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LIST OF APPROVED DRUG FROM 01.01.2011 TO 30.06.2011
S.No Name Of Drug Alpha Lipoic Acid USP 100mg + Methylcobalamin 1500mcg + Vitamin B6 IP 3mg + Folic Acid IP 1.5mg + Benfotiamine 50mg + Biotin USP 5mg + Chromium Picolinate USP Eq. to Chromuim 200mcg Capsule Ropinirole ER Tablet 1 mg. (Additional Strength) Indication Date of issue

1.

For the treatment of diabetic neuropathy

03.01.11

2.

Same as approved Monotherapy for the Maintenance Treatment of Patients with locally advanced metastatic non-small lung cancer whose disease has not progressed after four cycles of Platinum based First Line Chemotherapy. For the reduction of post operative inflammatory conditions of the eye

04.01.11

3.

Erlotinib HCl Tablet 150 mg (Additional Indication)

04.01.11

4.

Moxifloxacin HCl BP 0.5% w/v + Bromfenac Sodium 0.09% w/v Eye drop Ferrous Ascorbate 100mg + Folic Acid IP 1.5mg + Cyanocobalamin IP 15mcg + Zinc Sulphate Monohydrate Eq. to Elemental Zinc 22.5mg Tablet S (+) Etodolac 300mg +Thiocolchicoside 8mg Tablet

05.01.11

5.

For the treatment of iron deficiency anaemia

05.01.11

6.

For the treatment of patients with acute painful musculoskeletal conditions

05.01.11

7.

Beclomethasone Dipropionate IP 100mcg + Formoterol Fumarate Dihydrate BP Eq. to Formoterol Fumarate 6 mcg Metered Dose Inhaler Amlodipine Besilate IP Eq. to Amlodipine 5mg + Indapamide USP SR 1.5mg Tablet Metformin HCl IP 500mg + Alpha Lipoic Acid USP 200mg Tablet Spironolactone IP 25mg Furosemide IP 40mg Tablet +

For the treatment of bronchial asthma where use of inhaled corticosteroid therapy found appropriate For the treatment of mild to moderate hypertension For the treatment of patients with diabetic polyneuropathy Additional strength Indicated either alone or as adjuvant to radical Prostatetomy or radiotherapy in Patients with Locally advanced Prostate cancer at High risk for disease Progression. Same as approved

05.01.11

8.

05.01.11

9.

05.01.11

10.

05.01.11

11.

Bicalutamide mg.(Additional Indication)

Tablet Strength

150 and

05.01.11

12.

Paracetamol Chewable Tablet 500 mg. ( Additional Dosage Form) Methylcobalamin 500mcg + Folic Acid IP 1.5mg + Zinc Sulphate IP 25mg + Chromium Polynicotinate 200mcg + Selenium as Sodium Selenite USP 65 mcg + Inositol 100mg + Alpha Lipoic Acid 50mg + Streptococcus faecalis 30 Millions (30 lakh) + Clostridium butyricum 2 Million (20 lakh) + Bacillus mesentericus 1 Million (10 lakh) + Lactic acid bacillus 50 Million (500lakh) Capsule Dextromethorphan Extended Release Oral Suspension 30 mg per 5 ml Hydroquinone USP 2% w/w + Tretinoin USP 0.025% w/w + Allantoin USP 1%w/w Gel

05.01.11

13.

For Vitamins and Minerals deficiency states in adult patients

11.01.11

14.

For the Relief of Persistent Dry irritating cough in adult patients Only. For treatment of pigmentry disorders hyper

17.01.11

15.

31.01.11

16.

Paracetamol Fast Release Tablet 500mg (Additional Dosage Form) Each bowel contains: preparatory kit

Same as approved

10.02.11

17.

One enteric coated tablet Biscodyl IP 5mg & One sachet of powder for reconstitution contains: Polyethylene glycol 3350NF: 210gm + Sodium Bicarbonate IP 2.86gm + Sodium Chloride IP 5.6gm + Potassium Chloride IP 0.74gm Ferric Carboxymaltose equivalent to elemental Iron50mg/ml Injection Pidotimod Tablet 400 mg/800 mg & Oral Solution 400 mg/800 mg per 7ml Ursodeoxycholic Acid Suspension 125mg/5ml and 250 mg /5ml. Iloperidone Tablets 1mg/2mg/4mg/6mg/8mg /10mg/12mg Calf lung surfactant Intratracheal Suspension containing Phospholipids.... 35mg (containing 26 mg phosphatidylcholine of which 16mg is disaturated phosphatidylcholine) Proteins....0.65mg (including 0.26mg of surfactant associated proteins B) per ml

For bowel cleansing prior to colonoscopy in adult patients only

11.02.11

18.

For the treatment of iron deficiency in adults when oral iron preparations are ineffective or cannot be used. For infections of the respiratory system in secondary and primary immunodeficiency with alteration in maturation of T cells in adults only. For the treatment of patients with chronic cholestatic liver disease. For the acute treatment of adults with schizophrenia. (a). As a prophylaxis therapy for premature infants <29 weeks of gestational age at significant risk for Respiratory Distress Syndrome (RDS). (b). For the treatment of infants <72 hours of age with RDS (confirmed by clinical and radiologic findings) and requiring endotrachteal intubation.

11.02.11

19.

11.02.11

20.

11.02.11

21.

17.02.11

22.

17.02.11

23.

Baclofen ER Capsule 10 mg/50 mg. (Additional Strength) Dexketoprofen Trometamol ER Tablet 50 mg (Additional Strength) Gatifloxacin Eye drop 5 mg/ml

Same as approved

17.02.11

24.

Same as approved For the treatment of bacterial conjunctivitis caused by susceptible strains Advanced squmous cell carcinoma of Head and Neck SCCHN: 1. Diagnosed but unrectable locally advanced SCCHN 2. Recurrent SCCHN, if surgery or radiation is not feasible. 3. Palliative treatment metastatic SCCHN. of

21.02.11

25.

21.02.11

26.

Paclitaxel Injection 30mg/100 mg/300 mg (additional Indication)

24.02.11

27.

Eslicarbazepine Acetate Tablets 200mg/400mg/600mg/800mg Ketoprofen Plaster ( Size - 7cm x 10 cm) Meropenem IP 1000mg + Sulbactam sodium USP 500mg injection Dasatinib 20mg/50mg/70mg (Additional Indication)

As an adjunctive therapy in adults with partial-onset seizures with or without secondary generalisation. For the Relief Musculoskeletal pain Inflammation. of and

07.03.11

28.

09.03.11

29.

For the treatment of lower respiratory tract infection caused by gram negative bacteria in adults only Treatment of newly Diagnosed Adults with Chronic Myeloid Leukaemia (CML) in Chronic Phase.

15.03.11

30.

16.03.11

31.

Adenosylcobalamin 15mcg + Ferrous Ascorbate 100mg + Folic Acid IP 1.5mg + Zinc Sulphate USP Eq. to Elemental Zinc 22.5mg tablet Tioconazole Vaginal Gel 65mg per gm Aspirin (EC Tablets) 75mg/75mg/150mg +Rosuvastatin (Granules) 5mg/10mg/10mg Capsules

For the treatment of iron deficiency anaemia in adults only For the local treatment of vulvo vaginal candidiasis in adult patients. For the treatment of dyslipidemia associated with arthersclerotic arterial disease with risk of Myocardial infarction, stroke or peripheral vascular disease. For the treatment of duodenal ulcer in adults only. For acute treatment of schizophrenia in adults only. For the Treatment of Lower and upper respiratory tract infection and Typhoid fever in adults only For relief of moderate to severe acute pain in adults 18 years of age or older. Same as approved

21.03.11

32.

22.03.11 30.03.11

33.

34. 35.

Ilaprazole Tablets 5mg/10mg Asenapine Maleate Sublingual Tablets 5mg/10mg Cefpodoxime IP 100mg/200mg +Ofloxacin IP 100mg/200mg Tablets Tapentadol Hydrochloride Tablets 50mg/75mg/100mg Cefixime Trihydrate IP Eq. to Anhydrous Cefixime 100mg/200mg + Ofloxacin IP 100mg/200mg Dispersible Tablet (Additional dosage form ) S-Bupivacaine Hydrochloride Injection 2.5mg/5mg/7.5mg per ml Dexketoprofen 50mg Dicyclomine 20mg per Injection + 2ml

05.04.11 07.04.11 16.04.11

36.

37.

18.04.11 20.04.11

38.

39.

For surgical anaesthesia in adults for epidural (including caesarean section), intrathecal, peripheral nerve block. For the treatment of acute colicky pain in adult patients

28.04.11

28.04.11

40.

41.

Gatifloxacin 0.3% + Loteprednol Etabonate 0.5% + Benzalkonium Chloride 0.01% w/v Opthalmic suspension

For Post-Operative Steroid repulsive inflammatory Ocular conditions when Ocular bacterial infections or a risk of bacterial infection exists For the treatment of acute arthritis (including attacks of gout), chronic arthritis especially rheumatoid arthritis (chronic polyarthritis), ankylosing spondylitis (Morbus Bechterew) and other inflammatory, rheumatoid syndromes of vertebral column. For the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma. For the treatment of bacterial conjunctivitis. Same as approved

19.05.11

42.

Diclofenac Colestyramine 145.6 mg corresponding to 75mg Diclofenac Sodium Capsules.

19.05.11

43.

Brinzolamide Suspension 1%w/v

Ophthalmic

26.05.11

44.

Besifloxacin Ophthalmic Suspension 0.6% w/v Diclofenac (as EC Tablets) 25mg + Paracetamol 325 mg Capsule (Additional Strength) Amlodipine 10mg/10mg+ Telmisartan 40mg/80mg Tablets (Additional Strength)

31.05.11 31.05.11

45.

31.05.11

46.

Same as approved 1. PROBIO : Each sachet (1g) contains: Total Probiotic.... Not less than 1.25 Billion CFU (Lactobacillus acidophilus, Lactobacillus rhamnosus, Bifidobacterium longum, Saccharomyces boulardii) 2. PROBIO & PREBIO (F)s For the treatment of rotavirus diarrhoea. 09.06.11

47.

Each sachet (1g) contains: Probio (CMP 5) Total Probiotic...Not less than 1.25 Billion CFU (Lactobacillus acidophilus, Lactobacillus rhamnosus, Bifidobacterium longum, Saccharomyces boulardii) Fructo Oligo Saccharides . 100mg 3. PROBIO & PREBIO (D) Each sachet (1.3g) contains: Probio (CMP 5) Total probiotic... not less than 1.25 billion CFU (Lactobacillus acidophilus, Lactobacillus rhamnosus, Bifidobacterium longum, Saccharomyces boulardii) Fructo Oligo Saccharides...1000mg

48.

Paracetamol 325mg + Tramadol Hydrochloride 37.5 mg Tablets

Additional indication. (For Symptomatic Treatment of Moderate To Severe Pain.) For the treatment of signs and symptoms of benign prostatic hyperplasia (BPH) in adults only. For the treatment of agitation and aggressiveness in adult patients with cognitive impairment.

21.06.11

49.

Silodosin Capsules2mg/4mg/8mg

23.06.11

50.

Tiapride Hydrochloride Tablets 25mg/50mg/100mg

23.06.11

LIST OF APPROVED DRUG FROM 01.01.2010 TO 31.12.2010

NO 1 2 3 4 PRODUCT NAME Ferrous ascorbate 100mg + Folic acid 1.1 mg tablet and Omega-3-fatty acid 200mg capsules combikit Sphaeranthus Indicus Extract Tablets 700mg Febuxostat 40mg Additional Strength Dexamethasone Intravitreal Implant 0.7mg (in solid polymer drug delivery system) INDICATION For iron, folic acid & omega-3-fatty acid deficiency For the management of psoriasis. DATE OF APPROVAL 08/01/2010 08/01/2010 16/01/2010 16/01/2010

9 10

Same As approved For the treatment of macular edema following branch retinal vein occlusion (CRVO) For the Symptomatic treatment of various allergic conditions (rhinitis, Buclizine Hcl 25mg Tablet conjunctivitis and urticaria) and for (Additional Indication) prevention and treatment of motion sickness Indicated as a monotherapy for the maintenance treatment of locally advanced or metastatic Non Small Cell Lung Cancer (NSCLC) other Pemetrexed Disodium 500mg/100mg than predominantly squamous cell Powder for Injection (additional histology in patients whose disease indication) has not progressed immediately following platinum-based chemotherapy. First line treatment should be a platinum doublet with gemcitabine, paclitaxel or docetaxel. For lowering of intraoccular Levobetaxolol HCl Opthalmic pressure in patients with chronic Suspension 0.5% open-angle glaucoma or occular hypertension. For the improvement of ischemic Sarpogrelate Hydrochloride film symptoms including ulcer, coated Tablets 100mg associated with chronic arterial occlusion. Propanol 1-ol 18gm + Ethanol 100% For hygenic and surgical hand 45gm/100ml solution disinfection Aliskiren 150/160mg + For the treatment of hypertension Valsartan 300/320mg tablets

16/01/2010

16/01/2010

16/01/2010

16/01/2010

18/01/2010 19/01/2010

11

Piroxicam 20mg tab& Paracetamol 500mg tab combikit

For treatment of fever and pain associated with acute upper respiratory tract inflammation, acute musculoskeletal disorders, pain after operative intervetion and following trauma, chronic condition like rheumatoid arthritis, osteoarthritis etc for short term management of acute painful episodes.

19/01/2010

12

13

14 15

16

17

18

19 20

Soybean oil 60gm + Triglycerides (medium chain) 50gm + olive oil purified fish oil 30gm + dl-alphaTotal parenteral nutrition following tocopherol 163-225mg + glycerol major abdominal, major thoracic or (anhydrous) 25gm + Egg lecithin major urological surgery 12gm + sodium hydroxide (to approx pH 8) + sodium pleate 0.3mg emulsion for infusion in 100ml. In combination with other anti retroviral agents for the treatment of human immunodeficiency virus Raltegravir (as Potassium) film coated (HIV-1) infection in treatment Tablets 400mg experienced patients with evidence of HIV-1 replication despite ongoing retroviral therapy. Deflazacort Tablet 18mg (Additional Same as approved Strength) Pregabalin SR Tablet 75mg Same as approved (Additional Strength) For the prevention of venous Rivaroxaban film coated Tablets thromboembolism in patients (VTE) 10mg in adult patients undergoing hip or knee replacement surgery. Cinnarizine 20mg + Dimenhydrinate For the treatment of vertigo 40mg tablets Indicated in the treatment of Lipid Based Amphotericin-B Gel cutaneous and mucocutaneous 0.1% mycotic infections caused by candida (Monilia) species. Sodium Hyaluronate Injectable Gel Same as approved 14mg/ml, 18mg/ml, 25.5mg/ml (Additional Strength) Milnacipran Hcl 12.5mg (Addl. Same as approved Strength)

19/01/2010

27/01/2010

30/01/2010 30/01/2010

30/01/2010

03/02/2010

05/02/2010

06/02/2010 06/02/2010

21

Ropinirole 6mg ER Tablets (Addl. Strength)

Same as approved (1) Enforcement of suture and staple lines in lung resection procedures. (2)Patients undergoing cardiac surgery to prevent or reduce the incidence, severity and extend of post surgical adhesion formation. (3)Patients undergoing laparotomy or laproscopic abdomino-pelvic surgery as an adjunct to good surgical technique intended to reduce the incidence, severity and extent of post surgical adhesion formation. For the treatment of adult patients with peripheral neuropathy For Symptomatic Treatment of chronic stable angina pectoris in coronary artery disease patients with normal sinus rhythm, indicated in combination with beta-blockers in patients inadequately controlled with an optimal beta-blocker dose and whose heart rate is >60bpm. Same as approved

06/02/2010

22

Coseal Surgical Sealent 2/4/8ml (Addl. Indication)

06/02/2010

23

Pregabalin SR 75/150/300mg + Methylcobalamin 1500mcg tablets

09/02/2010

24

Ivabradine Hcl Tablets 5/7.5mg (Additional Indication)

10/02/2010

25

Paracetamol Solution for Infusion (10mg/ml) in 50ml (Additional Packsize)

10/02/2010

26

27

Indicated for the treatment of pain Ketorolac Tromethamine Ophthalmic and inflammation following cataract Solution 0.45% surgery. In combination with other approved anticancer drugs is indicated for remission induction in acute nonlymphocytic leukemia of adults and Cytarabine Injection 100mg children. It has also been found Additional Packsize (20ml) useful in the treatment of acute lymphocytic leukemia and the blast phase of chronic myelocytic leukemia. Intrathecal

10/02/2010

10/02/2010

administration of cytarabine is indicated in the prophylaxis and treatment of meningal leukemia.

28

Olopatadine Hcl Nasal Spray 0.6% w/w (Additional Indication) Sodium chloride 6.80gm + Potassium chloride 0.30 gm + Calcium chloride dihydrate 0.37gm + Magnesium chloride hexahydrate 0.20gm + Sodium acetate trihydrate 3.27gm + L-malic acid 0.67gm in 1000ml solution for infusion Chemically Modified Sodium Hyaluronate and Caboxymethylcellulose Absorbable Adhesion Barrier.

For the relief of the symptoms of seasonal allergic rhinitis in patients 6 years of age and older. Replacement of extracellular fluid losses in case of isotonic dehydration, especially if acidosis is being imminent or present

10/02/2010

29

11/02/2010

30

31

32

33 34

35

36

37

As an adjunct in abdominal or pelvic surgery for reducing the incidence, extent and severity of postoperative adhesions at the site of placement. For the treatment of patients with Lornoxicam 4mg/4mg + acute painful musculoskeletal Thiocolchicoside 4mg/8mg tablets conditions For the treatment of adult patients Cefixime 100mg/200mg + Cloxacillin with upper & lower respiratory tract 500mg/500mg tablets infections, skin and soft tissue infections Celecoxib Mouth Dissolving Tablet For the Treatment of Osteoarthritis 50/100/200 mg and Rheumatoid Arthritis Propofol 2% w/v Injection Same as Approved (additionalStrength) For treatment of resistant oedema associated with secondary Spironolactone 25mg + Furosemide hyperaldosteronism; resistant 20mg tablets hypertension, chronic cardic failure and hepatic cirrhosis Olopatadine5mg + Ambroxol30mg For the management of cough in tablets adult patients only Methylcobalamin750mcg + For the treaetment of painful Pregabalin75/150mg + Vitamin diabetic neuropathy in adults only B61.5mg + Folic acid0.75mg + Benfothiamine7.5mg capsules

11/02/2010

12/02/2010

12/02/2010

25/02/2010 27/02/2010

05/03/2010

05/03/2010

05/03/2010

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39

40

41

42 43 44 45

46

47 48 49 50

For the management of hyperphosphatemia in adults Calcium acetate 435mg + Magnesium patients with renal failure being carbonate 235mg tablets treated with dialysis (hemodialysis or peritoneal dialysis For the treatment of the symptoms of functional gastrointestinal Dicyclomine2.5mg + Dried disorders like irratible bowel Aluminimum Hydroxide200mg + syndrome, functional dyspepsia, Light Magnesium Oxide100mg + peptic ulcers., GERD which Simethicone 20mg per 5ml includes smooth muscle spasm, suspension. flatulence, abdominal distension, hyperacdity, gastric distress, bloting etc. For the treatment in adults patients Sertaconazole 2% w/v+ Zinc with dandruff/seborrheic dermatitis Pyrithione 1% w/v Shampoo of the scalp For the Treatment of respiratory tract infections, urinary tract Faropenam Sodium Extended Release infection, skin and skin structure Tablet 225/300/450 mg infections and gynaecological infections Amlodipine5mg + For the treatment of hypertension Ramipril10mg/5mg Tablets only (additional strength) For the treatment of Bronchial Doxofylline MR Tablet 650 mg Asthma and COPD in Adults Lidocaine7.5mg + Prilocaine2.5mg For the treatment of adult male per acutation spray patients with premature ejaculation For the treatment of the sign and Pramipexole Di HCl monohydrate ER symptoms of idiopathic parkinsons Tablet 0.375/0.75/1.5/3/4.5 mg disease For the treatment of symptoms of Drosperinone 3mg + Ethinyl premenstrual dysphoric disorders Estradiol0.02mg tablets (PMDD) in women (additional indication) Miglitol 25 mg + Metformin 500mg Additional Strength tablets Propranolol 40mg (SR Pellets) + For the prophylaxis of migraine Fluarizine 5mg/10mg capsules Citicholine 500mg + Piracetam For the treatment of acute stroke 400mg Tablets Diclofenac 50mg + For the treatment of acute

05/03/2010

05/03/2010

05/03/2010

08/03/2010

10/03/2010 11/03/2010 12/03/2010 13/03/2010

16/03/2010

16/03/2010 16/03/2010 16/03/2010 16/03/2010

Chlorzoxazone500mg Tablets Mecobalamin 750 mcg + Pyridoxine 1.5mg + Nicotinamide 45 mg + Benfotiamine 150mg Tablets Etoricoxib 1%+ Menthol 5% Spray Pantoprazole 40mg + Cinitapride (ER) 3mg Capsules Atorvastatin 20mg + Ramipril 2.5mg/5mg Capsules Lamotrigine Orodispersible Tablet 12.5 mg(additional strength) Trabectedin powder for Conc. solution for infusion (Additional Indication) Lornoxicam 8mg/8mg + Thiocolchicoside 4mg/8mg Tablets

inflammation conditions associated with spasm in adults only For the treatment of diabetic neuropathy in adults For the topical treatment of acute musculoskeletal pain For the treatment of patients suffering from non-ulcer dyspepsia (NUD) or gasteroesophageal reflux disease (GERD) Additional higher strength Same as Approved In combination with pegylated liposomal doxorubicin, it is indicated for the treatment of patients with relapsed platinumsensitive ovarian cancer Additional higher strength 16/03/2010 16/03/2010

51 52

53

17/03/2010

54 55

17/03/2010 20/03/2010

56

20/03/2010

57

23/03/2010

58

59 60

61

For the treatment of rheumatoid arthritis, osteoarthritis, ankylosing Diclofenac sodium SR Tablet 150 mg spondilytis,gout,painful post perative pain following dental surgery etc. Magnesium Valproate CR Tablet 200/ Same as Approved 300/400/ 500 mg (additonal strength) Lidocaine 2.5% w/w+Prilocaine 2.5% Additional higher Strength w/w Gel 1. For the treatment of dyslipidaemia, particularly in patients with combined mixed dyslipidaemia (characterised by Nicotinic Acid and Laropiprant elevated levels of LDL-cholesterol Modified Release Tablets: Nicotinic and triglycerides and low HDlAcid.........1000 cholesterol) and in patients with mg primary hypercholesterolemia Laropiprant...........20mg (heterozygous familial and nonfamilial). 2. In combination with

26/03/2010

26/03/2010 26/03/2010

26/03/2010

62

63

64 65 66

67

68 69 70

71

HMG-CoA reductase inhibitors (statins), when cholesterol lowering effect of HMG-CoA reductase inhibitor monotherapy is inadequate. It can be used as monotherapy only in patients in whom HMG-CoA reductase inhibitors are considered inappropriate or not tolerated. Diet or other non-pharmacological treatments (e.g. exercise, weight reduction) should be continued during therapy. For the treatment of gastric ulcer, Pantoprazole Mouth Dissolving duodenal ulcer & gastroesophageal Tablet 20/40 mg reflux disease (GERD). For the treatment of mixed Praziquntel 175mg + Pyrantel 504mg infections with roundworms and + Febental 525mg Tablets tapeworms in dogs For the treatment of inflammation Difluprednate Opthalmic Emulsion and pain associated with ocular 0.05% w/v surgery. For the relief of painful muscle Tolperisone Hcl SR 450mg Tablets spasms of the skeletal muscualture. For the treatment of patients with S(-)Metoprolol 25mg/50mg (ER) + both essential hypertension and Atorvastatin (IR)10mg tablets hypercholesterolemia Atorvastatin10mg + Ramipril 5mg + For secondary prophylaxis of Aspirin (EC pellets) 75mg/150mg + ischemic heart disease in patients Metoprolol (ER tablets) 25mg where use of such combinations in Capsules appropriate Lamotrigine 25mg Modified Release Same as Approved Tablet (Addl. Strength) Adjuvant treatment of adult patients Imatinib Mesylate 100/400mg Tablets following resection of gastro(Addl. Indication) intestinal stromal tumours (GIST) Azithromycin SR Granules for Oral Same as Approved Suspension 1gm (Addl. Strength) For the treatment of other Gemfibrozil Capsule USP & dyslipidemias: (a) Fredrickson Gemfibrozil Tablet USP Types III and V.(b) Associated with 200mg/600mg (Addl. Indication) diabetes.(C) Associated with xanthomata.

30/03/2010

30/03/2010

30/03/2010 30/03/2010 04/01/2010

05/04/2010

05/04/2010 05/04/2010 05/04/2010

05/04/2010

72

73

74

75

76

For the short term treatment of musculoskeletal pain associated with inflammation and spasm in adults only Doxophylline (SR) 400mg/800mg + For the treatment of bronchial Montelukast 10mg/10mg Tablets asthma in adults To reduce the risk of cardiovascular hospitalization in patients with paroxysmal or persistent atrial fibrillation (AF) or atrial flutter (AFL), with a recent episode of AF/AFL and associated Dronedarone( as Hydrochloride) film cardiovascular risk factors (i.e., age coated tablet .... 400 mg. > 70, hypertension, diabetes, prior cerebrovascular accident, left atrial diameter > 50mm or left ventricular ejection fraction [LVEF] < 40%), who are in sinus rhythm or who will be cardioverted. Dosulepin Hcl Tablet 25mg/75mg For the treatment of chronic pain. (Additional Indication) To reduce the rate of thrombotic cardiovascular (CV) events (including stent thrombosis) in patients with acute coronary syndrome (ACS) who are to be managed with percutaneous coronary intervention (PCI) as follows: Prasugrel (as Hydrochloride) film coated tablet ....5 mg / 10mg. Patients with unstable angina (UA) or non-ST-elevation myocardial infarction (NSTEMI). Ibuprofen 400mg + Chlorzoxazone 500mg Tablets Patients with ST-elevation myocardial infarction (STEMI) when managed with primary or delayed PCI. For the treatment of anxiety and depression. For the treatment of schizophrenia

07/04/2010

07/04/2010

08/04/2010

08/04/2010

13/04/2010

77 78

Tofisopam uncoated tablet JP... 50/100mg Zotepine tablet ....25/50/100mg

13/04/2010 15/04/2010

79

Armodafinil uncoated tablet ..50/150/250mg

80

Indacaterol ( as Maleate ) Inhalation Powder Hard Capsules .. ...150/300mcg

To improve wakefulness in patients with excessive sleepiness associated with treated obstructive sleep apnea (OSA), shift work sleep disorder (SWD) or narcolepsy. For maintenance bronchodilator treatment of airflow obstruction in adult patients with chronic obstructive pulmonary disease (COPD).

