List of Drugs Approved by DCGI 1969 To Aug 2008 Alfa

List of Drugs Approved by DCGI During Jan -1969 to Aug- 2008
S. o 1. 2. 3.
ame of Drug A mixture of sodium salt & Methyloglucamine salt ABACAVIR Abacavir Sulphate syrup 20mg/ml
Pharmacological Classification X-ray contrast medium Anti HIV For HIV Infection For adult patients with severe active rheumatoid arthritis who had an inadequate response to one more DMARDs such as methotixate or TNF antagonists For Alcohol dependency For the treatment of adult patients with chronic obstructive pulmonary disease and bronchial asthma Anti-hyertensive agent NSAID For acute painful condition in adults NSAID As Approved For pain, swelling etc For pain in post operative & post traumatic cases As Approved For short term treatment of pain due to post operative and post traumatic cAses For short term treatment of pain due to post operative and post traumatic cases As sweetener in pharmaceutical preparation For sever psoriasis in adults. For the treatment of rheumatoid arthritis patients
Date of Approval 1975 76 22.03.2002 29.08.06
4.
Abatacept powder for injection 250mg/vial
22.07.08
5.
Acamprosate Calcium
30.10.2002
6.
Acebrophylline capsules 100mg
29.05.08 1985-87 15-09-2003 29-06-2004 22-02-2006 21.12.06 08-06-2005 28.09.06 01.12.06 19.02.07
7. 8. 9. 10. 11. 12. 13. 14. 15.
Acebutolol HCl Aceclofenac Aceclofenac (100 mg) + Paracetamol(500 mg) Aceclofenac 200mg (S.R) tablet Aceclofenac dispersible tablet 100mg (new dosage form) Aceclofenac gel 1.5% alongwith linseed oil, menthol, Salicylate, Capsaicin Aceclofenac Inj. (150mg/ml) Aceclofenac Inj. 50mg/ml (additional strength) Aceclofenac injection (150mg/3ml)
16. 17. 18. 19.
Aceclofenac injection 150mg/ml Acesulfame Potassium Acitretin Actarit 100mg Tablets
23.01.08 05-04-2005 09-09-2005 22.07.08

20. 21. 22. 23. 24. 25. 26. 27. Acyclovir Adefovir Dipivoxil Albendazole Albendazole Alclomotasone Dipropionate Alendronate Sodium (equiv. to Alendronic acid 70mg) + Cholecalciferol 70mcg (equiv. to 2800 I.U Vit.D) Tablet Alfuzocin Hcl. ER (10mg) + Dutasteride 0.5mg tablet Alfuzosin E.R. Tablets (10 mg) Anti-viral Anti-Viral (Hepatitis-B) Vet. Anthelmintic Anthelimatic Topical Corticosteroid For osteoporosis For BPH in men with enlarged prostate For BPH For the treatment of essential hypertension in adult patients whose blood pressure is not adequately controlled on monotherapy. For hypertension For anxiety For Panic disorder with or without agoraphobia For Erectile Dysfunction For Parkinsonism 1985-87 04-03-2004 03/1979 to 07/ 1981 1985-87 1985-87 01-02-2006 14.06.07 14-05-2004
28.
Aliskiren 150/150/300/300mg + HCTZ 12.5/25/12.5/25mg tablets
08.05.08
29. 30. 31. 32. 33. 34.
Aliskiren Tablet 150mg/300mg Alprazolam Dispersible Tab. 0.125mg/0.25mg/0.50mg Alprazolam SR 0.25mg + Sertraline (As Hcl) 25mg/50mg tablet Alprostadil Injection Amantadine HCl Ambroxol + loratadine + Guaifenesin Syrup (30mg + 5mg + 50mg per 5ml)
08.06.07 20.09.06 09.08.06 09.05.2002 1969 - 1974
35. 36. 37. 38. 39. 40.
For the treatment of productive cough For the symptomatic relief of Ambroxol HCl 30mg + Guaiphenesin 100mg bronchospasm in bronchial + Terbutaline sulphate 2.5mg per 10ml Syrup asthma & chronic bronchitis Ambroxol HCl 75mg (S.R) + Desloratadine For relief of productive cough. 5mg Capsule. Ambroxol HCl. 15mg + Guiphenesin 50mg + For symptomatic relief of Terbutalin sulphate 1.25mg + Menthol 2.5mg bronchospasm in bronchial per 5 ml of syrup asthma and chronic bronchitis Amikacin Amiloride HCl Amino Acid, Glucose Parentral Solution (Solution for intravenous infusion) Antibiotic Diuretic anti-hypertensive
18.08.08 26.03.08 10-11-2005 26.03.08 1985-87 03/1979 to 07/ 1981
Indicated to meet daily requirement of nitrogen (amino 08.07.08 acids), energy (glucose) for
2

patients needing parentral Nutrition 41. 42. 43. Aminoglutetnimide Tabs Aminophylline CR 225/350mg Aminosidine Sulphate Anti-cancer Asthma, COPD, Bronchitis Antibiotic For cardiopulmonary resuscitation in the event of cardiac arrest related to ventricular fibrilation resistant to external electric shock. Same as Approved For schizophrenic disorder As Approved For apthous ulcers in people with normal immune system 1985-87 21.03.07 1975 76
44.
Amiodarone Injection (additional Indication).
05-10-2007.
45. 46. 47. 48. 49. 50. 51. 52. 53. 54. 55. 56. 57. 58. 59. 60. 61. 62.
Amisulpiride 300mg tablets (Additional Strength) Amisulpiride Tablet (50/100/200mg) Amisulpride 400mg tablet (additional strength) Amlexanox Oral PAste (5%)
20.03.08 01-08-2006 01.12.06 16.05.07 24-09-2004 06-09-2007. 23.02.07 07.05.07 05-06-2006 30-11-2005 24-04-2006 08-12-2005 14.02.07 21.02.07 01.11.06
Amlodipine (5 mg) + Ramipril (2.5 mg) tablet Anti-hypertensive Amlodipine (5mg) + Nebivolol (5mg) tablet (addl. Strength). Amlodipine (As besylate )5mg/10mg + Perindopril 4mg tablet Amlodipine (As besylate) 10mg + Perindopril 8mg tablets (additional strength) Amlodipine (as besylate) 5mg + Metoprolol Succinate equivalent to Metoprolol Tartrate 50mg. Amlodipine (as besylate) 5mg + Bisoprolol 5mg Tablet (Addl. Strength) Amlodipine (as besylate) 5mg + HCTZ 12.5mg Tablet Amlodipine (as besylate) 5mg + Losartan Pot. 50mg Amlodipine (As besylate) 5mg + Metoprolol (As succinate) ER 25mg (additional strength) Amlodipine (As besylate) 5mg/5mg/10mg + valsartan 80mg/160mg/160mg tablet Amlodipine 25mg + Metoprolol 25mg (additional lower strength) Amorolfine Amoscanate Amoxapine As approved. For hypertension As approved For hypertension For hypertension For hypertension For hypertension As approved Essential hypertension
Anti-Fungal Anti-amcabic Anti-capressant
25-11-2003 1985-87 1985-87

