,
15,

2023
2023
2023
2024
2026
2020

DEXMEDETOMIDINE HYDROCHLORIDE - PRECEDEX


N 021038 004
6716867
Mar 31, 2019
6716867*PED
Oct 01, 2019
8242158
Jan 04, 2032
8242158*PED
Jul 04, 2032
8338470
Jan 04, 2032
8338470*PED
Jul 04, 2032
8455527
Jan 04, 2032

U-1690
U-1690
DP
DS
U-1690
DP
DP
DP U-1690
DP
U-1690
DP

DP U-1412

DS
DS
DS

U-860
U-1364

U-1205
U-1205
U-1205

DP
DS DP

DP U-1552
DP U-1553
DP U-1554
DP
DS DP

U-1472
DP
DP
U-421

A - 15

PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 10 - October 2015
See List footnote for information regarding List content
APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

DEXMEDETOMIDINE HYDROCHLORIDE - PRECEDEX


N 021038 004
8455527*PED
Jul 04, 2032
8648106
Jan 04, 2032
8648106*PED
Jul 04, 2032

PATENT
CODES

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY

EXPIRATION

DATE

DP

DEXMETHYLPHENIDATE HYDROCHLORIDE - DEXMETHYLPHENIDATE HYDROCHLORIDE


A 078908 002

PC

Aug 01, 2015

DEXMETHYLPHENIDATE HYDROCHLORIDE - DEXMETHYLPHENIDATE HYDROCHLORIDE


A 078908 003

PC

Dec 19, 2015

DICHLORPHENAMIDE - KEVEYIS
N 011366 002

ODE

Aug 07, 2022

M-166

Jul 30, 2018

DICLOFENAC - ZORVOLEX
N 204592 001
8999387
9017721
>A> 9173854
>A> 9180096

Apr
Apr
Apr
Apr

23,
23,
23,
23,

2030
2030
2030
2030

DP
DP
DP

DICLOFENAC - ZORVOLEX
N 204592 002
8999387
9017721
>A> 9173854
>A> 9180096

Apr
Apr
Apr
Apr

23,
23,
23,
23,

2030
2030
2030
2030

DP
DP
DP

DICLOFENAC POTASSIUM - CAMBIA


N 022165 001
8927604

Jun 16, 2026

DICLOFENAC SODIUM - DYLOJECT


N 022396 001
6407079
8946292

Jun 18, 2019


Mar 22, 2027

DP

DICLOFENAC SODIUM - PENNSAID


N 204623 001
9066913
9101591
9132110
>A> 9168304
>A> 9168305

Oct
Oct
Oct
Oct
Oct

DP U-1488
DP U-1488
U-1488
DP
U-1488

17,
17,
17,
16,
17,

2027
2027
2027
2027
2027

DIPHENHYDRAMINE HYDROCHLORIDE; IBUPROFEN - ADVIL PM


N 021393 001 >A> 9155718
Jan 17, 2022

U-55

U-55

U-436

U-1659

DP

DOLUTEGRAVIR SODIUM - TIVICAY


N 204790 001
DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE - NAMZARIC
N 206439 001
5061703
Apr 11, 2015
U-1641
5061703*PED
Oct 11, 2015
8058291
Dec 05, 2029
U-1641
8168209
Nov 22, 2025
DP
8168209*PED
May 22, 2026
8173708
Nov 22, 2025
U-1641
8173708*PED
May 22, 2026
8283379
Nov 22, 2025
U-1641
8283379*PED
May 22, 2026
8293794
Nov 22, 2025
DP
DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE - NAMZARIC
N 206439 002
5061703
Apr 11, 2015
U-1641
5061703*PED
Oct 11, 2015
8039009
Mar 24, 2029
U-1641
8039009*PED
Sep 24, 2029

A - 16

PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 10 - October 2015
See List footnote for information regarding List content
APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY

EXPIRATION

DATE

DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE - NAMZARIC


N 206439 002
8058291
Dec 05, 2029
U-1641
8168209
Nov 22, 2025
DP
8168209*PED
May 22, 2026
8173708
Nov 22, 2025
U-1641
8173708*PED
May 22, 2026
8283379
Nov 22, 2025
U-1641
8283379*PED
May 22, 2026
8293794
Nov 22, 2025
DP
8329752
Nov 22, 2025
DP
8329752*PED
May 22, 2026
8338485
Nov 22, 2025
DP
8338486
Nov 22, 2025
U-1641
8362085
Nov 22, 2025
U-1641
8362085*PED
May 22, 2026
8580858
Nov 22, 2025
U-1641
8598233
Nov 22, 2025
DP
8598233*PED
May 22, 2026
DOXEPIN HYDROCHLORIDE - SILENOR
N 022036 001
9107898

May 01, 2028

DP U-620

DOXEPIN HYDROCHLORIDE - SILENOR


N 022036 002
9107898

May 01, 2028

DP U-620

DOXYCYCLINE HYCLATE - DOXTERIC


N 050795 006
6958161
8715724

Dec 15, 2022


Feb 03, 2028

DP U-918
DP

DRONEDARONE HYDROCHLORIDE - MULTAQ


N 022425 001
9107900
9107900

Apr 16, 2029


Apr 16, 2029

U-1726
U-1728

DULOXETINE HYDROCHLORIDE - DULOXETINE HYDROCHLORIDE


A 090694 003

PC

Jan 11, 2016

EDOXABAN TOSYLATE - SAVAYSA


N 206316 001
7365205

Jun 12, 2023

DS

NCE

Jan 08, 2020

EDOXABAN TOSYLATE - SAVAYSA


N 206316 002
7365205

Jun 12, 2023

DS

NCE

Jan 08, 2020

EDOXABAN TOSYLATE - SAVAYSA


N 206316 003
7365205

Jun 12, 2023

DS

NCE

Jan 08, 2020

D-149
I-711
ODE
PED
PED
PED

Jun
Jun
Aug
Dec
Dec
Feb

EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE - ATRIPLA


N 021937 001
9018192
Jun 13, 2026
U-750
9018192
Jun 13, 2026
U-1170
ELTROMBOPAG OLAMINE - PROMACTA
N 022291 001
6280959
6280959
6280959
6280959
6280959*PED
7160870
7160870
7160870
7160870
7160870*PED
7332481
7332481
7332481
7332481

Oct
Oct
Oct
Oct
Apr
Nov
Nov
Nov
Nov
May
May
May
May
May

30,
30,
30,
30,
30,
20,
20,
20,
20,
20,
24,
24,
24,
24,

2018
2018
2018
2018
2019
2022
2022
2022
2022
2023
2021
2021
2021
2021

DS
DS
DS
DS

DP
DP
DP
DP

U-930
U-1306
U-1575
U-1714

DS
DS
DS
DS

DP
DP
DP
DP

U-930
U-1306
U-1575
U-1714
U-930
U-1306
U-1575
U-1714

11,
11,
26,
11,
11,
26,

2018
2018
2021
2018
2018
2022

A - 17

PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 10 - October 2015
See List footnote for information regarding List content
APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

ELTROMBOPAG OLAMINE - PROMACTA



N 022291 001
7332481*PED

7452874

7452874*PED

7473686

7473686

7473686

7473686

7473686*PED

7547719

7547719

7547719

7547719

7547719*PED

7790704

7790704

7790704

7790704

7790704*PED

7795293

7795293

7795293

7795293

7795293*PED

8052993

8052993

8052993

8052993

8052993*PED

8052994

8052994*PED

8062665

8062665*PED

8071129

8071129*PED

8828430

8828430

8828430

8828430*PED

Nov
May
Nov
May
May
May
May
Nov
Jul
Jul
Jul
Jul
Jan
May
May
May
May
Nov
May
May
May
May
Nov
Aug
Aug
Aug
Aug
Feb
Aug
Feb
Aug
Feb
Aug
Feb
Aug
Aug
Aug
Feb

24,
24,
24,
24,
24,
24,
24,
24,
13,
13,
13,
13,
13,
24,
24,
24,
24,
24,
21,
21,
21,
21,
21,
01,
01,
01,
01,
01,
01,
01,
01,
01,
01,
01,
01,
01,
01,
01,

2021

2021

2021

2021

2021

2021

2021

2021

2025

2025

2025

2025

2026

2021

2021

2021

2021

2021

2023

2023

2023

2023

2023

2027

2027

2027

2027

2028

2027

2028

2027

2028

2027

2028

2027

2027

2027

2028

ELTROMBOPAG OLAMINE - PROMACTA



N 022291 002
6280959

6280959

6280959

6280959

6280959*PED

7160870

7160870

7160870

7160870

7160870*PED

7332481

7332481

7332481

7332481

7332481*PED

7452874

7452874*PED

7473686

7473686

7473686

7473686

7473686*PED

7547719

7547719

7547719

7547719

Oct
Oct
Oct
Oct
Apr
Nov
Nov
Nov
Nov
May
May
May
May
May
Nov
May
Nov
May
May
May
May
Nov
Jul
Jul
Jul
Jul

30,
30,
30,
30,
30,
20,
20,
20,
20,
20,
24,
24,
24,
24,
24,
24,
24,
24,
24,
24,
24,
24,
13,
13,
13,
13,

2018

2018

2018

2018

2019

2022

2022

2022

2022

2023

2021

2021

2021

2021

2021

2021

2021

2021

2021

2021

2021

2021

2025

2025

2025

2025

PATENT
CODES

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY

EXPIRATION

DATE

DS DP U-1714

DS
DS
DS
DS

DP
DP
DP
DP

U-930

U-1306

U-1575

U-1714

DS
DS
DS
DS

DP
DP
DP
DP

U-930

U-1306

U-1575

U-1714

U-930

U-1306

U-1575

U-1714

U-930

U-1306

U-1575

U-1714

DP
DP
DP
DP

U-930

U-1306

U-1575

U-1714

DP U-1714

DP U-1714

DP U-1714

DP U-1306

DP U-1619

DP U-1714

DS
DS
DS
DS

DP
DP
DP
DP

U-930
U-1306
U-1575
U-1714

DS
DS
DS
DS

DP
DP
DP
DP

U-930
U-1306

U-1575

U-1714

U-930

U-1306

U-1575

U-1714

DS DP U-1714

DS
DS
DS
DS

DP
DP
DP
DP

U-930

U-1306

U-1575

U-1714

DS
DS
DS
DS

DP
DP
DP
DP

U-930

U-1306

U-1575

U-1714

D-149
I-711
ODE
PED
PED
PED

Jun
Jun
Aug
Dec
Dec
Feb

11,
11,
26,
11,
11,
26,

2018

2018

2021

2018

2018

2022

A - 18

PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 10 - October 2015
See List footnote for information regarding List content
APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

ELTROMBOPAG OLAMINE - PROMACTA



N 022291 002
7547719*PED

7790704

7790704

7790704

7790704

7790704*PED

7795293

7795293

7795293

7795293

7795293*PED

8052993

8052993*PED

8052994

8052994

8052994

8052994

8052994*PED

8062665

8062665*PED

8071129

8071129*PED

8828430

8828430

8828430

8828430*PED

Jan
May
May
May
May
Nov
May
May
May
May
Nov
Aug
Feb
Aug
Aug
Aug
Aug
Feb
Aug
Feb
Aug
Feb
Aug
Aug
Aug
Feb

13,
24,
24,
24,
24,
24,
21,
21,
21,
21,
21,
01,
01,
01,
01,
01,
01,
01,
01,
01,
01,
01,
01,
01,
01,
01,

2026

2021

2021

2021

2021

2021

2023

2023

2023

2023

2023

2027

2028

2027

2027

2027

2027

2028

2027

2028

2027

2028

2027

2027

2027

2028

ELTROMBOPAG OLAMINE - PROMACTA



N 022291 003
6280959

6280959

6280959

6280959

6280959*PED

7160870

7160870

7160870

7160870

7160870*PED

7332481

7332481

7332481

7332481

7332481*PED

7452874

7452874*PED

7473686

7473686

7473686

7473686

7473686*PED

7547719

7547719

7547719

7547719

7547719*PED

7790704

7790704

7790704

7790704

7790704*PED

7795293

7795293

7795293

7795293

7795293*PED

8052993

Oct
Oct
Oct
Oct
Apr
Nov
Nov
Nov
Nov
May
May
May
May
May
Nov
May
Nov
May
May
May
May
Nov
Jul
Jul
Jul
Jul
Jan
May
May
May
May
Nov
May
May
May
May
Nov
Aug

30,
30,
30,
30,
30,
20,
20,
20,
20,
20,
24,
24,
24,
24,
24,
24,
24,
24,
24,
24,
24,
24,
13,
13,
13,
13,
13,
24,
24,
24,
24,
24,
21,
21,
21,
21,
21,
01,

2018

2018

2018

2018

2019

2022

2022

2022

2022

2023

2021

2021

2021

2021

2021

2021

2021

2021

2021

2021

2021

2021

2025

2025

2025

2025

2026

2021

2021

2021

2021

2021

2023

2023

2023

2023

2023

2027

PATENT
CODES

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY

EXPIRATION

DATE

U-930

U-1306

U-1575

U-1714

U-930

U-1306

U-1575

U-1714

DP U-1714

DP
DP
DP
DP

U-930

U-1306

U-1575

U-1714

DP U-1714

DP U-1714

DP U-1306

DP U-1619

DP U-1714

DS
DS
DS
DS

DP
DP
DP
DP

U-930
U-1306
U-1575
U-1714

DS
DS
DS
DS

DP
DP
DP
DP

U-930
U-1306

U-1575

U-1714

U-930

U-1306

U-1575

U-1714

DS DP U-1714

DS
DS
DS
DS

DP
DP
DP
DP

U-930

U-1306

U-1575

U-1714

DS
DS
DS
DS

DP
DP
DP
DP

U-930

U-1306

U-1575

U-1714

U-930

U-1306

U-1575

U-1714

U-930

U-1306

U-1575

U-1714

DP U-1714

D-149
I-711
ODE
PED
PED
PED

Jun
Jun
Aug
Dec
Dec
Feb

11,
11,
26,
11,
11,
26,

2018

2018

2021

2018

2018

2022

A - 19

PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 10 - October 2015
See List footnote for information regarding List content
APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

ELTROMBOPAG OLAMINE - PROMACTA



N 022291 003
8052993*PED

8052994

8052994*PED

8062665

8062665

8062665

8062665

8062665*PED

8071129

8071129*PED

8828430

8828430

8828430

8828430*PED

Feb
Aug
Feb
Aug
Aug
Aug
Aug
Feb
Aug
Feb
Aug
Aug
Aug
Feb

01,
01,
01,
01,
01,
01,
01,
01,
01,
01,
01,
01,
01,
01,

2028

2027

2028

2027

2027

2027

2027

2028

2027

2028

2027

2027

2027

2028

ELTROMBOPAG OLAMINE - PROMACTA



N 022291 004
6280959

6280959

6280959

6280959

6280959*PED

7160870

7160870

7160870

7160870

7160870*PED

7332481

7332481

7332481

7332481

7332481*PED

7452874

7452874*PED

7473686

7473686

7473686

7473686

7473686*PED

7547719

7547719

7547719

7547719

7547719*PED

7790704

7790704

7790704

7790704

7790704*PED

7795293

7795293

7795293

7795293

7795293*PED

8052993

8052993*PED

8052994

8052994*PED

8062665

8062665*PED

8071129

8071129

8071129

8071129

8071129*PED

8828430

8828430

Oct
Oct
Oct
Oct
Apr
Nov
Nov
Nov
Nov
May
May
May
May
May
Nov
May
Nov
May
May
May
May
Nov
Jul
Jul
Jul
Jul
Jan
May
May
May
May
Nov
May
May
May
May
Nov
Aug
Feb
Aug
Feb
Aug
Feb
Aug
Aug
Aug
Aug
Feb
Aug
Aug