23/04/2010

24/04/2010

81 82 83

84

85

86

87

88

Ranolazine ER Tablets 750mg Same as Approved 24/04/2010 (Additional Strength) Tacrolimus Capsules 3mg (Additional Same as approved 24/04/2010 Strength) For the treatment of patients with Cefixime 100mg/200mg + Ofloxacin 26/04/2010 typhoid fever and urinary tract 100mg/200mg Tablets infection in adults For symptomatic relief of dermatological condition associated Liquid paraffin 6% + White soft 29/04/2010 with dry skin including atopic paraffin 15%w/v Cream dermatitis, eczema, pruritus, ichthyosis, xerosis, psoriasis For the short term treatment of acutely decompensated chronic heart failure (ADHF) in situations Levosimendan Injection 2.5mg / ml where conventional therapy is not 30/04/2010 sufficient and in cases where ionotropic support is considered appropriate. As an adjuvant treatment in painful spasms associated with degenerative vertebral disorders and vertebral 31/04/2010 Thiocholchicoside SR Tablet 16 mg static problems, torticollis dorsal pain, low back pain, traumatological and neurological disorders. Telmisartan 40/80 mg+ Indapamide For the treatment essential 05/04/2010 SR 1.5/1.5 mg tablet hypertension one strip of 3 uncoated tablets of artesunate 150mg & one strip of 2 Additional strength 05/04/2010 uncoated tablets of FDC of Sulphadoxine IP 500mg + Pyrimethamine IP 25mg

89

90 91

92

93

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98

In combination with letrozole for the treatment of postmenopausal women with hormone receptor Lapatinib Ditosylate Tablets 250mg positive metastatic breast cancer (addl. Indication) that overexpresses the HER2 receptor for whom hormonal therapy is indicated. For the relief of bladder pain or Pentosan polysulfate Sodium discomfort associated with Cpasules 100mg interstitial cystitis. Indapamide (SR) 1.5mg/1.5mg For the treatment of hypertension +Nebivolol 2.5mg/5mg tablet not controlled with monotherapy For the treatment of gastirc Cinitapride (ER) 3mg + Omeprazole ulcer,gastroesophageal reflux (EC) 20mg Capsules disease(GERD) & Dyspepsia not responding to omeprazole alone For the treatment of elevated Timolol Maleate Long Acting intraocular pressure in patient with Ophthalamic Solution 5mg/ml ocular hypertension or open angle glaucoma. For the prevention of cardiovascular Telmisartan tablet 20/40/80 morbidity and mortality in patient mg(Additional indication) 55 years older at high risk of cardiovascular disease For the treatment of acute low back Dexketoprofen Trometamol 25mg + pain and other musculoskeletal Thiocolchicoside 4mg tablets painful & inflammatory conditions in adult patients For the treatment of Gastric ulcers and for amelioration of gastric mucosal lesions (erosion, Troxipide film coated Tablets 50mg hemorrhage, redness and edema) in /100mg the diseases such as acute gastritis, acute exacerbation stage of chronic gastritis. For the treatment of pulmonary arterial hypertension (WHO Group Ambrisentan film coated Tablets 5 mg I) in patients with WHO class II or / 10mg III symptoms to improve exercise capacity and delay clinical worsening. Risk reduction of MI stroke and Rosuvastatin Calcium arterial evascularisation procedure Tablet(Additional Indication) in patients without clinically evident

10/05/2010

11/05/2010 12/05/2010

12/05/2010

14/05/2010

14/05/2010

20/05/2010

20/05/2010

24/05/2010

24/05/2010

CHD but with multiple risk factor Paracetamol SR 1000mg Bilayered tablet Tacrolimus PR Caps 0.5/1/5 mg For symptomatic treatment of pain and fever For Prophylaxis of transplant rejection in adult kidney or liver allograft rejection

99 100

24/05/2010 24/05/2010

101

102

103

Rizatriptan Benzoate orally disintegrating tablet 10 mg(Additional Same as Already approved Dosage Form) For the treatment ofnon-diabetic Ramipril 1.25/ 2.5/5/10 overt glomerular or incipient mg(Additional Indication) nephropathy Use in patients with type-2 diabetes mellitus who are using a thiazolidinedione alone or in Exenatide Inj. (Additional Indication) combination with metformibn but have not achieved adequate glycemic control For the treatment of "Adult patients with newlydiagnosed glioblastoma multiforme concomitantly with radiotherapy (RT) and subsequently as monotherapy treatment."

24/05/2010

24/05/2010

24/05/2010

104

Temozolomide lyophilised powder 100mg / vial

24/05/2010

105

106

Children from the age of three years, adolescents and Adult patients with malignant giloma, such as glioblastoma multiforme or anaplastic astrocytoma, showing recurrence or progression after standard therapy. Fluticasone Propionate For the maintenance treatment of 50mcg/125mcg/250mcg + Salmeterol asthma and for the treatment of xinafoate 25mcg/25mcg/25mcg COPD associated with chronic Powder for inhalation bronchitis For filling any medium sized depression of the skin via mid Cross linked Hyaluronic Acid 24mg + dermis injection as well as for lip Lidocaine 3mg Pre-filled syrings definition. The presence of lidocaine is meant to reduce the

25/05/2010

28/05/2010

patients pain during the treatment

107

Aceclofenac 1% w/w + Menthol 5% Spray

108

Metformin SR 500mg/500mg + GliclazideSR 60mg/30mg + Pioglitazone 15mg/15mg tablets 3 tablets of artesunate 100mg + 3 tablets of Artesuante 50mg & 2 tablets of FDC of Pyrimethamine 25mg + Sulphadoxine 500mg combipack

For the treatment of acute painful inflammatory conditions in adults only As 3rd line treatment of type II diabetes mellitus when diet, exercise and the single agents and the second line therapy with two drugs do not result in adequate glycemic control

28/05/2010

28/05/2010

109

Additional strength

28/05/2010

110

111

112

113

114

To relive the uncomfortable Calcium carbonate 600mg symptoms of acid indigestion, heart +Simethicone 80mg Chewable tablet burn, gas or sour stomach For treatment of symptoms of hyperacidity (e.g. heartburn, Activated Dimethicone 50mg + epigastric discomfort, or their Magnesium Hydroxide 250mg+ Dried equivalents) that are often Aluminium Hydroxide250 mg + associated with dyspepsia, peptic Sorbitol (70%)1.25 gm /5ml Solution ulcers, gastritis, peptic esophagitis and indicated for relief of flatulence For secondary prevention of Aspirin 75mg + Simvastatin coronory heart disease/stroke in 10mg/20mg + Lisinopril 5mg/10mg + patients where use of such Atenolol 25mg/50mg Tablets combination is appropriate For gastric ulcers, improvement of gastric mucosal lesion (erosion, hemorrhage, redness and edema) Irsogladine Maleate Tablet 2mg /4mg caused by acute gastritis and acute exacerbation stage of chronic gastritis. As an adjunctive treatment of partial Lacosamide film coated tablet 50mg onset seizures in patients > 17 years /100mg /150mg /200mg of age.

28/05/2010

28/05/2010

01/06/2010

05/06/2010

10/06/2010

Indicated as palliative therapy as a single agent or in established combination therapy with other approved chemotherapeutic agents in the following: 1.Brain tumors glioblastoma, brainstem glioma, medulloblastoma, astrocytoma, ependymoma, and metastatic brain tumors. 2.Multiple myelomain combination with prednisone. 3.Hodgkins Diseaseas secondary therapy in combination with other approved drugs in patients who relapse while being treated with primary therapy, or who fail to respond to primary therapy. 4.Non-Hodgkins lymphomasas secondary therapy in combination with other approved drugs for patients who relapse while being treated with primary therapy, or who fail to respond to primary therapy. For the relief of symptoms of seasonal allergic rhinitis in adults and pediatric patients 2 years of age and older. For the prevention and treatment of gastrointestinal symptoms(nausea and vomitting) associated with ematogenic cancer chemotherapy For the control of ticks on cattle and ostriches For treatment of acute and chronic pain ,i.e, for painful increased muscle tone of the posture and motor muscles, primary headache, tum or pain, dysmenorrhea and pain after traumatologic / orthopaedic

115

Carmustine for inj. 100 mg

10/06/2010

116

Monteleukast Sodium Tablet 10mg; Monteleukast Sodium 4/5mg Chewable Tablet; Monteleukast Sodium Oral granule(Additional Indication) Ramosetron Dispersible Tablet 0.1 mg Amitraz 2%w/v pour on solution

12/06/2010

117

12/06/2010

118

12/06/2010

119

Flupirtine Maleate Capsules 100mg

12/06/2010

operations and injuries.

120

Lidocaine Patch 350mg (Additional Pack Size) Oseltamivir Phosphate (Additional indication) Methylcobalamin 1500mcg +Folic acid 0.7mg +Niacinamide 12mg injection Methylcobalamin 1500mcg +Pyridoxine 100mg +Nicotinamide 100mg injection 1 tablet of Tenofovir disoproxil 300mg + Lamivudine 300mg & 2 tablet of Nevirapine 200mg combipack Vitamin A (oily form) as palmiate 2000IU + Vitamin B1 1mg + Vitamin B2 1mg + Vitamin B6 1.34mg + Vitamin B12 1mcg + Ascorbic acid 33.3mg + Vitamin D3 200IU + Folic acid 0.3mg + Calcium pantothenate 1mg + Niacinamide 15mg + Dibasic calcium phosphate 100mg + Phosphorus 77mg+ Ferrous fumarate 50mg + Copper 0.01mg+ Potassium iodide 0.0015mg + Heavy magnesium oxide 1mg + Manganse sulphate 0.01mg + Potassium sulphate 1mg + Zinc sulphate 0.15mg Capsule Ramipril MR Capsules 2.5/5 mg (Additional Strength)

121

For the relief of pain associated with post-herpetic neuralgia. It should be applied only to intact skin. In the treatment of children 6 to 12 months of age during a pandemic influenza outbreak. For the treatment of diabetic neuropathy in adults For the treatment of diabetic neuropathy in adults For the treatment of HIV infection in adults

17/06/2010

19/06/2010

122

23/06/2010

123

23/06/2010

124

23/06/2010

125

For the treatment of vitamin deficiency states in adults

23/06/2010

126

Same As Approved

03/07/10

127

Sitagliptin Phosphate 25/50/100 mg Tablet (Additional Indication)

(i) Use of Sitagliptin Phosphate in combination with Metformin and a PPAR agonist as an adjunct to diet 03/07/10 & exercise in adult patients with type-2 Diabetes mellitus who are inadequately controlled on combination therapy with

Metformin and a PPAR agonist. (ii) Use of Sitagliptin Phosphate in combination with insulin, alone or in combination with Metformin. As monotherapy for maintenance treatment in patients with locally advanced or metastatic non-small 03/07/10 cell lung cancer with stable disease after 4 cycles of standard platinum based first line chemotherapy. Same as Approved Same As Approved For the topical treatment of acute musculoskeletal pain 03/07/10 03/07/10 06/07/10

128

Erlotinib HCl 25/100 mg Tablet (Additional Indication)

129 130 131

Gemcitabine HCl injection 2gm/vial (Additional Strength) Etizolam 0.25 mg tablet (Additional Strength) Dexketoprofen1.25% w/w +Linseed Oil 3.0%w/w +Menthol 5%w/w +Methyl Salicylate 10%w/w (12.5mg) Cefuroxime Sodium 750/1500mg +Sulbactam Sodium 375/750mg

132

133

HPMC 0.3% +Dextran 0.1% + Glycerin 0.2%

For the treatment of mild to 06/07/10 moderate lower respiratory tract infection For the temporary relief of burning and irritation due to dryness of the eye and for use as a protection 06/07/10 against further irritation. For the temporary relief of discomfort due to minorirritations of the eyes or to exposure to wind or sun

134

135

136

Cyanocobalamin 15mcg+Chromium Picolinate USP 250mcg+Folic Acid USP 1500 mcg+Nicotinamlide IP100 mg+Pyridoxine 3mg +Selenius Acid USP 100mcg+Zinc Sulfate Monohydrate USP 61.8 mg eq. to 22.5 mg Methylparaben 0.15%w/w +Propyl paraben 0.05%w/w+Glycerin 20%w/w +CMC 1.74%w/w +Allantoin 0.5%w/w +Benzyl alcohol 0.5%w/w. Clonazepam IR 0.5mg/0.5mg+ Paroxetine CR 12.5/25mg

For Mineral & Vitamins deficiency 06/07/10 states in adult patients

For short term treatment of chronic wounds including stage III & IV 06/07/10 pressure sores, leg ulcers For the treatment of patients with co-morbid depression and axiety 08/07/10

137

Nilotinib Capsules 200mg

138

Imipenem 50mg + Clistatin 50mg

For the treatment of chronic and accelerated phase Philadelphia chromosome positive chronic myelogenous leukemia (CML) in 10/07/10 adult patients resistant to or intolerant to prior therapy that included imatinib. Treatment of infection caused by susceptible bacteria for the following indication as in neonates and infants (below 3 months of age) 1. Lower respiratory tract infections 14/07/10 2. Urinary tract infections 3. Intraabdominal infections 4. Bacterial septicemia 5. bone and joint infections 6. Skin and Skin structure infections 7. Bacterial endocarditis Same as Approved 15/07/10 16/07/10 19/07/10

139 140 141

Lidocaine Lozenges 100mg (Additional Strength) Metoprolol succinate ER 25/50 mg+Telmisartan 20/40mg

142 143

144

145 146

For the treatment of essential hypertension For the treatment of patients with Etodolac 300/300mg acute painful musculoskeletal +Thiocolchicoside 4/8mg conditions For the treatment of adult patients Celecoxib 100/200mg +Diacerein with osteoarthritis of knee and/or 50/50mg hip joints Metoprolol succinate ER 25mg+50mg For the treatment of essential + Olmesartan 20/20mg hypertension 1 tablet of Atazanavir 300mg & 1 tablet of ritonavir Ritonavir 100mg & FDC of Tenofovir Disoproxil fumarate 300mg + Lamivudine 300mg (Each Co-pack contains :- 1 For the treatment of HIV infections in adults capsule of Atazanavir 300mg & 1 Tablet of Ritonavir 100mg & 1 Tablet of FDC of Tenofovir Disoproxil Fumarate 300mg + Lamivudine 300mg) Gliclazide 40/80mg+Metformin Additional strength 500mg+Pioglitazone15mg Lidocaine HCl Ophthalmic Sterile Indicated for ocular surface Gel 35 mg/ml anaesthesia during ophthalmologic

19/07/10 19/07/10

19/07/10

19/07/10 30/07/10

147

Naftopidil Tablets 25/50/75mg

148

Metformin 500/850/1000mg+Sitagliptin Phosphate 50/50/50mg (Additional Indication)

149

Bimatoprost Eye Drps 0.1mg/ml

procedures. For the treatment of dysuria 30/07/10 associated with benign prostratic hyperplasia. A) FDC is indicated as triple combination therapy with a PPARy agonist (i.e a thiazolidinedione) as an adjunct to diet and exercise in patients inadequtely controlled on their maximal tolerated dose of metfomin and a PPARy agonist. B) 02/08/10 FDC is also indicated as add-on to insulin(i.e triple combination therapy) as an adjucnjt to diet and exercise to improve glycemic contrl in patients when stable dosage of insulin and metformin alone do not provide adequte control. for the treatment of hypotrichosis of the eye-lashes by increasing their 05/08/10 growth including length, thickness & darkness. 05/08/10

150

151

152

153

S(+) Etodolac 5/10%w/w + Camphor For the painful & inflammatory 4%w/w + Menthol 10%w/w + conditions associated with joint, Methyl salicylate 5%w/w + Linseed tendons, ligaments and muscles oil 3%w/w For the treatment of lower RI, Skin Cefpodoxime and soft tissue, bone and joint 100/200mg+Dicloxacillin ER infections and ENT infections in 500/500mg adult patients prone to antibiotic induced diarrhoea Voglibose0.3 + Metformin (SR) Additional higher strength 500mg in the treatment of infections due to susceptible strains of the designated micro-organisms in the condition of E.N.T infection, skin & skin Amoxycillin Oral Suspension 200/400 structure infection, lower respiratory mg per 5ml tract infection, genito-urinary tract infection, gonorrhea, acute uncomplicated (anogenital & urethral) infections.

06/08/10

06/08/10

09/08/10

154

Olmesartan 40mg + Amlodipine 5mg (Additional Strength)

155

Doripenem 500 mg powder for injection (Additional Indication)

156

Nadolol tablet USP 20/40/80 mg

157

Fluconazole For Oral suspension 50/200 mg per 5ml (Pack Size : 35ml)

158

Metformin 500/500mg + Repaglinide 1/2mg

159

Hydroxyzine Hydrochloride SR Tablets 25/50/75mg

160 161 162

Rosuvastatin 5/10/20mg+Fenofibrate 67/145/160mg Fexofenadine 120mg + Montelukast 10mg Irinotecan HCl Trihydrate Injection 20 mg/ml (Pack Size 25ml) Cefixime SR 200mg/400mg + Ofloxacin SR 200mg/400mg Tablet

Additional indication: 1. For the treatmenmt of hypertension alone or with other antihypertensive agents 2. To use as initial therapy in patients who are likely to need multiple antihypertensive agents to achieve their blood pressure goals Complicated intra-abdominal infections and complicated urinary tract infections, including complicated and uncomplicated pyelonephritis and cases with concurrent bacteremia in the treatment of angina-pectoris, cardiac arrythmias & essential hypertension. for the treatment of systemic candidiasis, mucosal candidiasis, prevention of fungal infections in patients with malignancy. Indicated as an adjunct to diet and excersice to improve glycemic control in adults with type 2 diabetes mellitus who are already treated with a meglitinide & metformin or who have inadequte glycemic control on a meglotinide alone or metformin For management of pruritus due to allergic conditions such as chronic urticaria and atopic contact dermatoses, and in histamine mediated pruritus. For the treatment of combined hyperlipidemia in patients with normal hepatic and renal function For treatment of allergic rhinitis in adults only for the treatment of metastatic colorectal cancer . Additional strength

09/08/10

10/08/10

20/08/10

20/08/10

20/08/10

20/08/10

23/08/10 31/08/10 31.08.10

163

31.08.10

164

Ademetionine enteric coated Tablets ..200mg/400mg Memantine HCl ER Tablet 28mg

For the management of intrahepatic 01.09.10 cholestasis and liver disease. in the treatment of moderate to severe Alzheimer's disease. 06.09.10

165

166

Buserelin Acetate injection 1mg/ml (Additional Indication) Etodolac 400mg/400mg + Thiocolchicoside 4mg/8mg tablet Montelukast Sodium 10 mg Tablet, Montelukast Sodium 4/5 mg Chewable Tablet and Montelukast Sodium Oral Granules (Additional Indication). Acyclovir SR Tablet 1200 mg

indicated for the palliative (initial & maintenance treatment) of patients with hormone-dependent advanced 08.09.10 carcinoma of the Prostate gland (Stage D). Additional higher strength 09.09.10

167

168

For The relief of perennial allergic rhinitis in adults & pediatrics 11.09.10 patients 6 months of age and older. For the treatment of uncomplicated Herbis Zoster in immunocompetent 11.09.10 patients. For the improvement of myotonic conditions caused by neck shoulder 13.09.10 arm syndrome, scapulumeral periarthiritis and low back pain in adult patients only For the treatment of idiopathic pulmonary fibrosis. 14.09.10

169

170

Lornoxicam 4mg + Eperisone 50mg tablet

171

Pirfenidone film coated tablet ...200mg

172

Beclomethasone Dipropionate IP 0.025% w/w + Neomycin sulphate Additional lower strenth IP 0.5% w/w cream Amlodipine 5mg/2.5mg + Valsartan 320mg/80mg + HCTZ 12.5mg/12.5mg tablet Paracetamol 500mg/500mg +Thioclchicoside 4mg/8mg tablet Ketorolac Tromethamine 0.4% w/v +Moxifloxacin 0.5% w/v Opthalmic solution Additional strength

15.09.10

173

21.09.10

174

For the treatment of acute inflammation conditions associated 21.09.10 with spasm in adults only Additional lower strenth 21.09.10

175

176

Nilotinib Capsules 150 mg.

Treatment of newly diagnosed adult patients with Philadelphia chromosome positive chronic 29/09/10 myeloid leukemia (Ph+CML) in chronic phase. For the treatment of non productive 29.09.10 cough in adult patients 30.09.10

177

Levocloperastine ( as Fendizoate) Suspension eq. to Levocloperastine Hcl 20mg / 5ml.

178

Zileuton uncoated bilayered extended For the prophylaxis and chronic release tablet ...600mg treatment of asthma in adults.

179

Etodolac 400mg + Paracetamol IP 500mg tablet

Additional higher strength

01.10.10

180

For the treatment of symptoms of functional gastrointestinal disorders like irritable bowel syndrome, Dried Aluminium Hydroxide Gel IP functional dyspepsia, peptic ulcer, 600mg +Magnesium Hydroxide IP 05.10.10 gasteroesophagal reflux disease 300mg +Simethicone IP 25mg which include smooth muscle +Oxetacaine BP 10mg per 5ml syrup spasms, flatulence, abdominal distension, hyperacidity, gastric distress, bloting etc. S(-) Metoprolol Succinate ER Eq. to S (-) Metoprolol tartarate 25mg/50mg + Clopidogrel (IR) 75mg/75mg tablet For the treatment of essential hypertension who need antiplatelet therapy especially for prophylaxis of atherombotic event.

181

07.10.10

182

Exenatide Injection (Additional indication)

Exenatide is a glucagon like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to diet and 09.10.10 exercise to improve glycemic control in adults with Type 2 diabetes mellitus. Same as approved. 09.10.10

183

Bimatoprost Ophthalmic Solution 0.01% w/v (Additional Strength)

184

Drosperinone + Ethinylestradiol tablets Same as approved

For the treatment of moderate acne vulgaris in adult females, who have no known contraindications to oral contraceptive therapy, and have 09.10.10 achieved menarche. It should be used for the treatment of acne only if the patient desires an oral contraceptive for birth control. For the treatment of acute inflammation conditions associated 11.10.10 with spasm in adults only 11.10.10

185

Etodolac USP 400mg +Tolperisone HCL 150mg tablet

186

Citicoline 500mg +Piracetam 400mg Additional dosage form per 5 ml syrup Thiocolchicoside 0.25% +Methyl salicylate IP 100mg +Menthol IP 50mg +Absolute alchol IP 50mg per gm gel Amlodipine Besylate IP Eq. to Amlodipine 10mg/5mg/2.5mg +Telmisartan 80mg/40mg/20mg + HCTZ 25mg/12.5mg/12.5mg tablet Pregabalin 150mg/75mg +Methylcobalamin 750mcg +Alpha lipoic acid 100mg +Pyridoxine 3mg +Folic acid 1.5mg capsule Ferrous bisglycinate 60mg + Zinc sulphate monohydrate Eq. to Zinc 14mg + Copper as copper sulphate 1 mg + Selenium as selenomethionine 70mcg + Vitamin B6 IP 10mg + Methylcobalamin 1500mcg + Folic acid 5mg + Fish oil 10/40 (DHA 200mg) 500mg capsule.

187

For the topical treatment of painful muscles spasms of skeletal 11.10.10 musculature

188

For the treatment of essential hypertension

12.10.10

189

For the treatment of painful diabetic 12.10.10 neuropathy in adults only

190

For Vitamin and mineral deficiency 13.10.10

191

Combipack of 21 tablets of FDC of Ethinylestradiol IP 0.03 mg + Levonorgestrel IP 0.15 mg and 7 As contraceptive pill for women tablets of Ferrous Fumarate IP 75mg (Eq. to 24.375 mg of Ferrous iron) Amitriptyline Hydrochloride IP 4%w/w + Ketamine HCL eq. to Ketamine 2% w/w per gm cream. Paracetamol IP 500mg + Phenylephrine HCL IP 5mg +Caffeine (anhydrous) IP 30mg + Diphenhydramine HCL IP 25mg tablet. For the treatment of patients suffering from neuralgia

13.10.10

192

13.10.10

193

For the treatment of fever associated 13.10.10 with cold, nasal congestion in adults

194

Levocetirizine dihydrochloride 2.5mg Additional strength +Montelukast 5mg dispersible tablet Calcium citrate maleate Eq. to elemental calcium 250mg +Vitamin D3 IP 200 IU tablet For the treatment of calcium and Vitamin D deficiency states

13.10.10

195

13.10.10

196

197

198

(Additional indication) For the treatment of moderate acne vulgaris in women more than 18 years of age Levonorgesterel 100mcg +Ethniyl who have no therapy 13.10.10 estradiol IP 20mcg tablet contraindications to oral contraceptive therapy, desire contraceptiopn, and have achieved menarche For the treatment of mild to Eberconazole 1% w/w + Mometasone 13.10.10 moderate inflammed cutaneous Furate USP 0.1% w/w cream mycoses 1. For the treatment of chronic constipation in adults. Lubiprostone Soft Gelatin Capsules 16.10.10 2. For the treatment of irritable ..8mcg /24mcg bowel syndrome with constipation (IBS-C) in women > 18 years old. Pazopanib (as Hydrochloride) film coated Tablets200mg / 400mg For the treatment of patients with advanced renal cell carcinoma. 16.10.10

199

200

Eltrombopag (as Olamine) Tablets ...25mg / 50mg

201

Tolperisone HCL 150mg + Paracetamol IP 500mg tablet

202

Zaltoprofen film coated tablet 80mg JP

for the treatment of thrombocytopenia in patients with chronic immune (idiopathic) thrombocytopenic purpura who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. 16.10.10 (It should be used only in patients with ITP whose degree of thrombocytopenia and clinical condition increase the risk for bleeding. It should not be used in an attempt to normalize platelet counts). For the treatment of patients with 21.10.10 acute painful musculoskeletal conditions For anti inflammatory and analgesic activity in rheumatoid arthritis, osteoarthritis, low back pain, 31.10.10 periarthritis of shoulder, cervicobrachial syndrome, postoperative, post trauma, and post dental extraction. 04.11.10

203

Hyoscine Butylbromide 20 mg tablet Same as Approved. (Additional Strength)

204

Cerebroprotein Hydrolysate injection (Lyophilised) ..1050mg / 2100mg For amelioration of cranial injury, 04.11.10 cerebrovascular pathological (approx) equivalent to sequelae and aprosexia in dementia. nitrogen.30mg / 60mg respectively. Clebopride (as Malate) (1)Tablets...0.5 mg Ph. Eur. For the treatment of various disorders associated with altered gastrointestinal motility like nonulcer dyspepsia (NUD) and / or 04.11.10 chronic gastritis, gastroesophageal ( reflux disease (GERD), nausea and vomiting of organic or functional origin. 04.11.10

205

(2.) Syrup...0.1 mg / ml Ph. Eur. 3.) Injection...1 mg / 2mlPh. Eur.

206

Tolperisone HCl Mouth Dissolving tablet 50/100 mg (Additional Dosage Same as Approved. Form)

207

Oxybutynin Gel 100 mg

208

Dapoxetine ( as Hydrochloride) Tablets 30mg/60mg Opipramol dihydrochloride Tablet 50mg/100mg. Ondansetron Rapid Film Oral Strip 4/8 mg Acebrophylline SR Tablet 200 mg

209 210

211

For the treatment of overactive bladder with the symptoms of urge urinary incontinence, urgency and urinary frequency. For the treatment of premature ejaculation (PE) in men 18 to 64 years of age. For the Treatment of generalised anxiety disorder(GAD) and somatic disturbances. For chemotherapeutic induced nausea and vomiting. For the treatment of adult patients with chronic obstructive pulmonary disease (COPD) and bronchial asthma.

04.11.10

13.11.10

13.11.10. 16.11.10

23.11.10

212

213 214

215

216

217

Indicated For the treatment of Dry,scaly skin(xerosis) and Ammonium Lactate Cream 12% w/w ichthyosis vulgaris and for temporary relief of itching associated with these condition. Rabeprazole Sodium Powder oral suspension ( sachet of 20 mg) Same as approved (Additional dasage form) Temsirolimus Concentrate for For the treatment of advanced renal Infusion for Injection 25mg/ml cell carcinoma Indicated the relief of Dry eye symptoms associated with defecient Acetyl Cysteine Eye Drops 5% w/v tear secretion, impaired or abnormal mucus Production. Indicated for the Prophylaxis against alpha-hemolytic(viridans Clindamycin Palmitate Hcl For Oral group) sreptococci before dental, Solution 75mg/5ml. oral and upper respiratory tract surgery. Deferasirox Tablet for Oral Suspension (Additional Sosage Same as approved Form) Ramelteon film coated tablets 8mg For the treatment of insomnia characterized by difficulty with sleep onset.

03.12.2010

03.12.2010 11.12.2010

14.12.2010

14.12.2010

14.12.2010

218

15.12.2010

219

Memantine ER Tablet 7mg/14mg/21mg. (Additional Strength)

Solution for haemofiltration and haemodialysis (Each unit contains two compartments A & B. Before reconstitution: 1000ml of electrolyte solution in Compartment A contains: Calcium Chloride. 2H2O .....5.145gm Magnesium Chloride. 2H2O.... 2.033gm Lactic Acid....5.4gm 1000ml of buffer solution in Compartment B contains: Sodium Chloride....6.45gm Sodium Bicarbonate....3.090gm )

Same as approved

17.12.2010

220

For treatment of acute kidney disease (renal failure), as substitution solution in continuous haemofiltration and 23.12.2010 haemodiafiltration and as a dialysis solution in continuous haemodialysis.