For RTI, SRS of tissue infection, bons & joint infection, ENT infection in adults prone to antibiotic associated diarrhoea For RTI, SRS of tissue infection, bons & joint infection, ENT infection in adults prone to antibiotic associated diarrhoea Antibiotic Anti-biotic
63.
Amoxicillin 250mg + Lacto- Bacillus 1.7 billion Spores
31.01.08
64.
Amoxicillin 250mg/125mg + Cloxacillin 250mg/125mg + Lactic Acid Bacillus 1.7 Billion spores Amoxycillin Amoxycillin 1000mg + Clavulanate Potassium 62.5mg E.R tablet Amoxycillin 125mg/250mg/500mg + Lactobacillus 1.66 billion Spores (Capsules)
30.01.08
65. 66.
Dec. 1978 08-06-2006
67.
68.
Amoxycillin 250mg + Cloxacillin 250mg + Lactobacillus 2 billion spores capsules Amoxycillin 250mg + Dicloxacillin 250mg cap. Amphotericin B Lipid suspension injection (25mg/vial) with lipid suspension Ampicillin 250mg + Dicloxacillin 250mg tablet Amtolmetin Guacil tablets 600mg Anastrazole Apomorphine HCL-2mg/3mg Sublingual tablet. Apraclonidine Ophthalmic Sol. Aprepitant 40mg capsules (additional strength) Aprepitant cap (80mg/125mg) Aprotinin Aripiprazole
For the treatment of respiratory tract infection, skin and soft tissue infections & antibiotics 31.01.08 associated diarrhoea in adult patients For the treatment of lower RTI, skin & soft tissue bone & joint infections, ENT infections in 30.01.08 adult patients prone to antibiotic associated diarrhoea Anti biotic 28.08.06
69.
70.
For invasive fungal infection in patients who are refractory to 03.06.08 or intolerant of conventional amphotericin B therapy Antibiotic For the treatment of osteoarthritis & rheumatoid arthritis Anti cancer For erectile dysfunction in adult men. 13.12.06 07.03.08 10.02.2003 12/11/07
71. 72. 73. 74. 75. 76. 77. 78. 79.
Alpha 2-adrenoreceptor agonist 15.03.2002 Prevention of post-operative nausea & vomiting (additional indication) For chemotherapy induced nausea & vomiting Acute Pancreatitis 24.04.07 30.08.06 1969 - 1974 11.06.2003
Anti schizophrenia

80. 81. 82. 83. Artemether + Lumefantrine Dispersible tablet (40/80mg + 240/480mg ) (Additional Strength) Artemether 40mg/80mg + Lumefantrine 240mg/480mg tablets (additional Strength) Articaine Hydrochloride Aspirin 150mg + Clopidogrel (as bisulphate) 300mg tablet (addl. Strength) Aspirin 75mg / 150mg + Glycine 37.5mg/75mg tablet Aspirin Bolus (Vet.) 6gm/bolus) Atazanavir 150mg + Ritonavir 50mg capsules Atazanavir 300mg capsules (Additional strength) Atazanavir (100/150/200mg) Atenolol Atenolol (25mg, 50mg) + HCTZ (12.5mg) Atenolol 25mg/50mg + Indapamide SR 1.5mg Atenolol 50mg + HCTZ 25mg (addl. Strength) Atomoxetine (as HCl) Sachet (10/18/25/40mg) Atomoxetine 60mg capsule (Addl. Strength) Atomoxetine HCl (10,18, 25 & 40mg ) capsule Atorvastatin Atorvastatin (40mg) + Ezetimibe (10mg) Tablet (addl. Strength).
Same as approved Same as Approved Local anaesthitic agent As loading dose for prevention of in-stent restenosis in PCI For prevention of acute coronary syndrome in patients with CAD prophylaxis against stroke For Veterinary use. Anti HIV Same as approved Anti-HIV in adults. Anti-hypertensive agent Anti-Hypertensive For essential hypertension For hypertension For ADHD For ADHD For ADHD Antihyperlipidemic; HMGCoA reductase inhibitor As approved. For the treatment of dyslipidemia associated with atherosclerotic arterial disease with risk of myocardial infarction, stroke or peripheral vascular disease For the treatment of uncomplicated and complicated UTI, uncomplicated skin and skin structure infections, and
05.08.08 24.06.08 1985-87 22-06-2006
84.
10.08.06
85. 86. 87. 88. 89. 90. 91. 92. 93. 94. 95. 96. 97.
21-11-2005 12.12.06 08.01.08 24-04-2006 1985-87 13-01-2005 21.05.07 03-02-2006 15-12-2005 27-02-2006 09-11-2004 17.09.99 30-07-2007.
98.
Atorvastatin 10mg + Aspirin 75/150mg Capsules
18.01.08
99.
Atorvastatin 10mg + Fenofibrate 80mg tablet (Additional Indication)
25.01.08

complicated intra-abdominal infections 100. 101. 102. Atorvastatin 5mg + Fenofibrate 160mg (additional strength) Atorvastatin Calcium (10mg ) + Ramipril (2.5mg/5mg) tablet Atorvastatin Calcium (10mg) + Fenofibrate (145mg) (addl. strength) As Approved For treatment of patients with both hypertension and hypercholesterolemia. As Approved 01.12.06 15-10-2007. 30-10-2007.
103.
Atorvastatin Calcium 80mg tablets (Additional Strength)
Additional Strength (it should not be used routinely because of increased risk of adverse events. It should be reserved 25.02.08 for patients who are considered to be at higher risk after careful risk assessment Muscle agent Ant-rheumatic Anti-allergic Anti-allergic Cytotoxic agent Anti-Acne For the treatment of inflammatory papules and pustules of mild to moderate rosacea For RTI caused by susceptible organisms in adults. Conjunctivitis Anti-Bacterial Anti-malaria Antibiotic For alteration of intestinal bacterial flora Same as Approved For spasticity As approved 1985-87 1985-87 1975 76 03/1979 to 07/ 1981 1969 1974 08-07-2003
104. 105. 106. 107. 108. 109.
Atracurium Dibesylate Inj. Auranofin Autolysate of B-subtilis & B-megatherium Azatadine Maleate Azathioprine Azelaic Acid
110.
Azelaic acid Cream (15%) Azithromycin 500mg + Ambroxol S.R (75mg) Tablet. Azithromycin eye drops 1% Aztreonam b -arteether Injection (150 mg/2 ml) Bacampicillin Bacillus calusii spores suspension (2billion/5ml vial) Bacillus Clausii Spores (2 Billion) Capsules (additional dosage form) Baclofen E.R capsule (30mg) Baclofen ER (GRS) Capsule 45mg/60mg (additional strength)
23-02-2005
111. 112. 113. 114. 115. 116. 117. 118. 119.
05-07-2007. 06.06.07 01.11.2002 01-09-2004 1985-87 28-01-2005 23.07.08 01-08-2006 22.02.07