30,
30,
30,
30,
30,
20,
20,
20,
20,
20,
24,
24,
24,
24,
24,
24,
24,
24,
24,
24,
24,
24,
13,
13,
13,
13,
13,
24,
24,
24,
24,
24,
21,
21,
21,
21,
21,
01,
01,
01,
01,
01,
01,
01,
01,
01,
01,
01,
01,
01,

2018

2018

2018

2018

2019

2022

2022

2022

2022

2023

2021

2021

2021

2021

2021

2021

2021

2021

2021

2021

2021

2021

2025

2025

2025

2025

2026

2021

2021

2021

2021

2021

2023

2023

2023

2023

2023

2027

2028

2027

2028

2027

2028

2027

2027

2027

2027

2028

2027

2027

PATENT
CODES

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY

EXPIRATION

DATE

DP U-1714

DP
DP
DP
DP

U-714

U-930

U-1306

U-1575

DP U-1714

DP U-1306

DP U-1619

DP U-1714

DS
DS
DS
DS

DP
DP
DP
DP

U-930
U-1306
U-1575
U-1714

DS
DS
DS
DS

DP
DP
DP
DP

U-930
U-1306

U-1575

U-1714

U-930

U-1306

U-1575

U-1714

DS DP U-1714

DS
DS
DS
DS

DP
DP
DP
DP

U-930

U-1306

U-1575

U-1714

DS
DS
DS
DS

DP
DP
DP
DP

U-930

U-1306

U-1575

U-1714

U-930

U-1306

U-1575

U-1714

U-930

U-1306

U-1575

U-1714

DP U-1714

DP U-1714

DP U-1714

DP
DP
DP
DP

U-930

U-1306

U-1575

U-1714

DP U-1306

DP U-1619

D-149
I-711
ODE
PED
PED
PED

Jun
Jun
Aug
Dec
Dec
Feb

11,
11,
26,
11,
11,
26,

2018

2018

2021

2018

2018

2022

A - 20

PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 10 - October 2015
See List footnote for information regarding List content
APPL/PROD

NO

PATENT NO

PATENT

EXPIRATION

DATE

PATENT
CODES

ELTROMBOPAG OLAMINE - PROMACTA



N 022291 004
8828430

8828430*PED

Aug 01, 2027

Feb 01, 2028


ELTROMBOPAG OLAMINE - PROMACTA



N 022291 005
6280959

6280959

6280959

6280959

6280959*PED

7160870

7160870

7160870

7160870

7160870*PED

7332481

7332481

7332481

7332481

7332481*PED

7452874

7452874*PED

7473686

7473686

7473686

7473686

7473686*PED

7547719

7547719

7547719

7547719*PED

7790704

7790704

7790704

7790704*PED

7795293

7795293

7795293

7795293*PED

8052995

8052995

8052995*PED

Oct
Oct
Oct
Oct
Apr
Nov
Nov
Nov
Nov
May
May
May
May
May
Nov
May
Nov
May
May
May
May
Nov
Jul
Jul
Jul
Jan
May
May
May
Nov
May
May
May
Nov
Aug
Aug
Feb

30,
30,
30,
30,
30,
20,
20,
20,
20,
20,
24,
24,
24,
24,
24,
24,
24,
24,
24,
24,
24,
24,
13,
13,
13,
13,
24,
24,
24,
24,
21,
21,
21,
21,
01,
01,
01,

2018

2018

2018

2018

2019

2022

2022

2022

2022

2023

2021

2021

2021

2021

2021

2021

2021

2021

2021

2021

2021

2021

2025

2025

2025

2026

2021

2021

2021

2021

2023

2023

2023

2023

2027

2027

2028

DS
DS
DS
DS

DP
DP
DP
DP

U-930

U-1306

U-1575

U-1714

DS
DS
DS
DS

DP
DP
DP
DP

U-930

U-1306

U-1575

U-1714

ELTROMBOPAG OLAMINE - PROMACTA



N 207027 001
6280959

7160870

7332481

7452874

7473686

7547719

7790704

7795293

Oct
Nov
May
May
May
Jul
May
May

30,
20,
24,
24,
24,
13,
24,
24,

2018

2022

2021

2021

2021

2025

2021

2023

ELUXADOLINE - VIBERZI

N 206940 001
7741356

7786158

8344011

8609709

8691860

9115091

Mar
Mar
Mar
Mar
Jul
Jul

25,
14,
14,
14,
07,
07,

ELUXADOLINE - VIBERZI
N 206940 002
7741356
7786158
8344011
8609709

Mar
Mar
Mar
Mar

25,
14,
14,
14,

PATENT

DELIST

REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY

EXPIRATION

DATE

DP U-1714

D-149
I-711
ODE
PED
PED
PED

Jun
Jun
Aug
Dec
Dec
Feb

11,
11,
26,
11,
11,
26,

2018

2018

2021

2018

2018

2022

DS DP U-1736

DS DP U-1736

U-1736

DS DP

DS DP U-1736

DS DP U-1736

U-1736

U-1736

D-149
I-711
ODE
PED
PED

Jun
Jun
Nov
Dec
Dec

11,
11,
20,
11,
11,

2018

2018

2015

2018

2018

2028

2025

2025

2025

2028

2028

DS DP

DS

NCE

May 27, 2020


2028
2025
2025
2025

DS DP
DS

NCE

May 27, 2020

U-930

U-1306

U-1575

U-1714

DS DP U-1714

DS
DS
DS
DS

DP
DP
DP
DP

U-930

U-1306

U-1575

U-1714

DS DP U-930

DS DP U-1306

DS DP U-1575

U-930

U-1306

U-1575

U-930

U-1306

U-1575

DP U-1306

DP U-1575

U-1709

DS

DS
U-1709

DS DP U-1738

U-1709
DS

A - 21

PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 10 - October 2015
See List footnote for information regarding List content
APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

ELUXADOLINE - VIBERZI

N 206940 002
8691860
9115091

Jul 07, 2028


Jul 07, 2028

DS
U-1709

DS DP U-1738

ELVITEGRAVIR - VITEKTA

N 203093 001
8981103

Oct 26, 2026

DS DP

ELVITEGRAVIR - VITEKTA

N 203093 002
8981103

Oct 26, 2026

DS DP

EMPAGLIFLOZIN - JARDIANCE

N 204629 001

EMPAGLIFLOZIN - JARDIANCE

N 204629 002

EMPAGLIFLOZIN; LINAGLIPTIN - GLYXAMBI



N 206073 001
6303661
Apr
6890898
Feb
7078381
Feb
7407955
Aug
7459428
Feb
7579449
Nov
7713938
Apr
8119648
Aug
8178541
Aug
8178541
Aug
8551957
Oct
8673927
May
8846695
Jun
8883805
Nov

24,
02,
02,
12,
02,
05,
15,
12,
12,
12,
19,
04,
04,
26,

2017
2019
2019
2023
2019
2025
2027
2023
2023
2023
2029
2027
2030
2025

EMPAGLIFLOZIN; LINAGLIPTIN - GLYXAMBI



N 206073 002
6303661
Apr
6890898
Feb
7078381
Feb
7407955
Aug
7459428
Feb
7579449
Nov
7713938
Apr
8119648
Aug
8178541
Aug
8178541
Aug
8551957
Oct
8673927
May
8846695
Jun
8883805
Nov

24,
02,
02,
12,
02,
05,
15,
12,
12,
12,
19,
04,
04,
26,

2017
2019
2019
2023
2019
2025
2027
2023
2023
2023
2029
2024
2030
2025

U-1651
U-1652
U-1651

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY

EXPIRATION

DATE

M-160
M-161

Jun 26, 2018



Jun 26, 2018

M-160
M-161

Jun 26, 2018



Jun 26, 2018

NC
NCE
NCE

Jan 30, 2018



May 02, 2016

Aug 01, 2019

NC
NCE
NCE

Jan 30, 2018



May 02, 2016

Aug 01, 2019

DS DP

U-1651

DS

DS DP

DP
DP
DP
DP

U-1651

U-1653

U-1654

U-1651

U-1652

U-1652

DP

U-1651
U-1652
U-1651
DS DP

U-1651

DS

DS DP

DP
DP
DP
DP

U-1651

U-1653

U-1654

U-1651

U-1652

U-1652

DP

EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE - SYNJARDY



N 206111 001
7579449
Nov 05, 2025
7713938
Apr 15, 2027

DS
DS DP

NCE
NP

Aug 01, 2019

Aug 26, 2018


EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE - SYNJARDY



N 206111 002
7579449
Nov 05, 2025
7713938
Apr 15, 2027

DS
DS DP

NCE
NP

Aug 01, 2019

Aug 26, 2018


EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE - SYNJARDY



N 206111 003
7579449
Nov 05, 2025
7713938
Apr 15, 2027

DS
DS DP

NCE
NP

Aug 01, 2019

Aug 26, 2018


A - 22

PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 10 - October 2015
See List footnote for information regarding List content
APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE - SYNJARDY


N 206111 004
7579449
Nov 05, 2025
7713938
Apr 15, 2027

PATENT
CODES

PATENT
DELIST
REQUESTED

DS
DS DP

EXCLUSIVITY
CODE(S)

EXCLUSIVITY

EXPIRATION

DATE

NCE
NP

Aug 01, 2019


Aug 26, 2018

I-671
PED

May 14, 2016


Nov 14, 2016

I-671
PED

May 14, 2016


Nov 14, 2016

I-671
PED

May 14, 2016


Nov 14, 2016

EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR DISOPROXIL FUMARATE - COMPLERA


N 202123 001 >A> 7125879
Aug 09, 2022
DS DP U-257
ENZALUTAMIDE - XTANDI
N 203415 001
9126941

May 15, 2026

EPINEPHRINE - AUVI-Q
N 201739 001
8920377
8926594
9056170
>A> 9149579

Nov
Mar
Nov
Jul

23,
31,
23,
19,

2024
2026
2024
2025

DP
DP
DP

EPINEPHRINE - AUVI-Q
N 201739 002
8920377
8926594
9056170
>A> 9149579

Nov
Mar
Nov
Jul

23,
31,
23,
19,

2024
2026
2024
2025

DP
DP
DP

EPINEPHRINE - ADRENALIN
N 204640 001
9119876

Mar 13, 2035

DP

ERIBULIN MESYLATE - HALAVEN


N 201532 001
6214865

Jul 20, 2023

DS

ERLOTINIB HYDROCHLORIDE - TARCEVA


N 021743 001
5747498
5747498*PED
6900221
6900221
6900221
6900221
6900221*PED
7087613
7087613
7087613
7087613*PED
RE41065
RE41065*PED

Nov
May
Nov
Nov
Nov
Nov
May
Nov
Nov
Nov
May
Nov
May

08,
08,
09,
09,
09,
09,
09,
09,
09,
09,
09,
08,
08,

2018
2019
2020
2020
2020
2020
2021
2020
2020
2020
2021
2018
2019

DS DP U-659

ERLOTINIB HYDROCHLORIDE - TARCEVA


N 021743 002
5747498
5747498*PED
6900221
6900221
6900221
6900221
6900221*PED
7087613
7087613
7087613
7087613*PED
RE41065
RE41065*PED

Nov
May
Nov
Nov
Nov
Nov
May
Nov
Nov
Nov
May
Nov
May

08,
08,
09,
09,
09,
09,
09,
09,
09,
09,
09,
08,
08,

2018
2019
2020
2020
2020
2020
2021
2020
2020
2020
2021
2018
2019

DS DP U-659

ERLOTINIB HYDROCHLORIDE - TARCEVA


N 021743 003
5747498
5747498*PED
6900221
6900221
6900221

Nov
May
Nov
Nov
Nov

08,
08,
09,
09,
09,

2018
2019
2020
2020
2020

DS DP U-659

U-1588

U-1758

U-1758

DS
DS
DS
DS

DP
DP
DP
DP

U-659
U-875
U-1046
U-1403
U-659
U-1045
U-1403

DS DP

DS
DS
DS
DS

DP
DP
DP
DP

U-659
U-875
U-1046
U-1403
U-659
U-1045
U-1403

DS DP

DS DP U-659
DS DP U-875
DS DP U-1046

A - 23

PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 10 - October 2015
See List footnote for information regarding List content
APPL/PROD
NO

PATENT NO

PATENT

EXPIRATION

DATE

PATENT
CODES

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY

EXPIRATION

DATE

ERLOTINIB HYDROCHLORIDE - TARCEVA



N 021743 003
6900221
6900221*PED
7087613
7087613
7087613
7087613*PED
RE41065
RE41065*PED

Nov
May
Nov
Nov
Nov
May
Nov
May

ESLICARBAZEPINE ACETATE - APTIOM



N 022416 001
5753646
5753646

Jun 27, 2016



Jun 27, 2016

DS DP U-1451
DS DP U-1746

D-150
I-715

Aug 27, 2018

Aug 27, 2018


ESLICARBAZEPINE ACETATE - APTIOM



N 022416 002
5753646
5753646

Jun 27, 2016



Jun 27, 2016

DS DP U-1451
DS DP U-1746

D-150
I-715

Aug 27, 2018

Aug 27, 2018


ESLICARBAZEPINE ACETATE - APTIOM



N 022416 003
5753646
5753646

Jun 27, 2016



Jun 27, 2016

DS DP U-1451
DS DP U-1746

D-150
I-715

Aug 27, 2018

Aug 27, 2018


ESLICARBAZEPINE ACETATE - APTIOM



N 022416 004
5753646
5753646

Jun 27, 2016



Jun 27, 2016

DS DP U-1451
DS DP U-1746

D-150
I-715

Aug 27, 2018

Aug 27, 2018


ESOMEPRAZOLE MAGNESIUM - NEXIUM 24HR



N 204655 001
5690960
Nov
5690960*PED
May
5714504
Feb
5714504*PED
Aug
5877192*PED
Nov
5900424
May
5900424*PED
Nov
6369085
May
6369085*PED
Nov
6428810
Nov
6428810*PED
May
6875872*PED
Nov
7411070
May
7411070*PED
Nov

09,
09,
09,
09,
09,
09,
08,
08,

25,
25,
03,
03,
27,
04,
04,
25,
25,
03,
03,
27,
25,
25,

2020

2021

2020

2020

2020

2021

2018

2019

2014

2015

2015

2015

2014

2016

2016

2018

2018

2019

2020

2014

2018

2018

DS DP U-1403

U-659

U-1045

U-1403

DS DP

DP U-1509

DP U-1509

DS

U-1509

DS DP U-1509

DP U-1509

DS

ESOMEPRAZOLE MAGNESIUM; NAPROXEN - VIMOVO



N 022511 001
8945621
Oct 17, 2031

>A> 9161920
May 31, 2022

U-1661

U-1760

ESOMEPRAZOLE MAGNESIUM; NAPROXEN - VIMOVO



N 022511 002
8945621
Oct 17, 2031

>A> 9161920
May 31, 2022

U-1661

U-1760

ESTRADIOL - MINIVELLE

N 203752 005
6841716
8231906

Apr 27, 2020

Jul 04, 2030


DP

DS DP

EVEROLIMUS - AFINITOR

N 022334 001
8410131
8410131*PED
9006224

Nov 01, 2025



May 01, 2026

Jul 01, 2028


DS DP U-1368

EVEROLIMUS - AFINITOR

N 022334 002
8410131
8410131*PED
9006224

Nov 01, 2025



May 01, 2026

Jul 01, 2028


DS DP U-1368

U-1681

U-1681

A - 24

PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 10 - October 2015
See List footnote for information regarding List content
APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