221

Pyridoxine HCL IP 3mg + Nicotinamide IP 100mg + Cyanocobalamin IP 15mcg + Folic acid IP 500mcg + Chromium Picolinate USP 250mcg Tablet

For Mineral & Vitamins deficiency 23.12.2010 states in adult patients

222

Rosuvastatin Calcium IP 5mg/10mg + Additional strength Fenofibrate BP 160mg/160mg tablet Chlorhexidine gluconate IP 1%w/v + Surgical hand scrub & healthcare Ethyl Alcohol IP 61%w/v Solution personnel hand wash

29.12.2010

223

29.12.2010

LIST OF APPROVED DRUG FROM 01.01.2009 TO 31.12.2009

S. NO. DRUG NAME INDICATION For the treatement of osteoporosis in post-menopausal women and in men who are at increased risk of fracture,including those with a recent low-trauma hip fracture. APPROVAL DATE

1.

Zoledronic Acid Injection 5mg/100ml (Addl. Indication)

07.01.09

2.

Misoprostol Tablet 600mcg

Addl. Strength

09.01.09

3.

Acebrophylline Syrup 10mg/ ml

For the treatement of adult patients with chronic obstructive pulmonary disease(COPD) and bronchial asthma. (I) For the treatement and lasting prevention of flea infestations,treatment and control of flea allergy dermatitis, prevention of heartworm disease,treatement and prevention of ear mites in dogs and cats; (II) For the treatement and prevention of sarcoptic mange,roundworms and for control of tick infestations in dogs.

09.01.09

4.

Selamectin Tropical solution (for verterinary use.) 60mg/120mg per ml

09.01.09

5.

Methylcobalamin1500mcg + Calcium 200mg + Calcitriol 0.25mcg + Folic Acid1.5mg + Pyridoxine3mg Capsules Metoprolol tartrate tablets 50 mg (Addl. Indication)

For the treatment of vitamin deficiency states in adults

14.01.09

6.

Adjunct to the treatement of Hyperthyroidism For the treatment of secondary hyper parathyroidism in patients with chronic kidney diseases (CKD) on dialysis and for hypercalcemia in patients with parathyroid carcinoma For the prophylaxis of acute organ rejection in patients recieving allogenic hepatic transplantation.

14.01.09

7.

Cinacalet (as HCl) Tablet 30/60/90mg

14.01.09

8.

Mycophenolate mofetil Capsules 250mg, Tablets 500mg, Oral suspension 200mg/ml (addl. Indication) Liquid Paraffin1.25ml + Milk of Magnesia 3.75ml + Sodium Picosulphate 3.33mg per 5ml

23.01.09

9.

For symptomatic treatment of constipation in adults

29.01.09

10.

Ranolazine 1000mg ER Tabs (Additional Strength)

Same as approved

31.01.09

11.

Hyaluronic acid (cross linked) PreFor intradermal implantation and filled syringe 18mg/0.6ml and facial soft tissue augmentation 24mg/0.8ml For use in following: (I) Empirical therapy for presumed fungal infections in febrile neutropenic patients. (II) Treatment of Candidemia and the following Candida infections: Intra-abdominal abscesses, Peritonitis and Pleural space infections. (III) Treatment of Esophageal Candidiasis. (IV) Treatment of invasive Aspergillosis in patients who are refractory to or intolerant of other therapies (i.e, amphotericin B, lipid formulations of amphotericin B, and/or itraconazole) For the treatment of patients with candidemia, acute disseminated candidiasis, candida peritonitis, Micafungin ( as sodium) Powder abscess and esophageal candidiasis. for solution for infusion 50mg / vial For the prophylaxis of Candida infection in patients undergoing hematopoietic stem cell transplantation (HSCT) For prophylaxis and treatment of the Loteprednol Etabonate Nasal spray nasal symptoms of seasonal allergic 0.1% w/v rhinitis.

31.01.09

12.

Caspofungin acetate Injection (Addl. Indication)

31.01.09

13.

31.01.09

14.

31.01.09

15.

Rasagiline (as mesylate ) Tablet 0.5mg/1mg

For the tratment of signs and symptoms of idiopathic Parkinson's disease as intial monotherapy and as an addition to levodopa. To reduce the withdrawal symptoms, including nicotine craving, associated with quitting the smoking and quitting chewed tobacco and guthka containing tobacco. For the infestation of trematodes, nematodes, cestodes and arthropods of domestic animals, including milch and other food producing animals. For the short term use in acute painful & inflammatory conditions in adults

31.01.09

16.

Nicotine Polacrilex Gum 2mg & 4mg (Addl. Indication)

03.02.09

17.

Closantel Injection100mg/ ml (for verterinary use.)

05.02.09

18.

Lornoxicam 4mg + Paracetamol 500mg film coated tablets

05.02.09

19.

Cetrimide15% w/v + Chlorhexidine For cleansing of physically Gluconate 7.5% v/v + Isopropyl contaminated wounds and for preAlcohol 7.5% v/v Concentrate operative disinfection Solution Ketoconazole 2% w/v + Prepared Coal Tar 2% w/v (I.P. 1966) Solution Doripenem (as monohydrate) Injection 250mg/500mg

09.02.09

20.

For the treatment of dandruff

09.02.09

21.

For the treatment of nosocomial pneumonia in adults.

16.02.09

22.

For the relief of inflammatory and Halobetasol Scalp Approved 0.05% puritic manifestation of w/v corticosteroid respensive dermatosis

18.02.09

23.

Nicotine (as Polacrilex) Lozenges 2mg & 4mg

To reduce the withdrawal symptoms, including nicotine craving, associated with quitting the smoking and quitting chewed tobacco and guthka containing tobacco. For the treatment of menorrhagia For the treatment of dizziness and feeling of dizziness resulting from Meniere's disease, Meniere's syndrome and vertigo. In moderately to severly active rheumatoid arithritis in adults and may be used as monotherapy or concomitantly with DMARD's other than TNF antagonists

18.02.09

24.

Tranexamic Acid Tab SR 750mg

20.02.09

25.

Betahistine Mesilate Tablet 6mg/12mg

20.02.09

26.

Abatacept Injection 250mg/vial (Addl. Indication)

20.02.09

27.

For the treatment of invasive Anidulafungin Injection candidiasis including candidemia (Lyophilized powder) 50mg/100mg and esophageal candidiasis in adult per vial patients. Hydroquinone 2%+ Tretinoin 0.05% + Hydrocortisone1%Cream For the treatment of patients with skin hyperpigmentation

23.02.09

28.

23.02.09

29.

For the treatment of asthma and Doxyphylline 400 mg + Terbutaline chronic obstructive pulmonary 5mg tablets disease in adult patients only Hydroquinone 20mg + Tretinoin 0.25mg + Fluocinolone Acetonide 0.1mg per gm Cream For the treatment of melasma of face in adults

23.02.09

30.

23.02.09

31.

Ketoconazole 2% + Zinc Pyrithone For the treatment of pityriasis and dandruff of the scalp 1% Lotion

23.02.09

32.

Lamivudine 30mg + Zidovudine 60mg + Nevirapine 50mg Oral Suspension (Tablets for oral Suspension)

For the treatment of HIV patients

23.02.09

33.

As 3rd line treatment of type II diabetes mellitus when diet, Glibenclamide 5mg + Pioglitazone exercise and the single agents and 15mg + Metformin500mg film the second line therapy with two coated tablets drugs do not result in adequate glycemic control Aceclofenac 100mg + Tizanidine 2mg film coated tablets For the treatment of acute low back pain in adult patients only

23.02.09

34.

23.02.09

35.

Octinoxate 7.5% + Avobenzone 3% As sunscreen lotion for prevention + Oxybenzone 3% + Titanium of sunburn skin dioxide 2% lotion For the symptomatic relief of productive cough associated with allergic rhinitis, when both antihistamine and mucolytic agents are desired For single agent anesthesia in upper gastro intestinal endoscopy.

23.02.09

36.

Cetrizine 5/10mg + Ambroxol 30mg per 5ml syrup

23.02.09

37.

Lidocaine Lozenges 200/300mg

26.02.09

38.

Calamine 8% + Liquid Paraffin10% As antipruritic and smoothening agent lotion

26.02.09

39.

Nifedipine 0.3% + Lidocaine1.5% cream

For the treatment of anal fissures

26.02.09

40.

For the treatment of mild to moderate hypertension in adult patients (in whom combination Quinapril 20mg + HCTZ 25mg film therapy is appropriate) who have coated tablet been stabilized on the individual components given in the same proportion Levodopa 100/100/250 + Carbidopa 10/25/25mg mouth dissolving tablet For the symptomatic symptoms of idiopathic Parkinson's Disease

26.02.09

41.

04.03.09

42.

Paliperidone ER Tablets 1.5mg

Addl. Strength

04.03.09

43.

Losartan 100mg+ HCTZ 25 mg tablet

Additional higher strength

16.03.09

44.

Darunavir(as ethanolate) Tablet 300mg

For the treatment of human immunodeficiency virus (HIV) infection in antiretroviral treatment experienced adult patients, such as those patients with HIV-1 strains resistant to more than one protease inhibitor when co-administered with 100mg ritonavir, and with other antiretroviral agents. For the production of local or regional anasthesia for surgery and for acute pain management. As vitamin and phosphorous supplement for livestock, shirmp and fish.

19.03.09

45.

Ropivacaine HCl Inj.2/5/7.5/10mg

19.03.09

46.

Butaphosphan 100g + Methyl Hydroxybenzoate 1gm + Cyanocobalamin50 gm Oral powder (Veterinary Drug) Fluticasone furoate Nasal spray 27.5mcg per spray

19.03.09

47.

For the treatment of symptoms of allergic rhinitis.

19.03.09

48.

Octinoxate 7.5% + Avobenzone 2% A sunscreen lotion for prevention of + Oxybenzone 3% + Octocrylene sunburn skin 3%+ Zinc Oxide 2% lotion Omeprazole 20/40mg + Sodium Bicarbonate 600mg+ Magnesium Hydroxide 700mg sachet

19.03.09

49.

Additional Strength

19.03.09

50.

Ambroxol 30mg + Levo salbutamol For the symptomatic relief of bronchospasm in bronchial asthma 1mg+ Guiphenesin 50mg /5ml & chronic bronchitis syrup Montelucast 4 mg+ Levocetrizine 2.5 mg tablet

19.03.09

51.

Additional lower paedriatric dose

19.03.09

52.

Surgical Sealant

To be indicated for use in sealing suture lines along arterial and venous reconstructions.

26.03.09

53.

For the relief of pain associated with Lidocaine Patch 700mg in aqueous post-herpetic neuralgia. It should be base. (50 mg per gram adhesive) applied only to intact skin. For the treatment of hypotrichosis of the eyelashes by increasing their growth including length, thickness and darkness.

26.03.09

54.

Bimatoprost Opthalmic solution 0.03%

30.03.09

55.

For the treatment of patients with advanced soft tissue sarcoma, after Trabectedin powder for concentrate failure of anthracyclines and for solution for infusion 1 mg/ vial ifosfamide, or who are unsuited to recieve these agents. For the treatment of children (age 6to 12years) with chronic obstructive pulmonary disease(COPD) and bronchial asthma.

30.03.09

56.

Acebrophylline Syrup 10mg/ml (Additional Indication)

30.03.09

57.

Mesalamine PR Tablets 1.2gm

For the induction of remission in patients with active, mild to moderate ulcerative colitis.

30.03.09

58.

Mycophenolate Mofetil Tablets 750mg Additional Strength

Same as approved

31.03.09

59.

Ketorolac Tromethamine Gel 2%w/w

For the treatment of muscle, joint and post-traumatic stress.

31.03.09

60.

Theophylline 400mg SR + Montelukast 10mg Tablet

For the treatment of patients with bronchial asthma

31.03.09

61.

Hyaluronic Acid Sodium Salt 0.2 gm + Silver Sulfadiazine 1.0 gm/25 gm tube Hyaluronic Acid Sodium For the treatment of wound of different etiology Salt 50 mg + Silver Sulfadiazine 1.0 gm/ 100 gm gauze pads impregneted with cream. Telmisartan 80mg + Amlodipine 5mg tablet Hyaluronic Acid Sodium Salt (i) Each 15gm tube contains: Hyaluronic Acid Sodium Salt 0.2gm/100gm

31.03.09

62.

Additional higher strength

31.03.09

63. (ii) Sterile Gauze Pads impregnated with cream: Each gauze pad contains Hyaluronic Acid Sodium Salt 50/100mg

For the treatment of wound of different etiology

31.03.09

Abatacept Injection 250mg/vial (additional indication) 1.

For reducing signs and symptoms of moderately to severly active polyarticular juvenile idiopathic arthritis/juvenile rheumatoid arthritis in pediatric patients 6 years of age and older who have had an inadequate response to one or more DMARD's such as MTX

10.04.09

2.

Cetrizine 10 mg + Ambroxol 75 mg For symptomatic relief of SR Tablet productive cough associated with allergic rhinitis, when both antihistamine and mucolytic agents are desired Ciclesonide 200mcg + Formoterol 6mcg + Tiotropium 9mcg MDI Indicated as third line treatment of severe cases of COPD, when monotherapy and second line therapy with two drugs do not respond adequately.

13.04.2009

13.04.2009

3.

4.

For the tretament of patients with Each film coated bilayred tablet contains: Metoprolol 25mg/50mg + mild to modrate essential hypertension Chlorthalidone 12.5mg For the management of Caps fibromylagia.

13.04.2009

5.

Milnacipran 25/50mg (Addl. Indication) Lornoxicam SR 16mg Tabs

15.04.2009

6.

For the symptomatic treatment of pain and inflammation in patients of osteoarthritis & rheumatoid arthritis Same as approved

25.04.2009

7.

Palonosetron Hcl 0.075mg IV Inj (Addl. Strength)

25.04.2009

8.

Additional strength Each film coated bilayred tablet contains: Metoprolol 25mg/50mg + Chlorthalidone 6.25 mg /12.5mg

25.04.2009

9.

Albendazole 400 mg + Ivermectin 6 For the treatment of intestinal mg tablet helminthes and suppression of microfilaraemia especially with bancrofti infections Decitabine Lyophilized powder for For treatment of patients with injection 50mg/20ml vial myelodysplastic syndromes (MDS) including previously treated and untreated, de novo and secondary MDS of all French-AmericanBritish subtypes(refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, and chronic myelomonocytic leukemia) and intermediate-1, intermediate-2, and high-risk international Prognostic Scoring System groups. Retapamulin Ointment 1% For the topical treatment of bacterial skin and skin structure infections:Primary impetigo, secondarily infected traumatic lesions, secondarily infected dermatoses. For the tretament of pruritis and prickly heat

25.04.2009

25.04.2009

10.

25.04.2009

11.

12.

Each ml contains Calamine 15% w/v + Zinc oxide 5% w/v + Bentonite 3% w/v+ Glycerin 5%w/v + Sodium citrate 0.05 % w/v lotion

08.05.2009

13.

Each 1000 ml of emulsion contains: Medium chain triglycerides 100 gm + Soya oil 80 gm + Omega-3 acid triglycerides 20 gm + egg lecithin 12 gm + Glycerl 25 gm + Sodium oleate 0.30 gm + Alpha -tocopherol 0.20 gm + Ascorbypalmitate 0.30 gm + Sodium hydroxide max. 0.06 gm + water for injection 784 gm emulsion for infusion Sertaconazole Nitrate Powder 2% w/w & Lotion 2% w/v

For the supply of fats, including essential omega-6 fatty acids and omega-3 fatty acids, as part of a parenteral nutrition regimen in adults if oral or enteral nutrition is impossible, inadequte or contraindicated.

14.05.2009

14.

For the topical treatment of the superficial fungal infections of the skin. 1. To reduce of fatal coronary heart disease and non-fatal myocardial infarction, and to reduce the risk of stroke. 2. To reduce the risk of coronary revascularization procedures and the need for hospitalization due to angina in patients with coronary artery disease.

02.05.2009

Amlodipine Tablets 5mg/10mg (additional indication)

02.05.2009

15.

16.

Clindamycin Phosphate Inj. Prophylaxis of infection in neck and 150mg/ml & Clindamycin HCl head surgery Capsules 150mg/300mg (additional indication) Each 15 gm sachet contains: Lactulose 10 gm + Ispaghula husk 3.50 gm granules Sucralose For the treatment of chronic idiopathic constipation in adult patients only for use as sweetner in drug formulations

02.05.2009

16.05.2009

17.

09.05.2009

18.

CarvedilolTablets 3.125/6.25/12.5/25mg (additional indication) 19.

To reduce cardiovascular mortality in clinically stable patients who have survived the acute phase of a myocardial infarction and have a left ventricular ejection fraction of 40% (with or without symptomatic heart failure) For the treatment of Acute musculoskeletal pain

09.05.2009

20.

Dexketoprofen 12.5 mg/25 mg + Paracetamol 500 mg film coated tablets Pregabalin SR Tablet 150/300mg

18.05.2009

21.

For the treatment of peripheral neuropathic pain in adults

16.05.2009

Guaiphenesin ER Tablet 1200mg 22.

For the treatment of productive cough accompanied by Phlegm

16.05.2009

23.

Everolimus 5/10mg Tablets (Addl. Treatment of advance renal cell Indication) carcinoma

16.05.2009

Nimesulide ER 200mg 24. ( Additional Indication)

Acute pain in Orthopaedic, ENT, Dental and Post Operative condition

16.05.2009

25.

Palonesetron Injection 0.25mg/5ml For treatment of Post Operative (Additional Indication) Nausea & vomiting

16.05.2009

26.

Bendamustine Hydrochloride Lyophilized powder Injection 100mg/ vial Caffeine(as Citrate) Injection

For the treatment of patients with chronic lymphocytic leukemia.

16.05.09

27.

10mg / ml For the short term treatment of apnoea of prematurity of infants between 28 and < 33 weeks gestational age.

16.05.09

28.

Perindopril arginine 2.5mg/5mg/10mg film coated tablet

For the treatment of arterial hypertension, congestive heart failure and coronary artery disease.

16.05.09

29.

For the topical treatment of Each gm contains: Halobetasol 0.05% w/w + Mupirocin 2.0 % w/w inflammatory dermatitis with secondry bacterial infection gel Mometasone 0.1 % + Fusidic acid 2% cream/ointment For the treatment of dermatoses where secondry bacterial and/or candidial infection is present

16.05.09

25.04.09

30.

31.

Thiocolchicoside 8 mg + Etoricoxib Additional strength 60 mg tablets

25.04.09

32.

Methadone Hydrochloride 5mg/10mg per ml syrup; 5mg/ 10mg/ 20mg / 40mg tablet Trospium Chloride film coated tablet 20mg

For the treatment of opiod dependence and in maintainence treatment for opioid dependence. For the treatment of overactive bladder with the symptoms of urge urinary incontinence, urgency, and urinary frequency.

28.05.09

28.05.09

33.

34.

Arformoterol (as Tartrate ) 15mcg / For the long term, twice daily 2ml Inhalation Solution (morning and evening) maintainence treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. Zolmitriptan...5.0% w/v Benzalkonium Chloride NF ... 0.01% w/v Nasal spray For the acute treatment of migraine with or without aura in adults.

29.05.09

29.05.09

35.

36.

Dexmedetomidine ( as HCl) 100mcg /ml Injection Levetiracetam SR Tablet 500/750/1000mg

For sedation of initially and mechanically ventilated patients during treatment in an intensive care setting. same as approved

29.05.09

2.05.2009

37.

38.

Glatiramer Acetate Injection (20mg/ ml) & Pre-filled syringe (20mg/ml)

For the reduction of the frequency of relapses in patients with Relapsing-Remitting Multiple Sclerosis.

3.06.2009

39.

For the treatment of unresectable metastatic liver tumors from Yttrium-90 Microspheres Injection primary colorectal cancer with intra(Yttrium-90...3GBq (at the time of hepatic artery chemotherapy calibration) per vial) (IHAC) of FUDR (Floxuridine) For the treatment of cutaneous mycosis viz. Tinea pedis, Tinea corporis, Tinea cruris. 1) For the treatment of generelized or partial seizures as monothreapy or adjunctive threapy. 2) For prophylaxis of migraine headache in adults. 3) For the treatment of manic episodes associated with bi polar disorders For the treatment of chronic Hepatitis B in adults

3.06.2009

40. Luliconazole Cream 1%

3.06.2009

41.

Magnesium Valporate Prolonged release tablet 600mg

4.06.2009

42.

Tenofovir Disoproxil Fumerate 300mg

19.6.2009

43.

For the treatment of pulmonary arterial hypertension (WHO Group Bosentan (as monohydrate) Tablets I) in patients with WHO Class III or 62.5/125mg IV symptoms, to improve excercise ability and decrease the rate of clinical worsening. Lornoxicam 12 mg SR (additional strength) same as approved

23.6.2009

26.6.2009

44.

45.

for the treatment for mild to moderate susceptible infection Azithromycin SR Granules for oral including RTI, uncomplicated skin/ suspension 2000mg skin structure, non gonococcal urethritis, cervicitis As 2nd line treatment of patients with both essential hypertension and hypercholesterolemia who are not adequately controlled by combination of an anti-hypertensive with lipid lowering agent. For the treatment of Attention Deficit Hyperactivity Disorder (ADHD) same as approved

26.6.2009

1.07.2009

46.

Metoprolol 50/50/25 mg + Atorvastatin 20/10/10 mg + Ramipril 10/5/2.5 mg capsules

47.

Methyl Phenidate ER Tablet 10/20/30mg

10.07.2009

48.

Dasatinib Tablets 100mg (addl. Strength)

10.07.2009

49.

Voglibose 0.2 mg + Metformin 500mg Tablets

As 2nd line treatment of type II Diabetes mellitus when diet, exercise and the single agent do not result in adequate glycemic control.

13.7.2009

15.7.2009 Combipack of artesunate tablet For the treatment of P. falciparum and FDC Tablet of sulphadoxine resistant malaria patients + pyrimethamine Composition: A. combipack of 1 stip of 3 tablets of artesunate 25 mg and 1 strip of 1 tablet of sulphadoxine 125mg+ pyrimethamine 6.25 mg B. combipack of 1 stip of 3 tablets of artesunate 50 mg and 1 strip of 1 tablet of sulphadoxine 500mg+ pyrimethamine 25 mg C. combipack of 1 stip of 3 tablets of artesunate 100 mg and 1 strip of 1 tablet of sulphadoxine 500mg+ pyrimethamine 25 mg D. combipack of 1 stip of 3 tablets of artesunate 200 mg and 1 strip of 1 tablet of sulphadoxine 500mg+ pyrimethamine 25 mg. Milnacipran 100mg (additional Strength) same as approved 16.7.2009

50.

51.

52.

Rifaximin 400mg (additional Indication)

For the treatment of hepatic encephalopathy

18.7.2009

53.

Nevirapine tablet 50 mg for oral suspension mg

For the treatment of HIV infection in combination with other anti retro viral agents For the treatment of major depressive disorder (MDD)

18.7.2009

54.

Desvenlafaxine (as Succinate) ER Tablets 50mg/100mg

18.7.2009

Posaconazole Oral Suspension 40mg/ml

55.

For the treatment of oropharyngeal candidiasis, including oropharyngeal candidiasis refractory to itraconazole and/or fluconazole. For prophylaxis of invasive Aspergillus and Candida infections in patients, 13 years of age and older, who are at high risk of developing these infections due to being severly immunocompromised, such as hematopoietic stem cell transplant (HSCT) recipients with graft-versus-host disease (GVHD) or those with hematologic malignancies with prolonged neutropenia from chemotherapy. same as approved

18.7.2009

56.

Caffeine Citrate 20mg / ml (equivalent to 10mg of Caffeine base) Oral Solution (Addl. Dosage form) Amphotericin B Emulsion 5mg/ml (Addl. Indication)

18.7.2009

57.

Febrile Neutropenia in cancer patients

18.7.2009

58.

Hydroxy ethyl starch 10% Solution For the treatment of imminent or for infusion manifest hypovolemia and shock.

18.7.2009

59.

Naratriptan (as HCl) Tablets 1/ 2.5mg

For the acute treatment of migraine with or without aura in adults.

18.7.2009

60.

Colistimethate Sodium powder for solution for injection/infusion 500000IU and 2000000IU (additional Strength)

same as approved

20.7.2009

Simvastatin 20 mg + Ramipril 5mg + Atenolol 50 mg + HCTZ 12.5 mg + Aspirin 100 mg (EC Pellets) Capsules Colistimethate Sodium powder for solution for inhalation 500000IU/1000000IU/2000000IU

For secondary prevention of coronory heart disease/stroke in patients where use of such combination is appropriate Treatment by inhalation of Pseudomonas aeruginosa lung infection in patients with cystic fibrosis For the treatment of hypertension/ cardiac failure and myocardial infarction

21.7.2009

28.7.2009

61.

Ramipril MR capsule 10mg

62.

30.7.2009

Abacavir Sulfate Tablet 60mg 127. Zoledronic Acid Solution for Infusion Addl. Indication

For the treatment of HIV-1 infection 1.08.2009 in combination with other antiretroviral agents Prevention of clinical fractures after 1.08.2009 hip fracture in men and women

128.

129.

Sumatriptan 85 mg + Naproxen 500 Additional Strength for the mg Tablets treatment of migraine Aceclofenac(100mg) + Thiocolchicoside ( 8 mg) tablets Oxcarbazepine 150/300/600mg Tablet (Addl. Indication Ofloxacin 2mg + Ornidazole 5 mg per ml Infusion Clozapine Tablet200mg (Addl. Strength) Oxymetazoline Hydrochloride Nasal Spray50mcg/0.05%w/w

3.08.2009

130.

For the treatment of acute 3.08.2009 inflammation conditions associated with spasm in adults only Treatment of generalized tonicclonic seizures in adults and children for the treatment of diarrhoea of mixed infection in adult patients Indicated in the management of Schizophrenic patients 13.08.2009

131.

132. 133.

17.08.2009 19.08.2009

134.

Is indicated for the relief of 19.08.2009 stuffy,running nose associated with colds and influenza, also post nasal drip, sinusitis. Treatment of acute ST-segment elevation myocardial infarction including patients to be managed 19.08.2009

135.

Enoxaparin Sodium Injection (Addl.Indication)

medically or with subsequent percuaneous coronary intervention (PCI) 136. Fluvoxamine Maleate100/150mg ER Tablets For the treatment of obsessive compulsive disorder (OCD)and depression For single agent anesthesia in procedure involving the introduction of instrument & tubes into respiratory tract. Indicated as monotherapy or as adjunctive therapy in lithium or valproate for the maintenance treatment of Bipolar-1 disorder. 19.08.2009

137.

Lidocaine Lozenges 200/300mg (Addl. Indication)

19.08.2009

138.

Risperidone long acting injection (Addl. Indication)

29.08.2009

Exemestane 25mg Tablet (Addl. Indication) 139.

Indicated for adjuvant treatment of 29.08.2009 Post Menopausal Women with estrogen receptor positive early breast cancer who have received two-three year of tamoxifen and are switched to exemestane for completion of total of five years of adjuvant hormonal therapy. 01.09.2009

140

For the treatment of uncomplicated Artesunate (25/50/100mg) + Amodiaquine (67.5 mg/135/270mg) malaria due to plasmodium falciparum strain in various age bilayerd Tablets groups For the treatment of combined hyperlipidemia in patients with normal hepatic and renal function For the treatment of severe opioid responsive painconditions which are not adequately responding to nonopioid analgesics.For Hospital supply only.

01.09.2009

141

Ezetimibe 10 mg + Fenofibrate 145 mg Film coated tablets Buprenorphine Transdermal Patch Each Transdermal Patch having an area of 6.25cm, 12.5cm, and 25cmcontains: Buprenorphine5mg/10mg/20mg having release rate of 5mcg, 10mcg, 20mcg Buprenorphine per hour respectively(over a period of 7 days).

03.09.09

142

143

For the treatment of overactive bladder with the symptoms of urge Trospium Chloride ER Capsules 60 urinary incontinence, urgency and mg urinary frequency. Metoclopramide (as HCl) 200mg / 400mg per ml Intranasal Solution For the treatment of nausea and vomiting. For the treatment of heart failure as an adjunct to standard therapy in patients to improve survival, to prolong time to hospitalization for heart failure and to improve patients reported functional status.