120. 121. 122. 123. 124. 125. 126. 127. 128. 129. 130. Balanced salt intra ocular irrigating solution enriched with glutathione Dextrose, bicarbonate Balsalezide Disodium Bambuterol Basiliximab Inj. Beclomethasone Dipropionate Beclomethasone Dipropionate 0.25mg + Econazole 10mg + Neomycin 5mg per gm of Cream Bemiparin Sodium Solution for injection (5000/7500/10,000 I.U). Bendrofluazide Benorylate Benserazide HCl (in combination with Levodopa only) Benzoyl Peroxide Medicated Solution (each textured pad contains 4.5%/6.5%/8.5% of solution For intraocular irrigating during intraocular surgical procedures For ulcerative colitis Bronchodilator Immunosuppressant Topical Corticosteroid For the topical treatment of bacterial and fungal infections For deep vein thrombosis Diuretic Analgestic Anti-pyietic Parkinsonism For the topical treatment of acne vulgaris Indicated in the treatment of Meniers Syndreme, characterised by unilateral or bilateral tinnitus ,vertigo, sensonneural hearing loss For the treatment of steroid responsive dermatoses associated with superficial fungal infections of the skin Topical anti-inflammatory steroid Topical corticosteroid Cardiac giycoside Anticancer Respiratory infections, cold, bronchicles Anti-Glaucoma For reduction of IOP For Parkinsonism
26-04-2005 12.11.2002 13.12.99 28.05.99 1969 1974 30.01.08 08-06-2006 24.07.2003 Dec. 1978 1985-87 14.05.08
131.
Betahistine Dihydrochloride
1975 76
132.
Betamethasone 0.05% +Miconazole 2% Cream Betamethasone Benzoate Betamethasone Dipropionate Beta-methyldigoxin Bicalutamide Biclotymol Bimatoprost (Ophthalmic Sol.) Bimatoprost 300mg + Timolol (as maleate) 5mg/ml eye drops Biperlden HCl
12.03.08
133. 134. 135. 136. 137. 138. 139. 140.
1969 1974 03/1979 to 07/ 1981 Dec. 1977 07.03.2002 1985-87 08.01.2002 05-07-2006 1969 1974

141. 142. 143. 144. 145. 146. Bitoscanate Bivalirudin Injection (250mg/vial) Bleomycin Bleomycin Oil Suspension Bortezomib 2mg/vial (additional pack size) Bortezomib for injection (3.5mg/vial) Anthelmintic Anti-coagulant in PTCA Anti-cancer Anti-cancer As approved For the treatment of myeloma patients For the treatment of patients with mantle cell lymphoma who have received at least one prior therapy. For the treatment of mild to moderate psoriasis Alpha2-adrenoreceptor agonist, adjunct in glaucoma Ophthalmic For lowering of IOP in patients with open angle glaucoma occular hypertension For the treatment of postoperative inflammation & reduction of postoperative ocular pain in patients who have undergone cataract extraction Mucolytic agent Gynaecological disorders Antiasthamatic, immune boosting drug Preservative As appetite stimulant Antimalarial Diuretic Local analgesic For opioid dependence 1969 1974 25-08-2005 1969 1974 1985-87 28.03.07 18-05-2005
147.
Bortezomib Injection (additional indication)
05-09-2007.
148. 149. 150. 151.
Boswellia Serrata 0.05gm/gm of Cream Brimonidine Tartrate Brimonidine Tartrate (2mg/1.5mg) + Timolol (as HCl) 5mg/ml. Brimonidine Tartrate Opthalmic solution 0.1% (with purite as preservation 0.0005%) (additional strength)
28.03.08 18.05.99 25-11-2005 07.03.08
152. Bromfenac Sodium Eye Drop (0.09%)
14.08.08 03/1979 to 07/ 1981 1985-87 Feb, 2001 1969 1974 28-06-2006 21.12.99 03/1979 to 07/ 1981 1969 1974 06-04-2005
153. 154. 155. 156. 157. 158. 159. 160. 161.
Bromhexine HCl Bromocriptine Mesylate Broncho-Vaxom Bronopol (2-Bromo- 2-nitroproman-1, 3diol) Buclizine HCl tablet (25mg) & Syrup 6mg/5ml Bulaquine Bumetanide Bupivacaine HCl Buprenorphine (0.4mg) + Naloxone (0.1mg) sublingual tablet

162. 163. 164. 165. 166. 167. 168. 169. 170. 171. 172. 173. Buprenorphine HCl Bupropion SR Buserlin Acetate Butarphenol Tartarate Butarphenol tartrate 10mg/ml nasal spray Butenafine HCl cream Cabergoline Cabergoline 1 mg/2 mg/4 mg tablets Cabergoline 1mg tablet (additional strength) Calcium Pidolate equivalent to Calcium 500mg + Vit-D3 250 IU Calcium Polycarbophil (500mg) tablet Calcium Polycarbophil (500mg) Tablet Narcotic analgesic Smoking cessation adjunct Luetinising Hormone (Vet) Opoid Analgesic For management of pain in patients using opioid analgesics. Antifungal For hyperprolactemia For Parkinsons disease For Hyperprolactinemia For osteoporosis and calcium deficiency state. For constipation IBS For remission of acute symptoms of chronic pancreatitis and post-operative reflux esophagitis Antihypertensive (i). First line treatment of advanced 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. Antineoplastic Anti-hypertensive agent Vet, Antibiotic Antibiotic Gastric Ulcer 1985-87 10.04.2001 1985-87 11.09.2002 26-11-2007 14.02.2001 05.09.2002 07-05-2004 06.03.07 23-10-2007. 23-12-2004 06-07-2005
174.
Camostat Mesylate tablets 100mg
29.01.08
175.
Candesartan
31.08.2000
176.
Capecitabin Tablet (150mg/500mg). (For additional indication).
16-07-2007.
177. 178. 179. 180. 181.
Capecitabine Captopril Carbadox Carbenicillin Sodium Carbenoxolene Sodium
12.10.2000 1985-87 1975 76 1969 1974 1969 1974

182. 183. 184. 185. Carbocisteine Carboprest Tromethamine Carboprost Tromethamine Carboquene Mucclytic Agent Persistent & Cystic Corpus Luteum (Vet) Prostaglandin alxotificient Anti-cancer 1:- In newly diagnosed highgrade malignant glioma patients as an adjunct to surgery and radiation. 2:- In recurrent glioblastoma multiforme patients as an adjunct to surgery For abdominal pain & tinnitus in adult For invasive candidiasis fungal infection. Antibiotic Antibiotic Antibiotic Same as Approved Antibiotic Antibacterial For the treatment of community acquired pneumonia, acute exacerabation of chronic bronchitis, uncomplicated skin and skin structure infection, Pharyngitis/tonsillitis Anti-biotic Anti-biotic Same as Approved As approved Antibiotic 1985-87 1985-87 03/1979 to 07/ 1981 1985-87
186.
Carmustine (polifeprosan 20 with carmustine Implant (Wafer)
31.01.08
187. 188. 189. 190. 191. 192. 193. 194.
Caroverine cap. 20mg & Inj. 40mg/2ml Caspofungin Acetate injection (50mg/70mg per vial). Cefadroxil 250mg + Clavulanic acid 62.5mg dispersible tablet Cefadroxil 250mg + Clavulanic acid 62.5mg per 5ml syrup Cefadroxil 500mg + Clavulanic acid 125mg tablet Cefadroxyl (as monohydrate) 125mg + Clavulanic acid (as potassium) 31.25 per 5ml Syrup (Additional strength) Cefazolin Sodium Cefdinir
23.08.06 23-12-2005 30.08.06 30.08.06 30.08.06 25.07.08 1985-87 10.10.2001
195.
Cefdinir 250mg dispersible tablets & oral suspension 250mg/5ml
29.04.08
196. 197. 198. 199. 200.
Cefdinir Dispersible tablet (125mg) Cefditeron (as pivoxil) 200mg tablet Cefditoren pivoxil 400mg tablets (Additional Strength) Cefditorene pivoxil dispersible tablet (30mg/50mg) (New Dosage form for children) Cefepem (as Hcl) 0.5/1gm + Amikacin (as sulphate) 0.125/0.250gm Inj.
27-05-2004 03-03-2006 11.03.08 08.06.07 11.08.06
10

