Email Worksheet

The application form has six parts: 1) General

Information, 2) Establishment Information, 3) Product SUBJECT:
Information, 4) Supporting Information, 5) Sources and
Clients, and 6) Applicant Information. In the worksheet
'Form' (with the red tab) you will see a dashboard
where the different parts are identified. If the part is
appropriately filled up, a green 'PROCEED' will be
indicated.Required fields will appear sequentially.To BODY:
minimize errors and confusion, it is recommended that
a blank form be used for every application. If the form
is appropriately filled up, the composed body text (in
the green box) will appear.
Be careful to paste the body text completely as text
(not as an image or as an attachment). DON'T attach
any file to the email request. Printing Instructions
(Please print the following parts of the worksheet 'Form
For Drug Registration (excluding amendmen
For Non-Drug Registration (excluding amendmen
For Licensing (exclusing amendmen
For A

Application Process Overview

 IMPORTANT

READ THIS PAGE CAREFULLY.

Provide information only
when asked for.

of the worksheet 'Form' if applicable)

on (excluding amendments and compliances): pages 1 and 4.
on (excluding amendments and compliances): pages 1 and 3.
ng (exclusing amendments and compliances): pages 1 and 2.
For All Other Applications: page 1 only.
 APPLICATION FORM 5 SOURCES & CLIENTS

This is the application form. Without the

appropriate petition or declaration form, this
application may be rejected.
Document Tracking Number APPLICATION FORM STATUS
GENERAL INFORMATION:
ESTABLISHMENT INFORMATION:
Description (Optional): PRODUCT INFORMATION:
SUPPORTING INFORMATION:
1 GENERAL INFORMATION SOURCES & CLIENTS:
APPLICANT INFORMATION:
1.1 Product Center:

This form was last edited on 13 October 2016, 10:28 AM.


Off-white to beige, semi biconvex film-
CLOPIDOGREL (as BISULFATE) coated tablet with score on one side and
plain on the other side
Provide in this space a description of the
product in terms of rheology, thermal, Use this space to explain how the lot code
and geometry properties among others, used on the product label is correctly
as applicable; Indicate if appropriate interpreted
microbiological cultures present in the
product
CLOPIDOGREL (AS BISULFATE)
2) Active Pharmaceutical Ingredient;
3) Active Pharmaceutical Ingredient;
4) Active Pharmaceutical Ingredient;
5) Active Pharmaceutical Ingredient;
6) Active Pharmaceutical Ingredient;
7) Active Pharmaceutical Ingredient;
8) Active Pharmaceutical Ingredient;
9) Active Pharmaceutical Ingredient;
10) Active Pharmaceutical Ingredient;
11) Active Pharmaceutical Ingredient;
12) Active Pharmaceutical Ingredient;
NINBO BEITONG IMP. & EXP. CO. LTD., INDIA
2) API Manufacturer, Address Address Address;
3) API Manufacturer, Address Address Address;
4) API Manufacturer, Address Address Address;
5) API Manufacturer, Address Address Address;
6) API Manufacturer, Address Address Address;
7) API Manufacturer, Address Address Address;
8) API Manufacturer, Address Address Address;
9) API Manufacturer, Address Address Address;
10) API Manufacturer, Address Address Address;
11) API Manufacturer, Address Address Address;
12) API Manufacturer, Address Address Address;
KAMAGONG CHEMTRADE CORP./SAN PEDRO LAGUNA
2) API Supplier, Address Address Address;
3) API Supplier, Address Address Address;
4) API Supplier, Address Address Address;
5) API Supplier, Address Address Address;
6) API Supplier, Address Address Address;
7) API Supplier, Address Address Address;
8) API Supplier, Address Address Address;
9) API Supplier, Address Address Address;
10) API Supplier, Address Address Address;
11) API Supplier, Address Address Address;
12) API Supplier, Address Address Address;
 Department of Health
Food and Drug Administration
APPLICATION FORM STATUS: APPLICATION FORM 1
GENERAL INFORMATION: 0 0 0 0 0 0 0 SOURCES & CLIENTS: 0 1 0 1
ESTABLISHMENT INFORMATION: 0 0 0 0 1 Document Tracking Number 1 1
PRODUCT INFORMATION: 0 0 0 0 1 0 0 1 1
SUPPORTING INFORMATION: 0 1 0 0 0 0 0 1 1 1 1
APPLICANT INFORMATION: 0 0 0 0 Description (Optional):
PAYMENT INFORMATION: 0 0 0
GENERAL INFORMATION 1 1

1.1 Product Center: 0 1

1 1
0
1
0 1 1 1
1
1
1 1
0 1
30-Dec-1899 1
1 1
1
1
0 1 1
30-Dec-1899 1
0
0 1 1 1
0 0 1
0 0 0 1
1 1
1

0 1 1 1
0
1 1 1
Drug 1 0 HUHS 1 1
0 0 Food 0 Device 1 1
1 1
1 1 1
1 1
0 1 1 1
0 0
None 0 None 0
1 1

0 0
0 1 1
1 0
0
1 1 0 1 1
Type of Amendment: Other Amendments 0 0 1 1
Source: Add/ Delete FAL 0 License to Operate FAL 0 0 1 1
Source: Change of B FAL 0 Reclassification FAL 0 0 0 1 0 1
Change of Importer/ FAL 0 0 Change of DistributorFAL 0 0 0 01 1 01 1
TR 1 Finished Product FAL 0 Php -
None 0 None 0
FAL 0 Raw Material FAL 0
1 Free Sale, Certificate FAL 0 1 1 1
Pharmaceutical Produc FAL 0
Export Certificate FAL 0 0
Additional Productio FAL 0 0 1 1 1
1

1 1
1 1
1 1
0 1 0 1
This is the application form. Without the appropriate petition 01 1 01 1
or declaration form, this application may be rejected.
None 0 None 0
1 1

1 1

1 1
1 1
1 1
0 1 0 1
01 1 01 1
1
None 0 None 0
1
1 1 1
1
1
1 0 1 1 1
1
1 0 1
1 1 1
1 0 1 1 1
1 1
0 1 0 1
01 1 01 1
None 0 None 0
1 1
1
1
1 1 1
1
1
1 0 1 1 1
1 1 1
1 0 1 1 1
1 0 1 0 1
1 0 1 01 1 01 1

Page 12 of 19 441624475.xls 10/12/2019 03:05:03

 Department of Health
Food and Drug Administration
APPLICATION FORM

Page 13 of 19 441624475.xls 10/12/2019 03:05:03

 Department of Health
Food and Drug Administration
APPLICATION FORM

Page 14 of 19 441624475.xls 10/12/2019 03:05:03

 Department of Health
Food and Drug Administration
APPLICATION FORM

Page 15 of 19 441624475.xls 10/12/2019 03:05:03

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 APPLOTHER REQUEST PAYMENT DETAILS
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