04.09.2009

144

09.09.09

18.09.2009

145 Isosorbibe 20 mg + Hydralazine 37.5 mg tablets

146

Cefixime 200 mg + Dicloxacillin ER For the treatment of adult patients 500 mg Tablets with Upper and Lower respiratory tract infections, skin and soft tissue infections Chlorthalidone Tablet 6.25mg For the treatment of mild to moderate hypetension.

22.09.2009

147

03.10.09

148

Cefovecin( as sodium) 80mg/ ml Lyophilised powder for injection (Veterinary) Imidacloprid 10% + Moxidectin 1.0% & 2.5% Topical solution (Veterinary) Each pippette contains: (a) 0.4ml, 1.0ml, 2.5ml, 4ml of 10% Imidacloprid and 1.0% moxidectin (b) 0.4ml, 0.8ml of 10% Imidacloprid and 2.5% moxidectin

03.10.09 For the treatment of skin bacterial infections in dogs and cats. For the treatment and prevention of flea infestations, prevention of heartworm disease and treatment of infections with gastrointestinal nematodes in dogs and cats. 03.10.09

149

150

Isoflupredone AcetateSuspension for For the glucocorticoid, antiinflammatory or supportive therapy Injection (2mg per ml) ( For to cattle suffering from conditions Veterinary) such as: (1) Overwhelming infections with severe toxicity. (2) Bovine ketosis. (3) Musculoskeletal conditions. (4) Shock. (5) Parturient paresis (supportive stress therapy for milk fever). Saxagliptin (as HCl) 2.5mg/ 5mg Tablets As an adjunct to diet and exercise to improve glycemic control in adults with type-2 diabetes mellitus. (It should not be used for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis, as it would not be effective in these settings. For the treatment of moderate plaque psoriasis in adults same as approved

03.10.09

24.10.09

151

152

Calcipotriol Gel 0.005% (additional dosage form) Lamotrigine MR Tablets 150mg (Addl. Strength)

3.10.2009

153

3.10.2009

154

Metoprolol Tartrate ER Tablet 75mg same as approved (additional strength)

3.10.2009

Valganciclovir Powder for Oral Solution 50mg/ml 155

For the treatment of cytomegalovirus (CMV) retinitis in AIDS patients and for prevention of CMV disease in solid organ transplant patients at high risk

9.10.2009

156

Dexketoprofen Trometamol Gel 12.5mg/gm

For the painful and inflammatory conditions associated with joints, tendons, ligaments and muscle For the treatment of mild to moderate severe Alzheimer's Dementia

13.10.2009

157

Donepezil Hydrochloride Orodispersible Tablet 5mg/10mg

15.10.2009

158

Dexketoprofen Trometamol Injection Symptomatic treatment of acute pain 50mg/2ml of moderate to severe intensity, when oral administration is not appropriate such as post-operative pain, renal colic and low back pain. Bromocriptine Mesylate Tablet IP 0.8mg, (additional Indication) Indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. For the treatment of depression and schizophrenia in adults Additional strength

22.10.2009

22.10.2009

159

160

Levosulpride ER Tablet 100/150/200mg Ambroxol 30 mg+ Terbutaline 2.5 mg + Guaiphenesin 100mg + Menthol 2.5 mg per 5 ml syrup

27.10.2009

27.10.2009

161

162

Propofol 10 mg+ Lignocaine 2.5 mg Additional strength per ml injection Mecobalamin 750 mg + Pyridoxine Hydrochloride1.5 mg + Nicotinamide 45 mg tablets Olmesartan (20/40mg )+ Atorvastatin 5/10/20mg film coated tablets Deltamethrin (0.50% m/v) and Piperonyl Butoxide (2.0% m/v) per ml PourOn Solution For the treatment of diabetic neuropathy

27.10.2009

27.10.2009

163

164

For the treatment of co-existing essential hypertension and hyperlipidemia in adult patients Ready to use pour-on for cattle, sheep and goats. 1. For use in Cattle to control ticks, stable flies, horn flies, cattle louse

27.10.2009

29.10.2009

165

flies and nuisance flies e.g. house flies, to kill lice and protection against blackflies. 2. For use in sheep and goats for controlling Karoo paralysis, bontlegged and red-legged ticks 166 Glucosamine sulphate potassium chloride 500 mg + Ibuprofen IP 200mg film coated Tablets Methylcobalamin 1500 mcg + Gabapentin SR 600 mg film coated tablets Propofol 1% for injection (Additional Indication) For the treatment of adult patients 03.11.2009 with osteoarthritis of knee and/or hip joints Additional strength 4.11.2009

167

168

1. For conscious sedation for surgical and diagnostic procedures 05.11.2009 2. for sedation of ventilated patients receiving intensive care For the management of seasonal allergic rhinitis (SAR) 10.11.2009

169

Rupatadine 10 mg + Montelukast 10 mg Tablets

170

Eperisone 50 mg + Paracetamol 500 For improvement of mytonic mg Tablets conditions caused by neck shoulder arm syndrome , scapulhumeral periarthritis and low back pain in adult patients only Lafutidine Tablets ....5mg/10mg.

10.11.2009

171

For the treatment of: 11.11.2009 gastric ulcers, duodenal ulcers and stromal ulcers gastric mucosal lesions (erosion, hemorrhage, redness or edema) associated with acute gastritis and acute exacerbation of chronic gastritis. 1. Tablets 0.1mg & Injection 0.3-11.11.2009 for the prevention and treatment of gastrointestinal symptoms (nausea and vomiting) associated with emetogenic cancer chemotherapy. 2. Tablets 2.5mcg & 5mcg--- for the treatment of diarrhoea predominant irritable bowel syndrome.

Ramosetron Hydrochloride Tablets 2.5mcg, 5mcg, 0.1mg & Injecton 0.3mg /2ml 172

173

Tadalafil tablet 20 mg (Additional Indication) Flurbiprofen Sodium 0.03% Ophthalmic solution USP Dexmedetomidine HCl Injection (Additional Indication) Paliperidone ER tablet 12 mg (Additional Strength) 1) Triticum Vulgare Topical Cream Each 100gm of cream contains: Aqueous extract of Triticum Vulgare (dry residue 200mg / 100ml) ..... 15gm 2-phenoxyethanol Eur. Ph.....1gm 2) Triticum Vulgare Vaginal Pessary Each 3.5gm of vaginal pessary contains: Aqueous extract of Triticum Vulgare (dry residue 200mg/ 100ml) .....0.60gm 2-phenoxyethanol Eur. Ph.....0.04gm Febuxostat Tablets 80mg / 120mg

For the treatment of pulmonary arterial hypertension for the reduction of post-operative inflammatory condition Sedation of non-intubated patients prior to and/or during surgical and other procedure Same as approved

14.11.2009

14.11.2009

174

14.11.2009

175

14.11.2009

176

177

1) Triticum Vulgare Cream is 14.11.2009 indicated for the treatment of ulcers and bed sores. 2) Triticum Vulgare Vaginal Pessary is indicated for the treatment of phlogistic and dystrophic disorders of the female genital tract.

178

For treatment of chronic 14.11.2009 hyperuricemia in conditions where urate depression has already occured (including a history, or presence of tophus and /or gouty arthritis). For the treatment of 3 and 4 haemorrhoids (Addl. Indication). For the treatment of 1 and 2 internal haemorrhoids. 14.11.2009

179

Euphorbia Prostrata Dry Extract :100mg tablet (addl. Indication) Euphorbia Prostrata dry extract ethanolic 80%v/v[(35-70):1] cream 1% w/w

14.11.2009

180

181

Lactobacillus Rhammnosus 1 billion For the treatment of acute diarrhoea 4.11.2009 cells + Saccharomyces Boulardi 125 in children mg + Zinc Enriched yeast 20 mg sachets & capsules

182

Nimesulide 1.0% w/w + Ethanol 31% w/w topical solution

For the local application in relieving 17.11.2009 pain in acute low backache, tendonitis, tenosinovitis and sprains 20.11.2009

183

Diacerein Modified Release Capsule Symptomatic treatment of 100mg osteoarthritis of knee & hip For the treatment of essential Amlodipine hypertension 5mg/10mg/5mg/10mg/10mg + Valsartan 160mg/160mg/160mg/160mg/320mg + Hydrochlorothizide 12.5mg/12.5mg/25mg/25mg/25mg Tablets Maraviroc Tablets 150mg/300mg.

24.11.2009

184

185

For the treatment of patients infected 25.11.2009 with CCR5- trophic HIV-1. 25.11.2009

186

For the symptomatic treatment of S (+) Etodolac 150/200/300mg + Paracetamol 500/500/500mg Tablets acute pain and inflammation in patients with osteoarthritis, rheumatoid arthritis and ankylosing spondylitis Tacrolimus Granules for oral suspension 0.2/1 mg per sachet

187

Prophylaxis of transplant rejection in 26.11.2009 kidney, liver or heart allograft recipient 26.11.2009

Rifaximin Dispersible Tablet 200mg For infections diarrhoea in adults 188 Prednisolone Sodium Phosphate Orally Disintegrating Tablet 10/15/30mg Cinitapride Hydrogen Tartrate ER Tablet 3mg 190

189

Indicating for condition required 26.11.2009 Glucocorticoids activity including collagen disease, allergic disease and hypersensitive reaction For the treatment of gastroesophageal reflux disease (GERD) and functional inconveniences of the gastrointestinal motility 26.11.2009

Sevelamer Carbonate (Additional Indication) 191

for control of serum phosphorus in 26.11.2009 patients with chronic kidney disease on haemodialysis or peritoneal dialysis and patients with CKD not on dialysis with serum phosphate > 5.5 mg/dl

192

Oxcarbazepine Tablets (Additional Indication)150/300/600 mg

Monotherapy in the treatment of partial seizures in children ages 416

26.11.2009

193

Ketoprofen plaster 30 mg (7cm X 10 for the relief of musculoskeletal pain 11.12.2009 cm) & inflammation Acipimox Capsules 250mg. As adjunctive therapy to diet and weight loss in the treatment of type IIa, IIb and IV lipid disorders. Same as approved 26.11.2009

194 Amisulpiride SR Tablet 100 mg 195 Mycophenolate Sodium Enteric coated tablet 540 mg (Additional Strength) Loteprednol etabonate 0.5% w/v + Moxifloxacin 0.5% w/v opthalmic Suspension Ropinirole ER tablet 2/4/8mg 198 Diclofenac Diethyl amine transdermal patch 100 mg/37.5 sq cm (Additional Strength) Lornoxicam ER Tablet 8 mg (Additional Strength) Flurbiprofen plaster 20 mg (7cm X 10cm) Carvedilol Phosphate ER tablet 10/20/40/80mg 202

27.11.2009

Same as approved

29.10.2009

196

197

For the treatement of post operative steriod responsive inflammatory ocular infections or risk of bacterial ocular infections exists for the treatment of signs & symptoms of idiopathic Parkinson's disease same as approved

1.12.2009

3.12.2009

4.12.2009

199

same as approved

11.12.2009

200

201

for the relief of pain & inflammation 11.12.2009 due to rheumatoid arthritis , osteoarthritis and allied disorder 1. Mild to severe chronic heart 11.12.2009 failure. 2. Left ventricular dysfunction following myocardial infarction in clinically stable patients 3. hypertension For the treatment of acute and chronic infected eczematous dermatitis 15.12.2009

203

Halometasone monohydrate 0.05% w/w + Fusidic acid 2.00% w/w cream

204

For the treatment of type II diabetes 17.12.2009 Glimepiride 1/2 mg + Metformin 500 mg + Atorvastatin 10 mg tablets mellitus associated with dyslipidemia Betahistine Di hydrochloride CR capsule 24/32/48mg indicated in the treatment of 17.12.2009 Menier's syndrome, characterized by unilateral or bilateral tinnitus, vertigo, sensorineural hearing loss Indicated for the first line treatment 18.12.2009 of patients with locally advanced or metastatic non small cell lung cancer (NSLC) who have activating mutationof the EGFRTK". For selection,anxiolysis and amnesia 18.12.2009 prior to diagnostic, therapeutic or endoscopic procedure or before induction of anesthesia. For the treatment of productive cough accompanied by phlegm for the treatment of uncomplicated urinary tract infectins (such as cystitis and urethritis) For symptomatic treatment of nasal congestion with running nose (rhinorrhea) 18.12.2009

205

Gefitinib tab 250mg (Additional Indication) 206

Midazolam Hcl Syrup 2mg/ml 207 Guaiphenasin Syrup 133mg/5ml 208 Balofloxacin Tablet 100mg 209 Xylometazoline 0.5 mg + Ipratropium 0.6 mg Nasal spray

22.12.2009

23.12.2009

210

211

Doxofylline 400 mg + Ambroxol 30 For the treatment of patients with mg Tablets bronchial asthma and COPD, when use of both the drug is appropriate Ribavirin Capsules 200mg (Addl. Strength)

23.12.2009

212

Indicated in combination with peg 24.12.2009 interferon alpha-2b for the treatment of nave adult patients with chronic hepatitis C with clinically stable HIV co-infection. For the treatment of patients with 30.12.2009 bronchial asthma and COPD, where the use of combination is found appropriate 30.12.2009

213

Formoterol 6 mcg + Mometasone furoate 100/200/400mcg Metered dose Inhaler & Dry Powder Inhalation

214

Chlorohexidine Gluconate Gel 0.2% For the prevention of Plaque and treatment of gengivitis.

215

Chlorohexidine Gluconate Mouth wash 0.1%

For the prevention of Plaque and treatment of gengivitis.

30.12.2009

LIST OF APPROVED DRUG FROM 01.01.08 TO 31.12.08

S. No. Drug Name Me-salicylate 30% + Menthol 10% + camphor 4% Cream Indication For temporary relief from pain, swelling & inflammation due to musculoskeletal disorder Approval Date

29.11.07

Voglibose 0.2mg/0.3mg tablet (Mouth dissolving)

For improvement of parantial hyperphemia in diabetis mellitus only. When diet and/or exercise or oral, hypoglyceamic drug or insulin 28.12.07 preparation in addition to diet and or exercise do not result in adequate glycemic control. Same as Approved 31.01.08

Hydroxychloroquine 400mg tablets (Additional Strength) ISMN 30mg SR + Metoprolol Succinate equivalent to metoprolol tartrate 25mg/50mg tablets (Additional Strength) Halobetasol 0.05% + Clotrimazole 1.0% cream

Same as Approved

02.01.08

For the treatment of steroid responsive fungal infections including eczema and psoriasis For the treatment of disturbance of consciousness resulting from head injuries, brain operation and acute stage of cerebral infarction in adults only

04.01.08

Citicholine Syrup 750mg/5ml

04.01.08

Levodopa 200mg + Carbidopa 50mg For Parkinson's Disease C.R. tablet Nanocrystalline Silver Gel 0.002%

08.01.08

For the treatment of burns and wound 04.01.08 infections For the treatment of gastroesophageal reflux disease and functional 04.01.08 inconveniences of the gastrointestinal motility For the treatment of adult patients with HIV infection 07.01.08

Cinitapride (as hydrogen tartrate) 1mg tablet

10

Tenofovir disoproxil fumarate 300mg + Lamivudine 300mg tablet

11

For the treatment of Urinary tract infections, respiratory tract Cefixime 200mg/100mg + Lactic acid bacillus 2.5 billion spores tablet infections, biliary tract infections in adult patients prone to antibiotic & dispersible tablet associated diarrhoea D-Trans Fentanyl Metrix system (12mcg/hr.) (Additional Strength) Ceftazidime 500mg + Tobramycin 60mg per vial (Injection) Atazanavir 300mg capsules (Additional strength) Ertapenem for injection 1gm/vial (additional indication) Same as Approved

07.01.08

12

07.01.08

13

For the treatment of lower respiratory tract infection caused by 08.01.08 pseudomonas aeruginosa Same as approved For the prophylaxis of surgical site infections following elective colorectal surgery 08.01.08

14

15

15.01.08

16

Vildagliptin Tablets 50mg/100mg

As an adjunct to diet and exercise to improve glycemic control in patients 18.01.08 with type-II diabetes mellitus For the treatment of dyslipidemia associated with atherosclerotic arterial disease with risk of myocardial infarction, stroke or peripheral vascular disease

17

Atorvastatin 10mg + Aspirin 75/150mg Capsules

18.01.08

18

Smatriptan (as succinate ) 50mg + Naproxen sodium 550mg tablets

For the treatment of acute migraine

22.01.08

19

Sodium Valproate 666mg + valproic acid 290mg equivalent as sodium Same as Approved valproate 1000mg C.R. tablet (Additional Strength)

24.01.08

20

For serious CRTI, uncomplicated and Cefepime (as hydrochloride) complicated UTI, Uncomplicated 2000/1000/500mg + Sulbactam (as skin & skin structure, infection acute 24.01.08 sodium) 1000/500/250mg per vial of exacerbation of chronic bronchitis & injection intraabdominal infection. Paclitaxel Nanoparticle Solution for Ovarian cancer, non-small cell lung Injection 20mg/ml (Additional cancer and AIDS related Kaposis indication) Sarcoma Sorafenib tablets 200mg (Additional For hepatocellular Carcenoma Indication) For prophylaxes and treatment of both influenza A & B in adults and children (greater than or equal to 5 years) For the prophylaxis of acute organ rejection in patients receiving allogeneic hepatic transplantation

21

22.01.08

22

22.01.08

23

Zanamavir inhalation powder 5mg/blister (Additional Indication)

22.01.08

24

Mycophenolate Mofetil Capsule 250mg, 500mg & Oral suspension 200mg/ml (Additional Indication) Combikit 4 tablets of Alendronate sodium trihydrate equivalent to Alendronic acid 70mg each + 24 tablets of Calcium carbonate 1250mg (equivalent to 500mg Calcium) + cholecalciferol-250IU

23.01.08

25

For the treatment of osteoporosis in post-menopausal women

23.01.08

26

Aceclofenac injection 150mg/ml

For short term treatment of pain due to post operative and post traumatic cases

23.01.08

27

For the treatment of uncomplicated and complicated UTI, uncomplicated Atorvastatin 10mg + Fenofibrate 25.01.08 skin and skin structure infections, 80mg tablet (Additional Indication) and complicated intra-abdominal infections Sodium Valproate 499.5mg + Valproic acid 217.5mg equivalent as Same as Approved sodium valproate- 750mg CR tablet (Additional Strength) Diclofenac 50mg + Serratiopeptidase 10mg enteric coated tablet Gabapentin 100mg + methylcobalamin 500mcg tablets (Additional Strength) Cefpirome (as sulphate) 500/1000mg/2000mg + Sulbactam (as sodium ) 250mg/500mg/1000mg powder for injection Metformin HCl ER 500mg + Fenofibrate 80mg/160mg tablet For the treatment of acute pain in adults

28

24.01.08

29

24.01.08

30

Same as Approved

24.01.08

31

For the treatment of infection caused by sensitive organisms viz. lower 24.01.08 RTI, complicated UTI, Septicemia, bacteremia For the treatment of Type-II diabetes 25.01.08 associated with mixed dyslipidemia 28.01.08

32

33 34

Salicylic acid 10mg/20mg (Foaming For the treatment of acne vulgaris facewash solution)

Ozagrel Hcl. Tablets 100mg/200mg For the treatment of bronchial asthma 28.01.08 Rivastigmine transdermal patch (each patch of 5m2, 10m2,15m2 & 20m2 contain Rivastigmine base 9/18/27/36mg respectively For the treatment of patients with mild to moderately severe dementia of the Alzheimer type and dementia associated with Parkinsons disease

35

28.01.08

36

For the treatment of complicated skin Daptomycin powder for concentrate and skin structure infections and for for solution for infusion 28.01.08 staphylococus aureus bloodstream (350mg/500mg per vial) infections (bacteremia) Dextromethorphan Orodispersible For the relief of persistent dry 28.01.08

37

strip 5.5mg/11mg Diclofenac sodium 50mg + Dicyclomine HCl 20mg per ml of injection

irritating cough in adult patients only

38

For the treatment of acute colicky pain in adults

28.01.08

39

Travoprost 40mcg + Timolol (as Maleate) 5mg per ml of eye drops

For decrease of intraocular pressure in patients with open angle glaucoma or ocular hypertension, who are 28.01.08 insufficiently responsive to topical beta blockers or prostaglandin analogues For RTI, SRS of tissue infection, bons & joint infection, ENT infection 30.01.08 in adults prone to antibiotic associated diarrhoea For RTI, SRS of tissue infection, bons & joint infection, ENT infection 31.01.08 in adults prone to antibiotic associated diarrhoea For the treatment of lower RTI, skin & soft tissue bone & joint infections, ENT infections in adult patients 30.01.08 prone to antibiotic associated diarrhoea As 3rd line treatment of sever cases of COPD when monotherapy and second line therapy with two drugs do not respond adequately

40

Amoxicillin 250mg/125mg + Cloxacillin 250mg/125mg + Lactic Acid Bacillus 1.7 Billion spores

41

Amoxicillin 250mg + LactoBacillus 1.7 billion Spores

42

Amoxycillin 250mg + Cloxacillin 250mg + Lactobacillus 2 billion spores capsules

43

Tiotropium (as Tiotropium Bromide Monohydrate) 18mcg + Formoterol Fumarate Dihydro. 12mcg + Ciclesomide 400mcg per capsules

31.01.08

44

Metoprolol Succinate Equivalent to For the treatment of patient with both Metoprolol Tartrate [ER 25/50mg] + essential hypertension and 28.01.08 Atorvastatin (As calcium ) 10mg hypercholesterolemia tablets Levocetrizine Di HCl Dispersible tablet 5mg/10mg (New Dosage form) For allergic rhinitis & chronic urticaria

45

28.01.08

46

Oseltamivir 30mg & 45mg Capsules Same as Approved (Additional Strength) Fondaparinax Sodium injection (Additional Indication) Treatment of acute coronary syndrome (ACS) with and without ST-segment elevation For remission of acute symptoms of chronic pancreatitis and postoperative reflux esophagitis

28.01.08

47

28.01.08

48

Camostat Mesylate tablets 100mg

29.01.08

49

Hyaluronic Acid Salt 25mg + CrossFor intradermal implantation and Linked Hyaluronic acid 25mg per facial soft tissue agumentation ml in prefilledsyringe Ursodeoxycholic acid tablets 600mg For the treatment of patients with chronic cholestatic liver disease

30.01.08

50

30.01.08

51

Dalteparin Sodium Injection(Additional Indication)

For the extended treatment of symptomatic venous thromboembolism (VTE) proximal deep thrombosis (DVT) and/or 30.01.08 pulmonary embolism (PE), to reduce the recurrence of VTE in patients with cancer For the topical treatment of bacterial 30.01.08 and fungal infections For adjunctive therapy to improve glycemic control in patients with type-II diabetes mellitus, who have not achieved adequate glycemic control with metformin, a sulfonylurea or a combination of metformin and a sulfonylureas For the symptomatic treatment of acute pain and inflammation in patients with osteoarthritis, rheumatoid arthritis and ankylosing

52

Beclomethasone Dipropionate 0.25mg + Econazole 10mg + Neomycin 5mg per gm of Cream

53

Exenatide injection (Each 2ml vial contains- Exenatide 5mcg/10mcg per 0.2ml ) (Additional Strength)

30.01.08

54

Diclofenac Sodium 50mg + Paracetamol 500mg tablets

30.01.08

spondylitis

55

Gabapentin SR 600mg tablets

As adjunctive therapy in the treatment of partial seizures of epilepsy

30.01.08

56

Memantine 5mg /10mg + Donepezil For moderate to severe Alzheimer's 5mg Tablets disease Doxifluridine Capsules 100mg/200mg

31.01.08

57

For carcinoma of the stomach, colon, 31.01.08 rectum, breast, uterine, cervix and bladder 31.01.08

58

Haemodialysis Powder/Liquid Form For use for patients being treated by containing citrate hemodialysis

59

Carmustine (polifeprosan 20 with carmustine Implant (Wafer)

1:- In newly diagnosed high-grade malignant glioma patients as an adjunct to surgery and radiation. 2:- 31.01.08 In recurrent glioblastoma multiforme patients as an adjunct to surgery For the treatment of irritable bowel syndrome As adjunct to rest and physical therapy for relief of muscle spasm associated with acute painful musculoskeletal conditions For the topical treatment of the superficial mycosis like dermatophytosis 31.01.08

60

Cimetropium Bromide tablet 50mg

61

CyclobenzaprineHcl. Tablets 5mg/10mg

31.01.08

62

Sertaconazole Nitrate Cream 2%,

31.01.08

63

Cefpodoxime 50mg + Clavulanic acid 31.25mg dispersible tablet & dry syrup (Additional strength)

Same as Approved

31.01.08

64

Darifenacin (as hydrobromide) 7.5mg/15mg ER tablets

For the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency and frequency

31.01.08

65

Amoxycillin 125mg/250mg/500mg + Lactobacillus 1.66 billion Spores (Capsules)

For the treatment of respiratory tract infection, skin and soft tissue 31.01.08 infections & antibiotics associated diarrhoea in adult patients For steroid responsive dermatoses associated with superficial fungal infection of skin

66

Halobetasol 0.5mg + Miconazole 20mg per gram Cream

31.01.08

67

Montelucast 10mg + Levocetirizine For the treatment of allergic rhinitis 5mg film coated tablets in adults only

31.01.08

68

For short term intermittent treatment of moderate to severe melasma of the Hydroquinone 2% + Tretinoin 0.025% (w/w) Momentasone 0.10% face in the presence of measures for 31.01.08 Gel sun avoidance including use of sun screen Phenylephrine 5mg + Chlorpheniramine maleate 0.5mg + For the treatment of common cold Paracetamol 125mg + sodium citrate and cough associated with fever 60mg + Menthol 1mg (per 5ml) Syrup Diclofenac Sodium 100mg (SR Pellets) + Rabeprazole Sodium 20mg (E.C Pellets) Capsules Ciclesonide 160mcg/320mcg/Formoterol 12mcg + Tiotropium 18mcg Dry powder inhaler VSL # (Combination of lactic acid bacteria (VSL # 3) For treatment of painful inflammatory conditions associated with gastroduodenal ulcers As third line treatment of severe cases of COPD, when monotherapy and second line therapy with two drugs do not respond adequately For the treatment of irritable bowel syndrome

69

31.01.08

70

31.01.08

71

31.01.08

72

31.01.08

73

For the treatment of serious infection caused Gram-Ve bacteria including Clostimethate Sodium of 1,00,000IU LRTI, UTI, where commonly used 31.01.08 Injection anti bacterial agent may be infective because of bacterial resistance

74

Ramipril 5mg + HCTZ 12.5mg tablets (Additional Strength)

Same as Approved For the treatment of amoebiasis, urogenital trichomoniasis & giardiasis for the additional indication "acute manic episode associated with bipolar disorder additional Strength (it should not be used routinely because of increased risk of adverse events. It should be reserved for patients who are considered to be at higher risk after careful risk assessment

20.02.08

75

Metronidazole CR tablet 600mg

21.02.08

76

Quetiapine fumarate SR tablets

21.02.08

77

Atorvastatin Calcium 80mg tablets (Additional Strength)

25.02.08

78

Euphorbia Prostrata Dry Extract (ethanolic 80% (v/v) (35-70) :100mg For the treatment of haemorrhoid tablet Amtolmetin Guacil tablets 600mg Brimonidine Tartrate Opthalmic solution 0.1% (with purite as preservation 0.0005%) (additional strength) For the treatment of osteoarthritis & rheumatoid arthritis

29.02.08

79

07.03.08

80

For lowering of IOP in patients with open angle glaucoma occular 07.03.08 hypertension 1:- For repigmentation of idiopathic vitiligo alongwith phototherapy. 2:For symptomatic control of severe, recalcitrant, disabling psoriasis in conjunction with phototherapy Same as Approved

81

Methoxsalen USP-20mg Tablet

07.03.08

82

Cefditoren pivoxil 400mg tablets (Additional Strength) Doxofylline ER tablets 400mg/800mg (addl. Strength)

11.03.08

83

For the treatment of bronchial asthma 12.03.08 & COPD in adults

84

For the treatment of steroid Betamethasone 0.05% +Miconazole responsive dermatoses associated 2% Cream with superficial fungal infections of the skin Premetrxed disodium injection 100mg/vial (Additional Strength) Omeprazole 20mg/40mg + Sodium bicarbonate 1680mg per sachet powder for oral suspension ISMN 30mg SR + Atenolol 50mg tablets (Additional Strength) Temozolamide capsules 140mg/180mg (Addl. Strength) Amisulpiride 300mg tablets (Additional Strength) Nifedipine SR Tablets 10mg/20mg Ambroxol HCl. 15mg + Guiphenesin 50mg + Terbutalin sulphate 1.25mg + Menthol 2.5mg per 5 ml of syrup Ambroxol HCl 30mg + Guaiphenesin 100mg + Terbutaline sulphate 2.5mg per 10ml Syrup Boswellia Serrata 0.05gm/gm of Cream Etoricoxib injection 90mg/ml Same as Approved

12.03.08

85

12.03.08

86

For gastric ulcer, duodenal ulcer, and 12.03.08 GERD

87

Same as Approved

19.03.08

88

Same as Approved

31.03.08

89

Same as Approved For the treatment of essential hypertension For symptomatic relief of bronchospasm in bronchial asthma and chronic bronchitis

20.03.08

90

24.03.08

91

26.03.08

92

For the symptomatic relief of bronchospasm in bronchial asthma & 26.03.08 chronic bronchitis For the treatment of mild to moderate 28.03.08 psoriasis For short term use in acute painful condition in adults only 28.03.08

93

94

95

Drospirenone 3mg + Ethinyl estradiol 0.02mg tablets (Additional Oral contraceptive in women Strength)

28.03.08

96

Nimesulide 100mg ER + Levocetirizine HCl 5mg Tablets

For symptomatic treatment of acute rhinosinusitis

28.03.08

97

Dexketoprofen (as Trometamol ) tablets 12.5mg/25mg

For the treatment of mild to moderate pain, such as dental pain, 28.03.08 dysmenorrhoea & musculoskeletal pain For the treatment of pain and inflammation associated with cataract surgery For pain management in patients suffering with osteoarthritis of the knee, hip, shoulder and ankle

98

Nepafenac Opthalmic suspension (1mg/ml)

31.03.08

99

Hylan GF 20 Injection (Synvisc) (Additional Indication)

31.03.08

100

Docetaxel injection conc.