201. 202. Cefepime (250mg) + Tazobactam (31.25mg) Injection (addl. Strength). Cefepime (As Hcl) 500mg/1000mg + Tazobactum (as Sodium) 62.5mg/125mg As approved. Antibiotic For serious CRTI, uncomplicated and complicated UTI, Uncomplicated skin & skin structure, infection acute exacerbation of chronic bronchitis & intraabdominal infection. For bacterial meningitis in children. For bacterial meningitis in children Anti-Biotic Anti-biotic Anti-biotic Antibacterial Antibiotic Antibiotic Antibiotic Anti-biotic For the treatment of Urinary tract infections, respiratory tract infections, biliary tract infections in adult patients prone to antibiotic associated diarrhoea Antibiotic For surgical prophylaxis (additional indication) Antibiotic For the treatment of lower respiratory tract infection in children 30-07-2007. 30.08.06
203.
Cefepime (as hydrochloride) 2000/1000/500mg + Sulbactam (as sodium) 1000/500/250mg per vial of injection
24.01.08
204. 205. 206. 207. 208. 209. 210. 211. 212. 213.
Cefepime Injection (New indication) Cefepime injection 500mg/1gm/2gm (For additional indication) Cefepine HCl Cefetamet Pivoxil Hcl oral suspension 250mg/ml Cefetamet Pivoxil Suspension 250mg/5ml Cefetemet-piroxil Cefixime (50mg/100mg) + Clavulanic acid 31.125mg/62.5mg per ml dry syrup & tablet Cefixime 100mg + Cloxacillin (as Sodium) 500mg + Lactobacillus (45 million spore)tab. Cefixime 200mg + Cloxacillin 500mg (ER) + Lactobacillus 90 million Spore tab. (additional strength) Cefixime 200mg + Pot. Clavulanate (125mg) tablet Cefixime 200mg/100mg + Lactic acid bacillus 2.5 billion spores tablet & dispersible tablet Cefixime dispersible tablet 400mg (new dosage Form) Cefotaxim (As sodium) 0.5mg/1gm + Sulbactam (As sodium) 250mg/500mg injection (for additional indication) Cefotaxime Sodium Cefotaxime sodium + Sulbactam sodium for injection (Additional Indication)
14-06-2007. 14.06.07 30.10.2002 16-02-2006 09-08-2004 14.11.2002 29.08.06 31.08.06 14.11.06 20-07-2006
214.
07.01.08
215. 216. 217. 218.
22.11.06 18.05.07 1985-87 24.06.08
11

Cefpirome (as sulphate) 500/1000mg/2000mg + Sulbactam (as sodium ) 250mg/500mg/1000mg powder for injection Cefpodoxime (as Proxetil) (100mg/200mg) + Clavulanic acid (62.5/125mg) tablet. Cefpodoxime 50mg + Clavulanic acid 31.25mg dispersible tablet & dry syrup (Additional strength) Cefprozil Cefprozil 250mg/500mg+Clav. Acid-62.5mg /125mg. tab Cefprozil Dispersible Tablet (125 mg/ 250 mg) Cefprozil Powder for oral suspension (125mg/5ml) Ceftazidime + Tobramycin injection (1gm + 120mg) (Additional Strength) Ceftazidime 500mg /1000mg + Tazobactum (as sodium) 62.5mg/125mg per vial for injection Ceftazidime 500mg + Tobramycin 60mg per vial (Injection) Ceftazidime 500mg/1000mg + Sulbactam (As Sodium) 250mg/500mg For injection Ceftazidine (2gm) + Sulbactam (1gm) Injection (addl. strength for additional indication). For the treatment of infection caused by sensitive organisms viz. lower RTI, complicated UTI, Septicemia, bacteremia For LRTI, URTI and UTI. Same as Approved Antibiotic For the treatment of adult patients with upper&lower RTI, Skin & Skin structure infection Anti-biotic Antibiotic Same as approved Antibiotic For the treatment of lower respiratory tract infection caused by pseudomonas aeruginosa Antibiotic For serious abdominal infection. 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 infections, meningitis, surgical prophylaxis Antibiotic (For Veterinary Use) For LRTI
219.
24.01.08
220. 221. 222.
30-07-2007. 31.01.08 10-01-2003
223.
12/11/07
224. 225. 226. 227.
22-06-2004 06-01-2006 05.08.08 30.08.06
228.
08.01.08
229. 230.
08.06.07 06-09-2007.
231. Ceftriaxone + Sulbactam injection (Additional Indication)
18.08.08
232. 233.
Ceftiofur Sodium & Ceftiofur HCl Ceftriaxone (as sodium) (500mg/1000mg) + Sulbactam (as sodium) (250mg/500mg) powder for injection. Ceftriaxone (As sodium) 125mg/250mg + Sulbactam (As sodium) 62.5mg/125mg For injection (additional strength)
08.10.2002 08-12-2005
234.
As approved
01.03.07
12

235. 236. Ceftriaxone (as sodium) 250mg + Tazobactam 31.25 mg for injection (addl. Strength) Ceftriaxone 2gm+ Tazobactum 250mg for injection
Anti-biotic As Approved
05-07-2006 21-11-2007
237.
238. 239.
240.
For adult patients with infection caused susceptible Cefuroxime Axetil (250mg) + Clavulanic micro-organisms including Acid (125mg) Tablet. S.aureus viz UTI, upper and lower RTI and gonoccoccal urethritis. Cefuroxime Axetil (250mg) + Clavulanic acid For UTI, URTI and LRTI and (125mg) tablet. gonococcal urethritis. Cefuroxime Axetil ER tablets (500 Anti-biotic mg/1000mg) For adult patients with infection caused by susceptible Cefuroxime-125/250/500mg +Clav.Acidmicrobs,including 31.25/62.5/125mg s.aureus.(e.gUTI,Upper&lower RTI & gonococcal urethrities) Celecoxib Celecoxib Injection (100 mg/ml) Centbucidine Centbucridine (0.5%) + Feracrylem (3%) Cephalexin Cephradine Cerivastatin Cetirizine HCl drops (10mg/ml) Chenodeoxycholic Acid Chloroquine Phosphate eye drops (0.3mg/ml) Cholestyramine Powder for oral suspension (4gm/sachet) Ciclesonide 160mcg/320mcg + Formoterol Fumarate (12mcg) (Dry powder inhaler additional strength) Ciclesonide 160mcg/320mcg/Formoterol 12mcg + Tiotropium 18mcg Dry powder inhaler NSAID For acute pain Local anaesthetic For hemorrhoid & anal fissure Broad Spectrum antibiotic Antibotic Lipid lowering agent Anti-histaminic Dissolution of gall bladder stone For dry eye syndrome For hypercholesterolaemia As approved As third line treatment of severe cases of COPD, when monotherapy and second line therapy with two drugs do not
27-09-2007.
05-10-2007. 06-10-2004
10/05/07
241. 242. 243. 244. 245. 246. 247. 248. 249. 250. 251. 252.
22.02.2000 28-10-2004 1985-87 11-01-2005 1969 1974 1975 76 11.05.2000 08-11-2005 1985-87 13-07-2005 30-03-2006 27.02.07
253.
31.01.08
13