EVEROLIMUS - AFINITOR

N 022334 002
8410131
8410131*PED
9006224

Nov 01, 2025


May 01, 2026

Jul 01, 2028

DS DP U-1368

EVEROLIMUS - AFINITOR

N 022334 003
8410131
8410131*PED
9006224

Nov 01, 2025


May 01, 2026

Jul 01, 2028

DS DP U-1368

EVEROLIMUS - AFINITOR

N 022334 004
8410131
8410131*PED
9006224

Nov 01, 2025


May 01, 2026

Jul 01, 2028

DS DP U-1368

EXCLUSIVITY
CODE(S)

U-1681

U-1681

M-162

FEBUXOSTAT - ULORIC

N 021856 001
9107912

Sep 08, 2031

U-1346

FEBUXOSTAT - ULORIC

N 021856 002
9107912

Sep 08, 2031

U-1346

FENTANYL CITRATE - LAZANDA



N 022569 001
9078814

Jan 08, 2024

DP

FENTANYL CITRATE - LAZANDA



N 022569 002
9078814

Jan 08, 2024

DP

FENTANYL HYDROCHLORIDE - IONSYS



N 021338 001
6169920
6181963
8301238
8428708
8428709
8781571
9095706

Jan
Nov
Sep
May
Jun
Mar
Jan

DP U-736

DP

DP

U-736

DP U-736

DP U-736

DP

FERRIC CITRATE - AURYXIA



N 205874 001
8901349
9050316

Feb 18, 2024


Feb 18, 2024

U-1577

U-1577

FERRIC PYROPHOSPHATE CITRATE - TRIFERIC



N 206317 001
6689275
Dec 31, 2016
6779468
Dec 31, 2016
7816404
Apr 17, 2029

U-1656

U-1656

DP U-1656

02,
02,
30,
21,
11,
31,
17,

2018
2019
2031
2032
2032
2032
2033

FEXOFENADINE HYDROCHLORIDE - CHILDREN'S ALLEGRA ALLERGY



N 201373 001
8933097
Aug 16, 2032
DP

FEXOFENADINE HYDROCHLORIDE - CHILDREN'S ALLEGRA HIVES

N 201373 002
8933097
Aug 16, 2032

Apr
Apr
Aug
Jul

12,
12,
08,
02,

2017
2017
2031
2030

EXCLUSIVITY

EXPIRATION

DATE

U-1681

EXENATIDE SYNTHETIC - BYDUREON



N 022200 001

FINAFLOXACIN - XTORO

N 206307 001
6133260
6432948
8536167
9119859

PATENT
DELIST
REQUESTED

DP

DS DP

DS DP

U-1679

U-1679

Sep 24, 2018


A - 25

PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 10 - October 2015
See List footnote for information regarding List content
APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

FLIBANSERIN - ADDYI

N 022526 001
7151103
7420057
8227471

May 09, 2023


Aug 01, 2022
May 09, 2023

FLUOROURACIL - TOLAK

N 022259 001 >A> 7169401

Jul 18, 2023

DP

FLUTEMETAMOL F-18 - VIZAMYL



N 203137 001
8916131

Sep 16, 2028

DP

FLUTEMETAMOL F-18 - VIZAMYL



N 203137 002
8916131

Sep 16, 2028

DP

U-1734

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY

EXPIRATION

DATE

NCE

Aug 18, 2020

NP

Sep 18, 2018


I-708

Apr 30, 2018

NP

Apr 30, 2018

FLUTICASONE PROPIONATE - CUTIVATE



N 021152 001

NPP

Jan 16, 2018


GADOXETATE DISODIUM - EOVIST



N 022090 001

M-155

Mar 27, 2018


GADOXETATE DISODIUM - EOVIST



N 022090 002

M-155

Mar 27, 2018


NP
ODE

Jul 13, 2018



Jul 13, 2022

DS DP

U-1734

FLUTICASONE FUROATE; VILANTEROL TRIFENATATE - BREO ELLIPTA



N 204275 001
6537983
Aug 03, 2021
DP U-1401
6537983
Aug 03, 2021
DP U-1691

6759398
Aug 03, 2021
DP U-1401

6759398
Aug 03, 2021
DP U-1691

7101866
Aug 03, 2021
DS DP U-1401

7101866
Aug 03, 2021
DS DP U-1691

7439393
Sep 11, 2022
DS DP U-1401

7439393
Sep 11, 2022
DS DP U-1691

8511304
Jun 14, 2027
DP U-1424

8511304
Jun 14, 2027
DP U-1691

RE44874
Mar 23, 2023
DS DP U-1548

RE44874
Mar 23, 2023
DS DP U-1691

FLUTICASONE FUROATE; VILANTEROL TRIFENATATE - BREO ELLIPTA

N 204275 002
5873360
Feb 23, 2016
DP
6537983
Aug 03, 2021
DP U-1691

6759398
Aug 03, 2021
DP U-1691

7101866
Aug 03, 2021
DS DP U-1691

7439393
Sep 11, 2022
DS DP U-1691

7629335
Aug 03, 2021
DP

7776895
Sep 11, 2022
DP

8113199
Oct 23, 2027
DP

8161968
Feb 05, 2028
DP

8511304
Jun 14, 2027
DP U-1691

8534281
Aug 10, 2029
DP

8746242
Oct 11, 2030
DP

RE44874
Mar 23, 2023
DS DP U-1691

GEFITINIB - IRESSA

N 206995 001 >A> 5770599

May 05, 2017

DS DP U-1755

GLATIRAMER ACETATE - COPAXONE



N 020622 003
8969302
9155776

Aug 19, 2030


Aug 19, 2030

U-441

U-441

GLYCEROL PHENYLBUTYRATE - RAVICTI



N 203284 001
9095559

Mar 09, 2032

U-1383

A - 26

PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 10 - October 2015
See List footnote for information regarding List content
APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

GUANFACINE HYDROCHLORIDE - GUANFACINE HYDROCHLORIDE


A 200881 001

PC

May 30, 2015

GUANFACINE HYDROCHLORIDE - GUANFACINE HYDROCHLORIDE


A 200881 002

PC

May 30, 2015

GUANFACINE HYDROCHLORIDE - GUANFACINE HYDROCHLORIDE


A 200881 003

PC

May 30, 2015

GUANFACINE HYDROCHLORIDE - GUANFACINE HYDROCHLORIDE


A 200881 004

PC

May 30, 2015

GUANFACINE HYDROCHLORIDE - INTUNIV


N 022037 001

M-154

Mar 18, 2018

GUANFACINE HYDROCHLORIDE - INTUNIV


N 022037 002

M-154

Mar 18, 2018

GUANFACINE HYDROCHLORIDE - INTUNIV


N 022037 003

M-154

Mar 18, 2018

GUANFACINE HYDROCHLORIDE - INTUNIV


N 022037 004

M-154

Mar 18, 2018

HYDROCODONE BITARTRATE - ZOHYDRO ER


N 202880 001
9132096
Sep 12, 2034

DP

HYDROCODONE BITARTRATE - ZOHYDRO ER


N 202880 002
9132096
Sep 12, 2034

DP

HYDROCODONE BITARTRATE - ZOHYDRO ER


N 202880 003
9132096
Sep 12, 2034

DP

HYDROCODONE BITARTRATE - ZOHYDRO ER


N 202880 004
9132096
Sep 12, 2034

DP

HYDROCODONE BITARTRATE - ZOHYDRO ER


N 202880 005
9132096
Sep 12, 2034

DP

HYDROCODONE BITARTRATE - ZOHYDRO ER


N 202880 006
9132096
Sep 12, 2034

DP

HYDROCODONE BITARTRATE - HYSINGLA


N 206627 001
9023401
9056052
9060940
9084816
9095614
9095615

Oct
Oct
Oct
Aug
Aug
Aug

30,
30,
30,
24,
24,
24,

2021
2021
2021
2027
2027
2027

DP
DP

HYDROCODONE BITARTRATE - HYSINGLA


N 206627 002
9023401
9056052
9060940
9084816
9095614
9095615

Oct
Oct
Oct
Aug
Aug
Aug

30,
30,
30,
24,
24,
24,

2021
2021
2021
2027
2027
2027

DP
DP

HYDROCODONE BITARTRATE - HYSINGLA


N 206627 003
9023401
9056052

Oct 30, 2021


Oct 30, 2021

DP
DP

U-1556
DP
U-1556
DP

U-1556
DP
U-1556
DP

A - 27

PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 10 - October 2015
See List footnote for information regarding List content
APPL/PROD
NO

PATENT NO

PATENT

EXPIRATION
DATE

PATENT

CODES

HYDROCODONE BITARTRATE - HYSINGLA


N 206627 003
9060940
9084816
9095614
9095615

Oct
Aug
Aug
Aug

30,
24,
24,
24,

2021
2027
2027
2027

HYDROCODONE BITARTRATE - HYSINGLA


N 206627 004
9023401
9056052
9060940
9084816
9095614
9095615

Oct
Oct
Oct
Aug
Aug
Aug

30,
30,
30,
24,
24,
24,

2021
2021
2021
2027
2027
2027

DP
DP

HYDROCODONE BITARTRATE - HYSINGLA


N 206627 005
9056052
9060940
9084816
9095614
9095615

Oct
Oct
Aug
Aug
Aug

30,
30,
24,
24,
24,

2021
2021
2027
2027
2027

DP

HYDROCODONE BITARTRATE - HYSINGLA


N 206627 006
9056052
9060940
9084816
9095614
9095615

Oct
Oct
Aug
Aug
Aug

30,
30,
24,
24,
24,

2021
2021
2027
2027
2027

DP

HYDROCODONE BITARTRATE - HYSINGLA


N 206627 007
9056052
9060940
9084816
9095614
9095615

Oct
Oct
Aug
Aug
Aug

30,
30,
24,
24,
24,

2021
2021
2027
2027
2027

DP

IBRUTINIB - IMBRUVICA
N 205552 001
8497277
8497277
8497277
8957079
8999999
8999999
9125889

Dec
Dec
Dec
Dec
Jun
Jun
Jun

28,
28,
28,
28,
03,
03,
03,

2026
2026
2026
2026
2031
2031
2031

IBUPROFEN - CALDOLOR
N 022348 002
8871810
9012508
9114068
>A> 9138404

Sep
Sep
Sep
Sep

30,
14,
30,
30,

2029
2030
2029
2029

U-1599
U-981
U-1735
U-1756

ICATIBANT ACETATE - FIRAZYR


N 022150 001
5648333

Jul 15, 2019

DS DP U-1187

IDELALISIB - ZYDELIG
N 205858 001
8138195
8865730
8980901
>A> 9149477
RE44599
RE44599

Apr
Mar
May
May
Jul
Jul

2021
2033
2025
2025
2025
2025

DS DP U-1549
DS DP U-1615
U-1678
U-1757
U-1558
U-1615

IDELALISIB - ZYDELIG
N 205858 002
8138195
8865730

Apr 24, 2021


Mar 05, 2033

DS DP U-1549
DS DP U-1615

24,
05,
12,
12,
21,
21,

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY

EXPIRATION

DATE

U-1556
DP
U-1556
DP

U-1556
DP
U-1556
DP

U-1556
DP
U-1556
DP

U-1556
DP
U-1556
DP

U-1556
DP
U-1556
DP

U-1456
U-1491
U-1650
DS DP
U-1683
U-1684
U-1745

I-702
ODE

Jan 29, 2018



Jan 29, 2022

A - 28

PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 10 - October 2015
See List footnote for information regarding List content
APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

IDELALISIB - ZYDELIG

N 205858 002
8980901
>A> 9149477
RE44599
RE44599

May
May
Jul
Jul

12,
12,
21,
21,

2025
2025
2025
2025

U-1678

U-1757

U-1558

U-1615

ILOPERIDONE - FANAPT

N 022192 001
8652776
8999638
9072742
9074254
9074255
9074256
9138432
9157121

Aug
Oct
Jan
Dec
Dec
Feb
Sep
Apr

31,
28,
16,
28,
17,
10,
30,
05,

2030
2030
2031
2031
2030
2031
2025
2030

U-1685

U-1674

U-1674

U-1674

U-1674

U-1674

U-1737

U-1674

ILOPERIDONE - FANAPT

N 022192 002
8652776
8999638
9072742
9074254
9074255
9074256
9138432
9157121

Aug
Oct
Jan
Dec
Dec
Feb
Sep
Apr

31,
28,
16,
28,
17,
10,
30,
05,

2030
2030
2031
2031
2030
2031
2025
2030

U-1685

U-1674

U-1674

U-1674

U-1674

U-1674

U-1737

U-1674

ILOPERIDONE - FANAPT

N 022192 003
8652776
8999638
9072742
9074254
9074255
9074256
9138432
9157121

Aug
Oct
Jan
Dec
Dec
Feb
Sep
Apr

31,
28,
16,
28,
17,
10,
30,
05,

2030
2030
2031
2031
2030
2031
2025
2030

U-1685

U-1674

U-1674

U-1674

U-1674

U-1674

U-1737

U-1674

ILOPERIDONE - FANAPT

N 022192 004
8652776
8999638
9072742
9074254
9074255
9074256
9138432
9157121

Aug
Oct
Jan
Dec
Dec
Feb
Sep
Apr

31,
28,
16,
28,
17,
10,
30,
05,

2030
2030
2031
2031
2030
2031
2025
2030

U-1685

U-1674

U-1674

U-1674

U-1674

U-1674

U-1737

U-1674

ILOPERIDONE - FANAPT

N 022192 005
8652776
8999638
9072742
9074254
9074255
9074256
9138432
9157121

Aug
Oct
Jan
Dec
Dec
Feb
Sep
Apr

31,
28,
16,
28,
17,
10,
30,
05,

2030
2030
2031
2031
2030
2031
2025
2030

U-1685

U-1674

U-1674

U-1674

U-1674

U-1674

U-1737

U-1674

ILOPERIDONE - FANAPT

N 022192 006
8652776
8999638
9072742
9074254
9074255
9074256
9138432
9157121

Aug
Oct
Jan
Dec
Dec
Feb
Sep
Apr

31,
28,
16,
28,
17,
10,
30,
05,

2030
2030
2031
2031
2030
2031
2025
2030

U-1685

U-1674

U-1674

U-1674

U-1674

U-1674

U-1737

U-1674

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY

EXPIRATION

DATE

A - 29

PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 10 - October 2015
See List footnote for information regarding List content
APPL/PROD
NO

PATENT NO

PATENT

EXPIRATION
DATE

PATENT

CODES

ILOPERIDONE - FANAPT

N 022192 006
8652776
8999638
9072742
9074254
9074255
9074256
9138432
9157121

Aug
Oct
Jan
Dec
Dec
Feb
Sep
Apr

31,
28,
16,
28,
17,
10,
30,
05,

2030
2030
2031
2031
2030
2031
2025
2030

U-1685

U-1674

U-1674

U-1674

U-1674

U-1674

U-1737

U-1674

ILOPERIDONE - FANAPT

N 022192 007
8652776
8999638
9072742
9074254
9074255
9074256
9138432
9157121

Aug
Oct
Jan
Dec
Dec
Feb
Sep
Apr

31,
28,
16,
28,
17,
10,
30,
05,

2030
2030
2031
2031
2030
2031
2025
2030

U-1685

U-1674

U-1674

U-1674

U-1674

U-1674

U-1737

U-1674

INDACATEROL MALEATE - ARCAPTA NEOHALER



N 022383 001
8658673
Jun 02, 2020

DS DP U-1168

INDOMETHACIN - TIVORBEX

N 204768 001
8992982
9089471

Apr 23, 2030


Apr 23, 2030

DP

INDOMETHACIN - TIVORBEX

N 204768 002
8992982
9089471

Apr 23, 2030


Apr 23, 2030

DP

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY

EXPIRATION

DATE

U-55

U-55

INSULIN ASPART RECOMBINANT - NOVOLOG FLEXTOUCH



N 020986 005
8920383
Jul 17, 2026
9108002
Jan 20, 2026
9132239
Feb 01, 2032

DP

DP

DP

INSULIN ASPART; INSULIN DEGLUDEC - RYZODEG 70/30

N 203313 001
5866538
Jun 20, 2017
6899699
Jan 02, 2022
7615532
May 25, 2025
7686786
Aug 03, 2026
8672898
Jan 02, 2022
8684969
Oct 20, 2025
8920383
Jul 17, 2026
9108002
Jan 20, 2026
9132239
Feb 01, 2032