For additional indication "advanced gastric adenocarcinoma, locally advanced squamous cell carcinoma 31.03.08 of head & neck, Harmone refraetory metastatic prostrate cancer, locally advanced or metastatic breast cancer

101

Methylcobalamin 1000mcg + Pyridoxine Hcl IP 100mg + Nicotinamide IP 100mg + DPanthenol IP 50mg per 2 ml of injection

For peripheral neuropathy

31.03.08

102

Lamivudine 20mg + Stavudine 5mg Same as Approved dispersible tablets (Additional Sgtrength)

01.04.08

103

For short-term treatment of Nicardipine Hcl. Injection 2.5mg/ml hypertension when oral therapy is not 07.04.08 feasible or not desirable Diclofenac Potassium 50mg + Serratiopeptidase (as enteric coated pellets) 15mg capsules (Additional Strength)

104

For the treatment of acute pain in adults

08.04.08

105

Diacerin 50mg + Aceclofenac 100mg tablets Rabeprazole sodium Enteric coated pellets 15.4% w/w (20mg/129.83mg)

For the treatment of adult patients with osteoarthritis of knee and or hip 11.04.08 joints

106

Same as Approved

16.04.08

107

Live freeze-dried lactic acid bacteria For the treatment of irritable bowel and bifidobacteria capsules syndrome Miltefosin Capsule 10mg/50mg (Additional Indication)

10.04.08

108

Treatment of cutaneous leishmaniasis 16.04.08 As an antimicrobial barrier for management of partial thickness burns, incisions, skin grafts, donor 16.04.08 sites, lacerations, abrasions and Stage I-IV dermal ulcers (vascular, venous, pressure and diabetic) For the treatment of adult patients with osteoarthritis of knee and hip joints

109

Silver Wound Dressing

110

Diacerin 50mg + Glucosamine sulphate 500mg tablets.

21.04.08

111

For focal spasticity, including the Clostridium Botulinum type-A toxin treatment of arm symptoms haemagglutinin complex (Additional associated with focal spasticity in Indication) conjunction with physiotherapy For the treatment of systemic candidiasis, mucosal candidiasis, prevention of fungal infections in patients with malignancy

22.04.08

112

Fluconazole Dispersible tablets 50mg

22.04.08

113

In combination with dexamethasone Lenalidomide Capsule for the treatment of multiple 22.04.08 5mg/10mg/15mg/25mg (Additional myeloma patients who have received Indication) at least one prior therapy Sitagliptin ( As Phosphate) 50mg + Metformin Hcl. 500mg/1000mg Film coated tablets As an adjunct to diet & exercise to improve glycemic control in patients 28.04.08 with type-two diabetes mellitus

114

115

Lansoprazole for injection 30mg/vial

For short term treatment of errosive esophagitis when patients are unable 28.04.08 to take the oral formulation For the treatment of RA in children 5 28.04.08 years of age and above

116

Naproxen Suspension 125mg/5ml

117

For control of serum phosphorus in Sevelamer Carbonate 400mg/800mg patients with chronic kidney disease tablets & sachet 400mg/800mg on dialysis Rabeprazole Sodium (With Sodium For the treatment of gastric ulcer, bicarbonate as buffer) 10mg/20mg duodenal ulcer, Zollinger Ellison tablets Syndrome and GERD Pantoprazole Sodium (With Sodium For the treatment of gastric ulcer, bicarbonate as buffer) 20mg/40mg duodenal ulcer, Zollinger Ellison tablets Syndrome and GERD For the treatment of community acquired pneumonia, acute Cefdinir 250mg dispersible tablets & exacerabation of chronic bronchitis, oral suspension 250mg/5ml uncomplicated skin and skin structure infection, Pharyngitis/tonsillitis Pregabalin capsules (Addl. Indication) Pregabalin 75mg/150mg + Methylcobalamin 750mcg capsules (Additional Strength) management of fibromyalgia syndrome

28.04.08

118

28.04.08

119

28.04.08

120

29.04.08

121

29.04.08

122

Same as Approved

08.05.08

123

Aliskiren 150/150/300/300mg + HCTZ 12.5/25/12.5/25mg tablets

For the treatment of essential hypertension in adult patients whose 08.05.08 blood pressure is not adequately controlled on monotherapy . For diabetes insipidus and noctural emuresis Same as Approved

124

Desmoprission lyophilisate Oral tablets 60mcg/120mcg/240mcg per tablets Losartan Potassium 25mcg +

08.05.08

125

14.05.08

Amlodipine (as besylate) 5mg tablets. (Additional Strength) Lecithin Liquid (each 5 ml contains For alcoholic liver disease, drug lecithin 500mg equivalent to induced hepatitis essential phospholipids 250mg Halobetasol 0.05% + Salicylic acid 6% Ointment (additional Strength)

126

14.05.08

127

For the treatment of plaque psoriasis 14.05.08

128

Benzoyl Peroxide Medicated For the topical treatment of acne Solution (each textured pad contains vulgaris 4.5%/6.5%/8.5% of solution Deflazocort 24mg tablets (Additional strength) Sodium Chondroitin sulfate 40mg + sodium Hyaluronate 30mg per ml Intraocular Injection (additional strength) Esomeprazole (with Sodium bicarbonate as buffer) 20mg/40mg tablets Telmisartan 40 mg + Atorvastatin (as calcium) 10 mg Tablets Milnacipran Hcl. 25mg/50mg equivalent to Milnacipran free base 21.77 or 43.55 mg. tablet. Metolazone 2.5mg + Losartan Potassium 25mg/50mg tablets Same as Approved

14.05.08

129

14.05.08

130

For use as a surgical aid in anterior segments procedure including catract 14.05.08 extraction & intra-ocular lens implantation For the treatment of GERD, gastric and duodenal ulcer, Zollinger-Ellison 14.05.08 syndrome For coexisting essential hypertension 22.05.08 & hyperlipidemia For the treatment of adult patients with major depressive disorder For hypertension in patients whose blood pressure is not adequately controlled in monotherapy For essential hypertension in adult patients whose blood pressure is not adequately controlled on monotherapy For the treatment of secondary hyperthyroidism in patients with

131

132

133

22.05.08

134

28.05.08

135

Metolazone 2.5mg + Ramipril 2.5mg/5mg

28.05.08

136

Doxercalciferol 0.5mcg/2.5mcg Soft

29.05.08

Gelatin capsules

chronic kidney disease on dialysis For the treatment of adult patients with chronic obstructive pulmonary disease and bronchial asthma

137

Acebrophylline capsules 100mg

29.05.08

138

Sofalcone Capsule (100mg/50mg)

For the treatment of gastric ulcer and management of gastric mucosal lesions (erosion, hemorrhage, redness 02.06.08 or edema) associated with acute gastritis or acute exacerbation of chronic gastritis For the relief of pain and 02.06.08 inflammation in patients with rheumatoid arthritis and osteoarthritis

139

S(+) Etodolac ER tablets 200mg/300mg

140

For the treatment of adult patients Diclofenac Sodium 50mg + Codeine with signs & symptoms of acute Phosphate 50mg tablets painful conditions Sodium Hyaluronate injectable gel (each 0.6ml. 1ml pre filled syringe contains, sodium Hyaluronate 20mg/ml, 22.5mg/ml Amphotericin B Lipid suspension injection (25mg/vial) with lipid suspension

02.06.08

141

For intradermal implantation and facial soft tissue augmentation

03.06.08

142

For invasive fungal infection in patients who are refractory to or intolerant of conventional amphotericin B therapy

03.06.08

143

Dexrabeprazole 10mg (EC) + Domperidone 30mg SR Capsules

For the treatment of Gastroeasophageal Reflux Disease 09.06.08 (GERD) in patients not responding to dexrabeprazole alone For acute low back pain & other musculoskeletal painful and inflammatory condition in adults

144

Thiocolchicoside 4mg/8mg + Ketoprofen 50mg/100mg tablets Cefotaxime sodium + Sulbactam sodium for injection (Additional

11.06.08

145

For the treatment of lower respiratory 24.06.08 tract infection in children

Indication) Artemether 40mg/80mg + Lumefantrine 240mg/480mg tablets Same as Approved (additional Strength) For the treatment of chronic stable anginapectoris in patients with normal sinus rhythm who have a contraindication or intolerance for Beta-blockers Indicated to meet daily requirement of nitrogen (amino acids), energy (glucose) for patients needing parentral Nutrition Same as Approved For the treatment of RTI, UTI and abdominal infections in adults

146

24.06.08

147

Ivabradine (Hcl.) 5mg/7.5mg Tablets

03.07.08

148

Amino Acid, Glucose Parentral Solution (Solution for intravenous infusion) Temoporfin 1mg/ml Injection (Additional Strength) Pazufloxacin Mesylate i.v. infusion 300mg/100ml & 500mg/100ml

08.07.08

149

08.07.08

150

09.07.08

151

Metoprolol ER + Amlodipine tablets For coronary artery (Additional Indication) disease/ischaemic lheartt disease Fenofovir Disoproxil fumarate 300mg + Lamivudine 300mg + Efavirenz 600mg tablets Vildagliptin 50mg/50mg/50mg + Metformin Hcl 500mg +850mg +1000mg tablets

16.07.08

152

18.07.08

153

For the treatment of type_II diabetes mellitus when single drug therapy 21.07.08 alongwith diet, exercise do not result in adequate glycemic control For Testosterone replacement therapy of male hypogonadism when 22.07.08 testosterone dificiency has been confirmed by clinical feature or biochemical tests

154

Testosterone Undecanoate 250mg/ml Injection

155

Abatacept powder for injection 250mg/vial

For adult patients with severe active rheumatoid arthritis who had an inadequate response to one more DMARDs such as methotixate or TNF antagonists For the treatment of rheumatoid arthritis patients

22.07.08

156

Actarit 100mg Tablets Tenofovir Fumarate 300mg + Lamivudine 300mg + Efavirenz 600mg Tablets Bacillus Clausii Spores (2 Billion) Capsules (additional dosage form) Gatifloxacin 0.3% + Ketorolac Tramthamine 0.4% eye Drop Ketorolac Tromethamine 4mg + Gatifloxacin 3mg Eye Drops

22.07.08

157

For the treatment of HIV infection in 23.07.08 adults

158

Same as Approved For reduction of part operative inflammatory condition of eyes For the reduction of post operative inflammatory conditions of the eye

23.07.08

159

24.07.08

160

24.07.08

161

Cefadroxyl (as monohydrate) 125mg + Clavulanic acid (as potassium) Same as Approved 31.25 per 5ml Syrup (Additional strength)

25.07.08

162

Doxercalciferol (0.5/ 2.5mcg) Soft Gelatin Capsule (Additional Indication)

For the treatment of secondary hyperparathyroidism in patients with 05.08.08 stage 3 or stage 4 chronic kidney disease

163

Artemether + Lumefantrine Dispersible tablet (40/80mg + 240/480mg ) (Additional Strength)

Same as approved

05.08.08

164

Ceftazidime + Tobramycin injection (1gm + 120mg) (Additional Same as approved Strength)

05.08.08

165 Olopatadine Nasal Spray (0.6%)

For the relief of the symptoms of seasonal allergic rhinitis in patients 12 years of age and older For the symptomatic treatment of pain and inflammation condition in patients with osteoarthritis

05.08.08

14.08.08

166 Loxoprofen Sodium tablet (60mg)

167

Dexibuprofen Suspension 50mg/5ml For the treatment of mild to moderate 14.08.08 pain, reduction of fever For the treatment of postoperative inflammation & reduction of postoperative ocular pain in patients who have undergone cataract 14.08.08 extraction for the treatment of acute bacterial otitis media, skin & soft structure infections, UTI, uncomplicated gonorrhoea, pelvic inflammatory disease, bacterial septicemia, bone and joint infections, intra abdominal 18.08.08 infections, meningitis, surgical prophylaxis

168 Bromfenac Sodium Eye Drop (0.09%)

169 Ceftriaxone + Sulbactam injection (Additional Indication)

170

For the treatment of disturbance of consciousness as resulting from head Citicoline Chewable tablet (500mg) injuries , brain operation and acute stage of cerebral infraction in adult 18.08.08 only Ambroxol + loratadine + Guaifenesin Syrup (30mg + 5mg + 50mg per 5ml)

171

For the treatment of productive cough

18.08.08

172

Ferrous Ascorbate + Folic Acid + Zinc FC Tablets (100mg + 1.5 mg + For the treatment of iron deficiency 22.5 mg)

18.08.08

anaemia

173

Cyclobenzaprine 7.5mg tablets (Additional Strength)

Same as approved

18.08.08

174

S-Metoprolol Succinate Oral Solution (Each Ml contains: SMetoprolol Succinate 9.5mg equal to S-Metoprolol Tartrate 10mg)

For the treatment of haemodynamically stably patients with definite or suspected acute Myocardial Infarction to reduce cardio-vascular mortality.

19.08.08

175 Doxorubicin HCl Pegylated Liposomal Injection (20/50MG) (Additional Indication) Povidone Iodine Sachet (containing Effervescent Granules) Each 2gm Sachet contains: 175mg (available iodine 17.5mg) Sodium Chondroitin Sulphate + Sodium Hyaluronate injection (40mg + not more than 17mg per ml)

In combination with bortezumab for the treatment of progressive multiple myeloma in patients who have received at least one prior therapy and who have already undergone or 23.08.08 are unsuitable for bone marrow transplant As mouthwash for oral hygeine in various oropharyngeal conditions, surgery, dental infections, and halitosis

176

25.08.08

177

Same as approved

25.08.08

178

Metolazone + Spironolactone FC Tablets (2.5/5mg + 50mg)

For the treatment of oedema associated with congestive heart failure, cirrhosis and nephritic syndrome

25.08.08

179

Tretinoin Microsphere Gel (0.1% W/V)

For topical treatment of acne vulgaris 26.08.08

180

Misoprostol 50Mcg tablet (Additional Strength)

Same as approved

26.08.08

181

Ferrous Ascorbate + Folic Acid Suspension (Equiv. to elemental iron Same as approved 30mg + 550mcg per 5ml) (New Dosage Form)

27.08.08

182

Guaiphenesin ER Tablet (600mg)

For the treatment of productive cough accompanied by phlegm

28.08.08

183

Clopidogrel 300mg Tablet (addl. Strength) Capecitabine 150/500mg Tablets (addl. Indication) Lopinavir + Ritonavir (100 + 25mg) Tablets (additional strength) Ixabepilone lyophilized powder inj. 15mg/45mg per vial

As approved

02.09.08

184

For the treatment of patients with metastatic colorectal cancer For the treatment of patients with HIV infection

02.09.08

185

08.09.08

186

in combination with capecitabine for the treatment of patients with metastatic or locally advanced breast cancer resistant to treatment with an anthracycline and a taxane, or whose cancer is taxane resistant and for whom further anthracycline therapy is contraindicated. For the relief of inflammatory and pruritic manifestation of noninfected corticosteroid responsive

13.09.08

187

Halometasone (as monohydrate ) 0.05% Cream

13.09.08

dermatoses like eczema

188

Calcium and Magnesium 24% (Veterinary) injectable solution.

For the treatment of milk fever, hypocalcaemia tetanies and disorders of calcium metabolism in dairy cattle. for the treatment of essential hypertension

13.09.08

189

Telmisartan + Ramipril (40mg + 2.5mg ) Tablets (Additional Strength) Drotaverine + Aceclofenac (80mg + 100mg) Tablets

15.09.08

190

For the treatment of adult patients with muscular pain associated with spasm For the treatment of mild to moderate hypertension in adult patients whose blood pressure is not adequately controlled by monotherapy for the treatment of essential hypertension

15.09.08

191

Losartan + Chlorthalidone (25/25/50/50mg + 6.25/12.5/6.25/12.5mg) Tablets

15.09.08

192

Olmesartan + Ramipril (5mg + 40mg) tablets (Additional Strength) Fluconazole + Zinc Pyrethrone (Each 30/60ml bottle contains: 2% + 1%) Lotion Citicoline CR Tab 1000mg

15.09.08

193

For the treatment of seborrhoeic dermatitis

15.09.08

194

For the treatment of patients with serious cerebral injuries of vascular traumatic nature with or without loss of consciousness & for treatment of degenerative damages & chronic cerebral vascular injuries in senile dementia.

16.09.08

195

Montelukast Suspension 5mg/5ml

For the treatment of Prophylaxis & chronic treatment of Asthma in Pediatrics patients 12 months of age & older. For relieving symptoms of seasonal allergic rhinitis in Pediatric patients 2 years of age & older & perennial allergic rhinitis in Pediatric Patients 6 months of age & older.

16.09.08

196

Etoricoxib roll on Topical Solution 1% v/v

For the treatment of pain, swelling & inflammatory conditions due to arthritis. As already approved

16.09.08

197

Risedronate Sodium 150mg Tablet (Additional Strength) Levosulpiride Inj. 25mg/ml, 2ml

16.09.08

198

For the treatment of depression and schizophrenia in adults when oral therapy is not possible For the acute and maintenance treatment of schizophrenia For treatment of bovine respiratory disease (BRD, Shipping fever, pneumonia) associated with Mannhenia haemolytica, Pasteurella multocida, andHistophilus somni in beef, non-lactating dairy, and lactating dairy cattle For treatment of sub clinical mastitis in dairy cattle at the time of dry off asssociated with staphylococcus aureus, Streptococcus dysgalactiae,

26.09.08

199

Paliperidone ER Tablet 3mg / 6mg / 9mg Ceftiofur Crystalline free acid Suspension equi to Ceftiofur ---200 mg(veterinary)

26.09.08

200

26.09.08

201

Ceftiofur HCl Suspension(as HCl salt) ----500mg (veterinary)

26.09.08

and Streptococcus uberis.

202

Ceftiofur HCl Suspension (as HCl salt) ----125mg (veterinary)

For treatment of clinical mastitis in lactating dairy cattle asssociated with coagulase- negative staphylococci, Streptococcus dysgalactiae, and Escherichia coli. For the treatment of acute uncomplicated urinary tract infections (acute cystitis) caused by susceptible strains of Escherichia coli or Staphylococcus saprophyticus For the relief of painful muscle spasms of the skeletal musculature For the short term use in acute painful and inflammatory condition For the treatment of disturbance of consciousness resulting from head injuries, brain operation & acute stage of cerebral infraction in adult. Indicated for the treatment of mastitis, metritis, pneumonia, pleuritis, fever and relieving of acute pain in musculoskeletal disorders in animals For the treatment of calcium and Vitamin D deficiency states (pregnancy, lactation, growing Children)

26.09.08

203

Nitrofurantoin SR Tab. 100mg

26.09.08

204

Tolperisone HCl Tablet 50 / 100 / 150mg Etoricoxib + PCM (60mg + 500mg) Tablets Citicoline Oral Drops

26.09.08

205

30.09.08

206

30.09.08

207

Paracetamol + Meloxicam + Benzyl Alcohol + Lignocaine (5mg/ml + 150mg/ml + 1% + 1% ) Injection

30.09.08

208

Calcium (as Calcium Citrate Malate) + Colecalciferol (as Colecalciferol Concentrate) + Folic Acid (250mg + 100IU +

30.09.08

50mcg) Tablets

209

Artemether + Lumefantrine (80mg + 480mg/5ml) Dry syrup

for the treatment of chloroquine resistant/multidrug resitant on complicated malaria For the treatment of hyperprolactinemia and inhibition of lactation. In combination with cisplatin is indicated for the first line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology For the prevention and treatment of mycoplasma induced chronic respiratory disease in broilers and breeders, the prevention and treatment of diseases due to clostridium perfringens (necrotic enteritis, wet litter, cholangiohepatitis), the prevention and treatment of ornithobacterium rhinotacheale (ORT) Treatment of patients with multiple myeloma For the treatment of vulvo-vaginal candidiasis in women

30.09.08

210

Cabergoline 1mg Tablets (Additional indication)

01.10.08

211

Pemetrexed disodium500mg / 100mg powder for sol. (Addl.indication )

08.10.08

212

Tylvalosin tartrate oral soluble granules Sachet 62.5% w/w (Veterinary)

08.10.08

213

Bortezomib inj.3.5mg/vial (Additional Indication) Sertaconazole Nitrate Vaginal Tab.500mg

09.10.08

214

09.10.08

215

Fosfomycin Tromethamine Sachet 3gms

For the treatment of uncomplicated urinary tract infections (acute cystitis) in women due to susceptible strains of E.Coli and Entreococcus faecalis As monotherapy for the treatment of metastatic or locally advanced breast cancer in patients whose tumors are resistant or refractory to cytotoxic chemotherapy. Previous therapy should have included as anthracycline, a taxane, and capecitabine For the treatment of essential hypertension For topical treatment of Acne vulgaris. For the treatment of systemic lupus erythematosus Indicated in the regular treatment of patients with moderate to severe COPD with frequent symptoms and a history of exacerbations For post operative steroid responsive inflammatory ocular condition when bacterial ocular infections or a risk of bacterial ocular infections exists. For the treatment of acute inflammation conditions associated with spasm in adults only

09.10.08

216

Ixabepilone lyophilized powder (additional Indication)

09.10.08

217

Eprosartan Mesylate 400 mg / 600mg Tablets Tretinoine Gel as Micro Sphere 0.04% % 0.1% Hydroxychloroquine Sulphate (Additional indication ) Budesonide + Formoterol (80/160mcg + 4.5mcg) Inhalational Powder (Additional Indication) Azithromycin + Dexamethasone (10mg + 1mg) Eye Drops

11.10.08

218

14.10.08

219

17.10.08 17.10.08

220

221

21.10.08

222

Diclofenac + Thiocolchicoside (50mg (EC) + 8mg) Capsules

21.10.08

223

Adapalene 0.1% + Benzoyl Peroxide 2.5% gel

For the treatment of acne vulgaris

24.10.08

224 Aceclofenac Roll - On 1%

For the treatment of acute musculoskeletal pain in patients

24.10.08

225 Citicoline Troches 200/500mg

For the treatment of patients with 31.10.08 serious cerebral injuries of vascular traumatic nature with or without loss of consciousness and for treatment of degenerative damages and chronic cerebral vascular injuries in senile dementia.

226 Amisulpride S.R.Bilayered tablet 200/400mg

For acute and chronic schizophrenic 03.11.08 disorders, in which positive symptoms and or negative symptoms are prominent, including patients characterised by predominant negative symptoms. For the treatment of hypocalcaemia and/or osteoporosis 04.11.08

227 Calcitriol + Calcium + Zinc (0.25mcg + 200mg + 7.5mg) Capsules 228 Atazanavir + Ritonavir(300mg + 100mg) FC Tablets 229 Timolol Maleate SR Eye Drops 5.0mg / ml

For the treatment of patients with HIV 04.11.08 infection For the treatment of elevated intraocular pressure in patients with ocular hypertension or open angle glaucoma. 08.11.08

230 Rosuvastatin Calcium tablets 5/10/20/40mg (Addl. Indication)

1) As an adjunctive therapy to diet for 08.11.08 the treatment of adult patients with hypertriglyceridemia. 2)As an adjunctive therapy to diet to slow the progression of atherosclerosis in adult patients as part of a treatment strategy to lower Total-C and LDL-C to target levels. For the treatment of advanced gastric 08.11.08 carcinoma

231 Paclitaxel inj.30/100/300mg vial (Addl. Indication)

232 Montelucast + Desloratidine(10mg For the treatment of allergic rhinitis + 5mg) FC Tablets in adults only

10.11.08

233 Amlodipine + Metoprolol (2.5/5 mg + 25/50mg (ER))Tablets

Additional Lower Strength

10.11.08

234 Losartan + HCTZ (100 mg + 25 mg) Tablets 235 Phenyramidol HCl tablet 400mg

Additional Strength

10.11.08

For the treatment of lumbago, integumental pain, musculoskeletal pain

14.11.08

236 Salicylic Acid + Coal Tar (3% + 1%) For scaling of seborrhea, seborrheic Solution dermatitis, psoriasis of scalp 237 Salicylic Acid + Coal Tar + Precipitated Sulphur (3% + 1% + 3%) Ointment For the treatment of psoriasis and fungal skin infection

17.11.08

17.11.08

238 Thiocolchicoside + Etoricoxib(4mg For the acute treatment of + 60 mg) FC Tablets inflammatory musculoskeletal disorders associated with painful muscle spasm in adults. 239 Tamsulosin + Tolterodine (0.4mg Additional Lower Strength MR Pellets + 2mg/4mg ER Pellets) Capsules 240 Calcium Hypochlorite 4gm Sachet For purification of contaminated (Calcium Hypochlorite 0.542% ground water sources. Other Ingredients: 99.458%) 241 Sumatriptan + Naproxen (50mg + 275mg) Tablets Additional Lower Strength

17.11.08

17.11.08

23.11.08

24.11.08

242 Amoxycillin + Clavulanic acid(1gm For the treatment and management of 25.11.08 + 62.5mg ) FC Tablets patients with community acquired pneumonia or acute bacterial sinusitis due to beta lactamase producing pathogens 243 Buprenorphine + Naloxone (2 mg/0.4mg + 0.5/0.1 mg) Tablets Additional Lower Strength 02.12.08

244 Atorvastatin + Metformin(10mg + 500mg SR) Tablets

As adjunctive therapy to diet and exercise in patients with diabetic dyslipidemia

04.12.08

245 Pemetrexed disodium 500mg / 100mg powder for sol. (Addl. Indication)

As monotherapy for the second-line 04.12.08 treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology

246 Magnesuim Valproate Tablet 200mg/400mg

For the treatment of generalized or 04.12.08 partial seizures as monotherapy or adjunctive therapy. For the treatment of maniac episodes associated with bipolar disorders. For prophylaxis of migraine headache in adults. 08.12.08

247 Ursodeoxycholic Acid 300/600 SR For the dissolution of Radiolucent Tablets (Additional Strength) collestral goll stone, chronic cholestatic liver disease in particular primary biliary cirrhosis, primary sclerosing cholangitis & cholestasis associated with cyatic fibrosis. 248 Rifampicin + INH + Piperine (200mg + 300mg + 10mg ) Capsules 249 Rifampicin +Piperine (200mg + 10mg ) Capsules 250 Amphotericin B Lipid suspension 50mg/ vial (Addl. Strength) For the treatment of adult patients with pulmonary tuberculosis

11.12.08

For the treatment of adult patients with pulmonary tuberculosis Additional Strength

11.12.08

12.12.08

251 Desmopressin Acetate tablet 0.1/0.2 mg

For the treatment of cranial diabetes 12.12.08 insipidus , primary noctumal enuresis in patients. For the medical termination of 16.12.08 intrauterine pregnancy (MTP) of up to 63 days gestation based on the first day of the last menstrual period

252 Mifepristone + Misoprostol (1 tab of mifepristone 200mg and 4 tab of misoprostol 200mcg) Combipack

253 Lamotrigine MR Tablets 50/100mg

For the treatment of bipolar I disorder. (addl. Indication)

17.12.08

254 Levosulpride Injection 25mg/2ml (Additional Strength)

For the treatment of different Gastro intestinal problems like functional dyspepsia, nausea, vomiting & diabetic gastroparesis. For the treatment of schizophrenia and depression in adults. As an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful, musculoskeletal conditions. In combination with cisplatin and 5fluorouracil is indicated for the induction treatment of patients with locally advanced squamous cell carcinoma of the head and neck.