respond adequately 254. 255. 256. 257. 258. 259. 260. 261. 262. 263. 264. 265. Ciclesonide Inhaler 80/160mcg per actuation Ciclesonide Nasal Spray 50mcg/spray Ciclesonide rotacaps (200/400mcg) Ciclesonide160mcg/320mcg cap. for inhalation Ciclopiroxolamine Ciclsonide 100mcg/ 200mcg/400mcg + Formotorol Fumarate 6mg rotacaps Ciclsonide 80mcg/160mcg + Formotorol 4.5mg inhaler Cifixime 200mg + Erdosteine 300mg Capsules Cilostazol Cilostazole E.R Tablet (100mg/200mg). Cimetidine Cimetropium Bromide tablet 50mg For persistent Asthma For seasonal & perennial allergic rhinitis in adults, adolescents aged 12 years For Asthma Anti asthmatic Anti-fungal Anti asthmatic Anti asthratic Acute Exacerbation of chronic bronchitis For intermittent claudication. For management intermittent claudication. Anti-ulcer 06-02-2006 08.06.07 19-05-2006 28.11.06 1985-87 29.08.06 29.08.06 21.03.07 23-01-2003 30-10-2007. 03/1979 to 07/ 1981
266.
Cinitapride (as hydrogen tartrate) 1mg tablet
For the treatment of irritable 31.01.08 bowel syndrome For the treatment of gastroesophageal reflux disease 04.01.08 and functional inconveniences of the gastrointestinal motility Anti-histaminic Antibacterial Anti-cancer Antidepressant As Approved For the treatment of disturbance of consciousness resulting from head injuries, brain operation and acute stage of cerebral infarction in adults only Membrane permeability enhancer As approved 1985-87 Aug, 2001 Apr. 1982 03.10.2001 26-11-2007
267. 268. 269. 270. 271.
Cinnarizine Ciprofloxacin 1g SR Cisplatin Citalopram Hydrobromide Citicholine (asSod.)-200mg/ 500mg /750mg granules per sachet.
272.
Citicholine Syrup 750mg/5ml
04.01.08
273. 274.
Citicholine Tablet 500 mg & Injection 250 mg/ml Citicoline (750mg) tablet (additional strength), syrup 500mg/5ml (new dosage
20-08-2004 10.04.07
14

Form) (not For children) 275. Citicoline tablet 200mg (additional strength) As approved 25.05.07
276. Citicoline Chewable tablet (500mg)
For the treatment of disturbance of consciousness as resulting from head injuries , brain operation and acute stage 18.08.08 of cerebral infraction in adult only Anti-Cancer Anti-bacterial agent Anti-histaminic For acne For plaque psoriasis Topical Corticosteroid Topical Corticosteroid Fertility drug Anti-hypertensive agent Diuretic Antithrombotic; platelet aggregation inhibitor Anti-leprosy drug Protein anabolizing agent For the treatment of serious infection caused Gram-Ve bacteria including LRTI, UTI, where commonly used anti bacterial agent may be infective because of bacterial resistance For focal spasticity, including the treatment of arm symptoms associated with focal spasticity in conjunction with physiotherapy Anti-fungal & local antitrichomonial agent 09-09-2003 1985-87 03/1979 to 07/ 1981 08.03.07 20-07-2006 1985-87 1985-87 1969 1974 1975 76 03/1979 to 07/ 1981 22.02.2001 1969 1974 1985-87
277. 278. 279. 280. 281. 282. 283. 284. 285. 286. 287. 288. 289.
Cladribine Clavulanic Acid Clemastin (as Hydrogen Fumarate)
Clindamycin 1% + Isotretinoin 0.05% gel Clobestasol Propionate (0.05%) + Calcipotriol Ointment (0.005%) Ointment. Clobetasol Propionate Clobetasone 17-Butyrate Clomiphene Citrate Clonidine HCl Clopamide Clopidogrel Clorazimine Clostebol Acetate
290.
Clostimethate Sodium of 1,00,000IU Injection
31.01.08
291.
Clostridium Botulinum type-A toxin haemagglutinin complex (Additional Indication) Clotrimazole
22.04.08
292.
1975 76
15

293. 294. 295. Clotrimazole (10mg) + Methyl-prednisolone aceponate 1mg/gm of cream. Comb kit of two capsule of Azaranari 150mg each + 1 tablet of Ritonavir 100mg) Comb pack of 1 bottle of ciprofloxacin Injection (200mg/100ml) & 1 bottle of Ornidazole injection 500mg/100ml) Combi pack of 1 tablet of Residronate sodium (35mg) + 6 tablet of calcium carbonate equivalent to 500mg calcium each 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 Combikit of 2 tablet of Lamivudine (150mg) + Zidovudine (300mg) each and 1 tablet of Egavirenz (600mg) Combikit of 2 tablet of Stavudine (40mg) + Lamivudine (150mg) each & 1 tablet of Efavirenz (600mg) Combikit of Tamsulosin HCl 0.4mg M.R capsule (10 no.) & Dutasteride Soft Gelatin Capsule 0.5mg (10no.) Combipack of 12 Artesunate 50mg tablets & 6 Mefloquin-250mg tablets Combipack of 12 tablet of Artesunate (50mg) each + 3 tablet of each containing Sulfadoxine (500mg) + Pyrmethamine (25mg) Tablet. (Addl. Strength) Combipack of 21 tablet of Quinin sulphate 600mg each & 8 capsule of Doxycycline (as Hcl) 100mg each) Combipack of one cap. Of aprepitant .125mg & two cap. Of aprepitant 80mg each (combipack) Combipack of two tablet of chloroquine phosphate (250mg) each + 14 tablet of Proguanil HCl (100mg) each Cyclandelate For fungal infection of skin associated with inflammation. For HIV infection Antibiotic For osteoporosis in postmenopausal women For the treatment of osteoporosis in postmenopausal women 12-7-2007. 02.04.07 20.04.07
296.
01.05.07
297.
23.01.08
298.
For HIV infection in adults
07-06-2005
299.
For HIV infection in adults
07-06-2005
300. 301.
For BPH For drug resistant P.falciparum malaria infection. As Approved
19-01-2006 12/06/07
302.
01-08-2007.
303.
For P. Falciparam malaria
10.08.06
304.
As Approved
10.10.06
305. 306.
For drug resistant malaria. Vasodilator As adjunct to rest and physical therapy for relief of muscle spasm associated with acute painful musculoskeletal conditions Same as approved For Ophthalmic use
10-10-2007. 1969 1974
307.
CyclobenzaprineHcl. Tablets 5mg/10mg
31.01.08
308. 309.
Cyclobenzaprine 7.5mg tablets (Additional Strength) Cyclosporin Eye drops (0.1%) (addl. Strength)
18.08.08 02-06-2006
16