DP

DP

DS DP

DP

DP

DP

DP

DP

DP

NCE

Sep 25, 2020


INSULIN DEGLUDEC - TRESIBA



N 203314 001
6899699
7615532
7686786
8672898
8684969
8920383
9108002
9132239

Jan
May
Aug
Jan
Oct
Jul
Jan
Feb

02,
25,
03,
02,
20,
17,
20,
01,

2022
2025
2026
2022
2025
2026
2026
2032

DP

DS DP

DP

DP

DP

DP

DP

DP

NCE

Sep 25, 2020


INSULIN DEGLUDEC - TRESIBA



N 203314 002
6899699
7615532
7686786
8672898
8684969
8920383

Jan
May
Aug
Jan
Oct
Jul

02,
25,
03,
02,
20,
17,

2022
2025
2026
2022
2025
2026

DP
DS DP

DP

DP

DP

DP

NCE

Sep 25, 2020

A - 30

PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 10 - October 2015
See List footnote for information regarding List content
APPL/PROD
NO

PATENT NO

INSULIN DEGLUDEC - TRESIBA



N 203314 002
9108002
9132239

PATENT

EXPIRATION
DATE

PATENT

CODES

Jan 20, 2026


Feb 01, 2032

DP

DP

INSULIN DETEMIR RECOMBINANT - LEVEMIR FLEXTOUCH



N 021536 005
8920383
Jul 17, 2026
9108002
Jan 20, 2026
9132239
Feb 01, 2032

DP

DP

DP

INSULIN GLARGINE RECOMBINANT - LANTUS SOLOSTAR



N 021081 002
8992486
Jun 05, 2024
9011391
Mar 26, 2024

DP

DP

INSULIN GLARGINE RECOMBINANT - TOUJEO SOLOSTAR



N 206538 001
7918833
Sep 23, 2027
7918833*PED
Mar 23, 2028

8512297
Sep 15, 2024
8556864
Mar 03, 2024
8603044
Mar 02, 2024
8679069
Apr 12, 2025
8992486
Jun 05, 2024
9011391
Mar 26, 2024

DP

DP

DP

INSULIN LISPRO RECOMBINANT - HUMALOG KWIKPEN



N 205747 001
6034054
Jun 11, 2018
6034054
Jun 11, 2018
6551992
Jun 11, 2018
6551992
Jun 11, 2018
7291132
Aug 09, 2024

DP U-1707

DP U-1708

DP U-1707

DP U-1708

DP

INSULIN RECOMBINANT HUMAN - AFREZZA



N 022472 001 >A> 8729019
Dec 26, 2028
8912193
Jun 12, 2029

DP

DP U-1538

INSULIN RECOMBINANT HUMAN - AFREZZA



N 022472 003
6444226
Jun 29, 2020
6652885
Jun 29, 2020
7305986
Jan 16, 2023
7464706
Mar 02, 2023
7648960
Jun 29, 2020
7943178
Jun 29, 2020
7943572
Aug 10, 2026
8119593
Aug 11, 2029
8146588
Apr 24, 2023
8156936
Jan 16, 2023
8215300
Nov 24, 2022
8258095
Aug 11, 2029
8389470
Jun 29, 2020
8394414
May 15, 2015
8424518
Oct 17, 2031
8485180
Mar 25, 2030
8499757
Feb 19, 2032
8551528
Jun 11, 2030

EXCLUSIVITY
CODE(S)

EXCLUSIVITY

EXPIRATION

DATE

NP

Feb 25, 2018


NP

Jun 27, 2017


DP

DP

DP

DP

DP

DP

INSULIN GLULISINE RECOMBINANT - APIDRA SOLOSTAR



N 021629 003
8992486
Jun 05, 2024
9011391
Mar 26, 2024

INSULIN RECOMBINANT HUMAN - AFREZZA



N 022472 002
7943572
Aug 10, 2026
8424518
Oct 17, 2031
8623817
Sep 18, 2029
>A> 8729019
Dec 26, 2028
8912193
Jun 12, 2029

PATENT
DELIST
REQUESTED

U-1539

DP

U-1537

DP

DP U-1538

DP U-1534

U-1535

DP

DP

U-1535

DP U-1535

U-1539

U-1537

DP

DP

DP

U-1537

DP U-1697

DP U-1533

DP

DP

DP

DP

A - 31

PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 10 - October 2015
See List footnote for information regarding List content
APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

INSULIN RECOMBINANT HUMAN - AFREZZA


N 022472 003
8623817
Sep 18, 2029
8636001
Jul 12, 2032
>A> 8729019
Dec 26, 2028
8734845
Jun 11, 2030
8778403
Jun 11, 2030
8889099
Jun 29, 2020
8912193
Jun 12, 2029

U-1537
DP
DP
DP
DP U-1538
DP U-1621
DP U-1538

IPRATROPIUM BROMIDE - ATROVENT HFA


N 021527 001
8474447

DP

Jan 17, 2030

IRINOTECAN HYDROCHLORIDE - ONIVYDE


N 207793 001

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

>A> NP

EXCLUSIVITY

EXPIRATION

DATE

Oct 22, 2018

ISAVUCONAZONIUM SULFATE - CRESEMBA


N 207500 001
6812238
7459561

Oct 31, 2020


Oct 31, 2020

DS
DS

NCE
ODE
GAIN
GAIN

Mar
Mar
Mar
Mar

06,
06,
06,
06,

2020
2022
2025
2027

ISAVUCONAZONIUM SULFATE - CRESEMBA


N 207501 001
6812238
7459561

Oct 31, 2020


Oct 31, 2020

DS
DS

NCE
ODE
GAIN
GAIN

Mar
Mar
Mar
Mar

06,
06,
06,
06,

2020
2022
2025
2027

ISOTRETINOIN - ABSORICA
N 021951 001
8952064
9078925
9089534

Sep 21, 2021


Sep 21, 2021
Sep 21, 2021

DP
DP
DP

ISOTRETINOIN - ABSORICA
N 021951 002
8952064
9078925
9089534

Sep 21, 2021


Sep 21, 2021
Sep 21, 2021

DP
DP
DP

ISOTRETINOIN - ABSORICA
N 021951 003
8952064
9078925
9089534

Sep 21, 2021


Sep 21, 2021
Sep 21, 2021

DP
DP
DP

ISOTRETINOIN - ABSORICA
N 021951 004
8952064
9078925
9089534

Sep 21, 2021


Sep 21, 2021
Sep 21, 2021

DP
DP
DP

ISOTRETINOIN - ABSORICA
N 021951 005
7435427
8367102
8952064
9078925
9089534

Sep
Sep
Sep
Sep
Sep

21,
21,
21,
21,
21,

2021
2021
2021
2021
2021

DP

ISOTRETINOIN - ABSORICA
N 021951 006
7435427
8367102
8952064
9078925
9089534

Sep
Sep
Sep
Sep
Sep

21,
21,
21,
21,
21,

2021
2021
2021
2021
2021

DP

U-1347
DP
DP
DP

U-1347
DP
DP
DP

A - 32

PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 10 - October 2015
See List footnote for information regarding List content
APPL/PROD

NO

PATENT NO

PATENT

EXPIRATION

DATE

PATENT
CODES

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

IVABRADINE HYDROCHLORIDE - CORLANOR



N 206143 001
7361649

Apr
7361650

Apr
7867996

Feb
7879842

Feb

17,
14,
22,
22,

2026

2026

2026

2026

DS
DS
DS
DS

DP
DP
DP
DP

U-1694
U-1694

U-1694

U-1694

NCE

Apr 15, 2020

IVABRADINE HYDROCHLORIDE - CORLANOR



N 206143 002
7361649

Apr
7361650

Apr
7867996

Feb
7879842

Feb

17,
14,
22,
22,

2026

2026

2026

2026

DS
DS
DS
DS

DP
DP
DP
DP

U-1694
U-1694

U-1694

U-1694

NCE

Apr 15, 2020

U-1311

I-705

Dec 30, 2017


NCE
ODE

Jul 02, 2020



Jul 02, 2022

IVACAFTOR - KALYDECO

N 203188 001
8354427

Jul 06, 2026


IVACAFTOR - KALYDECO

N 207925 001
7495103

8324242

8354427

8410274

8754224

8883206

May
Apr
Jul
Dec
Dec
Feb

20,
18,
06,
28,
28,
27,

2027

2027

2026

2026

2026

2033

DS DP

IVACAFTOR - KALYDECO

N 207925 002
7495103

8324242

8354427

8410274

8754224

8883206

May
Apr
Jul
Dec
Dec
Feb

20,
18,
06,
28,
28,
27,

2027

2027

2026

2026

2026

2033

DS DP

IVACAFTOR; LUMACAFTOR - ORKAMBI



N 206038 001
7495103

8324242

8410274

8507534

8653103

8716338

8741933

8754224

8846718

8993600

May
Apr
Dec
Sep
Dec
Nov
Nov
Dec
Dec
Dec

20,
18,
28,
20,
04,
08,
08,
28,
04,
11,

2027

2027

2026

2030

2028

2026

2026

2026

2028

2030

DS DP

IVERMECTIN - SOOLANTRA

N 206255 001
5952372

6133310

7550440

8080530

8093219

8415311

8470788

8815816

9089587

Sep
Apr
Apr
Apr
Apr
Apr
Apr
Apr
Mar

18,
26,
22,
22,
22,
22,
22,
22,
13,

2018

2019

2024

2024

2024

2024

2024

2024

2034

U-1311

U-1311

DP

DS DP

DP

U-1311

U-1311

DP

DS DP

DP

U-1311
DP

DS DP

DP

DP U-1718

U-1717

DS DP

U-1717

DP

DP
DP
DP
DP
DP
DP

KETOROLAC TROMETHAMINE - ACULAR LS



N 021528 001
8946281

May 28, 2024

KETOROLAC TROMETHAMINE - ACUVAIL

N 022427 001
8992952

Aug 05, 2024


U-1631

U-1631

U-1631

U-1631

U-1631

U-1631

U-1631

U-1631

U-1631

U-1662

DP

KETOROLAC TROMETHAMINE; PHENYLEPHRINE HYDROCHLORIDE - OMIDRIA



N 205388 001
9066856
Oct 23, 2033
DP

A - 33

PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 10 - October 2015
See List footnote for information regarding List content
APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

LAMIVUDINE - LAMIVUDINE

A 203564 001

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY

EXPIRATION

DATE

PC

Sep 01, 2015

LAMIVUDINE - EPIVIR
N 020564 001
5905082
5905082*PED

May 18, 2016


Nov 18, 2016

DS DP

D-147

Mar 23, 2018

LAMIVUDINE - EPIVIR
N 020564 003
5905082
5905082*PED

May 18, 2016


Nov 18, 2016

DS DP

D-147

Mar 23, 2018

LAMIVUDINE - EPIVIR
N 020596 001
5905082
6004968
6004968*PED

May 18, 2016


Mar 20, 2018
Sep 20, 2018

DS DP
DP U-248

D-147

Mar 23, 2018

LAMOTRIGINE - LAMOTRIGINE
A 200828 001

PC

Sep 28, 2015

LAMOTRIGINE - LAMOTRIGINE
A 200828 002

PC

Sep 28, 2015

LAMOTRIGINE - LAMOTRIGINE
A 200828 003

PC

Sep 28, 2015

LAMOTRIGINE - LAMOTRIGINE
A 200828 004

PC

Sep 28, 2015

LAMOTRIGINE - LAMICTAL
N 020241 001

M-159

May 18, 2018

LAMOTRIGINE - LAMICTAL
N 020241 002

M-159

May 18, 2018

LAMOTRIGINE - LAMICTAL
N 020241 003

M-159

May 18, 2018

LAMOTRIGINE - LAMICTAL
N 020241 004

M-159

May 18, 2018

LAMOTRIGINE - LAMICTAL
N 020241 005

M-159

May 18, 2018

LAMOTRIGINE - LAMICTAL
N 020241 006

M-159

May 18, 2018

LAMOTRIGINE - LAMICTAL CD
N 020764 001

M-159

May 18, 2018

LAMOTRIGINE - LAMICTAL CD
N 020764 002

M-159

May 18, 2018

LAMIVUDINE; RALTEGRAVIR POTASSIUM - DUTREBIS



N 206510 001
7169780
Oct 03, 2023
7217713
Oct 21, 2022
7435734
Oct 21, 2022
7754731
Mar 11, 2029
7820660
Apr 25, 2023

DS DP
U-1663
U-1663
DS DP U-1663
DS

A - 34

PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 10 - October 2015
See List footnote for information regarding List content
APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY
EXPIRATION
DATE

LAMOTRIGINE - LAMICTAL CD
N 020764 003

M-159

May 18, 2018

LAMOTRIGINE - LAMICTAL CD
N 020764 004

M-159

May 18, 2018

LAMOTRIGINE - LAMICTAL ODT


N 022251 001

M-159

May 18, 2018

LAMOTRIGINE - LAMICTAL ODT


N 022251 002

M-159

May 18, 2018

LAMOTRIGINE - LAMICTAL ODT


N 022251 003

M-159

May 18, 2018

LAMOTRIGINE - LAMICTAL ODT


N 022251 004

M-159

May 18, 2018

LAMOTRIGINE - LAMICTAL XR
N 022115 001 >A> 9144547

Sep 22, 2023

DP

LAMOTRIGINE - LAMICTAL XR
N 022115 002 >A> 9144547

Sep 22, 2023

DP

LAMOTRIGINE - LAMICTAL XR
N 022115 003 >A> 9144547

Sep 22, 2023

DP

LAMOTRIGINE - LAMICTAL XR
N 022115 004 >A> 9144547

Sep 22, 2023

DP

LAMOTRIGINE - LAMICTAL XR
N 022115 005 >A> 9144547

Sep 22, 2023

DP

LAMOTRIGINE - LAMICTAL XR
N 022115 006 >A> 9144547

Sep 22, 2023

DP

LANTHANUM CARBONATE - FOSRENOL


N 204734 001
8980327

Dec 01, 2030

DP

LANTHANUM CARBONATE - FOSRENOL


N 204734 002
8980327

Dec 01, 2030

DP

LAPATINIB DITOSYLATE - TYKERB


N 022059 001
8821927

Sep 18, 2029

DS DP

LEDIPASVIR; SOFOSBUVIR - HARVONI


N 205834 001
9085573

Mar 21, 2028

DS DP U-1470

LENALIDOMIDE - REVLIMID
N 021880 001
9056120
9101621
9101622

Apr 11, 2023


May 15, 2023
May 15, 2023

U-1215
U-1216
U-1216

I-706
ODE

Feb 17, 2018


Feb 17, 2022

LENALIDOMIDE - REVLIMID
N 021880 002
9056120
9101621
9101622

Apr 11, 2023


May 15, 2023
May 15, 2023

U-1215
U-1216
U-1216

I-706
ODE

Feb 17, 2018


Feb 17, 2022

A - 35

PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 10 - October 2015
See List footnote for information regarding List content
APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY

EXPIRATION

DATE

LENALIDOMIDE - REVLIMID
N 021880 003
9056120
9101621
9101622

Apr 11, 2023


May 15, 2023
May 15, 2023

U-1215
U-1216
U-1216

I-706
ODE

Feb 17, 2018


Feb 17, 2022

LENALIDOMIDE - REVLIMID
N 021880 004
9056120
9101621
9101622

Apr 11, 2023


May 15, 2023
May 15, 2023

U-1215
U-1216
U-1216

I-706
ODE

Feb 17, 2018


Feb 17, 2022

LENALIDOMIDE - REVLIMID
N 021880 005
9056120
9101621
9101622

Apr 11, 2023


May 15, 2023
May 15, 2023

U-1215
U-1216
U-1216

I-706
ODE

Feb 17, 2018


Feb 17, 2022

LENALIDOMIDE - REVLIMID
N 021880 006
5635517
9056120
9101621
9101622

Oct
Apr
May
May

U-1211
U-1215
U-1216
U-1216

I-706
ODE

Feb 17, 2018


Feb 17, 2022

LENVATINIB MESYLATE - LENVIMA


N 206947 001
7253286
7612208
9006256

Oct 19, 2021


Sep 19, 2026
Jul 27, 2027

DS DP
DS DP

NCE
ODE

Feb 13, 2020


Feb 13, 2022

LENVATINIB MESYLATE - LENVIMA


N 206947 002
7253286
7612208
9006256

Oct 19, 2021


Sep 19, 2026
Jul 27, 2027

DS DP
DS DP

NCE
ODE

Feb 13, 2020


Feb 13, 2022

LEUPROLIDE ACETATE - LUPRON DEPOT


N 020517 003
7429559
8815801
8921326

Jan 13, 2019


Jun 28, 2022
Feb 05, 2031

LEVALBUTEROL HYDROCHLORIDE - XOPENEX


N 020837 001

M-151

Jan 22, 2018

LEVALBUTEROL HYDROCHLORIDE - XOPENEX


N 020837 002

M-151

Jan 22, 2018

LEVALBUTEROL HYDROCHLORIDE - XOPENEX


N 020837 003

M-151

Jan 22, 2018

LEVALBUTEROL HYDROCHLORIDE - XOPENEX


N 020837 004

M-151

Jan 22, 2018

LEVALBUTEROL TARTRATE - XOPENEX HFA


N 021730 001

M-156

Mar 12, 2018

04,
11,
15,
15,

2019
2023
2023
2023

DS

U-1695

U-1695

DP
DP
DP U-1666

LEVETIRACETAM - SPRITAM
N 207958 001
6471992

Feb 20, 2018

DP

LEVETIRACETAM - SPRITAM
N 207958 002
6471992

Feb 20, 2018

DP

LEVETIRACETAM - SPRITAM
N 207958 003
6471992

Feb 20, 2018

DP

A - 36

PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 10 - October 2015
See List footnote for information regarding List content
APPL/PROD
NO

PATENT NO

LEVETIRACETAM - SPRITAM
N 207958 004
6471992

PATENT
EXPIRATION
DATE

PATENT
CODES

Feb 20, 2018

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY

EXPIRATION

DATE

DP

LEVOLEUCOVORIN CALCIUM - LEVOLEUCOVORIN CALCIUM


A 203563 001

PC

Oct 20, 2015

LEVOLEUCOVORIN CALCIUM - LEVOLEUCOVORIN CALCIUM


A 203563 002

PC

Oct 20, 2015

LEVONORGESTREL - LILETTA
N 206229 001

NP

Feb 26, 2018

LINEZOLID - LINEZOLID
A 078061 001

PC

Dec 19, 2015

LINEZOLID - LINEZOLID
A 200222 001

PC

Jul 04, 2015

LEVOTHYROXINE SODIUM - LEVOTHYROXINE SODIUM


N 202231 001
9006289
Oct 03, 2032
>A> 9168238
Aug 29, 2032
>A> 9168239
Aug 29, 2032

DP
DP
DP

LEVOTHYROXINE SODIUM - LEVOTHYROXINE SODIUM


N 202231 002
9006289
Oct 03, 2032
>A> 9168238
Aug 29, 2032
>A> 9168239
Aug 29, 2032

DP
DP
DP

LEVOTHYROXINE SODIUM - LEVOTHYROXINE SODIUM


N 202231 003
9006289
Oct 03, 2032
>A> 9168238
Aug 29, 2032
>A> 9168239
Aug 29, 2032

DP
DP
DP

LINACLOTIDE - LINZESS
N 202811 001
8933030

Feb 17, 2031

DP

LINACLOTIDE - LINZESS
N 202811 002
8933030

Feb 17, 2031

DP

LINAGLIPTIN - TRADJENTA
N 201280 001
8673927
8853156

May 04, 2027


Mar 05, 2031

U-1503
U-1642

LINAGLIPTIN; METFORMIN HYDROCHLORIDE - JENTADUETO


N 201281 001
8673927
May 04, 2027
>A> 9155705
May 21, 2030

DP

LINAGLIPTIN; METFORMIN HYDROCHLORIDE - JENTADUETO


N 201281 002
8673927
May 04, 2027
>A> 9155705
May 21, 2030

DP

LINAGLIPTIN; METFORMIN HYDROCHLORIDE - JENTADUETO


N 201281 003
8673927
May 04, 2027
>A> 9155705
May 21, 2030

DP

LINEZOLID - ZYVOX
N 021131 002

6559305
6559305*PED

Jan 29, 2021


Jul 29, 2021

U-1503

U-1503

U-1503

DS

A - 37

PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 10 - October 2015
See List footnote for information regarding List content
APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

LINEZOLID - ZYVOX

N 021131 003
6559305

6559305*PED

Jan 29, 2021


Jul 29, 2021

LIRAGLUTIDE RECOMBINANT - VICTOZA



N 022341 001
8846618

Jun 27, 2022

LIRAGLUTIDE RECOMBINANT - SAXENDA



N 206321 001
6268343

6458924

6899699

7235627

7686786

8114833

8672898

8684969

8846618

8920383

9108002

9132239

Aug
Aug
Jan
Aug
Aug
Aug
Jan
Oct
Jun
Jul
Jan
Feb

22,
22,
01,
22,
03,
13,
02,
20,
27,
17,
26,
01,

2022
2017
2022
2017
2026
2025
2022
2025
2022
2026
2026
2032

LISDEXAMFETAMINE DIMESYLATE - VYVANSE



N 021977 001
7105486
Feb
7223735
Feb
7671031
Feb
7674774
Feb
7678770
Feb
7678771
Feb
7687467
Feb
7700561
Feb

24,
24,
24,
24,
24,
24,
24,
24,

2023
2023
2023
2023
2023
2023
2023
2023

LISDEXAMFETAMINE DIMESYLATE - VYVANSE



N 021977 002
7105486
Feb
7223735
Feb
7671031
Feb
7674774
Feb
7678770
Feb
7678771
Feb
7687467
Feb
7700561
Feb

24,
24,
24,
24,
24,
24,
24,
24,

2023
2023
2023
2023
2023
2023
2023
2023

LISDEXAMFETAMINE DIMESYLATE - VYVANSE



N 021977 003
7105486
Feb
7223735
Feb
7671031
Feb
7674774
Feb
7678770
Feb
7678771
Feb
7687467
Feb
7700561
Feb

24,
24,
24,
24,
24,
24,
24,
24,

2023
2023
2023
2023
2023
2023
2023
2023

LISDEXAMFETAMINE DIMESYLATE - VYVANSE



N 021977 004
7105486
Feb
7105486
Feb
7223735
Feb
7671031
Feb
7674774
Feb
7678770
Feb
7678771
Feb
7687467
Feb
7700561
Feb

24,
24,
24,
24,
24,
24,
24,
24,
24,

2023
2023
2023
2023
2023
2023
2023
2023
2023

PATENT
CODES

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY

EXPIRATION

DATE

DS

DP

DS DP U-1255

DS DP U-1255

DP

DS DP

DP

DP

DP

DP

DP

DP

DP

DP

U-727

I-703

Jan 30, 2018


I-703

Jan 30, 2018


I-703

Jan 30, 2018


I-703

Jan 30, 2018


DP

U-727

DP U-842

U-842

DP U-842

DP U-842

DP

U-727
DP

U-727

DP U-842

U-842

DP U-842

DP U-842

DP

U-727
DP

U-727

DP U-842

U-842

DP U-842

DP U-842

DP

U-727
U-842

DP

U-727

DP U-842

U-842

DP U-842

DP U-842

DP

A - 38

PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 10 - October 2015
See List footnote for information regarding List content
APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY

EXPIRATION

DATE

LISDEXAMFETAMINE DIMESYLATE - VYVANSE



N 021977 005
7105486
Feb
7671031
Feb
7674774
Feb
7678770
Feb
7678771
Feb
7687467
Feb
7700561
Feb

24,
24,
24,
24,
24,
24,
24,

2023
2023
2023
2023
2023
2023
2023

U-842
U-727

DP U-842

U-842

DP U-842

DP U-842

DP

I-703

Jan 30, 2018


LISDEXAMFETAMINE DIMESYLATE - VYVANSE



N 021977 006
7105486
Feb
7105486
Feb
7223735
Feb
7671031
Feb
7674774
Feb
7678770
Feb
7678771
Feb
7687467
Feb
7700561
Feb

24,
24,
24,
24,
24,
24,
24,
24,
24,

2023
2023
2023
2023
2023
2023
2023
2023
2023

U-727
U-842

I-703

Jan 30, 2018


LISDEXAMFETAMINE DIMESYLATE - VYVANSE



N 021977 007
7223735
Feb
7655630
Feb
7659253
Feb
7659254
Feb
7662787
Feb
7662788
Feb
7671030
Feb
7671031
Feb
7674774
Feb
7678770
Feb
7678771
Feb
7687466
Feb
7687467
Feb
7700561
Feb
7713936
Feb
7718619
Feb

24,
24,
24,
24,
24,
24,
24,
24,
24,
24,
24,
24,
24,
24,
24,
24,

2023
2023
2023
2023
2023
2023
2023
2023
2023
2023
2023
2023
2023
2023
2023
2023

I-703

Jan 30, 2018


DP

U-727

DP U-842

U-842

DP U-842

DP U-842

DP

DP
DS

DS DP U-727

U-1034

DS

U-727

DP U-727

U-727

DP U-842

U-842

DP

DP

DP U-842

DP

U-727

DP U-842

LOMITAPIDE MESYLATE - JUXTAPID



N 203858 001
5712279

Feb 21, 2016

DS

U-1317

LOMITAPIDE MESYLATE - JUXTAPID



N 203858 002
5712279

Feb 21, 2016

DS

U-1317

LOMITAPIDE MESYLATE - JUXTAPID



N 203858 003
5712279

Feb 21, 2016

DS

U-1317

LOMITAPIDE MESYLATE - JUXTAPID



N 203858 004
5712279
6492365
7932268
8618135

Feb
Dec
Aug
Mar

21,
10,
19,
07,

2016
2019
2027
2025

DS

U-1317
U-1318
U-1316

U-1316

NCE
ODE

Dec 21, 2017



Dec 21, 2019

LOMITAPIDE MESYLATE - JUXTAPID



N 203858 005
5712279
6492365
7932268
8618135

Feb
Dec
Aug
Mar

21,
10,
19,
07,

2016
2019
2027
2025

DS

U-1317
U-1318
U-1316

U-1316

NCE
ODE

Dec 21, 2017



Dec 21, 2019

LOMITAPIDE MESYLATE - JUXTAPID


N 203858 006
5712279
6492365
7932268
8618135

Feb
Dec
Aug
Mar

21,
10,
19,
07,

2016
2019
2027
2025

DS

U-1317
U-1318
U-1316
U-1316

NCE
ODE

Dec 21, 2017


Dec 21, 2019

A - 39

PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 10 - October 2015
See List footnote for information regarding List content
APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

LOMITAPIDE MESYLATE - JUXTAPID


N 203858 006
5712279
6492365
7932268
8618135

Feb
Dec
Aug
Mar

LORATADINE - CLARITIN
N 020641 002
6132758

Jun 01, 2018

DP

LORCASERIN HYDROCHLORIDE - BELVIQ


N 022529 001
8946207
8980881
8980881
8980881
8980881
8999970
8999970
8999970

Jun
Dec
Dec
Dec
Dec
Feb
Feb
Feb

2024
2025
2025
2025
2025
2033
2033
2033

DP

LOXAPINE - ADASUVE
N 022549 001
8955512
8991387

Oct 26, 2021


May 21, 2024

DP
DP

LULICONAZOLE - LUZU
N 204153 001
8980931
9012484

Apr 28, 2034


Sep 06, 2033

DP
DS DP U-540

LURASIDONE HYDROCHLORIDE - LATUDA


N 200603 001
RE45573

Jun 23, 2025

DS

LURASIDONE HYDROCHLORIDE - LATUDA


N 200603 002
RE45573

Jun 23, 2025

DS

LURASIDONE HYDROCHLORIDE - LATUDA


N 200603 003
RE45573

Jun 23, 2025

DS

LURASIDONE HYDROCHLORIDE - LATUDA


N 200603 004
RE45573

Jun 23, 2025

DS

LURASIDONE HYDROCHLORIDE - LATUDA


N 200603 005
RE45573

Jun 23, 2025

DS

MEGESTROL ACETATE - MEGACE ES


N 021778 001
9040088
9101540
9101549
9107827

Apr
Apr
Apr
Apr

21,
10,
19,
07,

16,
20,
20,
20,
20,
07,
07,
07,

22,
22,
22,
22,

2016
2019
2027
2025

2024
2024
2024
2024

DS

U-1317
U-1318
U-1316
U-1316

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

NCE
ODE

EXCLUSIVITY

EXPIRATION

DATE

Dec 21, 2017


Dec 21, 2019

U-1252
U-1253
U-1254
U-1255
U-1688
U-1689
U-1692

U-755
DP U-755
U-755
U-755

MELOXICAM - VIVLODEX
N 207233 001

>A> NP

Oct 22, 2018

MELOXICAM - VIVLODEX
N 207233 002

>A> NP

Oct 22, 2018

MESALAMINE - ASACOL HD
N 021830 001
9089492

Nov 15, 2021

DP

MESALAMINE - APRISO
N 022301 001
8940328
8956647

Apr 20, 2018


Apr 20, 2018

DP
DP

A - 40

PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 10 - October 2015
See List footnote for information regarding List content
APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE - ACTOPLUS MET



N 021842 001
9101660
Jan 22, 2027
DP

METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE - ACTOPLUS MET

N 021842 002
9101660
Jan 22, 2027
DP

METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE - ACTOPLUS MET XR

N 022024 001
9060941
Sep 19, 2023
DP

METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE - ACTOPLUS MET XR

N 022024 002
9060941
Sep 19, 2023
DP

METHOTREXATE - OTREXUP

N 204824 001
8945063

Mar 19, 2030

DP U-1442

METHOTREXATE - OTREXUP

N 204824 002
8945063

Mar 19, 2030

DP U-1442

METHOTREXATE - OTREXUP

N 204824 003
8945063

Mar 19, 2030

DP U-1442

METHOTREXATE - OTREXUP

N 204824 004
8945063

Mar 19, 2030

DP U-1442

METHOTREXATE - OTREXUP

N 204824 005
8945063

Mar 19, 2030

DP U-1442

METHYLPHENIDATE - DAYTRANA

N 021514 001
9034370

Oct 07, 2025

DP

METHYLPHENIDATE - DAYTRANA

N 021514 002
9034370

Oct 07, 2025

DP

METHYLPHENIDATE - DAYTRANA

N 021514 003
9034370

Oct 07, 2025

DP

METHYLPHENIDATE - DAYTRANA

N 021514 004
9034370

Oct 07, 2025

DP

METHYLPHENIDATE HYDROCHLORIDE - CONCERTA



N 021121 001
9000038
Jul 31,
9000038
Jul 31,
9000038*PED
Jan 31,
9029416
Jul 31,
9144549
Jul 31,
9144549
Jul 31,