17.12.08

255 Cyclobenzaprine HCl ER Capsule 15/30mg

17.12.08

256 Docetaxel injection concentrate 80mg/2ml, 20mg/0.5ml (Additional Indication )

17.12.08

257 Salicylic Acid + Cetyl Alcohol + Stearyl Alcohol (2% + 2.65% + 0.26%) Lotion 258 Azathioprine 25mg Tablets

For the treatment of scaly dermatoses 18.12.08

Additional Strength

19.12.08

259 Paracetamol solution for infusion 10mg/ml

For short term treatment of moderate 23.12.08 pain, especially following surgery and for the short term treatment of fever, when administration by i.v route is clinically justified Indicated for the treatment of lower respiratory tract infections in adult patients 1. For LRTI infections, 2. for UTI Complicated and uncomplicated, 3. for bacterial septicemia, 4. for bone and joint infections, 5. for gynaecologic infections including endometritis, pelvic cellutitis, and other infections of female genital tract, 6. for CNS infections including meningitis 24.12.08

260 Gemifloxacin + Ambroxol (320mg + 75mg SR) FC Tablets

261 Ceftazidime + Sulbactam (500/1000mg + 250/500mg) Injection

24.12.08

262 Paracetamol + Phenylephrine Hydrochloride (Each 6gm Sachet contains: 500mg + 10mg) Sachet

For the treatment of fever associated with cold, nasal congestion in adults

24.12.08

263 Carboinoxamine Maleate + Ammonium Chloride + Sodium Citrate (Each 5 ml contains: 2 mg + 120 mg + 120 mg) syrup

For symptomatic treatment of cough

24.12.08

264 Diclofenac + Thiocolchicoside (50 mg + 4 mg) Capsules

Additional Lower Strength

24.12.08

LIST OF APPROVED DRUG IN YEAR 2007

.No.
1 2 3 4 5

Drug Name
R-Ondansetron (As Hcl. Dihydrate) (1mg/ml) injection Torsemide 10mg + Amiloride 5mg tablets

Indication

Date of Approval

Chemotherapy induced nausea & vomiting 12.01.07 Edema Associated with congestive heart failure & hypertension 17.01.07 19.01.07 23.01.07 23.01.07

Fexofenadine suspension (30mg/5ml) SeAsonal allergic rhinitis & chronic idiopathic urticaria Sildenafil Citrate 20mg Tablet For pulmonary osterial hypertension Pioglitazone 15mg/30mg + MetFormin As approved ER 1000mg tablet (additional strength) FluvAstatin Tablet (As calcium) As approved 10mg/20mg/40mg (additional strength) Halobetazol Propionate Cream (0.05%) Corticosteroid responsive dermatomes Eszopiclone tablet (1mg/2mg/3mg) Diltiazem Hcl. 2% gel Nalbuphine injection 10mg/20mg per ml. Levonorgestrel 1.5mg tablets Pantaprazole sodium 20mg/40mg Tablet (with sodium bicarbonate As buffer) For insomnia For anal fissure For moderate to severe pain For emergency contraceptive For gAstric ulcer, duodenal ulcer, Z. E Syndrome, GERD

29.01.07

6 7 8 9 10 11 12

02.02.07 07.02.07 07.02.07 07.02.07 07.02.07 07.02.07

13 14 15 16

levofloxacin (250mg/500mg) + ambroxol SR 75mg tablet Testosterone cypionate (100mg/200mg) + Cotton seed oil 736/566mg per ml injection Rosiglitazone 1mg + Metofmin Hcl 500mg tablet (additional strength) Loteprednol Etabonate 5mg + Tobramycine 3mg per ml ophthalmic solution Amlodipine (As besylate) 5mg + Metoprolol (As succinate) ER 25mg (additional strength) Glibeneclamide 5mg + MetFormin SR 850mg tablet (additional strength) Aceclofenac injection (150mg/3ml)

For lower respiratory tract infection in adult 08.02.07 For testosterone deficiency (i) primary hypogonadism (ii) Hypogonadotropine hypogonadism As approved 08.02.07

08.02.07

For steroid responsive inflammatory ocular 14.02.07 condition As approved 14.02.07

17 18 19

As approved

15.02.07

For short term treatment of pain due to post 19.02.07 operative and post traumatic cAses 20.02.07

20

Metoprolol (As succinate) 50mg/25mg Angina pectoris in adults ER) + Amlodipine 5mg/2.5mg tablet (For additional indication) Ramipril 10mg + HCTZ 12.5mg tablet (additional strength) Amlodipine (As besylate) 5mg/5mg/10mg + valsartan 80mg/160mg/160mg tablet As approved Essential hypertension

21 22 23 24 25 26 27 28 29 30

20.02.07 21.02.07

Glatiramer Acetate injection (20mg/ml) Multiple sclerosis Baclofen ER (GRS) Capsule 45mg/60mg (additional strength) As approved

21.02.07 22.02.07 23.02.07 26.02.07 26.02.07 26.02.07 27.02.07

Amlodipine (As besylate )5mg/10mg + For hypertension Perindopril 4mg tablet Olopatadine Hcl. Tablet 2.5mg/5mg Metoprolol (As succinate) ER 25mg/50mg + Ramipril 2.5mg/5mg Allergic nAsal inflammation hives, itching with skin diseAses Essential hypertension

Rabeprazole Sodium 20mg/10mg with For Duodenal ulcer, G.U, Z.E.S. & GERD sodium bicarbonate As buffer Ciclesonide 160mcg/320mcg + Formoterol Fumarate (12mcg) (Dry powder inhaler additional strength) As approved

Moxonidine tablet 0.2mg/0.3mg/0.4mg For hypertension

27.02.07

31

Ceftriaxone (As sodium) 125mg/250mg As approved + Sulbactam (As sodium) 62.5mg/125mg For injection (additional strength) Quetiapine (As fumarate) SR 400mg tablet (additional strength) Cabergoline 1mg tablet (additional strength) As approved For Hyperprolactinemia

01.03.07

32 33 34 35 36

05.03.07 06.03.07 07.03.07

Levofloxacin Oral Solution (each 240ml Antibiotic (For adult use only) bottle contains Levofloxacin 125mg/5ml.) Clindamycin 1% + Isotretinoin 0.05% gel Estradiol topical emulsion 2.5mg/gm For acne Vasomotor symptoms Associated with menopause

08.03.07 16.03.07 16.03.07

37

Levosalbutamol MDI (50mcg/actuation) As approved & Dry Powder inhaler (100mcg/capsule) (New Dosage Form) Polonosetron (As Hcl.) For Injection 0.25mg/5ml Cifixime 200mg + Erdosteine 300mg Capsules Aminophylline CR 225/350mg Etoricoxib 10mg + Methyl salicylate 20mg per gm. of cream Eberconazole cream (1%)

38 39 40 41 42 43 44 45 46

Chemotherapy induced nausea & Vomiting 20.03.07 Acute Exacerbation of chronic bronchitis Asthma, COPD, Bronchitis Acute Musenlosleteal pain Dermatophyte infection of skin such As Tcorporis, T-c, T-Pedis 21.03.07 21.03.07 21.03.07 22.03.07 23.03.07 23.03.07 28.03.07 02.04.07

ISMN 60mg Sr + Atenolol 50mg/100mg For angina pectoris Levonorgestrel 0.03mg tablet Bortezomib 2mg/vial (additional pack size) Comb kit of two capsule of Azaranari 150mg each + 1 tablet of Ritonavir 100mg) For control of fertility As approved For HIV infection

47 48 49 50

Mecobalamine 500mcg + Alpha Lipoic For diabetic neuropathy acid 100mg soft gelatin capsule Propofol 10mg + Lignocaem 1mg per ml injection Ezetimibe 10mg + Fenofibrate 160mg tablet Methylprednisolone Acrponate topical solution 0.1% For induction of anesthesia For combined hypertipidemia Atopic dermatitis (eczema) inflammatory and allergic skin reaction

02.04.07

04.04.07 04.04.07 04.04.07

51 52 53 54 55 56 57 58 59

Citicoline (750mg) tablet (additional strength), syrup 500mg/5ml (new dosage Form) (not For children) Ertapenem For injection (1gm/vial) Letrozole 2.5mg tablet (for additional indication) Quetiapine SR Tablets 50mg ( additional strength) Metoprolol (As succinate) 25mg + Amlodipine (As besylate) 5mg (additional strength) Sunitinib Maleate Capsules 12.5mg/25mg/50mg Comb pack of 1 bottle of ciprofloxacin Injection (200mg/100ml) & 1 bottle of Ornidazole injection 500mg/100ml) Aprepitant 40mg capsules (additional strength) Olopatadime Ophthalmic solution (0.2%) (additional Strength)

As approved

10.04.07

Antibiotic For induction of ovulation in anovulatory infertility ( additional indication) As approved As approved

10.04.07 10.04.07

10.04.07 10.04.07

For G.I. Stromal tumor, advanced renal cell 10.04.07 carcinoma Antibiotic 20.04.07

Prevention of post-operative nausea & vomiting (additional indication) As approved

24.04.07 24.04.07

60

Combi pack of 1 tablet of Residronate For osteoporosis in postmenopausal women 01.05.07 sodium (35mg) + 6 tablet of calcium carbonate equivalent to 500mg calcium each Levocetirizem 2Hcl. Dispersible tablet (2.5mg) Amlodipine (As besylate) 10mg + Perindopril 8mg tablets (additional strength) Etodolac ER tablets 400mg/500mg Levosulpiride tablet (25mg) For allergic rhinitis & chronic urticaria As approved 08.05.07 07.05.07

61 62 63 64

For osteoarthritis & rheumatoid arthritis

09.05.07

10.05.07 For G.I. problem like fanatical dyspepsia, nausea, vomiting and diabetic gAstroperisis For Obese Patients BMI 30kg/m2 or overweight patients BMI 27kg/m2 with Associated risk factors such As type-I diabetes or dyslipidemia For constipation 11.05.07

Rimonabant tablet 20mg 65 Lactitol monohydrate Syrup 66.67/100ml

66 67 68

14.05.07 16.05.07

S(-) Metoprolol (As succinate) 25mg + For essential hypertension S(-) Amlodipine (As besylate 2.5/5mg Amlexanox Oral PAste (5%) For apthous ulcers in people with normal immune system

16.05.07

69

Lenalidomide capsule (5mg/10mg/15mg/25mg)

For transfusion dependent anemia due to myalodysplastic syndrom Associated with deletion 5q cytogenic abnormality

16.05.07

70

Cefotaxim (As sodium) 0.5mg/1gm + For surgical prophylaxis (additional Sulbactam (As sodium) 250mg/500mg indication) injection (for additional indication) Lornoxicam tablet 4mg/ 8mg For Osteoarthritis rheumatoid arthritis

18.05.07

71 72

21.05.07 21.05.07 21.05.07

Atenolol 25mg/50mg + Indapamide SR For essential hypertension 1.5mg Livetiracetam conc. for infusion 100mg/ml (new dosage form) As adjunctive therapy in partial onset seizures in adults with epilepsy when oral administration is temporarily not feasible For abnormality of vibration sense and abnormal change in heart rate associated with diabetic peripheral neuropathy As approved

73

Eplerstat tablet 50mg 74 Citicoline tablet 200mg (additional strength) Varenicline (As tartrate) 0.5mg/1mg tablets Azithromycin eye drops 1%

25.05.07

75 76 77 78

25.05.07

As an aid to smoking cessation treatment in 29.05.07 adults Conjunctivitis 06.06.07 08.06.07

Ciclesonide Nasal Spray 50mcg/spray For seasonal & perennial allergic rhinitis in adults, adolescents aged 12 years Antibiotic Ceftazidime 500mg/1000mg + Sulbactam (As Sodium) 250mg/500mg For injection Isotretinoin 0.05% + Erythromycin 2% For acne gel Aliskiren Tablet 150mg/300mg For hypertension Glimepiride 1mg/2mg. + Metformin SR As approved 1000mg tablet (additional strength) Cefditorene pivoxil dispersible tablet (30mg/50mg) (New Dosage form for children) As approved

08.06.07

79 80 81 82

08.06.07 08.06.07 08.06.07

08.06.07

83 84 85

Dexrabeprazole sodium Enteric Coated For Duodenal ulcer, Gastric ulcer & GERD tablet 5mg/10mg Renolazine Extend ReleAse tablet (500mg) For Chronic Angina

13.06.07 14.06.07

86

Phenytoin sodium ER capsules (300mg) (New dosage form)

For control of generalized toni-clonic and 14.06.07 treatment & prevention of seizures occurring during or following neurosurgery 14.06.07 14.06.07 15.06.07

87 88 89 90 91 92 93 94

Alfuzocin Hcl. ER (10mg) + Dutasteride For BPH in men with enlarged prostate 0.5mg tablet Cefepime injection 500mg/1gm/2gm (For additional indication) For bacterial meningitis in children

Tranexamic acid mouthwash (50mg/ml) For prevention of oral hemorrhage in anticoagulant treated patients undergoing oral surgery Deflazocort oral suspension (6mg/5ml) As approved (new Dosage Form) Tolterodine tartrate ER 4mg + Tamsulocin Hcl. ER 0.4mg tablet Omeprazole 20mg/40mg + Sodium Bicarbonate 1100mg capsules For BPH with overactive bladder For duodenal ulcer, gastric ulcer & GERD

15.06.07 15.06.07 15.06.07

Dexrabeprazole Sodium E. coated For duodenal ulcer, gastric ulcer and 13-06-2007. tablet 5mg/10mg. GERD. Cefepime Injection (New indication) For bacterial meningitis in children. Phenytoin Sodium E.R (300mg) 14-06-2007.

95

For control of generalised tonic-clonic 14-6-2007. (grand-mal) and prevention and treatment of seizures occuring during or following neurosurgery.

Tranexamic (50mg/ml) 96

acid

Mouth

Wash For prevention of oral hemorrhage in 15.6.2007. anticoagulant treated patients undergoing oral surgery.

97

Deflazacort Oral Suspension For asthma, rheumatoid arthritis when 15-06-2007. (6mg/5ml) (New dosage form) glucocorticosteriod therapy is warranted.

98

Tolterodine Tartrate 4mg (ER) + For BPH with overaction bladder in 15-06-2007. Tamsulosin HCL 0.4mg Capsule. Adults only. Omeprazole (E.coated) Sodium Bicarbonate capsule. 40mg + For gastric ulcer, duodenal ulcer and 18-6-2007. 1100mg GERD.

99

100 101

Mebeverine HCl prolonged release For irritable bowel syndrome capsule (200mg). Azithromycin 500mg + Ambroxol For RTI caused S.R (75mg) Tablet. organisms in adults. by

19-06-2007. susceptible 05-07-2007.

Pholcodiene Syrup (4mg/5ml). 102 Exenatide Injection -pre-filled pen (250mcg/ml).

For symptomatic relief of dry ticklish 06-07-2007. and unproductive coughs in children above 1 years. For adjunctive therapy to improve 06-07-2007. glycemic control in patients with TypeII diabetes mellitus, who have not achieved adequate glycemic control with Metformin, a sulfonyl urea or a combination of metformin and sulfonylurea.

103

104

Moxifloxacin HCL (0.5%) + For reduction of post-operative 11-07-2007. Ketorolac Tromethamine 0.5% inflammatory conditions of the eyes. Ophthalmic Solution. Levofloxacin (15mg) + Prednisolone For post-operative steriod responsive 11-07-2007. Acetate 10mg per ml eye drops. inflammatory ocular conditions when ocular bacterial infections or a risk of bacterial infection exists.

105

Loteprednol Etabonate (0.5%) Levofloxacin (1.5%) Eye drops. 106

+ For post-operative steriod responsive 12-07-2007. inflammatory ocular conditions when ocular bacterial infections or a risk of bacterial infection exists.

107

Clotrimazole (10mg) + Methyl- For fungal infection of skin associated 12-7-2007. prednisolone aceponate 1mg/gm of with inflammation. cream. Capecitabin (150mg/500mg). indication). Tablet (i). First line treatment of advanced 16-07-2007. additional gastric cancer in combination with platinum based regimen.(ii). Treatment of patients with locally advanced or metastatic breast cancer in combination with docetaxel following failure of cytotoxic chemotherapy.

(for

108

Rifabutin Capsule (150mg).

109

For treatment of pulmonary T.B only in 16-07-2007. patients co-infected with HIV. (It should never be used as a substitute to Rifampicin in T.B patients without HIV co-infection).

110

Lapatinib (as Ditosylate) (250mg) In combination with capecitabine it is 24-07-2007. Tablet. indicated in patients with advanced or metastatic breast cancer whose tumour overexpress HER2 and who have received prior therapy including trastuzumab.

111

Levocetirizine Di-HCl mouth For the treatment of allergic rhinitis 25-07-2007. dissolving tablets (5mg) (new and chronic urticaria. dosage form). Idaravone Injection (1.5mg/ml). For improvement of neurologic 26-07-2007. symptoms, disorders of activitis of daily living and functional disorder associated with acute ischemic stroke.

112

113

Diclofenac Sodium (75mg/ml) For management of painful conditions 30-07-2007. Injection (addl. Strength). in post-operative cases, rheumatoid arthritis and osteoarthritis. Cefpodoxime (as Proxetil) For LRTI, URTI and UTI. (100mg/200mg) + Clavulanic acid (62.5/125mg) tablet. Atorvastatin (40mg) + Ezetimibe As approved. (10mg) Tablet (addl. Strength). Cefepime (250mg) + Tazobactam As approved. (31.25mg) Injection (addl. Strength). VSL # 3 (Probiotic Blend) sachet For rotavirus diarrhoea in children. 30-07-2007.

114

115

30-07-2007. 30-07-2007.

116

117 118

31-07-2007. 31-07-2007. 31-07-2007.

119

Sorafenib (as Tosylate) (200mg) For advanced renal cell carcinoma. Tablet. Methylcobalamin (500mcg) + Alpha For diabetic neuropathy. Lipoic Acid (100mg) + Pyridoxine (3mg) + Folic acid (1.5mg) Soft Gelatin Capsule.

120

Halobetasol Propionate (0.5mg) + For plaque psoriasis. Salicylic Acid 30mg per gm of ointment. Combipack of 12 tablet of As Approved Artesunate (50mg) each + 3 tablet of each containing Sulfadoxine (500mg) + Pyrmethamine (25mg) Tablet. (Addl. Strength)

01-08-2007.

01-08-2007.

121

122

Omeprazole (20mg/40mg)+Sod. For duodenal, gastric ulcer, GERD, and 08/01/07 Bicarbonate-600mg+ erosive esophagitis, Mg.Hydroxide-700mg .chew tab. Deferasirox dispersible (400mg) (addl. Strength). tablet As approved 17-08-2007.

123

124

Tegafur (100mg) + Uracil (224mg) For first line treatment of metastatic 22-08-2007. capsule. colorectal cancer in combination with calcium folinate.

Bortezomib indication) 125

Injection

(additional For the treatment of patients with 05-09-2007. mantle cell lymphoma who have received at least one prior therapy.

126

Amlodipine (5mg) + Nebivolol (5mg) As approved. tablet (addl. Strength). Ceftazidine (2gm) + Sulbactam For serious abdominal infection. (1gm) Injection ( addl. strength for additional indication).

06-09-2007. 06-09-2007.

127

128

Polyethylin Glycol 400 (0.4%) + For temprory relief of dryness, irritation 18-9-2007. Propylene Glycol (0.3%). burning, stinging, grittiness or foreign body sensation caused due to environmental factors.

129

Resperidone E.R. (long-acting) As approved. injection (12.5mg/vial) (addl. strength). Levocetirizine Di-HCl syrup As approved. (2.5mg/5ml) (for use in children 2 years and above).

25-09-2007.

26-09-2007.

130

R-Sibutramine (2.5mg/5mg) 131

Capsule As an adjunctive therapy for the 26-09-2007. management of obesity including weight loss and maintenance of weight loss in pateints whose BMI is 30Kg/m2 or higher. + For adult patients with infection caused 27-09-2007. susceptible micro-organisms including S.aureus viz UTI, upper and lower RTI and gonoccoccal urethritis.

Cefuroxime Axetil (250mg) Clavulanic Acid (125mg) Tablet. 132

133

Sulphur Hexafluoride Powder and For diagnostic use in echocardiography 28-09-2007. solvent for dispersion for injection doppler of macrovasculature an doppler (45mcg/ml). of microvasculature.

134

Ondansetron orally disintegrating For chemotherapy induced nausea and 28-09-2007. tablet (4mg/8mg) (additional vomiting dosage form) Cefuroxime Axetil (250mg) Clavulanic acid (125mg) tablet. Cefuroxime-125/250/500mg +Clav.Acid-31.25/62.5/125mg + For UTI, URTI and LRTI and gonococcal 05-10-2007. urethritis. For adult patients with infection caused 10/05/07 by susceptible microbs,including s.aureus.(e.g-UTI,Upper&lower RTI & gonococcal urethrities)

135

136

Amiodarone Indication). 137

Injection

(additional For cardiopulmonary resuscitation in 05-10-2007. the event of cardiac arrest related to ventricular fibrilation resistant to external electric shock.

138

Risedronate Sodium tablet (35mg) For osteoporosis in men at high risk of 08-10-2007. (additional indication) fracture. Sucralfate (70mg ) + Metronidazole For infected wounds and ulcers. (10mg) + Povidone Iodine (50mg) per gram of Ointment. 09-10-2007.

139

Levetiracetam indication)

Tablet

140

(addl. (i) (i) As monotherapy in partial 09-10-2007. onset seizures with or without secondary generalisation in patients with 16 years of age with newly diagnosed epilepsy. (ii) As adjunctive therapy in myoclonic seizures in adults and adolescents from 12 years of age with Juvenile myoclonic epilepsy. In primary generalised tonicclonic seizures in adults and adolescents from 12 years of age with idiopathic generalised epilepsy.

141

Combipack of two tablet of For drug resistant malaria. chloroquine phosphate (250mg) each + 14 tablet of Proguanil HCl (100mg) each

10-10-2007.

142

Paclitaxel (protein bound particle) For breast cancer after failure of 11-10-2007. for injectable suspension (paclitaxel combination chemotherapy for (100mg) + Albumin Human 900mg metastatic disease or relapse within 6 per 20ml. months of adjuvant chemotherapy.

143

Olmesartan Medoxomil (20mg) + For mild to moderate hypertension. Amlodipine Besylate (5mg) Tablet.

15-10-2007.

144

Atorvastatin Calcium (10mg ) + For treatment of patients with both 15-10-2007. Ramipril (2.5mg/5mg) tablet hypertension and hypercholesterolemia.

145

Omeprazole(20mg) + Sodium As approved. bicarbonate (1100mg) tablet (addl. strength).

15-10-2007.

146

Moxifloxacin HCl (5mg) + For inflammation after ocular surgery 16-10-2007. Prednisolone Acetate (10mg)per ml. and where a risk of bacterial ocular (eye drops) infection exists. Methylcobalamine (500mcg) + For diabetic neuropathy. Alpha Lipoic acid (100mg) + Pyridoxine HCl (1.5mg) + Thiamine (2mg) + Calcium Picolinate (200mg) tablet. 16-10-2007.

147

148

Satranidazole (300mg) + Ofloxacin For diarrhoea of mixed infection in 18-10-2007. (200mg) Tablet. adults. Methylcobalamin 500mcg+beta For adult carotine-10.33mg+alpha lipoic acid neuropathy. 100mg+B6 1.5mg+B1 2mg & Cr.polynicotinate. Calcium Pidolate equivalent Calcium 500mg + Vit-D3 250 IU Etizolam Tablet (0.5mg/1mg). Oxaprozine Tablet (600mg) patients with diabetic 18-10-2007.

149

150 151

to For osteoporosis and calcium deficiency 23-10-2007. state. For anxiety disorder associated with 29-10-2007. depression. For relief of signs and symptoms of 30-10-2007. osteoarthritis, rheumatoid arthritis.

152 Prulifloxacin (600mg) Tablet. 153

For acute uncomplicated lower urinary 30-10-2007. tract infection (simple cystitis), complicated lower UTI, acute exacerbation of chronic bronchitis.

154

Cilostazole E.R (100mg/200mg). Atorvastatin Fenofibrate strength)

Tablet For management intermittent claudication.

30-10-2007. 30-10-2007.

155

Calcium (10mg) + As Approved (145mg) (addl.

156

Sitagliptin (25mg/50mg/100mg).

Tablet As adjunct to diet and exercise to 30-10-2007. improve glycemic control in patients with type-II diabetes.

157

Miglitol (50mg) + Metformin HCl SR For adult with Type-II diabetes mellitus 31-10-2007. (500mg) tablet. where simple drug therapy, diet and exercise do not result in adequate glycemic control.

158

Mupirocin (2%) + For atopic dermatitis. Methylprednisolone Aceponate (0.1%) Cream.

31-10-2007.

159

Methyl cobalamine 500mcg+folic For Vitamins and mineral deficiency 31-10-2007 acid1.5mg+B5-5mg,+Zn.sulphate states. 25mg+Cr.Polynicotinate 200mcg+selenium-65mcg+inositol1.5mg + alpha lipoic acid 100mg capsule

160

Methylcobalamine 500mcg+folic For diabetic neuropathy acid1.5mg+ alpha lipoic acid 300mg +Benfetiamin-50mg. capsule Methyl prednisolone aceponate- For treatment of psoriasis 1mg + salicylic acid-50mg ointment

13-11-2007

19-11-2007

161

162 163 164 165 166 167

Propanol 50gm+povidone 1gm in 100ml solution

iodine- For surgical disinfection. -doAs Approved

&

hygenic

hand 19-11-2007 19-11-2007 20-11-2007 21-11-2007 21-11-2007 26-11-2007

Propanol-18 gm+Ethenol(100%)45gm in 100ml solution Voglibose disp.tab.0.2mg/0.3mg Ceftriaxone 2gm+ 250mg for injection

Tazobactum As Approved

Methylprednisolone aceponate-1mg For the treatment of atopic dermatitis + Mupirocin-20mg. cream Citicholine(as 200mg/500mg/750mg per sachet. Butarphenol nasal spray tartrate Sod.)- As Approved granules

168

169 170

10mg/ml For management of pain in patients 26-11-2007 using opioid analgesics. 28-11-2007

Deferasirox 100mg dis.tablet(addl. As Approved strength)

171

Methyl cobalamine 500mcg+folic For Vitamins and mineral deficiency 29-11-2007 acid1.5mg+B6-3mg,+Zn.sulphate patients. 61.8mg+Ca.Pantothenate 10mg+ Niacinamide-50mg +chrimium50mcg capsule Methylcobalamine 500mcg+folic For diabetic neuropathy acid 1.5mg+ alpha lipoic acid 100mg +B6-3mg+Thiamine 10mg capsule Doxophylline400mg+Salbutamol(as 2mg/4mg Tablets 29-11-2007

172

173

For treatment of Bronchial asthma in 29-11-2007 sulphate)- adults

174

Gatifloxacin (as sequihydrate)-3mg For reduction of post-operative 29-11-2007 + Flurbiprofen sod.-0.3mg/ml eye inflammatory conditions of eye ,when drops. bacterial infection exists.

175

Sertanidazole-300mg+ 200mg tablet

Ofloxacin- For treatment of diarrhoea of mixed 29-11-2007 infection in adults patients.