310. 311. Cyproterone Tablet Daclizumab For Prostatic Cancer Immunosuppressive agent For the extended treatment of symptomatic venous thromboembolism (VTE) proximal deep thrombosis (DVT) and/or pulmonary embolism (PE), to reduce the recurrence of VTE in patients with cancer For the treatment of complicated skin and skin structure infections and for staphylococus aureus bloodstream infections (bacteremia) For the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency and frequency For chronic hepatitis B infection Anti-cancer For Vitiligo As Approved As approved For chronic iron overload due to blood transfusion Anti-asthma, anti-arthritis. 10-06-2003 12.10.2000
312.
Dalteparin Sodium Injection(Additional Indication)
30.01.08
313.
Daptomycin powder for concentrate for solution for infusion (350mg/500mg per vial)
28.01.08
314.
Darifenacin (as hydrobromide) 7.5mg/15mg ER tablets Dasatinib tablet 20mg/50mg/70mg tablet Daunorubicin Decapeptide Deferasirox 100mg dis.tablet(addl. strength) Deferasirox dispersible tablet (400mg) (addl. Strength). Deferasirox dispersible tablet 125/250/500mg. Deflazacort (1,6,30mg) tablet
31.01.08
315. 316. 317. 318. 319. 320. 321.
30.08.06 1969 1974 22.10.2001 28-11-2007 17-08-2007. 10-07-2006 02-11-2004
322.
323. 324.
325.
326.
For asthma, rheumatoid Deflazacort Oral Suspension (6mg/5ml) (New arthritis when dosage form) glucocorticosteriod therapy is warranted. Deflazocort 24mg tablets (Additional Same as Approved strength) Deflazocort oral suspension (6mg/5ml) (new As approved Dosage Form) Indicated in the treatment of induction of labour for various Desamino-Oxytocin reasons and for adequate uterine Desflurane liquid for inhalation For induction & maintenance (240mg/bottle). of anaesthesia.
15-06-2007.
14.05.08 15.06.07
1969 1974
22-02-2006
17

327. 328. 329. 330. 331. 332. Desloratadine (2.5mg) + Ambroxol (30mg) +Guiphenasine (50mg) + Menthol 1mg/5ml Syrup Desloratidine Desmoprission lyophilisate Oral tablets 60mcg/120mcg/240mcg per tablets Desoximetasone Dexarazoxane Injection Dexibuprofen 200mg/300mg +Paracetamol 500mg tablet
For productive cough Antiallergic For diabetes insipidus and noctural emuresis Topical corticosteroid Cardio Protective Agent For RA, OA & ankolysing spondylosis For the treatment of mild to moderate pain, reduction of fever For OA, RA & ankylosing spondylitis For the treatment of mild to moderate pain, such as dental pain, dysmenorrhoea & musculoskeletal pain For the treatment of Gastroeasophageal Reflux Disease (GERD) in patients not responding to dexrabeprazole alone For duodenal ulcer, gastric ulcer and GERD. For Duodenal ulcer, Gastric ulcer & GERD Ulcers & burns For the temporary relief of cough due to throat irritation, sneezing & ruunning nose. For the relief of persistent dry irritating cough in adult patients only For Osteoarthritis For the treatment of adult patients with osteoarthritis of knee and or hip joints For the treatment of adult patients with osteoarthritis of knee and hip joints Antihypertensive
02-03-2005 30.10.2001 08.05.08 1975 76 26.02.2002 10.08.06
333. Dexibuprofen Suspension 50mg/5ml 334. Dexibuprofen Tablet (200mg/300mg/400mg) Dexketoprofen (as Trometamol ) tablets 12.5mg/25mg
14.08.08 06-02-2006
335.
28.03.08
336.
Dexrabeprazole 10mg (EC) + Domperidone 30mg SR Capsules Dexrabeprazole Sodium E. coated tablet 5mg/10mg. Dexrabeprazole sodium Enteric Coated tablet 5mg/10mg Dextranomer Dextrometharpahan HBr10mg+Chlorphenaramine maleate-2mg /5ml syrup. Dextromethorphan Orodispersible strip 5.5mg/11mg Diacerein Diacerin 50mg + Aceclofenac 100mg tablets Diacerin 50mg + Glucosamine sulphate 500mg tablets. Diazoxide
09.06.08
337. 338. 339. 340.
13-06-2007. 13.06.07 1985-87 12/11/07
341. 342. 343.
28.01.08 12-03-2004 11.04.08
344. 345.
21.04.08 Aug. 1978
18

346. 347. 348. 349. Diclofenac 50mg + Serratiopeptidase 10mg enteric coated tablet Diclofenac Potassium 50mg + Serratiopeptidase (as enteric coated pellets) 15mg capsules (Additional Strength) Diclofenac Sodium Diclofenac Sodium (75/50mg) as (E.C) + Misoprostol 200mcg. Diclofenac Sodium (75mg/ml) Injection (addl. Strength). Diclofenac Sodium 100mg (SR Pellets) + Rabeprazole Sodium 20mg (E.C Pellets) Capsules Diclofenac Sodium 50mg + Codeine Phosphate 50mg tablets Diclofenac sodium 50mg + Dicyclomine HCl 20mg per ml of injection Diclofenac Sodium 50mg + Paracetamol 500mg tablets Diclofenac Transdermal patch 100 mg/50 Cm2 Diclofenac Transdermal Patch (200 mg/75 cm2) Dicloxacillin Didanosine Didanosine Powder for oral solution (2gm/4gm per bottles) Diflorasone Diacetate Cream (0.5mg/gm) Dilazep HCl Diltiazem Diltiazem Hcl. 2% gel Dimethothrazine Dimethylpolysiloxane For the treatment of acute pain in adults For the treatment of acute pain in adults Anti-Inflammatory agent For OA & RA For management of painful conditions in post-operative cases, rheumatoid arthritis and osteoarthritis. For treatment of painful inflammatory conditions associated with gastroduodenal ulcers For the treatment of adult patients with signs & symptoms of acute painful conditions For the treatment of acute colicky pain in adults For the symptomatic treatment of acute pain and inflammation in patients with osteoarthritis, rheumatoid arthritis and ankylosing spondylitis For Osteoarthritis & soft tissue injury For pain relief. Antibiotic Anti HIV Anti-AIDS For corticosteroid responsive dermatoses Sympathomimetic agent Coronory vasodilator For anal fissure Anti-histaminic Skin protective cream 24.01.08 08.04.08 1985-87 28-02-2006
350.
30-07-2007.
351.
31.01.08
352.
02.06.08
353.
28.01.08
354.
30.01.08
355. 356. 357. 358. 359. 360. 361. 362. 363. 364. 365.
10-08-2004 06-10-2004 Jul-78 15.11.2000 26-08-2005 08-02-2005 03/1979 to 07/ 1981 1985-87 07.02.07 1969 1974 1969 1974
19

366. 367. 368. 369. 370. Dimetridazole Diphenoxylate HCl Disopyramide Divalproax Sodium Divalproex Sodium E.R. Tablets (750mg/1000 mg) Vet. Drug Anti-diarrhoeal agent Anti-arrhythmic agent Antiepileptic Anti-Epileptic For additional indication "advanced gastric adenocarcinoma, locally advanced squamous cell carcinoma of head & neck, Harmone refraetory metastatic prostrate cancer, locally advanced or metastatic breast cancer Anti-emetic 1975 76 1969 1974 Jan-77 17.01.2002 24-06-2004
371.
Docetaxel injection conc.
31.03.08
372. 373. 374. 375. 376. 377. 378. 379. 380. 381. 382. 383.
Domperidone
1985-87 22-11-2005 Jan. 1982 20.03.2001 03/1979 to 07/ 1981 03-10-2003 01-09-2004 May-77 Sep. 1977 30-11-2005 11.03.99 1969 1974
Domperidone (10mg) + Activaed dimethicone For dyspepsia, colicy pain & (125mg) chewable tablet GERD. Donarol Donepezil HCl Dopamine HCl Dorzolamide Dorzolamide (20 mg) + Timolol (5 mg) per ml Eye drops Dothiapine HCl Doxapram HCl Doxazosin (as Mesylate) 4mg/8mg E.R. Tablet Doxazosin Mesylate Doxepin HCl Doxercalciferol 0.5mcg/2.5mcg Soft Gelatin capsules Gonadotropic inhibitor For Alzheimer's Dementia Cardiac drug Opthalmic For reduction of elevated IOP. Anti-depressant Respiratory stimulant For hypertension Antihypertensive agent Psychotic drug For the treatment of secondary hyperthyroidism in patients with chronic kidney disease on dialysis For the treatment of secondary hyperparathyroidism in patients with stage 3 or stage 4
384.
29.05.08
385.
Doxercalciferol (0.5/ 2.5mcg) Soft Gelatin Capsule (Additional Indication)
05.08.08
20