2017
2017
2018

2017
2017
2017

METHYLPHENIDATE HYDROCHLORIDE - CONCERTA



N 021121 002
9000038
Jul 31,
9000038
Jul 31,
9000038*PED
Jan 31,
9029416
Jul 31,
9144549
Jul 31,
9144549
Jul 31,

2017
2017
2018

2017
2017
2017

METHYLPHENIDATE HYDROCHLORIDE - CONCERTA



N 021121 003
9000038
Jul 31,
9000038
Jul 31,
9000038*PED
Jan 31,
9029416
Jul 31,
9144549
Jul 31,
9144549
Jul 31,

2017
2017
2018

2017
2017
2017

U-666

U-1693

DP U-666

U-1747

U-1748

U-666

U-1693

DP U-666

U-1747

U-1748

U-666

U-1693

DP U-666

U-1747

U-1748

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY

EXPIRATION

DATE

A - 41

PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 10 - October 2015
See List footnote for information regarding List content
APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

METHYLPHENIDATE HYDROCHLORIDE - CONCERTA


N 021121 003
9000038
Jul 31, 2017
9000038
Jul 31, 2017
9000038*PED
Jan 31, 2018
9029416
Jul 31, 2017
9144549
Jul 31, 2017
9144549
Jul 31, 2017

PATENT
CODES

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY

EXPIRATION

DATE

U-666
U-1693
DP U-666
U-1747
U-1748

METHYLPHENIDATE HYDROCHLORIDE - CONCERTA


N 021121 004
9000038
Jul 31, 2017
9000038
Jul 31, 2017
9000038*PED
Jan 31, 2018
9029416
Jul 31, 2017
9144549
Jul 31, 2017
9144549
Jul 31, 2017

DP U-666
U-1747
U-1748

METHYLPHENIDATE HYDROCHLORIDE - QUILLIVANT XR


N 202100 001
8956649
Feb 15, 2031
9040083
Feb 15, 2031

DP U-1665
DP

METHYLPHENIDATE HYDROCHLORIDE - APTENSIO XR


N 205831 001
6419960
Dec 16, 2019
7083808
Dec 16, 2019
7247318
Dec 16, 2019
7438930
Dec 16, 2019
8580310
Dec 16, 2019
9066869
Dec 16, 2019

DP
DP
DP
DP
DP
DP

NP

Apr 17, 2018

METHYLPHENIDATE HYDROCHLORIDE - APTENSIO XR


N 205831 002
6419960
Dec 16, 2019
7083808
Dec 16, 2019
7247318
Dec 16, 2019
7438930
Dec 16, 2019
8580310
Dec 16, 2019
9066869
Dec 16, 2019

DP
DP
DP
DP
DP
DP

NP

Apr 17, 2018

METHYLPHENIDATE HYDROCHLORIDE - APTENSIO XR


N 205831 003
6419960
Dec 16, 2019
7083808
Dec 16, 2019
7247318
Dec 16, 2019
7438930
Dec 16, 2019
8580310
Dec 16, 2019
9066869
Dec 16, 2019

DP
DP
DP
DP
DP
DP

NP

Apr 17, 2018

METHYLPHENIDATE HYDROCHLORIDE - APTENSIO XR


N 205831 004
6419960
Dec 16, 2019
7083808
Dec 16, 2019
7247318
Dec 16, 2019
7438930
Dec 16, 2019
8580310
Dec 16, 2019
9066869
Dec 16, 2019

DP
DP
DP
DP
DP
DP

NP

Apr 17, 2018

METHYLPHENIDATE HYDROCHLORIDE - APTENSIO XR


N 205831 005
6419960
Dec 16, 2019
7083808
Dec 16, 2019
7247318
Dec 16, 2019
7438930
Dec 16, 2019
8580310
Dec 16, 2019
9066869
Dec 16, 2019

DP
DP
DP
DP
DP
DP

NP

Apr 17, 2018

METHYLPHENIDATE HYDROCHLORIDE - APTENSIO XR


N 205831 006
6419960
Dec 16, 2019
7083808
Dec 16, 2019
7247318
Dec 16, 2019

DP
DP
DP

NP

Apr 17, 2018

U-666
U-1693

A - 42

PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 10 - October 2015
See List footnote for information regarding List content
APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

METHYLPHENIDATE HYDROCHLORIDE - APTENSIO XR


N 205831 006
7438930
Dec 16, 2019
8580310
Dec 16, 2019
9066869
Dec 16, 2019

DP
DP
DP

METHYLPHENIDATE HYDROCHLORIDE - APTENSIO XR


N 205831 007
6419960
Dec 16, 2019
7083808
Dec 16, 2019
7247318
Dec 16, 2019
7438930
Dec 16, 2019
8580310
Dec 16, 2019
9066869
Dec 16, 2019

DP
DP
DP
DP
DP
DP

METRONIDAZOLE - NUVESSA
N 205223 001
7893097
8658678
8877792
8946276

Feb
Jun
Feb
Jun

MIFEPRISTONE - KORLYM
N 202107 001
8921348

Aug 27, 2028

19,
27,
02,
28,

2028
2028
2028
2032

U-1682
DP
U-1664

U-1643

U-282

MINOCYCLINE HYDROCHLORIDE - ARESTIN


N 050781 001
7699609
Mar 29, 2022

DP

MINOXIDIL - WOMEN'S ROGAINE


N 021812 002
6946120

DP U-702

Apr 20, 2019

MORPHINE SULFATE - MORPHINE SULFATE


N 204223 001
9072781
Mar 12, 2034

DP

MORPHINE SULFATE - MORPHINE SULFATE


N 204223 002
9072781
Mar 12, 2034

DP

MORPHINE SULFATE - MORPHINE SULFATE


N 204223 003
9072781
Mar 12, 2034

DP

MORPHINE SULFATE - MORPHINE SULFATE


N 204223 004
9072781
Mar 12, 2034

DP

MORPHINE SULFATE - MORPHINE SULFATE


N 204223 005
9072781
Mar 12, 2034

DP

EXCLUSIVITY
CODE(S)

NP

DP

MINOCYCLINE HYDROCHLORIDE - MINOCIN


N 050444 001
9084802
May 12, 2031

PATENT
DELIST
REQUESTED

MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE - EMBEDA


N 022321 001
8623418
Nov 07, 2029

U-1640

MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE - EMBEDA


N 022321 002
8623418
Nov 07, 2029

U-1640

MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE - EMBEDA


N 022321 003
8623418
Nov 07, 2029

U-1640

MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE - EMBEDA


N 022321 004
8623418
Nov 07, 2029

U-1640

MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE - EMBEDA


N 022321 005
8623418
Nov 07, 2029

U-1640

EXCLUSIVITY
EXPIRATION
DATE

Apr 17, 2018

A - 43

PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 10 - October 2015
See List footnote for information regarding List content
APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE - EMBEDA



N 022321 006
8623418
Nov 07, 2029
MOXIFLOXACIN HYDROCHLORIDE - MOXEZA

N 022428 001
9114168
May 29, 2029

EXCLUSIVITY

EXPIRATION

DATE

DP

Jan 31, 2033

NALOXEGOL OXALATE - MOVANTIK



N 204760 001
7056500
9012469

Jun 29, 2024


Apr 02, 2032

DP U-1185

DS DP

NALOXEGOL OXALATE - MOVANTIK



N 204760 002
7056500
9012469

Jun 29, 2024


Apr 02, 2032

DP U-1185

DS DP

NALOXONE HYDROCHLORIDE - EVZIO



N 205787 001
8926594
8939943
9022022
9056170

Mar
Feb
Feb
Nov

2026
2031
2031
2024

EXCLUSIVITY
CODE(S)

U-1640

NAFTIFINE HYDROCHLORIDE - NAFTIN



N 204286 001 >A> 9161914

31,
28,
28,
23,

PATENT
DELIST
REQUESTED

U-540

DP

DP

DP

DP

NALOXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE - TARGINIQ



N 205777 001
8969369
May 10, 2022
DP U-1556

9056051
May 10, 2022
DP U-1556

9073933
Mar 30, 2025
DS

9084729
May 10, 2022
DP U-1556

>A> 9161937
May 10, 2022
DP U-1556

>A> 9168252
May 10, 2022
DP U-1556

NALOXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE - TARGINIQ

N 205777 002
8969369
May 10, 2022
DP U-1556

9056051
May 10, 2022
DP U-1556

9073933
Mar 30, 2025
DS

9084729
May 10, 2022
DP U-1556

>A> 9161937
May 10, 2022
DP U-1556

>A> 9168252
May 10, 2022
DP U-1556

NALOXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE - TARGINIQ

N 205777 003
8969369
May 10, 2022
DP U-1556

9056051
May 10, 2022
DP U-1556

9073933
Mar 30, 2025
DS

9084729
May 10, 2022
DP U-1556

>A> 9161937
May 10, 2022
DP U-1556

>A> 9168252
May 10, 2022
DP U-1556

NAPROXEN SODIUM; SUMATRIPTAN SUCCINATE - TREXIMET

N 021926 001
6060499
Aug 14, 2017
6060499*PED
Feb 14, 2018

6586458
Aug 14, 2017
6586458*PED
Feb 14, 2018

7332183
Oct 02, 2025
7332183*PED
Apr 02, 2026

8022095
Aug 14, 2017
8022095*PED
Feb 14, 2018

NAPROXEN SODIUM; SUMATRIPTAN SUCCINATE - TREXIMET

N 021926 002
5872145
Aug 14, 2017
5872145*PED
Feb 14, 2018

6060499
Aug 14, 2017
6060499*PED
Feb 14, 2018

6586458
Aug 14, 2017
6586458*PED
Feb 14, 2018

DP U-867

DP U-867

DP U-867

DP U-867

DP U-1719

DP U-1719

DP U-1719

NP
PED

May 14, 2018

Nov 14, 2018


A - 44

PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 10 - October 2015
See List footnote for information regarding List content
APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

NAPROXEN SODIUM; SUMATRIPTAN SUCCINATE - TREXIMET


N 021926 002
7332183
Oct 02, 2025
7332183*PED
Apr 02, 2026
NEPAFENAC - ILEVRO
N 203491 001
8921337

EXCLUSIVITY
CODE(S)

DP

NETUPITANT; PALONOSETRON HYDROCHLORIDE - AKYNZEO


N 205718 001
8951969
Nov 18, 2030

DP

NICOTINE - NICODERM CQ
N 020165 004
8999379

Feb 13, 2020

U-1686

NICOTINE - NICODERM CQ
N 020165 005
8999379

Feb 13, 2020

U-1686

NICOTINE - NICODERM CQ
N 020165 006
8999379

Feb 13, 2020

U-1686

NICOTINE POLACRILEX - NICORETTE


N 022360 001
8940772

Apr 30, 2029

DP

NICOTINE POLACRILEX - NICORETTE


N 022360 002
8940772

Apr 30, 2029

DP

NINTEDANIB ESYLATE - OFEV


N 205832 001
7989474

Apr 06, 2024

U-1677

NINTEDANIB ESYLATE - OFEV


N 205832 002
7989474

Apr 06, 2024

U-1677

NITRIC OXIDE - INOMAX


N 020845 003

>A> M-167

Apr
Oct
Oct
Aug
Sep
Aug
Mar

29,
11,
11,
12,
24,
04,
12,

2022
2024
2024
2027
2028
2031
2024

OLODATEROL HYDROCHLORIDE - STRIVERDI RESPIMAT


N 203108 001
8733341
Dec 16, 2029
9027967
Mar 31, 2027

EXCLUSIVITY
EXPIRATION
DATE

DP U-1719

Mar 31, 2032

OLAPARIB - LYNPARZA
N 206162 001
7151102
7449464
7981889
8143241
8247416
8859562
8912187

PATENT
DELIST
REQUESTED

DS DP
DS DP
DS DP

Oct 09, 2018

ODE

Dec 19, 2021

NC
NCE

May 21, 2018


Jul 31, 2019

U-1634
DS
U-1634
U-1634

DP
DP

OLODATEROL HYDROCHLORIDE; TIOTROPIUM BROMIDE - STIOLTO RESPIMAT


N 206756 001
5964416
Oct 04, 2016
DP
6149054
Dec 19, 2016
DP
6176442
Oct 04, 2016
DP
6453795
Dec 05, 2016
DP
6726124
Oct 04, 2016
DP
6846413
Aug 28, 2018
DP
6977042
Aug 28, 2018
DP
6988496
Feb 23, 2020
DP
7056916
Dec 07, 2023
DS DP
7104470
Oct 04, 2016
DP
7220742
May 12, 2025
DS DP U-1703
7246615
May 31, 2016
DP
7284474
Aug 26, 2024
DP
7396341
Oct 10, 2026
DP

A - 45

PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 10 - October 2015
See List footnote for information regarding List content
APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY

EXPIRATION

DATE

OLODATEROL HYDROCHLORIDE; TIOTROPIUM BROMIDE - STIOLTO RESPIMAT


N 206756 001
7491719
Nov 10, 2023
DS DP
7727984
Nov 10, 2023
DS
7786111
Nov 10, 2023
DP
7802568
Feb 26, 2019
DP
7837235
Mar 13, 2028
DP
7896264
May 26, 2025
DP
7988001
Aug 04, 2021
DP
8034809
May 12, 2025
U-1702
8044046
Nov 10, 2023
U-1702
8733341
Dec 16, 2029
DP
9027967
Mar 31, 2027
DP
RE39820
Jan 30, 2018
DS DP U-1702
OLOPATADINE HYDROCHLORIDE - PAZEO
N 206276 001
8791154

May 19, 2032

OMBITASVIR; PARITAPREVIR; RITONAVIR


N 207931 001
6037157
6037157*PED
6703403
6703403*PED
7148359
7148359*PED
7364752
7364752*PED
8268349
8268349*PED
8399015
8399015*PED
8420596
8420596*PED
8642538
8686026
8691938
9006387
9044480

- TECHNIVIE
Jun 26, 2016
Dec 26, 2016
Jun 26, 2016
Dec 26, 2016
Jul 19, 2019
Jan 19, 2020
Nov 10, 2020
May 10, 2021
Aug 25, 2024
Feb 25, 2025
Aug 25, 2024
Feb 25, 2025
Apr 10, 2031
Oct 10, 2031
Sep 10, 2029
Jun 09, 2031
Apr 13, 2032
Jun 10, 2030
Apr 10, 2031

OMEGA-3-CARBOXYLIC ACIDS - EPANOVA


N 205060 001
9012501
9050308
9050309
9132112

Feb
Jan
Jan
Feb

OMEPRAZOLE - OMEPRAZOLE
N 022032 001
9023391

Aug 16, 2025

DP

ONDANSETRON - ZUPLENZ
N 022524 001
9095577

Jul 13, 2030

DP

ONDANSETRON - ZUPLENZ
N 022524 002
9095577

Jul 13, 2030

DP

OSELTAMIVIR PHOSPHATE - TAMIFLU


N 021246 002 >A> 5763483
>A> 5763483*PED

Aug 23, 2016


Feb 23, 2017

OSPEMIFENE - OSPHENA
N 203505 001
8642079

Jul 09, 2028

OXCARBAZEPINE - OXTELLAR XR
N 202810 001
9119791

Apr 13, 2027

07,
04,
04,
07,

2025
2033
2033
2025

DP U-1680

NP
PED

Jan 30, 2018


Jul 30, 2018

U-1635

NCE
NP

Dec 19, 2019


Jul 24, 2018

U-1635
DP
DP
DP
DP
DS DP
DS DP U-1638
DP
DS DP
U-1687
U-1638

DP U-1511
U-1511
DS
DP U-1511

DS DP U-1113

DP

U-1298

A - 46

PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 10 - October 2015
See List footnote for information regarding List content
APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