176

Zoledronic acid 5mg/100ml Post-menopausal osteoporosis. solution for infusion (addl. indication). Olmesartan medoximil-20mg Ramipril-5mg. tablet

6-12-2007.

177

+ For treatment of essential hypertention. 12/06/07

178

Levosulpiride Tablet (50mg/100mg) For depression and schizophrenia in 12/06/07 (addl. strength for addl. indication). adults.

179

Combipack of 12 Artesunate 50mg For drug resistant P.falciparum malaria 12/06/07 tablets & 6 Mefloquin-250mg infection. tablets Pregabalin-75mg/150mg +Methylcobalamine 500mcg cap For the treatment of adult patients with 12/10/07 peripheral neuropathy.

180

181

Doxycycline-100mg spores-5 billion

+L.bacillus For adult patients prone intrabdominal bacterial infection Antibiotic associated diarrhoea

to 12/11/07 &

182

Cefprozil 250mg/500mg+Clav. For the treatment of adult patients with 12/11/07 Acid-62.5mg /125mg. tab upper&lower RTI, Skin & Skin structure infection

183

Dextrometharpahan HBr- For the temporary relief of cough due to 12/11/07 10mg+Chlorphenaramine maleate- throat irritation, sneezing & ruunning 2mg /5ml syrup. nose. Lornoxicam 8mg /2ml inj. For Short-term treatment of mild to 12/11/07 moderate pain, when oral administration is inappropriate(i.e after dental surgery)

184

185

Apomorphine Sublingual tablet.

HCL-2mg/3mg For erectile dysfunction in adult men.

12/11/07

186

Escitlopram (as oxalate)10mg + For comobid depression and anxiety 12/12/07 Clonazepam-0.5mg tablet (addl. disorder. Strength). Doxophylline injection-10mg /ml For bronchial asthama & COPD in 31-12-2007 adult patients, when oral therapy is in approriate.

187

LIST OF APPROVED DRUG FROM 01.01.2010 TO 31.12.2010

Name Of Drug S.No 1 2 Nebivolol (as HCl) 5mg + Valsartan 80mg Pharmacological Classification For hypertension Date of Approval 6/1/2006 17/01/2006 19/01/2006 Cefprozil Powder for oral suspension (125mg/5ml) Antibiotic Combikit of Tamsulosin HCl 0.4mg M.R capsule For BPH (10 no.) & Dutasteride Soft Gelatin Capsule 0.5mg (10no.) Alendronate Sodium (equiv. to Alendronic acid For osteoporosis 70mg) + Cholecalciferol 70mcg (equiv. to 2800 I.U Vit.D) Tablet Atenolol 50mg + HCTZ 25mg (addl. Strength) For hypertension Tamsulosin HCl (MR) 0.4mg + Dutasteride 0.5mg tablet Erdosteine Powder for oral suspension 35mg/ml Moxifloxacin Eye Ointment (5mg/gm) Dexibuprofen Tablet (200mg/300mg/400mg) 9 Pegaptinib Sodium Injection (0.3mg). 10 11 12 13 14 Ciclesonide Inhaler 80/160mcg per actuation For BPH For chronic obstructive bronchitis For ophthalmic use. For OA, RA & ankylosing spondylitis For neovascular (wet) age related macular degeneration. For persistent Asthma

1/2/2006

4 5 6 7 8

3/2/2006 6/2/2006 6/2/2006 6/2/2006 6/2/2006 6/2/2006 6/2/2006 7/2/2006 8/2/2006 13/02/2006 15/02/2006

Metoprolol Succinate equiv. to Metoprolol Tartrate For hypertension 50mg + Amlodipine (as besylate) 5mg Doxofylline Tablet (400mg) For bronchial asthma & COPD. Zanamavir inhalation powder 5mg/blister Testosterone Transdermal Spray (12.5mg/spray) (addl. Lower strength) For influenzae For replacement therapy in males with Testosterone deficiency. Anti-biotic Anti-fungal For induction & maintenance of anaesthesia. NSAID For HIV-1 infection Anti-epileptic For ADHD For OA & RA Ophthalmological diagnostic agent Anti-biotic For leg ulcer, diabetic ulcer etc. Anti-AIDS For reduction of unwanted facial hair in women. Chronic congestive heart failure For chronic pulmonary infection cystic fibrosis. For constipation & hepatic encepthalopathy

15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 Lactulose Enema (20%) 31 Propionyl-L-Carnitine HCl Tablet (500mg) & injection 300mg/vial Tobramycin Inhalation solution (300mg/5ml) Aceclofenac 200mg (S.R) tablet Tenofovir Disoproxil Fumarate (300mg) + Emtricitabine (200mg) tablet Levetiracetam Oral Solution (100mg/ml). Atomoxetine 60mg capsule (Addl. Strength) Diclofenac Sodium (75/50mg) as (E.C) + Misoprostol 200mcg. Fluorescein Sodium Solution for Injection (100mg/ml) Cefditeron (as pivoxil) 200mg tablet Sodium Hyaluronate Cream 0.2% Saquinavir (500mg) tablet (addl. Strength) Eflornithine HCl Cream (139mg/gm) Cefetamet Pivoxil Hcl oral suspension 250mg/ml Voriconazole Powder for oral soluion (40mg/ml) Desflurane liquid for inhalation (240mg/bottle).

16/02/2006 21/02/2006 22/02/2006 22/02/2006 23/02/2006 24/02/2006 27/02/2006 28/02/2006 2/3/2006 3/3/2006 16/03/2006 20/03/2006 22/03/2006 22/03/2006 22/03/2006 28/03/2006

32 33 34 35 36 37

Haloperidol Tablet (0.5mg) (addl. Lower strength) Cholestyramine Powder for oral suspension (4gm/sachet) Doxofylline Syrup (20mg/ml) Resperidone Tablet & Syrup (addl. Ind ) D-trans Fentantyl Transdermal patches Pantoprazole (as Sodium) (E.C) 40mg + Itopride (150mg) S.R Oseltamivir formulation (additional indication)

As approved earlier. For hypercholesterolaemia For bronchial asthma & COPD. Acute mania & mixed episode in bipolar-I disorder. For pain For GERD For Prophylaxis of influenzae in adult and children >14 years of age Anti-HIV in adults. Angina Pectoris For hypertension Acne vulgaris For Asthma & COPD For insomnia

30/03/2006 30/03/2006 30/03/2006 4/4/2006 5/4/2006 8/4/2006 24/04/2006

38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 61 62 63 Atazanavir (100/150/200mg) Nicorandil E.R Tablet (10mg/20mg) Amlodipine (as besylate) 5mg + HCTZ 12.5mg Tablet Nadifloxacin Gel 1% Formoterol Fumarate (6mcg) + Fluticasone Propionate (100/250/500mcg) dry powder inhaler Midazolam (as maleate) 7.5mg/15mg tablet

24/04/2006 24/04/2006 24/04/2006 10/5/2006 10/5/2006 10/5/2006 18/05/2006 19/05/2006 19/05/2006 19/05/2006 22/05/2006 24/05/2006 24/05/2006 25/05/2006 25/05/2006 31/05/2006 2/6/2006 2/6/2006 5/6/2006 6/6/2006 8/6/2006 8/6/2006 8/6/2006 8/6/2006 8/6/2006

Olmesartan (as Medoxomil) 10mg (addl. Strength) Anti-hypertensive Pregabalin Capsule 25/50/100/200mg (addl. Same as approved. Strength) Oxcarbazepine S.R 450mg/900mg (addl. Strength). Anti-epileptic Ciclesonide rotacaps (200/400mcg) Itopride 150mg capsule (S.R) For Asthma For GERD

Nevibolol (as HCl) 5mg + Amlodipine (as besylate) For hypertension 5mg/10mg Levocetrizine 5mg + Ambroxol Hydrochloride SR For production cough (75mg) tablet Ibandronic Acid Tablet (150mg) addl. Strength Same as approved. Zonisamide capsule 25/50mg (addl. Strength) Cyclosporin Eye drops (0.1%) (addl. Strength) Gatifloxacin (0.3%) + Prednisolone Acetate (1%) eye drops Amlodipine (as besylate) 5mg + Metoprolol Succinate equivalent to Metoprolol Tartrate 50mg. Nadifloxacin (1%) + Miconazole Nitrate (2%) + Mometasone Furoate (0.1%) Cream Bemiparin Sodium Solution for injection(5000/7500/10,000 I.U). Icodextrin 7.5% peritoneal dialysis solution Lamotrigin 200mg tablet (addl. Strength) dispersible tablet (5mg/50mg/100mg/200mg Amoxycillin 1000mg + Clavulanate Potassium 62.5mg E.R tablet Lopinavir 200mg + Ritonavir 50mg Tablet (addl. Strength) Same as approved. For Ophthalmic use For Ophthalmic use For hypertension For dermatoses For deep vein thrombosis For peritoneal dialysis Anti-epileptic Anti-biotic Anti-HIV Perflutren liquid microsphere injectable suspension For diagnostic use

64 65 66 67 68

Olopatadine Ophthalmic solution( 0.1%)

For allergic conjunctivitis

8/6/2006 8/6/2006 15/06/2006 22/06/2006 27/06/2006 28/06/2006 28/06/2006 5/7/2006 5/7/2006 6/7/2006

Ferrous ascorbate (equivalent to 50mg Iron) + Folic For iron deficiency anemia acid 1.5mg. Methyl Prednisolone Aceponate Cream (0.1%) For atopic dermatitis Aspirin 150mg + Clopidogrel (as bisulphate) 300mg As loading dose for prevention tablet (addl. Strength) of in-stent restenosis in PCI Levofloxacin 0.5% Ear drops For otitis media Olmesartan 40mg + HCTZ 25mg tablet (addl. 69 Strength) 70 Buclizine HCl tablet (25mg) & Syrup 6mg/5ml Ceftriaxone (as sodium) 250mg + Tazobactam 71 31.25 mg for injection (addl. Strength) Bimatoprost 300mg + Timolol (as maleate) 5mg/ml 72 eye drops Mebeverine HCl 135mg + Isabgula husk 3.5gm 73 sachet. Anti-hypertensive As appetite stimulant Anti-biotic For reduction of IOP Irritable bowel syndrome For overactive bladder with urge urinary incontinence urgency & urinary frequency For insomnia For chronic iron overload due to blood transfusion

74 Solifenacin Succinate Tablet (5mg/10mg). 75 Zolpidem Tartrate E.R tablet (6.25mg/12.5mg).

6/7/2006 10/7/2006 10/7/2006 12/7/2006 12/7/2006 20/07/2006 20/07/2006 20/07/2006 20/07/2006 26/07/2006 27/07/2006 1/8/2006 1/8/2006 1/8/2006 1/8/2006 1/8/2006 4/8/2006 8/8/2006 8/8/2006 8/8/2006

76 Deferasirox dispersible tablet 125/250/500mg. Vitamin C 500mcg + Zinc Citrate 2.2mg + Selenium 77 60mcg tablet. For vitamin C deficiency Lamivudine 40mg + Stavudine 10mg dispersible 78 tablet. For HIV infection Levocetrizine 2.5/5mg + Ambroxol 30mg/5ml of 79 syrup For productive cough 80 Cefixime 200mg + Pot. Clavulanate (125mg) tablet Anti-biotic ISMN SR 30mg + Aspirin75/150mg tablet (addl. 81 Strength). Same as approved Clobestasol Propionate (0.05%) + Calcipotriol 82 Ointment (0.005%) Ointment. For plaque psoriasis 83 Sodium Hyaluronate Injection (1%). 84 Forskolin Eye drop (1%). 85 Baclofen E.R capsule (30mg) 86 Amisulpiride Tablet (50/100/200mg) 87 Quetiapine S.R tablet 200/300mg. For OA

For open angle glaucoma For spasticity For schizophrenic disorder For psychotic disorder For OA, RA acute pain & primary dysmenorrhoea

88 Lumiracoxib Tablet (100/200/400mg). Tenofovir Disoproxil Fumarate300mg + Emtricitabin 89 200mg + Efavirenz 600mg tablet For HIV-1 infection 90 Oxandrolone Tablet (2.5/10mg) Erdosteine 150mg + Guaiphenesin 50mg + 91 Terbutaline 1.25mg per 5ml syrup Rosiglitazone (as maleate)2mg + Glibenclamide 92 5mg + MetFormin 500mg tablet 93 L- Lysine Hcl Ointment (150mg/gm)

To promote weight gain Mucolytic Anti Diabetic For wounds of various etiology

Levocitirizine 2 Hcl 5mg+ Ambroxol Hcl SR 75mg + 94 Pseudoephedrine Hcl 120mg SR Capsules Alprazolam SR 0.25mg + Sertraline (As Hcl) 95 25mg/50mg tablet Dexibuprofen 200mg/300mg +Paracetamol 500mg 96 tablet ISMN SR 60mg + Metoprolol Succinate ER 97 25/50mg

For SAR, PAR & Chronic idiopathic urticatia For Panic disorder with or without agoraphobia For RA, OA & ankolysing spondylosis For angina & Hypertension For prevention of acute coronary syndrome in patients with CAD prophylaxis against stroke

9/8/2006 9/8/2006 10/8/2006 10/8/2006

Aspirin 75mg / 150mg + Glycine 37.5mg/75mg 98 tablet Combipack of 21 tablet of Quinin sulphate 600mg each & 8 capsule of Doxycycline (as Hcl) 100mg 99 each) 100 Pravastatin 40mg tablet (Additional strength) Olanzapine powder For oral suspensian 101 (10mg/5ml) Cefepem (as Hcl) 0.5/1gm + Amikacin (as 102 sulphate) 0.125/0.250gm Inj. Lamivudine 20mg + Nevirapine 35mg + Stavudine 103 5mg tablet Nadifloxacin (10mg/gm) + Mometasone Furoate 104 (1mg/gm) cream Premetrexed(Disodium) powder For solution For 105 Inj. 500mg/vial Gliclazide 40mg/80mg + MetFormin Hcl 500mg + 106 Rosiglitazone 2mg tablet

10/8/2006

For P. Falciparam malaria As Approved For schizophrenia in adults Antibiotic Anti HIV For mixed infection of skin Anti Cancer Ant- diabetic For abdominal spasmodic pain, colics of hepatobilliary track, abdominal colics For neck-shoulder orm syndrome scapula hum oral per arthritis and low back pain For abdominal pain & tinnitus in adult For metastatic breast cancer Anti biotic For infections diarrhea in adults For skin & skin structure infection & intra abdominal infection Anti HIV Antibiotic Anti asthratic Anti asthmatic For HIV Infection

10/8/2006 10/8/2006 11/8/2006 11/8/2006 11/8/2006 17/08/06 21/08/06 22/08/06

107 Tiropramide Hcl (100mg) tablet

22/08/06

108 Eperisone Hcl (50mg ) tablet 109 Caroverine cap. 20mg & Inj. 40mg/2ml 110 Paclitaxel nanoparticle Inj. (20mg/ml) 111 Amoxycillin 250mg + Dicloxacillin 250mg cap. 112 Rifaximine 200mg tab.

23/08/06 23/08/06 23/08/06 28/08/06 28/08/06

113 Tigecycline powder For Inj. 50mg/vial 114 Stavudine SR 100mg tablet Cefixime (50mg/100mg) + Clavulanic acid 115 31.125mg/62.5mg per ml dry syrup & tablet Ciclsonide 80mcg/160mcg + Formotorol 4.5mg 116 inhaler Ciclsonide 100mcg/ 200mcg/400mcg + Formotorol 117 Fumarate 6mg rotacaps 118 Abacavir Sulphate syrup 20mg/ml

28/08/06 29/08/06 29/08/06 29/08/06 29/08/06 29/08/06

S(-) pantoprazole (as sodium) 20mg (E.C.) + 119 Domperidome SR 30mg tablet 120 Cefadroxil 500mg + Clavulanic acid 125mg tablet Cefadroxil 250mg + Clavulanic acid 62.5mg 121 dispersible tablet Cefadroxil 250mg + Clavulanic acid 62.5mg per 122 5ml syrup 123 Human Insulin (r-DNA) Powder inhaler 124 Fulvestrant Inj. 250mg/5ml prefilled syringe 125 S(-) Pantoprazole (as Sodium) Inj. 20mg/vial 126 Dasatinib tablet 20mg/50mg/70mg tablet 127 Telbivudine 600mg tablet

FOR GERD Antibiotic Antibiotic Antibiotic For type-I & Type-2 Diabetes Anti Cancer For peptic ulcer, GERD & Zollinger Ellison Syndrome For chronic hepatitis B infection For chronic hepatitis B infection For chemotherapy induced nausea & vomiting

30/08/06 30/08/06 30/08/06 30/08/06 30/08/06 30/08/06 30/08/06 30/08/06 30/08/06 30/08/06 30/08/06 30/08/06 30/08/06 30/08/06 30/08/06 31/08/06 20/09/06 22/09/06 26/09/06 28/09/06 28/09/06 10/10/2006 14/10/06 1/11/2006 2/11/2006 13/11/06

128 Aprepitant cap (80mg/125mg) Telmisartan 40mg + Amlodipine (as Besylate) 5mg 129 tablet For essential hypertension 130 Gemifloxacin (as msylate) 320mg tablet Ceftazidime 500mg /1000mg + Tazobactum (as 131 sodium) 62.5mg/125mg per vial for injection Cefepime (As Hcl) 500mg/1000mg + Tazobactum 132 (as Sodium) 62.5mg/125mg Antibiotic Antibiotic Antibiotic For visceral leishmaniasis (Kalaazar)

133 Paromomycin Inj. 375mg/ml Cefixime 100mg + Cloxacillin (as Sodium) 500mg + 134 Lactobacillus (45 million spore)tab. Antibiotic Alprazolam Dispersible Tab. 135 0.125mg/0.25mg/0.50mg For anxiety 136 Epinastine Hcl (0.05%) Opthlamic solution Levofloxacin tablet (250mg /500mg) & Infusion 137 5mg/ml (For additional indication) 138 Feracrylum 1% mouth gargle 10mg/ml

For allergic conjunctivitis For prostatitis As hacmostatic agent in dental surgery For pain in post operative & post traumatic cases

139 Aceclofenac Inj. (150mg/ml) combipack of one cap. Of aprepitant .125mg & two 140 cap. Of aprepitant 80mg each (combipack) As Approved Formoterol fumarate 6mcg + Fluficasone propinate 141 50mcg/125mcg/250mcg MDI For Asthma & COPD Amlodipine 25mg + Metoprolol 25mg (additional 142 lower strength) 143 144 Estrogen vaginal tablet 25mcg Esomeprazole 40mg (E.C.) + Itopride 150mg SR Capsules Cefixime 200mg + Cloxacillin 500mg (ER) + Lactobacillus 90 million Spore tab. (additional strength) Cefixime dispersible tablet 400mg (new dosage Form) For atropic viginitis For GERD

145 146

Antibiotic Antibiotic

14/11/06 22/11/06

147 148 149 150 151 152 153

Trandalopril 1mg/2mg/4mg/2mg + Verapamil (ER) 240mg/240mg/240mg/180mg Ciclesonide 160mcg/320mcg cap. for inhalation Rabeprazole 20mg (EC) + Itopride SR 150mg Metoprolol succinate 25mg /50mg ER + HCTZ 12.5mg Atorvastatin 5mg + Fenofibrate 160mg (additional strength) Aceclofenac Inj. 50mg/ml (additional strength) Amisulpride 400mg tablet (additional strength)

Anti hypertensive Anti asthmatic For GERD Anti hypertensive As Approved As Approved As Approved For cervical ripening, prevention of post partum haemorrhage & First trimester of aboration with mifepristone Anti HIV For IBS Antibiotic For acute Musculoskeletal pain For diarrhea For naturopathic pain & partial Seizures As Approved

23/11/06 28/11/06 28/11/06 30/11/06 1/12/2006 1/12/2006 1/12/2006

154 155 156 157 158 159 160 161

Misoprostol tablet 25mcg/100mcg/200mcg (additional strength indication Atazanavir 150mg + Ritonavir 50mg capsules Mebeverine Hcl 135mg + Chlordiazepoxide 5mg tablet Ampicillin 250mg + Dicloxacillin 250mg tablet Etoricoxib 10mg + Methyl Salicylate 100mg + Mentol 50mg + Linseedoril 30mg per gm. of Gel Racecadotril dispersible tablet (10mg/30mg) (new dosage Form) Gabapentin ER 450/600/900mg tablet Aceclofenac dispersible tablet 100mg (new dosage form)

8/12/2006 12/12/2006 12/12/2006 13/12/06 14/12/06 15/12/06 15/12/06 21/12/06

LIST OF DRUGS APPROVED DURING 2005

S.No 267 268 269 270 271 Name Of Drug Centbucridine (0.5%) + Feracrylem (3%) Atenolol (25mg, 50mg) + HCTZ (12.5mg) Levocetirizine Syrup (2.5mg/5ml) Pitavastatin (1mg/2mg) Tablet Ofloxacin (200mg) + Ornidazole (500mg) Bacillus calusii spores suspension (2billion/5ml vial) Pharmacological Classification For hemorrhoid & anal fissure Anti-Hypertensive For allergic rhinitis & urticaria Lipid Lowering agent For diarrhea of mixed infection For alteration of intestinal bacterial flora Date of Approval 11-01-2005 13-01-2005 13-01-2005 14-01-2005 20-01-2005 28-01-2005

272

273 274

Lamivudine (40mg) +Nevirapine (70mg +Stavudine (10mg) (in 5ml) powder for suspension Diflorasone Diacetate Cream (0.5mg/gm)

Anti-HIV.

28-01-2005

For corticosteroid responsive dermatoses

08-02-2005

275

Etonogestrel (11.7mg) + Ethinylestradiol (2.7mg) Contraceptive rings Metaxalone (400mg) + Diclofenac Potassium (50mg) tablet Tranexamic Acid (500mg) + Mefenamic acid (250mg) tablet Fluconazole (2%) + Zinc Pyrethione (1%) suspension Azelaic acid Cream (15%)

For Contraceptive in women

15-02-2005

276

277 278

For acute painful musculoskeletal condition in adult For primary dysmenorrhoea and pain associated with menorrhagia in women For seborrhoic dermatitis For the treatment of inflammatory papules and pustules of mild to moderate rosacea For non-productive cough in adults

22-02-2005

22-02-2005

22-02-2005 23-02-2005

279 Levodropropizine oral suspension (30mg/5ml) Duloxetine HCl (60mg) tablet (additional strength) Desloratadine (2.5mg) + Ambroxol (30mg) +Guiphenasine (50mg) + Menthol 1mg/5ml Syrup Levofloxacin Ophthalmic Solution (0.5%) Metformin Oral Solution (100mg/ml) Tirofiban (0.25mg/ml injection) 285 (additional strength) Omeprazole (20mg) 286 Enteric coated + Domperidone (30mg) (S.R.) capsule Stavudine powder for suspension Erdosteine (150mg/300mg) Capsules 288 Tazarotene (1mg) +Mometasone Furoate (1mg) per gram cream Levetiracetam (250mg,500mg, 290 750mg) Tablets Esomeprazole Sodium For injection 291

280 281

25-02-2005 28-02-2005

For productive cough

02-03-2005

282

283 284

For susceptible bacterial conjunctivitis For type-II diabetes mellitus For acute coronary syndrome including patients undergoing PTCA or atherectomy For GERD not responding to Omeprazole.

04-03-2005 04-03-2005 09-03-2005

10-03-2005

287

For HIV-1 infusion For chronic obstructive bronchitis For plaque psoriasis

11-03-2005

11-03-2005 01-04-2005

289

As adjunctive therapy in treatment of partial onset seizures in adults with epilepsy. For GERD in patients with esophagitis and/or severe symptoms of reflux as an alternative to oral therapy when oral intake is not appropriate

04-04-2005

04-04-2005

292 293 294

Rupatadine (10mg) tablet Acesulfame Potassium Buprenorphine (0.4mg) + Naloxone (0.1mg) sublingual tablet Lamivudine (40mg) +Stavudine (10mg/5ml) reconstituted solution S(-) Metoprolol Succinate S.R. tablets (equivalent to S(-) Metoprolol Tartrate 12.5mg/25mg/50mg) R(-) Ondansetron (2mg/4mg) tablet Balanced salt intra ocular irrigating solution enriched with glutathione Dextrose, bicarbonate Gliclazide M.R. (30mg/60mg)+

For perinial allergic rhinitis As sweetener in pharmaceutical preparation For opioid dependence

05-04-2005 05-04-2005 06-04-2005

For HIV infection

08-04-2005

295

For Hypertension

15-04-2005

296

297

298

For chemotherapeutic induced nausea and vomiting For intraocular irrigating during intraocular surgical procedures For type-II diabetes

15-04-2005 26-04-2005

27-04-2005

299

Metformin HCl (500mg) ER Tablet Drosperinone (3mg) + Ethinylestradiol (0.035mg tablet) Simvastatin (10/20mg) + Ezetimibe (10mg) Tab Oral Contraceptive For primary Hypercholesterolemia 11-05-2005 11-05-2005

300

301 Ramipril (5mg) + Telmisartan (40mg) tablet 302 303 Intralipid 30% Montelukast Granules (4mg/pack) 304 Bortezomib for injection (3.5mg/vial) Nelfinavir 625mg tablet (addl.strength) 306 Sevelamer (400mg/800mg) tablet 307 S(-)Pantoprazole (10mg/20mg) tablet Tazarotene (0.05%) + Mometasone Furoate (0.1%) Cream (addl.strength) R (-) Ondansetron oral Solution (1mg/5ml)

For Hypertension

11-05-2005

305

For patients with essential fatty acid deficiencies For Prophylaxis and chronic treatment of asthma in adult and pediatric patients of 12 months age and older For the treatment of myeloma patients For HIV patients

12-05-2005 17-05-2005

18-05-2005 20-05-2005

308 309 310

For control of serum phosphorus in patients with chronic kidney disease and hemodialysis. For gastric ulcer, duodenal ulcer & GERD For Plaque psoriasis

20-05-2005

20-05-2005 24-05-2005

For Chemotherapy induced nausea and vomiting

24-05-2005

311 312

313

Gatifloxacin (200mg) +Ornidazole (500mg) tablet Combikit of 2 tablet of Stavudine (40mg) + Lamivudine (150mg) each & 1 tablet of Efavirenz (600mg) Combikit of 2 tablet of Lamivudine (150mg) + Zidovudine (300mg) each and 1 tablet of Egavirenz (600mg) Aceclofenac gel 1.5% alongwith linseed oil, menthol, Salicylate, Capsaicin Emtricitabine (200mg) capsule Eplerenone Tablet (25mg/50mg) Strontium Ranelate Granules (2gm/Sachet) Lamivudine 30/60mg + Stavudine 6mg/12mg + Nevirapine 50mg/100mg dispersible tablet Nitazoxanide (500mg) + Ofloxacin (200mg) Tablet Midazolam Maleate Bulk Calcium Polycarbophil (500mg) Tablet FDC of Papain + Urea Ointment Testosterone Gel 1%.