chronic kidney disease 386. 387. 388. 389. 390. 391. For carcinoma of the stomach, colon, rectum, breast, uterine, cervix and bladder For the treatment of bronchial asthma & COPD in adults For bronchial asthma & COPD. For bronchial asthma & COPD. For bronchial asthama & COPD in adult patients, when oral therapy is in approriate. For treatment of Bronchial asthma in adults 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 are unsuitable for bone marrow transplant Anti-cancer drug For adult patients prone to intrabdominal bacterial infection & Antibiotic associated diarrhoea Metallic Poisoning Cough Syrup Oral Contraceptive Oral contraceptive in women For severe sepsis For pain Same as Approved
Doxifluridine Capsules 100mg/200mg Doxofylline ER tablets 400mg/800mg (addl. Strength) Doxofylline Syrup (20mg/ml) Doxofylline Tablet (400mg) Doxophylline injection-10mg /ml Doxophylline-400mg+Salbutamol(as sulphate)-2mg/4mg Tablets
31.01.08 12.03.08 30-03-2006 08-02-2006 31-12-2007 29-11-2007
392.
Doxorubicin HCl Pegylated Liposomal Injection (20/50MG) (Additional Indication)
23.08.08
393.
Doxorubicin HCl Doxycycline-100mg +L.bacillus spores-5 billion D-Penicillamine Dried IVY Leaf Extract (7.5gm/100ml) Drosperinone (3mg) + Ethinylestradiol (0.035mg tablet) Drospirenone 3mg + Ethinyl estradiol 0.02mg tablets (Additional Strength) Drotrecogin alpha D-trans Fentantyl Transdermal patches D-Trans Fentanyl Metrix system (12mcg/hr.) (Additional Strength) Duloxetine HCl (60mg) tablet (additional strength) Duloxetine HCl (20,30,40mg) Tablet Dutasteride
1975 76
394.
12/11/07
395. 396. 397. 398. 399. 400. 401. 402. 403. 404.
1969 1974 15-09-2005 11-05-2005 28.03.08 23.07.2002 05-04-2006 07.01.08 28-02-2005
Anti-depressant For BPH
02-11-2004 16-02-2004
21

405. 406. 407. 408. 409. 410. 411. 412. 413. 414. 415. 416. 417. 418. 419. Ebastine Eberconazole cream (1%) Econazole Efavirenz Efavirenz Oral Solution (30mg/ml) Eflornithine HCl Cream (139mg/gm) Emtricitabine (200mg) capsule Enalapril (2.5mg/5mg) + HCTZ (12.5) Tablet (Addl. Strength) Entacapone (200mg) tablet Entecavir Tablet (0.5mg/1.0mg) & oral solution (0.05mg/ml). Eperisone Hcl (50mg ) tablet Epicillin Epinastine Hcl (0.05%) Opthlamic solution Epirubicin Inj. Eplerenone Tablet (25mg/50mg) Antiallergic Dermatophyte infection of skin such As T-corporis, T-c, TPedis Topical Anti-fungal Anti-HIV Anti-AIDS For reduction of unwanted facial hair in women. For HIV infection in adults For Hypertension For Parkinsons disease For chronic Hepatitis-B infection. For neck-shoulder orm syndrome scapula hum oral per arthritis and low back pain Antibiotic For allergic conjunctivitis Anti-cancer For hypertension For abnormality of vibration sense and abnormal change in heart rate associated with diabetic peripheral neuropathy Platlet Aggregation Inhibitor For chronic obstructive bronchitis Mucolytic For chronic obstructive bronchitis For metastatic non-small cell lung cancer. Antibiotic For the prophylaxis of surgical site infections following 28.09.2001 22.03.07 03/1979 to 07/ 1981 06.06.2001 25-08-2005 22-03-2006 09-06-2005 17-10-2005 30-12-2004 05-12-2005 23.08.06 1969 1974 22.09.06 1985-87 10-06-2005
420.
Eplerstat tablet 50mg
25.05.07
421. 422. 423. 424. 425. 426. 427.
Eptifibatide Erdosteine (150mg/300mg) Capsules Erdosteine 150mg + Guaiphenesin 50mg + Terbutaline 1.25mg per 5ml syrup Erdosteine Powder for oral suspension 35mg/ml Erlotinib Hydrochloride (25mg/100mg/150mg Tablet Ertapenem For injection (1gm/vial) Ertapenem for injection 1gm/vial (additional indication)
25.08.99 11-03-2005 08.08.06 06-02-2006 13-07-2005 10.04.07 15.01.08
22

elective colorectal surgery For co-morbid depression & anxiety disorder. Anti depressant For comobid depression and anxiety disorder. For the treatment of GERD, gastric and duodenal ulcer, Zollinger-Ellison syndrome For GERD Antiulcer For GERD in patients with esophagitis and/or severe symptoms of reflux as an alternative to oral therapy when oral intake is not appropriate Antineoplastic Vasomotor symptoms Associated with menopause Anti-cancer Estrogen For atropic viginitis For insomnia Ant rheumatic, Tumor Necrosis Factor Receptor Non-thiazide seluretic diuretic Anti-diamhoeal agent For anxiety disorder associated with depression. For osteoarthritis & rheumatoid arthritis Anaesthetic agent For Contraceptive in women NSAID For acute Musculoskeletal pain
428. 429. 430. 431. 432. 433.
Escitalopram (10mg) + Clonazepam (0.5mg) Escitalopram Oxalate. Escitlopram (as oxalate) 10mg + Clonazepam-0.5mg tablet (addl. Strength). Esomeprazole (with Sodium bicarbonate as buffer) 20mg/40mg tablets Esomeprazole 40mg (E.C.) + Itopride 150mg SR Capsules Esomeprazole Mag.
27-08-2004 24.01.2003 12/12/07 14.05.08 13.11.06 04.12.2001
434.
Esomeprazole Sodium For injection
04-04-2005
435. 436. 437. 438. 439. 440. 441. 442. 443. 444. 445. 446. 447. 448. 449.
Estemestane Estradiol topical emulsion 2.5mg/gm Estramustine Phosphate Caps Estriol Succinate Estrogen vaginal tablet 25mcg Eszopiclone tablet (1mg/2mg/3mg) Etanercept-Recomb. Ethacranic acid Ethacridine Lactate Etizolam Tablet (0.5mg/1mg). Etodolac ER tablets 400mg/500mg Etomidate Etonogestrel (11.7mg) + Ethinylestradiol (2.7mg) Contraceptive rings Etoricoxib Etoricoxib 10mg + Methyl Salicylate 100mg + Mentol 50mg + Linseedoril 30mg per gm.
18.10.2001 16.03.07 1985-87 03/1979 to 07/ 1981 02.11.06 07.02.07 07.12.2001 1969 1974 1969 1974 29-10-2007. 09.05.07 1985-87 15-02-2005 05-03-2004 14.12.06
23