OXCARBAZEPINE - OXTELLAR XR
N 202810 002
9119791

Apr 13, 2027

U-1298

OXCARBAZEPINE - OXTELLAR XR
N 202810 003
9119791

Apr 13, 2027

U-1298

OXYBUTYNIN CHLORIDE - GELNIQUE


N 022204 001
8920392

Mar 26, 2031

U-1644

OXYCODONE HYDROCHLORIDE - OXYCONTIN


N 022272 001
9060976
Aug 06, 2022
9073933
Mar 30, 2025

DS

OXYCODONE HYDROCHLORIDE - OXYCONTIN


N 022272 002
9060976
Aug 06, 2022
9073933
Mar 30, 2025

DS

OXYCODONE HYDROCHLORIDE - OXYCONTIN


N 022272 003
9060976
Aug 06, 2022
9073933
Mar 30, 2025

DS

OXYCODONE HYDROCHLORIDE - OXYCONTIN


N 022272 004
9060976
Aug 06, 2022
9073933
Mar 30, 2025

DS

OXYCODONE HYDROCHLORIDE - OXYCONTIN


N 022272 005
9060976
Aug 06, 2022
9073933
Mar 30, 2025

DS

OXYCODONE HYDROCHLORIDE - OXYCONTIN


N 022272 006
9060976
Aug 06, 2022
9073933
Mar 30, 2025

DS

OXYCODONE HYDROCHLORIDE - OXYCONTIN


N 022272 007
9060976
Aug 06, 2022
9073933
Mar 30, 2025

DS

EXCLUSIVITY
CODE(S)

EXCLUSIVITY

EXPIRATION

DATE

DP

M-153
NPP

Apr 16, 2016


Aug 13, 2018

DP

M-153
NPP

Apr 16, 2016


Aug 13, 2018

DP

M-153
NPP

Apr 16, 2016


Aug 13, 2018

DP

M-153
NPP

Apr 16, 2016


Aug 13, 2018

DP

M-153
NPP

Apr 16, 2016


Aug 13, 2018

DP

M-153
NPP

Apr 16, 2016


Aug 13, 2018

DP

M-153
NPP

Apr 16, 2016


Aug 13, 2018

NCE

Feb 03, 2020

NCE

Feb 03, 2020

NCE

Feb 03, 2020

NP

May 18, 2018

PACLITAXEL - ABRAXANE
N 021660 001
9101543

Feb 21, 2026

PALBOCICLIB - IBRANCE
N 207103 001
6936612
7208489
7456168

Jan 22, 2023


Jan 16, 2023
Jan 16, 2023

DS DP
DS DP

PALBOCICLIB - IBRANCE
N 207103 002
6936612
7208489
7456168

Jan 22, 2023


Jan 16, 2023
Jan 16, 2023

DS DP
DS DP

PALBOCICLIB - IBRANCE
N 207103 003
6936612
7208489
7456168

Jan 22, 2023


Jan 16, 2023
Jan 16, 2023

DS DP
DS DP

PALIPERIDONE PALMITATE - INVEGA TRINZA


N 207946 001
6077843
May 12, 2017
6077843*PED
Nov 12, 2017

PATENT
DELIST
REQUESTED

U-1434

U-1658

U-1658

U-1658

DP U-543

A - 47

PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 10 - October 2015
See List footnote for information regarding List content
APPL/PROD
NO

PATENT
EXPIRATION
DATE

PATENT NO

PATENT
CODES

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY

EXPIRATION

DATE

PALIPERIDONE PALMITATE - INVEGA TRINZA


N 207946 002
6077843
May 12, 2017
6077843*PED
Nov 12, 2017

DP U-543

NP

May 18, 2018

PALIPERIDONE PALMITATE - INVEGA TRINZA


N 207946 003
6077843
May 12, 2017
6077843*PED
Nov 12, 2017

DP U-543

NP

May 18, 2018

PALIPERIDONE PALMITATE - INVEGA TRINZA


N 207946 004
6077843
May 12, 2017
6077843*PED
Nov 12, 2017

DP U-543

NP

May 18, 2018

PALONOSETRON HYDROCHLORIDE - ALOXI


N 021372 001
9066980
9125905
>A> 9173942

Jan 30, 2024


Jan 30, 2024
Jan 30, 2024

DP U-528
DP
DP

PALONOSETRON HYDROCHLORIDE - ALOXI


N 021372 002
9125905
>A> 9173942

Jan 30, 2024


Jan 30, 2024

DP
DP

PANOBINOSTAT LACTATE - FARYDAK


N 205353 001
6552065
6833384
7067551
7989494
8883842

Aug
Sep
Aug
Jan
Jun

31,
30,
31,
17,
13,

2021
2021
2021
2028
2028

DS DP
DS DP U-1669
U-1669
DS DP
U-1669

NCE
ODE

Feb 23, 2020


Feb 23, 2022

PANOBINOSTAT LACTATE - FARYDAK


N 205353 002
6552065
6833384
7067551
7989494
8883842

Aug
Sep
Aug
Jan
Jun

31,
30,
31,
17,
13,

2021
2021
2021
2028
2028

DS DP
DS DP U-1669
U-1669
DS DP
U-1669

NCE
ODE

Feb 23, 2020


Feb 23, 2022

PANOBINOSTAT LACTATE - FARYDAK


N 205353 003
6552065
6833384
7067551
7989494
8883842

Aug
Sep
Aug
Jan
Jun

31,
30,
31,
17,
13,

2021
2021
2021
2028
2028

DS DP
DS DP U-1669
U-1669
DS DP
U-1669

NCE
ODE

Feb 23, 2020


Feb 23, 2022

PAROXETINE MESYLATE - BRISDELLE


N 204516 001
8946251

Aug 04, 2026

PATIROMER SORBITEX CALCIUM - VELTASSA


N 205739 001

>A> NCE

Oct 21, 2020

PATIROMER SORBITEX CALCIUM - VELTASSA


N 205739 002

>A> NCE

Oct 21, 2020

PATIROMER SORBITEX CALCIUM - VELTASSA


N 205739 003

>A> NCE

Oct 21, 2020

DS DP U-904

PERAMPANEL - FYCOMPA
N 202834 001

I-710

Jun 19, 2018

PERAMPANEL - FYCOMPA
N 202834 002

I-710

Jun 19, 2018

A - 48

PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 10 - October 2015
See List footnote for information regarding List content
APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY

EXPIRATION

DATE

PERAMPANEL - FYCOMPA
N 202834 003

I-710

Jun 19, 2018

PERAMPANEL - FYCOMPA
N 202834 004

I-710

Jun 19, 2018

PERAMPANEL - FYCOMPA
N 202834 005

I-710

Jun 19, 2018

PERAMPANEL - FYCOMPA
N 202834 006

I-710

Jun 19, 2018

POMALIDOMIDE - POMALYST
N 204026 001

I-707

Apr 23, 2018

POMALIDOMIDE - POMALYST
N 204026 002

I-707

Apr 23, 2018

POMALIDOMIDE - POMALYST
N 204026 003

I-707

Apr 23, 2018

POMALIDOMIDE - POMALYST
N 204026 004

I-707

Apr 23, 2018

PHENTERMINE HYDROCHLORIDE; TOPIRAMATE - QSYMIA


N 022580 001
9011905
Jun 09, 2028
9011906
Jun 09, 2028

DP

PHENTERMINE HYDROCHLORIDE; TOPIRAMATE - QSYMIA


N 022580 002
9011905
Jun 09, 2028
9011906
Jun 09, 2028

DP

PHENTERMINE HYDROCHLORIDE; TOPIRAMATE - QSYMIA


N 022580 003
9011905
Jun 09, 2028
9011906
Jun 09, 2028

DP

PHENTERMINE HYDROCHLORIDE; TOPIRAMATE - QSYMIA


N 022580 004
9011905
Jun 09, 2028
9011906
Jun 09, 2028

DP

U-1262

U-1262

U-1262

U-1262

PIRFENIDONE - ESBRIET
N 022535 001
7696236

Dec 18, 2027

U-1601

POLIDOCANOL - VARITHENA
N 205098 001
RE40640

Oct 14, 2016

DS DP U-1462

PONATINIB HYDROCHLORIDE - ICLUSIG


N 203469 001
9029533
9029533
9029533
9029533
9029533

Dec
Dec
Dec
Dec
Dec

22,
22,
22,
22,
22,

2026
2026
2026
2026
2026

U-836
U-1283
U-1699
U-1700
U-1701

PONATINIB HYDROCHLORIDE - ICLUSIG


N 203469 002
9029533
9029533
9029533
9029533
9029533

Dec
Dec
Dec
Dec
Dec

22,
22,
22,
22,
22,

2026
2026
2026
2026
2026

U-836
U-1283
U-1699
U-1700
U-1701

A - 49

PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 10 - October 2015
See List footnote for information regarding List content
APPL/PROD
NO

PATENT NO

PATENT

EXPIRATION
DATE

PATENT

CODES

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY

EXPIRATION

DATE

PONATINIB HYDROCHLORIDE - ICLUSIG



N 203469 003
9029533
9029533
9029533
9029533
9029533

Dec
Dec
Dec
Dec
Dec

2026
2026
2026
2026
2026

U-836

U-1283

U-1699

U-1700

U-1701

POSACONAZOLE - NOXAFIL

N 205596 001
9023790

Jul 04, 2031

DP U-1698

PREDNISONE - RAYOS

N 202020 001
9040085

Apr 23, 2024

U-1362

PREDNISONE - RAYOS

N 202020 002
9040085

Apr 23, 2024

U-1362

PREDNISONE - RAYOS

N 202020 003
9040085

Apr 23, 2024

U-1362

REGADENOSON - LEXISCAN

N 022161 001
9045519
9085601

Jun 22, 2019


Feb 02, 2027

DP

DP

REGORAFENIB - STIVARGA

N 203085 001
8637553
8680124

Feb 16, 2031


Jun 02, 2030

DS DP

RIFAXIMIN - XIFAXAN

N 022554 001
6861053
6861053
7452857
7452857
7605240
7605240
7718608
7718608
7915275
7915275
7935799
7935799
8193196
8193196
8309569
8309569
8741904
8741904
8741904
8946252
8969398

Aug
Aug
Aug
Aug
Aug
Aug
Aug
Aug
Feb
Feb
Aug
Aug
Sep
Sep
Jul
Jul
Feb
Feb
Feb
Jul
Oct

2019
2019
2019
2019
2019
2019
2019
2019
2025
2025
2019
2019
2027
2027
2029
2029
2026
2026
2026
2029
2029

U-1707

U-1708

U-1707

U-1708

U-1707

U-1708

U-1707

U-1708

U-1707

U-1708

U-1707

U-1708

DS DP U-1707

DS DP U-1708

U-1707

U-1708

DS
U-1526

DS
U-1707

DS
U-1708

U-1481

U-1481

I-709

May 27, 2018


RILPIVIRINE HYDROCHLORIDE - EDURANT



N 202022 001 >A> 7125879
Aug 09, 2022
>A> 7125879
Aug 09, 2022
>A> 7125879
Aug 09, 2022

DS DP U-1153

DS DP U-1307

DS DP U-1740

NPP

Aug 26, 2018


RISEDRONATE SODIUM - RISEDRONATE SODIUM


A 077132 001

PC

Nov 28, 2015

RISEDRONATE SODIUM - RISEDRONATE SODIUM


A 077132 002

PC

Nov 28, 2015

22,
22,
22,
22,
22,

11,
11,
11,
11,
11,
11,
11,
11,
23,
23,
11,
11,
02,
02,
18,
18,
27,
27,
27,
24,
02,

U-1506

A - 50

PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 10 - October 2015
See List footnote for information regarding List content
APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY

EXPIRATION

DATE

RISEDRONATE SODIUM - RISEDRONATE SODIUM


A 077132 003

PC

Nov 28, 2015

RIVASTIGMINE - RIVASTIGMINE
A 204403 003

PC

Feb 29, 2016

NCE

Sep 01, 2020

NCE

Jul 07, 2020

NCE

Jul 07, 2020

NCE

Jul 07, 2020

ROFLUMILAST - DALIRESP
N 022522 001
5712298

Jan 27, 2020

DS DP U-1115

ROLAPITANT HYDROCHLORIDE - VARUBI


N 206500 001
7049230
7563801
7981905
7981905
8178550
8361500
8404702
8470842
8796299

Dec
Apr
Apr
Apr
Apr
Oct
Oct
Jan
Dec

2023
2027
2027
2027
2027
2029
2029
2029
2022

DS DP U-1741
DP
U-1741
U-1742
DS DP
DP
U-1741
U-1741
U-1741

RUXOLITINIB PHOSPHATE - JAKAFI


N 202192 001
9079912
9079912

Dec 12, 2026


Dec 12, 2026

U-1573
U-1721

RUXOLITINIB PHOSPHATE - JAKAFI


N 202192 002
9079912
9079912

Dec 12, 2026


Dec 12, 2026

U-1573
U-1721

RUXOLITINIB PHOSPHATE - JAKAFI


N 202192 003
9079912
9079912

Dec 12, 2026


Dec 12, 2026

U-1573
U-1721

RUXOLITINIB PHOSPHATE - JAKAFI


N 202192 004
9079912
9079912

Dec 12, 2026


Dec 12, 2026

U-1573
U-1721

RUXOLITINIB PHOSPHATE - JAKAFI


N 202192 005
9079912
9079912

Dec 12, 2026


Dec 12, 2026

U-1573
U-1721

SACUBITRIL; VALSARTAN - ENTRESTO


N 207620 001
7468390
8101659
8404744
8796331
8877938

Nov
Jan
Jan
Jan
May

27,
14,
14,
14,
27,

2023
2023
2023
2023
2027

SACUBITRIL; VALSARTAN - ENTRESTO


N 207620 002
7468390
8101659
8404744
8796331
8877938

Nov
Jan
Jan
Jan
May

27,
14,
14,
14,
27,

2023
2023
2023
2023
2027

SACUBITRIL; VALSARTAN - ENTRESTO


N 207620 003
7468390
8101659
8404744
8796331
8877938

Nov
Jan
Jan
Jan
May

27,
14,
14,
14,
27,

2023
2023
2023
2023
2027

08,
04,
04,
04,
04,
09,
09,
18,
17,

DP
DP
DP
U-1723
DS DP

DP
DP
DP
U-1723
DS DP

DP
DP
DP
U-1723
DS DP

A - 51

PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 10 - October 2015
See List footnote for information regarding List content
APPL/PROD
NO