For diarrhoea of mixed infection in adults For HIV infection in adults

06-06-2005 07-06-2005

For HIV infection in adults

07-06-2005

For pain, swelling etc

08-06-2005

314 315 316 317 318

For HIV infection in adults For hypertension For post-menopausal women with Osteoporosis For pediatric patients with HIV infection For urogenital infection in adults. Anesthetic IBS For debriment of necrotic tissues. For replacement therapy in male with Testosterone deficiencies and hypogonadotropic hypogonadism For metastatic nonsmall cell lung cancer. For dry eye syndrome For neuropathic pain Anti-hypertension Addl. Strength Anti-hypertension Anti-bacterial Anti-bacterial For Parkinsons disease

09-06-2005 10-06-2005 14-06-2005 14-06-2005

30-06-2005

319 320 321 322

05-07-2005 06-07-2005 11-07-2005 12-07-2005

323

324 325 326 327 328 329 330 331 332

Erlotinib Hydrochloride (25mg/100mg/150mg Tablet Chloroquine Phosphate eye drops (0.3mg/ml) Mecobalamine E.R. tablet (1500mcg) Olmesartan Medoxomil (5mg/20mg/40mg) Tablet Ursodeoxycholic Acid (500mg) S.R Tablet FDC of Amlodipine (5mg) + Bisoprolol (2.5mg) FDC of Ceftriaxone (500mg/100mg) + Tazobactum (12.5mg/62.5mg) Injection Feropenem Sodium (150mg/200mg) Tablet Levodopa (50mg/100mg/150mg) + Carbidopa (12.5mg/25mg/37.5mg + Entacapone (200mg) tablet

13-07-2005 13-07-2005 19-07-2005 21-07-2005 20-07-2005 21-07-2005 21-07-2005 21-07-2005 25-07-2005

Saquinavir (as mesylate) 500mg Tablet 333 Pramipexole Di-hydrochloride Tablet (0.125mg/0.25mg/0.5mg/1mg/1.5mg). FDC of Atorvastatin (10mg) + Niacin (375mg/500mg E.R) Capsule FDC of Levocetirizine (5mg) + Ambroxol (75mg S.R) Capsule FDC of Gabapentin (300mg) + Methylcobalamin (500mcg) Tablet Phenytoin Sodium (300mg) tablet FDC of Calciptriol (50mcg) + Betamethasone Dipro (0.5mg/gm) Ointment FDC of Glimepiride (1mg/2mg) + Pioglitazone (15mg)+ Metformin (500mg E.R) Tablet Tenofovir Disoproxil Fumarate Tablet (300mg) Sucralfate (7%) + Povidone Iodine (5%) Ointment Bivalirudin Injection (250mg/vial) Efavirenz Oral Solution (30mg/ml) Didanosine Powder for oral solution (2gm/4gm per bottles) Sodium Valproate (750mg/1000mg) C.R. Tablet Oxcarbazepine S.R. (150mg/300mg/600mg) Tablet Acitretin Dried IVY Leaf Extract (7.5gm/100ml) Nimesulide 1% + Methyl Salicylate 5%.

Addl. Strength. For Parkinsons disease

25-07-2005

25-07-2005

334 335 336 337 338 339

For Hypercholesterolemia Anti-histaminic & mucolytic For neuropathic pain in adults. Addl. Strength For psoriasis vulgaris.

26-07-2005 29-07-2005 05-08-2005 05-08-2005 12-08-2005

Anti-diabetic

12-08-2005

340 341 342 343 344 345 346 347 348 349 350 351 352 353 354 355 356 357

Anti-HIV Anti-infective Anti-coagulant in PTCA Anti-AIDS Anti-AIDS Addl. Strength Anti-epileptic For sever psoriasis in adults. Cough Syrup Aerosol For local application in acute pain. Antiseptic gel. For hyperhomocysteinemia Ophthalmic Anti-epileptic For acute diarrhoea For irritable bowel syndrome For Hypertension

17-08-2005 18-08-2005 25-08-2005 25-08-2005 26-08-2005 26-08-2005 08-09-2005 09-09-2005 15-09-2005 16-09-2005

Feracrylum (1%) + Metronidazole 1%) FDC of Methylcobalamin (1500mcg E.R) + Pyridoxine (20mg) + Folic Acid (5mg) Tablet Ketorolac Tromethamine 0.4% Eye drops (addl. Strength) Levetiracetam Oral Solution (100mg/ml) Zinc (Gluconate) oral solution (20mg/5ml) Trimebutine Maleate Enalapril (2.5mg/5mg) + HCTZ (12.5) Tablet (Addl. Strength)

16-09-2005 16-09-2005

20-09-2005 22-09-2005 05-10-2005 10-10-2005 17-10-2005

358 358 359 360 361 362 363 364 365 366 367 368 369

Oseltamivir (as phosphate) Capsule (75mg) & oral suspension (12mg/ml) Cetirizine HCl drops (10mg/ml) Lanthanum Carbonate Chewable tablet (250mg/500mg) Ambroxol HCl 75mg (S.R) + Desloratadine 5mg Capsule. Sodium Hyaluronate 0.1% eye drops (addl. Strength) FDC of S-Metoprolol Succinate Tartrate equivalent to Metoprolol Tartrate (E.R) 25/50mg + HCTZ (12.5mg) Tablet. Stavudine 10mg+Lamivudine 40mg+ Nevirapine 70mg dispersible tablet Voglibose (0.2mg/0.3mg) Tablet Lactitol Sachet (10gm/20gm). Aspirin Bolus (Vet.) 6gm/bolus) Domperidone (10mg) + Activaed dimethicone (125mg) chewable tablet Moxifloxacin (0.5%) + Dexamethasone Phosphate (0.1%) Eye drops Pregabalin capsule (75/150/300mg)

For influenzae Anti-histaminic For the treatment of hyperphosphatemia. For relief of productive cough. Ophthalmic use. For essential hypertension For HIV infection Anti-diabetic For the treatment of constipation. For Veterinary use. For dyspepsia, colicy pain & GERD. For Ophthalmic use. For neuropathic pain.

25-10-2005 08-11-2005 09-11-2005 10-11-2005

10-11-2005 11-11-2005

11-11-2005 17-11-2005 21-11-2005 21-11-2005 22-11-2005 24-11-2005 25-11-2005

370

Methotrexate Topical gel (1%) Addl. Strength Brimonidine Tartrate (2mg/1.5mg) + Timolol (as HCl) 5mg/ml. Testosterone Spray (25mg)

Psoriasis. Ophthalmic

25-11-2005

25-11-2005

371

372 373 374 375 376 Omeprazole Powder for suspension (20mg/Sachet) Doxazosin (as Mesylate) 4mg/8mg E.R. Tablet Amlodipine (as besylate) 5mg + Bisoprolol 5mg Tablet (Addl. Strength) FDC of Olmesartan Medoxomil (20mg/40mg/40mg) + HCTZ(12.5mg/12.5mg/25mg) Phenylephrine 2.5% Eye drops

For replacement therapy in males with testosterone deficiency. Anti-ulcer For hypertension For hypertension For essential hypertension Ophthalmic

29-11-2005

30-11-2005 30-11-2005 30-11-2005 02-12-2005

02-12-2005

377 378 Entecavir Tablet (0.5mg/1.0mg) & oral solution (0.05mg/ml). For chronic Hepatitis-B infection. 05-12-2005

379 380 381 382

Ketorolac Tromethamine 5mg + Ofloxacin 3mg/ml Eye drops Hyoscine-N-Butylbromide (10mg) + Paracetamol 500mg Tablet Amlodipine (as besylate ) 5mg + Losartan Pot. 50mg Travoprost Eye drops (40mcg/ml) Ceftriaxone (as sodium) (500mg/1000mg) + Sulbactam (as sodium) (250mg/500mg) powder for injection. Atomoxetine (as HCl) Sachet (10/18/25/40mg) Levofloxacin Oph. Solu. (1.5%) 15mg/ml. (Addl. Strength). Zonisamide (100mg) capsule Methimazole Tablet ( 5mg/10mg) Caspofungin Acetate injection (50mg/70mg per vial).

Ophthalmic For spasmodic pain For hypertension For glaucoma & ocular hypertension. For LRTI

07-12-2005 08-12-2005 08-12-2005 08-12-2005 08-12-2005

383

384 385 386 387 388

For ADHD Ophthalmic Anti-epileptic For hyperthyroidism. For invasive candidiasis fungal infection.

15-12-2005 16-12-2005 21-12-2005 22-12-2005 23-12-2005

LIST OF DRUGS DURING 2004

S.NO 188 189 190 191 192 193 194 195 196 197 198 199 Name Of Drug Dutasteride Gefitinib Imidapril Adefovir Dipivoxil Etoricoxib Diacerein Nitazoxanide Trolamine Cream (0.67%) Neotame Oxybutynine E.R. tablets Cabergoline 1 mg/2 mg/4 mg tablets Rabeprazole Sodium Injection 20 Alfuzosin E.R. Tablets (10 mg) Tiagabine HCl tablet (2/ 4 /12 /16 mg) Racecadotril Sachet (10 mg/30 mg) Ibandronic Acid Inj ( 1 mg/ml) Pharmacological Classification For BPH Anti-cancer Anti-hypertensive Anti-Viral (Hepatitis-B) NSAID For Osteoarthritis Anti-Diarrhoeal For Topical use Sweetening Agent For Neurogenic bladder disorder For Parkinsons disease For Gastric and Deudonal Ulcers & GERD For BPH Anti-Epileptic Anti-diarrhoeal For Anti-Cancer For organ rejection Date of Approval 16-02-2004 17-02-2004 23-02-2004 04-03-2004 05-03-2004 12-03-2004 17-03-2004 20-03-2004 22-04-2004 05-05-2004 07-05-2004 12-05-2004

200 201 202 203 204

14-05-2004 14-05-2004 18-05-2004 18-05-2004 21-05-2004

TacrolimusCapsule (0.5mg/1mg/5 mg)

205 206 207

Cefdinir Dispersible tablet (125mg) Linezolid (600 mg) Tablet FDC of Gatifloxacin 0.3% + Dexamethasone Phos. 0.1% w/w Eye drops

Anti-biotic For Osteomyelitis in adults For post-operative inflammatory and bacterial infection of eyes. Anti-biotic Anti-Epileptic Anti-Depression For short-term treatment of post-operative pain. For GERD For acute painful condition in adults Anti-AIDS

27-05-2004 30-05-2004 15-06-2004

208 209 210 211

Cefprozil Dispersible Tablet (125 mg/ 250 mg) Divalproex Sodium E.R. Tablets (750mg/1000 mg) Lithium Carbonate ER (450mg) tablet Nimesulide Injection 75mg/ml.

22-06-2004 24-06-2004 28-06-2004 28-06-2004

212 213

FDC of Esomeprazole 20 mg/40 mg + Domperidone 30 mg SR Capsule Aceclofenac (100 mg) + Paracetamol(500 mg) FDC of Lamivudine 300 mg (E.R) + Zidovudine 600 mg (E.R) + Nevirapine 400 mg tablets Levosalbutamol Tablet 1 mg/2mg & Syrup 1 mg/5 ml. Memantine HCl tablet 5 mg/10 mg. Pimcrolimus 10 mg/gm cream FDC of Rabeprazole (20 mg) + Mosapride S.R. (15 mg) Tablet Rebamipide 100 mg tablet Cefetamet Pivoxil Suspension 250 mg/5ml Diclofenac Transdermal patch 100 mg/50 Cm2 Fluconazole Gel (0.5%) FDC of Atorvastatin (10 mg/20 mg) + Ezetimibe (10 mg) Table Miglitol Tablet 25 mg/50 mg/100 mg FDC of Buprenorphin 2 mg + Naloxone (0.5 mg) FDC of Sucralfate 0.07 + metronidazole 0.01 gm + Lignocain 0.04 gm per gram of cream

29-06-2004. 29-06-2004 15-07-2004

214.

215. 216. 217. 218. 219. 220. 221. 222 . 223. 224 . 225.

For Obstructive airway disease For dementia of Alzheimers type For atopic dermatitis For GERD

16-07-2004

19-07-2004 23-07-2004 27-07-2004

For gastric ulcer Anti-biotic For Osteoarthritis & soft tissue injury Anti-fungal For Hypercholesterolemia Anti-Diabetic For Opiod Dependency For bedsore, haemorrhoid fistula and anal fussure

28-07-2004 09-08-2004 10-08-2004 12-08-2004 13-08-2004 18-08-2004 19-08-2004 19-08-2004

226.

227.

Citicholine Tablet 500 mg & Injection 250 mg/ml FDC of Glibenclamide 2.5 mg/ 5 mg + Metformin SR 500 mg tablet Lamotrigine S.R. tablet 50 mg/100 mg/200 mg Moxifloxacin Eye drops (0.5%) Risperidone long-acting suspension for injection 25 mg/37.5 mg/50 mg per vial

Membrane permeability enhancer Anti-diabetic Anti-Epileptic For bacterial conjunctivitis For Schizophrenia

20-08-2004

20-08-2004 26-08-2004 26-08-2004 26-08-2004

228. 229. 230

231

232

Escitalopram (10mg) + Clonazepam (0.5mg) Everolimus Tablets (0.25 mg/ 0.5 mg/0.75 mg/1.0 mg)

For co-morbid depression & anxiety disorder. Immunosuppressant

27-08-2004 30-08-2004

234

235

Dorzolamide (20 mg) + Timolol (5 mg) per ml Eye drops Gemcitabine (1.4 gm/vial) b -arteether Injection

For reduction of elevated IOP.

01-09-2004

236

Anti-cancer Anti-malaria

01-09-2004 01-09-2004

237

(150 mg/2 ml) Ziprasidone powder for injection (after reconstitution 20 mg/ml) Voriconazole Tablet (50 mg/200 mg) Infusion (200 mg/vial) FDC of Nebivolol (5 mg) + S(-) Amlodipine (2.5 mg ) tablet Anti-psychotic 03-09-2004

238

Anti-fungal

09-09-2004

239

Anti-hypertensive

14-09-2004

240

241

FDC of Valdecoxib (20 mg) + Paracetamol (500 mg) tablet

For pain relief in adults.

20-09-2004

242

243

Amlodipine (5 mg) + Ramipril (2.5 mg) tablet FDC of Rabeprazole Sodium (20 mg) + Domperidone(30 mg) S.R Capsule (500

Anti-hypertensive For GERD

24-09-2004 04-10-2004

244

Cefuroxime Axetil ER tablets mg/1000mg)

Anti-biotic

06-10-2004

245 246

Diclofenac Transdermal Patch (200 mg/75 cm2) Gatifloxacin Eye Ointment (1%) Nimesulide Injection (100 mg/ml) (Veterinary)

For pain relief. Ophthalmic use Veterinary use

06-10-2004 06-10-2004 08-10-2004

247

248

Isotretinoin Gel (0.05%) FDC of Epi-Growth Factor (1 gm) + Silversulphadiazine Cream

For acne For Burns

11-10-2004 19-10-2004

249

250

FDC of Amlodipine (5mg/10 mg) + Atorvastatin (10/20/40 mg)

For co-existing hypertension & hyperlipidemia

20-10-2004

251

Levosalbutamol rotacaps (100 mcg/capsule) & inhaler (50 mcg /actuation) Celecoxib Injection (100 mg/ml) Orlistat (120 mg) Capsule Duloxetine HCl (20,30,40mg) Tablet Deflazacort (1,6,30mg) tablet Atomoxetine HCl (10,18, 25 & 40mg ) capsule Ursodeoxycholic acid S.R. Capsule (450mg) Methylphenidate HCl (18, 36, 54 mg) E.R. tablet FDC of Lovastatin (20mg) + Nicacin ER (500mg) tablet FDC of Gatifloxacin (400mg) + Ambroxol HCl (75mg) tablet FDC of Nebivolol HCl (5mg) + Hydrochlorothiazide (12.5mg) tablet FDC of Atorvastatin Calcium (10mg) + Finofibrate (160mg) tablet

For obstructive airway disease.

20-10-2004

252 253 254 255

For acute pain Anti-obesity Anti-depressant Anti-asthma, anti-arthritis. For ADHD

28-10-2004 27-10-2004 02-11-2004 02-11-2004 09-11-2004

256

257 258

For dissolution of gall stones For ADHD For Lipid-lowering

01-12-2004 08-12-2004 20-12-2004

259

RTI in adults.

21-12-2004

260

Anti-hypertensive

22-12-2004

261

For hyperlipidemia

22-12-2004

262

263 264 265 266

Calcium Polycarbophil (500mg) tablet Pantoprazole (40mg) + Domperidone (20mg) ( 10mg IR + 10mg SR) Imiquimod Cream 5% w/w Entacapone (200mg) tablet

For constipation GERD

23-12-2004 23-12-2004

For warts in adults For Parkinsons disease

28-12-2004 30-12-2004

LIST OF DRUGS APPROVED DURING 2003

Sl.No. 149 150 151 152 153 154 155 156 157 158 159 160 161 162 163 164 165 166 167 168 169 170 171 172 173 174 175 176 177 Name of Drug Cefprozil Cilostazol Escitalopram Oxalate. Anastrazole Rizapriptan Gadobenate(Dimeglumine IV Injection) Tacrolimus Ointment Metolazone Tiotropium Bromide Gadoversetamide Injection Torsamide Cyproterone Tablet Aripiprazole Azelaic Acid Bendrofluazide Imipenem +Cilastatin Vinpocetin Tirofiban HCl I.V Teriparatide Cladribine Tadalafil S-Atenolol Rosuvastatin Tazarotene Aceclofenac Ibopamine HCl Trandolapril Dorzolamide Fenoverine Pharmacological Classification Antibiotic For intermittent claudication. Anti depressant Anti cancer Anti migrain MRI Contrast Medium Immuno-modulator Diuretic Anti asthematic MRI Contrast Medium Diuretic For Prostatic Cancer Anti schizophrenia Anti-Acne Diuretic Anti-Bacterial Anti-pychotic Anti-Platelet For Osteoporosis Anti-Cancer For Erectile Dysfunction Anti-hypertensive Lipid lowering Agent Anti-Acne NSAID Opthalmic Anti-Hypertensive Opthalmic Anti-spasmodic Date of Approval 10-01-2003 23-01-2003 24.01.2003 10.02.2003 27.02.2003 07.03.2003 10-03-2003 23.04.2003 16.04.2003 04.06.2003 09.06.2003 10-06-2003 11.06.2003 08-07-2003 24.07.2003 25-07-2003 01.08.2003 12.08.2003 04-09-2003 09-09-2003 11-09-2003 11-09-2003 12-09-2003 12.09.2003 15-09-2003 03-10-2003 03-10-2003 03-10-2003 08-10-2003

178 179 180 181 182 183 184 185 186 187

Risedronate Sodium Fondaparinax Sodium Metadoxine Valgancyclovir Isopropyl Unoprostone Amorolfine Fluvastatin Sodium Modafinil Sufentanil Citrate Ezetimibe

For Osteoporosis LMWH For Hepatic Disorder For CMV Ophthalmic Anti-Fungal Lipid Lowering Agent For sleeping disorder Anesthetic Agent Lipid Lowering Agent

17-10-2003 22-10-2003 24-10-2003 20-11-2003 25-11-2003 25-11-2003 25-11-2003 15-12-2003 17-12-2003 18-12-2003

LIST OF DRUGS APPROVED DURING 2001

Sl.No. 93 94 95 96 97 98 99 100 100A 101 102 103 104 105 106 107 108 109 110 110 111 112 113 114 115 Name of Drug Bimatoprost (Ophthalmic Sol.) Meropenem Inj. Fosinopril Sodium Divalproax Sodium Zaleplon Tizanidine SR Thymogen Inj. Montelukast Sodium Methyl Cobalamin Mifepristone Dexarazoxane Injection Tranexamic Acid Bicalutamide Loteprednol Etabonate Ophtalmic Sol. Apraclonidine Ophthalmic Sol. Mizolastine Miltefosine Ziprasidone HCl ABACAVIR Nadifloxacin Cream Meloxicam Inj. (Vet) Mesalazine SR Tamsulosin HCl Famciclovir Nateglinide Pharmacological Classification Anti-Glaucoma Beta-lactum Antibiotic Antihypertensive Antiepileptic Sedative-Hypnotic Multiple Sclerosis Anticancer Antiasthmatic (Leukotriene Receptor Antagonist) Peripheral Neuropathy Progesterone Antagonist Cardio Protective Agent Antifibrinolytic Anticancer Corticosteroid, ophthalmic anti-inflammatory Alpha 2-adrenoreceptor agonist Antiallergic For Kalazar For Schizophrenia Anti HIV Antibacterial; antiacne NSAID Bowel disease (inflammatory) For BPH Antiviral Antidiabetic Date of Approval 08.01.2002 08.01.2002 10.01.2002 17.01.2002 17.01.2002 06.02.2002 12.02.2002 13.02.2002 13-02.2002 13.02.2002 26.02.2002 06.03.2002 07.03.2002 15.03.2002 15.03.2002 15.03.2002 15.03.2002 18.03.2002 22.03.2002 28.03.2002 02.04.2002 04.04.2002 04.04.2002 11.04.2002 01.05.2002

116 117 118 119 120 121 122 123 124 125 126 127 128 129 130 131 132 133 134 135 136 137 138 139 140 141 142 143 144 145 146 147 148

Lercanidine HCl Itopiride Capsules Alprostadil Injection Vimpocetine Quetiapine Fumerate Isotretinoin Soft Gel Cap. Nebivolol HCl Sirolimus Drotrecogin alpha Pygenum Africum Valdecoxib Thalidomide S (-) Amlodipine Besylate Cabergoline Butarphenol Tartarate Gemtuzumab Quinapril Valacyclovir Fosphenytoin Sod. Ceftiofur Sodium & Ceftiofur HCl Metaxalone Meglumine gadoteric Cefepine HCl Acamprosate Calcium Aztreonam Tegaserod Maleate Parecoxib Inj. Balsalezide Disodium Cefetemet-piroxil Telmisartan Levocetrizine Poractant Reboxetine

Antihypertensive Gastro Prokinetic Agent For Erectile Dysfunction Vasodilator Antipsychotic For Acne vulgaris Antihypertensive Immunosuppressant For severe sepsis For BPH NSAID For Leprosy Anti-hypertensive For hyperprolactemia Opoid Analgesic For Myeloid Leukemia Anti Hypertensive Anti-viral Anti-Epileptic Antibiotic (For Veterinary Use) Muscle Relaxant Contrast media Anti-Biotic For Alcohol dependency Anti-Bacterial For irritable bowel syndrome NSAID For ulcerative colitis Antibacterial Antihypertensive Anti-Histaminic For respiratory distress in preterm babies Anti-depressant

07.05.2002 09.05.2002 09.05.2002 13.05.2002 31.05.2002 21.06.2002 12.07.2002 15.07.2002 23.07.2002 30.07.2002 01.08.2002 12.08.2002 16.08.2002 05.09.2002 11.09.2002 12.09.2002 19.09.2002 25.09.2002 01.10.2002 08.10.2002 08.10.2002 16.10.2002 30.10.2002 30.10.2002 01.11.2002 01.11.2002 01.11.2002 12.11.2002 14.11.2002 25.11.2002 12.12.2002 24.12.2002 31.12.2002

LIST OF DRUGS APPROVED DURING 2001

Sl.No. 52 53 54 Name of Drug Sildenafil Citrate Triflusal Thymosin Alfa-1 Inj. Pharmacological Classification Male Erectile Dysfunction Platelet Aggregation Inhibitor Immunomodulator Date of Approval 08.01.2001 17.01.2001 17.01.2001

55 56 57 58 59 60 61 62 63 64 65 66 67 68

Vinorelbin Tartrate Inj. Broncho-Vaxom Indinavir Sulphate Butenafine HCl cream Mirtazapine Clopidogrel Mosapride Donepezil HCl Bupropion SR Raloxifene HCl Efavirenz Moxifloxacin Misoprostol Human Recombinant Granulocyte Colony Stimulating Factor Inj. Nelfinavir Mesylate Ciprofloxacin 1g SR Tolterodine-L-Tartrate Ebastine Leflunomide Citalopram Hydrobromide Gatifloxacin Linezolid Genirelix Racecadotril Cefdinir Iobitridol Estemestane Decapeptide Oxcarbazepine Desloratidine Zolendronic Acid Zafirlukast Ropinirole Esomeprazole Mag. Etanercept-Recomb.

(for chronic Hepatitis-B) Antineoplastic aggregation inhibitor Antiasthamatic, immune boosting drug Antiviral (Anti-HIV) Antifungal Antidepressant Antithrombotic; platelet aggregation inhibitor Prokinetic agent, GERD For Alzheimer's Dementia Smoking cessation adjunct Menopausal osteoporosis Anti-HIV Antibacterial Antiulcer agent Haemopoietic stimulant, antineutropenic Anti-HIV Antibacterial Overactive Bladder Antiallergic Anti-rheumatoid Arthritis Antidepressant Antibacterial Antibacterial Antigonadotropin releasing hormone (fertility drug) Antidiarrhoel Antibacterial Contrast Medium Antineoplastic For Vitiligo Antiepileptic Antiallergic For Hypercalcaemia Antiasthmatic (Leukotriene Receptor Antagonist) Dopamine Agonist (for Parkinson's Disease) Antiulcer Antirheumatic, Tumor Necrosis Factor Receptor Anticancer

17.01.2001 Feb, 2001 01.02.2001 14.02.2001 14.02.2001 22.02.2001 12.03.2001 20.03.2001 10.04.2001 04.05.2001 06.06.2001 26.06.2001 21.06.2001 29.06.2001

69 70 71 72 73 74 75 76 77 78 79 80 81 82 83 84 85 86 87 88 89

02.07.2001 Aug, 2001 13.09.2001 28.09.2001 01.10.2001 03.10.2001 03.10.2001 04.10.2001 08.10.2001 10.10.2001 10.10.2001 17.10.2001 18.10.2001 22.10.2001 30.10.2001 30.10.2001 05.11.2001 03.12.2001 03.12.2001 04.12.2001 07.12.2001

90

Imatinib Mesylate

09.12.2001

91 92

Valsartan Rabeprazole

Antihypertensive Antiulcer; Proton pump inhibitor

10.12.2001 27.12.2001

LIST OF DRUGS APPROVED DURING 2000

Sl.No. 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 Name of Drug Oxiconazole Temozolomide Olanzapine Fluvoxamine Maleate Celecoxib Nevirapine Repaglinide Ganciclovir Trapidil Cerivastatin Rofecoxib Irbesartan Rosiglitazone Maleate Granisetron Rituximab Trastuzumab Rosiglitazone Moclobemide Candesartan Venlafaxine Hdrochloride Paroxetine Hydrochloride Iomeprol Capecitabine Daclizumab Pioglitazone Hydrochloride Didanosine Octy.lonium Bromide Pravastatin Pharmacological Classification Antifungal Antineoplastic Antipsychotic Antidepressant NSAID Anti HIV Antidiabetic Antiviral Adjunct in angioplasty Lipid lowering agent NSAID Antihypertensive Antidiabetic Antiemetic Antineoplastic Antineoplastic Antidiabetic Antidepressant Antihypertensive Antidepressant Antidepressant Contrast medium Antineoplastic Immunosuppressive agent Antidiabetic AntiHIV Irritable bowel syndrome Lipid lowering agent Date of Approval 17.01.2000 17.01.2000 27.01.2000 21.02.2000 22.02.2000 06.03.2000 23.03.2000 05.04.2000 11.05.2000 11.05.2000 26.06.2000 26.06.2000 28.06.2000 05.07.2000 10.07.2000 10.07.2000 14.07.2000 28.07.2000 31.08.2000 18.09.2000 04.10.2000 05.10.2000 12.10.2000 12.10.2000 17.10.2000 15.11.2000 12.12.2000 20.12.2000

LIST OF DRUGS APPROVED DURING 1999

Sl.No. 1 Name of Drug Glimepiride Pharmacological Classification Antidiabetic agent Date of Approval 22.01.99

2 3 4 5 6 7 8

Mycophenolate Mofetil Meloxicam Tetrabenazine Doxazosin Mesylate Nafarelin Acetate Milrinone Lactate Inj. Brimonidine Tartrate

9 10 11 12 13 14 15 16 17 18 19 20 21 22 23

Nabumetone Zolpidem Basiliximab Inj. Topotecan Hydrochloride Fludarabine Phosphate IV Inj. Zuclopenthixol Acetate Piperacillin - Tazobactam Inj. Topiramate Eptifibatide Atorvastatin Sulpiride Bambuterol Bulaquine Fenofibrate Sibutramine Hydrochloride

Immunosuppressant NSAID Pre-Synaptic monoamine depleting agent Antihypertensive agent Antiendometriotic agent; gonadotropin inhibitor Cardiotonic Alpha2-adrenoreceptor agonist, adjunct in glaucoma NSAID Sedative-Hypnotic Immunosuppressant Antineoplastic Antineoplastic Antimaniac & antischizoprenic Antibiotic Antiepileptic Platlet Aggregation Inhibitor Antihyperlipidemic; HMGCoA reductase inhibitor Antipsychotic Bronchodilator Antimalarial Lipid lowering agent Appetite suppressant

07.02.99 16.02.99 10.03.99 11.03.99 17.03.99 17.05.99 18.05.99

18.05.99 28.05.99 28.05.99 15.06.99 26.06.99 29.07.99 13.08.99 23.08.99 25.08.99 17.09.99 26.10.99 13.12.99 21.12.99 22.12.99 23.12.99

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