PATENT NO

SIMEPREVIR SODIUM - OLYSIO



N 205123 001
9040562

PATENT
EXPIRATION
DATE

Jul 28, 2026

PATENT
CODES

DS DP U-1467

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

>A> D-151
>A> I-717

EXCLUSIVITY

EXPIRATION

DATE

Oct 05, 2018



Oct 05, 2018

SIROLIMUS - RAPAMUNE

N 021083 001

ODE

May 28, 2022


SIROLIMUS - RAPAMUNE

N 021110 001

ODE

May 28, 2022


SIROLIMUS - RAPAMUNE

N 021110 002

ODE

May 28, 2022


SIROLIMUS - RAPAMUNE

N 021110 003

ODE

May 28, 2022


SIROLIMUS - RAPAMUNE

N 021110 004

ODE

May 28, 2022


NCE

Jul 24, 2020


SODIUM OXYBATE - XYREM



N 021196 001
8952062
8952062
9050302

Dec 22, 2019


Dec 22, 2019
Mar 15, 2033

U-1101

U-1102

U-1532

SOFOSBUVIR - SOVALDI

N 204671 001
9085573

Mar 21, 2028

DS DP U-1470

SOMATROPIN RECOMBINANT - NORDITROPIN FLEXPRO



N 021148 008
8920383
Jul 17, 2026
9108002
Jan 20, 2026
9132239
Feb 01, 2032

DP

DP

DP

SOMATROPIN RECOMBINANT - NORDITROPIN FLEXPRO



N 021148 009
8920383
Jul 17, 2026
9108002
Jan 20, 2026
9132239
Feb 01, 2032

DP

DP

DP

SOMATROPIN RECOMBINANT - NORDITROPIN FLEXPRO



N 021148 010
8920383
Jul 17, 2026
9108002
Jan 20, 2026
9132239
Feb 01, 2032

DP

DP

DP

SOMATROPIN RECOMBINANT - NORDITROPIN FLEXPRO



N 021148 011
5849700
Dec 15, 2015
5849704
Dec 15, 2015
6899699
Jan 02, 2022
7686786
Aug 03, 2026
8672898
Jan 02, 2022
8684969
Oct 20, 2025
8841252
Dec 26, 2017
8920383
Jul 17, 2026
9108002
Jan 20, 2026
9132239
Feb 01, 2032

U-1041

DS DP U-1041

DP

DP

DP

DP

DP

DP

DP

DP

SONIDEGIB PHOSPHATE - ODOMZO



N 205266 001
8063043
8178563

Sep 15, 2029


Feb 06, 2029

DS DP
DS
U-1722

SORAFENIB TOSYLATE - NEXAVAR



N 021923 001
8124630
8841330

Jan 12, 2020


Jan 12, 2020

U-1459

U-1696

A - 52

PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 10 - October 2015
See List footnote for information regarding List content
APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

SPINOSAD - NATROBA

N 022408 001
6063771

Jul 25, 2023

DP U-1670

SUMATRIPTAN SUCCINATE - ZECUITY



N 202278 001
8983594

Nov 19, 2030

DP U-1328

TACROLIMUS - ENVARSUS XR

N 206406 001
7994214
>A> 8486993
>A> 8586084
>A> 8591946
>A> 8617599
>A> 8623410
>A> 8623411
>A> 8664239
>A> 8685998
>A> 8889185
>A> 8889186

Aug
Aug
Aug
Aug
Aug
Aug
Aug
May
May
Aug
Aug

30,
30,
30,
30,
30,
30,
30,
30,
30,
30,
30,

2024
2024
2024
2024
2024
2024
2024
2028
2028
2024
2024

TACROLIMUS - ENVARSUS XR

N 206406 002
7994214
>A> 8486993
>A> 8586084
>A> 8591946
>A> 8617599
>A> 8623410
>A> 8623411
>A> 8664239
>A> 8685998
>A> 8889185
>A> 8889186

Aug
Aug
Aug
Aug
Aug
Aug
Aug
May
May
Aug
Aug

30,
30,
30,
30,
30,
30,
30,
30,
30,
30,
30,

TACROLIMUS - ENVARSUS XR

N 206406 003
7994214
>A> 8486993
>A> 8586084
>A> 8591946
>A> 8617599
>A> 8623410
>A> 8623411
>A> 8664239
>A> 8685998
>A> 8889185
>A> 8889186

Aug
Aug
Aug
Aug
Aug
Aug
Aug
May
May
Aug
Aug

30,
30,
30,
30,
30,
30,
30,
30,
30,
30,
30,

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY

EXPIRATION

DATE

M-152

Nov 30, 2017


DP
DP U-1752

U-1752

DP

DP

DP

U-1752

U-1752

DP U-1752

U-1752

U-1752

ODE

Jul 10, 2022


2024
2024
2024
2024
2024
2024
2024
2028
2028
2024
2024

DP
DP U-1752

U-1752

DP

DP

DP

U-1752

U-1752

DP U-1752

U-1752

U-1752

ODE

Jul 10, 2022


2024
2024
2024
2024
2024
2024
2024
2028
2028
2024
2024

DP
DP U-1752

U-1752

DP

DP

DP

U-1752

U-1752

DP U-1752

U-1752

U-1752

ODE

Jul 10, 2022


TAPENTADOL HYDROCHLORIDE - NUCYNTA ER



N 200533 001
8536130
Sep 22, 2028

U-1739

TAPENTADOL HYDROCHLORIDE - NUCYNTA ER



N 200533 002
8536130
Sep 22, 2028

U-1739

TAPENTADOL HYDROCHLORIDE - NUCYNTA ER



N 200533 003
8536130
Sep 22, 2028

U-1739

TAPENTADOL HYDROCHLORIDE - NUCYNTA ER



N 200533 004
8536130
Sep 22, 2028

U-1739

TAPENTADOL HYDROCHLORIDE - NUCYNTA ER



N 200533 005
8536130
Sep 22, 2028

U-1739

TASIMELTEON - HETLIOZ

N 205677 001
9060995

U-1710

Jan 25, 2033

A - 53

PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 10 - October 2015
See List footnote for information regarding List content
APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

TEDUGLUTIDE RECOMBINANT - GATTEX KIT


N 203441 001
5789379
Apr 14, 2016
9060992
Nov 01, 2025

PATENT
CODES

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

DS DP U-1320
U-1320

TESTOSTERONE - ANDROGEL
N 021015 001
9125816
9132089

Aug 30, 2020


Aug 30, 2020

U-490
U-490

TESTOSTERONE - ANDROGEL
N 021015 002
9125816
9132089

Aug 30, 2020


Aug 30, 2020

U-490
U-490

TESTOSTERONE - ANDROGEL
N 021015 003
9125816
9132089

Aug 30, 2020


Aug 30, 2020

U-490
U-490

TESTOSTERONE - ANDROGEL
N 022309 001
9125816
9132089

Aug 30, 2020


Aug 30, 2020

U-1103
U-1103

TESTOSTERONE - ANDROGEL
N 022309 002
9125816
9132089

Aug 30, 2020


Aug 30, 2020

U-1103
U-1103

TESTOSTERONE - ANDROGEL
N 022309 003
9125816
9132089

Aug 30, 2020


Aug 30, 2020

U-1103
U-1103

TESTOSTERONE - AXIRON
N 022504 001
8435944
8993520

Sep 27, 2027


Jun 02, 2026

U-1390
U-1390

TICAGRELOR - BRILINTA
N 022433 001

I-714

TICAGRELOR - BRILINTA
N 022433 002
6251910
6525060
7250419
7265124
>A> 8425934

Jul
Dec
Dec
Jul
Apr

TIGECYCLINE - TYGACIL
N 021821 001
8975242

Oct 24, 2028

DP

TIOTROPIUM BROMIDE - SPIRIVA RESPIMAT


N 021936 001
8733341
Dec 16, 2029
9027967
Mar 31, 2027

DP
DP

TIOTROPIUM BROMIDE - SPIRIVA RESPIMAT


N 021936 002
5964416
Oct
6149054
Dec
6176442
May
6453795
Dec
6726124
Oct
6846413
Aug
6977042
Aug
6988496
Feb
7104470
Oct
7246615
May
7284474
Aug
7396341
Oct
7802568
Feb

DP
DP
DP
DP
DP
DP
DP
DP
DP
DP
DP
DP
DP

15,
02,
02,
09,
17,

04,
16,
31,
05,
04,
28,
28,
23,
04,
31,
26,
10,
26,

2018
2019
2019
2021
2030

2016
2016
2016
2016
2016
2018
2018
2020
2016
2016
2024
2026
2019

EXCLUSIVITY

EXPIRATION

DATE

DS
DS DP U-1171
DS DP U-1171
DS DP U-1171
DP

>A> NCE
NS

NP

Sep 03, 2018

Jul 20, 2016


Sep 03, 2018

Sep 15, 2018

A - 54

PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 10 - October 2015
See List footnote for information regarding List content
APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY

EXPIRATION

DATE

TIOTROPIUM BROMIDE - SPIRIVA RESPIMAT


N 021936 002
7837235
Mar
7896264
May
7988001
Aug
8733341
Dec
9027967
Mar
RE39820
Jan

13,
26,
04,
16,
31,
30,

TIPIRACIL HYDROCHLORIDE; TRIFLURIDINE N 207981 001 >A> 5744475


Mar
>A> 6479500
Mar
>A> 7799783
Dec

LONSURF
28, 2016
16, 2020
16, 2026

DS DP U-1751
U-1751
U-1751

NCE

Sep 22, 2020

TIPIRACIL HYDROCHLORIDE; TRIFLURIDINE N 207981 002 >A> 5744475


Mar
>A> 6479500
Mar
>A> 7799783
Dec

LONSURF
28, 2016
16, 2020
16, 2026

DS DP U-1751
U-1751
U-1751

NCE

Sep 22, 2020

TOPIRAMATE - TROKENDI XR
N 201635 001
8298576
8992989

Apr 04, 2028


Nov 16, 2027

DP U-106
DP U-1675

TOPIRAMATE - TROKENDI XR
N 201635 002
8298576
8992989

Apr 04, 2028


Nov 16, 2027

DP U-106
DP U-1675

TOPIRAMATE - TROKENDI XR
N 201635 003
8298576
8992989

Apr 04, 2028


Nov 16, 2027

DP U-106
DP U-1675

TOPIRAMATE - TROKENDI XR
N 201635 004
8298576
8992989

Apr 04, 2028


Nov 16, 2027

DP U-106
DP U-1675

TOPIRAMATE - QUDEXY XR
N 205122 001
9101545

Mar 19, 2033

DP

TOPIRAMATE - QUDEXY XR
N 205122 002
9101545

Mar 19, 2033

DP

TOPIRAMATE - QUDEXY XR
N 205122 003
9101545

Mar 19, 2033

DP

TOPIRAMATE - QUDEXY XR
N 205122 004
9101545

Mar 19, 2033

DP

TOPIRAMATE - QUDEXY XR
N 205122 005
9101545

Mar 19, 2033

DP

>A> NCE

Oct 23, 2020

2028
2025
2021
2029
2027
2018

DP
DP
DP
DP
DP
DS DP

TRABECTEDIN - YONDELIS
N 207953 001
TRAMETINIB DIMETHYL SULFOXIDE - MEKINIST
N 204114 001
8703781
Oct 15, 2030

DS DP U-1712

TRAMETINIB DIMETHYL SULFOXIDE - MEKINIST


N 204114 002
8703781
Oct 15, 2030

DS DP U-1712

TRAMETINIB DIMETHYL SULFOXIDE - MEKINIST


N 204114 003
8703781
Oct 15, 2030

DS DP U-1712

A - 55

PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 10 - October 2015
See List footnote for information regarding List content
APPL/PROD
NO

PATENT
EXPIRATION
DATE

PATENT NO

TRANEXAMIC ACID - LYSTEDA


N 022430 001
8957113
9060939

PATENT
CODES

Mar 04, 2025


Mar 04, 2025

DP U-1182
DP

Oct 10, 2029


Mar 13, 2029

DP
DP

TRAZODONE HYDROCHLORIDE - DESYREL


N 018207 001
8133893

Mar 13, 2029

DS DP

TRAZODONE HYDROCHLORIDE - DESYREL


N 018207 002
8133893

Mar 13, 2029

DS DP

TRAZODONE HYDROCHLORIDE - DESYREL


N 018207 003
8133893

Mar 13, 2029

DS DP

TRAZODONE HYDROCHLORIDE - DESYREL


N 018207 004
8133893

Mar 13, 2029

DS DP

TREPROSTINIL DIOLAMINE - ORENITRAM


N 203496 001
7417070
9050311

Jul 30, 2026


May 24, 2024

DS
DS DP

TREPROSTINIL DIOLAMINE - ORENITRAM


N 203496 002
7417070
9050311

Jul 30, 2026


May 24, 2024

DS
DS DP

TREPROSTINIL DIOLAMINE - ORENITRAM


N 203496 003
7417070
9050311

Jul 30, 2026


May 24, 2024

DS
DS DP

TREPROSTINIL DIOLAMINE - ORENITRAM


N 203496 004
7417070
9050311

Jul 30, 2026


May 24, 2024

DS
DS DP

TRETINOIN - RETIN-A-MICRO
N 020475 003
5955109

Sep 21, 2016

DP U-134

ULIPRISTAL ACETATE - ELLA


N 022474 001 >A> 8512745
8962603

Jun 02, 2030


Jun 12, 2030

DP

TRAVOPROST - IZBA
N 204822 001

8178582
9144561

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY

EXPIRATION

DATE

U-1657

UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE - ANORO ELLIPTA


N 203975 001
8511304
Jun 14, 2027
DP U-1476
URIDINE TRIACETATE - XURIDEN
N 208169 001 >A> 6258795

Jul 10, 2018

VALGANCICLOVIR HYDROCHLORIDE - VALCYTE


N 021304 001

VALGANCICLOVIR HYDROCHLORIDE - VALCYTE


N 022257 001

VILAZODONE HYDROCHLORIDE - VIIBRYD


N 022567 001

DP

NCE
ODE

Sep 04, 2020


Sep 04, 2022

D-148
NPP

Apr 23, 2018


Apr 23, 2018

D-148
NPP

Apr 23, 2018


Apr 23, 2018

D-146

Mar 16, 2018

A - 56

PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 10 - October 2015
See List footnote for information regarding List content
APPL/PROD
NO

PATENT NO

PATENT
EXPIRATION
DATE

PATENT
CODES

PATENT
DELIST
REQUESTED

EXCLUSIVITY
CODE(S)

EXCLUSIVITY

EXPIRATION

DATE

VILAZODONE HYDROCHLORIDE - VIIBRYD


N 022567 002

D-146

Mar 16, 2018

VILAZODONE HYDROCHLORIDE - VIIBRYD


N 022567 003

D-146

Mar 16, 2018

ZOLMITRIPTAN - ZOMIG
N 021450 003

NPP

Jun 12, 2018

ZOLMITRIPTAN - ZOMIG
N 021450 004

NPP

Jun 12, 2018

VORTIOXETINE HYDROBROMIDE - BRINTELLIX


N 204447 001
8722684
Jun 30, 2031
8969355
Jun 15, 2027

DS DP

VORTIOXETINE HYDROBROMIDE - BRINTELLIX


N 204447 002
8722684
Jun 30, 2031
8969355
Jun 15, 2027

DS DP

VORTIOXETINE HYDROBROMIDE - BRINTELLIX


N 204447 003
8722684
Jun 30, 2031
8969355
Jun 15, 2027

DS DP

VORTIOXETINE HYDROBROMIDE - BRINTELLIX


N 204447 004
8722684
Jun 30, 2031
8969355
Jun 15, 2027

DS DP

U-1668

U-1668

U-1668

U-1668

Footnote:
1. Patents are published upon receipt by the Orange book Staff and may not reflect the official receipt date as

described in 21 CFR 314.53(d)(5).

2. Patents listed prior to August 18, 2003 are flagged with method of use claims only as applicable and

submitted by the sponsor. They may not be flagged with respect to other claims which may apply.

B-1

PATENT AND EXCLUSIVITY TERMS


Due to space limitations in the patent and exclusivity columns,
abbreviations and references have been developed. Refer to the APPROVED DRUG
PRODUCTS WITH THERAPEUTIC EQUIVALENCE EVALUATIONS, 35h Edition for a full listing of
patent and exclusivity terms (Abbreviations, Dosing Schedule, Indications,
and Patent Use Codes).
The current complete list of patent terms is available at
http://www.accessdata.fda.gov/scripts/cder/ob/docs/pattermsall.cfm

The current complete list of exclusivity terms is available at


http://www.accessdata.fda.gov/scripts/cder/ob/docs/excltermsall.cfm

S-ar putea să vă placă și