of Gel Etoricoxib 10mg + Methyl salicylate 20mg per gm. of cream Etoricoxib injection 90mg/ml
450. 451. 452. 453.
Acute Musenlosleteal pain For short term use in acute painful condition in adults only For the treatment of haemorrhoid
21.03.07 28.03.08 29.02.08 30-08-2004
454.
455.
456. 457. 458. 459. 460. 461. 462. 463. 464. 465. 466.
Euphorbia Prostrata Dry Extract (ethanolic 80% (v/v) (35-70) :100mg tablet Everolimus Tablets (0.25 mg/ 0.5 mg/0.75 Immunosuppressant mg/1.0 mg) For adjunctive therapy to improve glycemic control in patients with type-II diabetes Exenatide injection (Each 2ml vial containsmellitus, who have not Exenatide 5mcg/10mcg per 0.2ml ) achieved adequate glycemic (Additional Strength) control with metformin, a sulfonylurea or a combination of metformin and a sulfonylureas For adjunctive therapy to improve glycemic control in patients with Type-II diabetes Exenatide Injection -pre-filled pen mellitus, who have not (250mcg/ml). achieved adequate glycemic control with Metformin, a sulfonyl urea or a combination of metformin and sulfonylurea. Indiacated for the treatment of Extract of Centella Asiatica uicers, burns, skin grafts, (Medecassol) kelcids, bed sores,etc. Ezetimibe Ezetimibe 10mg + Fenofibrate 160mg tablet Famciclovir FDC of Papain + Urea Ointment FDC of Amlodipine (5mg) + Bisoprolol (2.5mg) FDC of Amlodipine (5mg/10 mg) + Atorvastatin (10/20/40 mg) FDC of Atorvastatin (10 mg/20 mg) + Ezetimibe (10 mg) Table FDC of Atorvastatin (10mg) + Niacin (375mg/500mg E.R) Capsule FDC of Atorvastatin Calcium (10mg) + Finofibrate (160mg) tablet FDC of Buprenorphin 2 mg + Naloxone (0.5 mg) Lipid Lowering Agent For combined hypertipidemia Antiviral For debriment of necrotic tissues. Anti-hypertension
30.01.08
06-07-2007.
1975 76 18-12-2003 04.04.07 11.04.2002 11-07-2005 21-07-2005 20-10-2004 13-08-2004 26-07-2005 22-12-2004 19-08-2004
For co-existing hypertension & hyperlipidemia For Hypercholesterolemia For Hypercholesterolemia For hyperlipidemia For Opiod Dependency
24

467. 468. 469. 470. 471. 472. 473. 474. 475. FDC of Calciptriol (50mcg) + Betamethasone Dipro (0.5mg/gm) Ointment FDC of Ceftriaxone (500mg/100mg) + Tazobactum (12.5mg/62.5mg) Injection FDC of Epi-Growth Factor (1 gm) + Silversulphadiazine Cream FDC of Esomeprazole 20 mg/40 mg + Domperidone 30 mg SR Capsule FDC of Gabapentin (300mg) + Methylcobalamin (500mcg) Tablet FDC of Gatifloxacin (400mg) + Ambroxol HCl (75mg) tablet FDC of Gatifloxacin 0.3% + Dexamethasone Phos. 0.1% w/w Eye drops FDC of Glibenclamide 2.5 mg/ 5 mg + Metformin SR 500 mg tablet FDC of Glimepiride (1mg/2mg) + Pioglitazone (15mg)+ Metformin (500mg E.R) Tablet FDC of Lamivudine 300 mg (E.R) + Zidovudine 600 mg (E.R) + Nevirapine 400 mg tablets FDC of Levocetirizine (5mg) + Ambroxol (75mg S.R) Capsule FDC of Lovastatin (20mg) + Nicacin ER (500mg) tablet FDC of Methylcobalamin (1500mcg E.R) + Pyridoxine (20mg) + Folic Acid (5mg) Tablet FDC of Nebivolol HCl (5mg) + Hydrochlorothiazide (12.5mg) tablet FDC of Nebivolol (5 mg) + S(-) Amlodipine (2.5 mg ) tablet FDC of Olmesartan Medoxomil (20mg/40mg/40mg) + HCTZ(12.5mg/12.5mg/25mg) FDC of Rabeprazole (20 mg) + Mosapride S.R. (15 mg) Tablet FDC of Rabeprazole Sodium (20 mg) + Domperidone(30 mg) S.R Capsule FDC of S-Metoprolol Succinate Tartrate equivalent to Metoprolol Tartrate (E.R) 25/50mg + HCTZ (12.5mg) Tablet. FDC of Sucralfate 0.07 + metronidazole 0.01 gm + Lignocain 0.04 gm per gram of cream FDC of Valdecoxib (20 mg) + Paracetamol (500 mg) tablet Fenfluramine HCl For psoriasis vulgaris. Anti-bacterial For Burns For GERD For neuropathic pain in adults. RTI in adults. For post-operative inflammatory and bacterial infection of eyes. Anti-diabetic Anti-diabetic 12-08-2005 21-07-2005 19-10-2004 29-06-2004. 05-08-2005 21-12-2004 15-06-2004 20-08-2004 12-08-2005
476. 477. 478. 479. 480. 481. 482. 483. 484. 485. 486. 487. 488.
Anti-AIDS Anti-histaminic & mucolytic For Lipid-lowering For hyper-homocysteinemia Anti-hypertensive Anti-hypertensive For essential hypertension For GERD For GERD For essential hypertension For bedsore, haemorrhoid fistula and anal fussure For pain relief in adults. Glycoliptic agent
15-07-2004 29-07-2005 20-12-2004 16-09-2005 22-12-2004 14-09-2004 02-12-2005 27-07-2004 04-10-2004 11-11-2005 19-08-2004 20-09-2004 1969 1974
25

489. 490. 491. 492. 493. 494. 495. 496. Fenofibrate Fenofovir Disoproxil fumarate 300mg + Lamivudine 300mg + Efavirenz 600mg tablets Fenoverine Feracrylum (1%) + Metronidazole 1%) Feracrylum 1% mouth gargle 10mg/ml Feropenem Sodium (150mg/200mg) Tablet Ferrous ascorbate (equivalent to 50mg Iron) + Folic acid 1.5mg. Ferrous Ascorbate + Folic Acid + Zinc FC Tablets (100mg + 1.5 mg + 22.5 mg) Ferrous Ascorbate + Folic Acid Suspension (Equiv. to elemental iron 30mg + 550mcg per 5ml) (New Dosage Form) Fexofenadine suspension (30mg/5ml) Flavanoides extracted from Rutacea, containing standard amount of Diosmin Flavoxate HCl Fluconazole (2%) + Zinc Pyrethione (1%) suspension Anti-spasmodic Antiseptic gel. As hacmostatic agent in dental surgery Anti-bacterial For iron deficiency anemia For the treatment of iron deficiency anaemia Same as approved SeAsonal allergic rhinitis & chronic idiopathic urticaria Haemarrhcides Anti-spasmodic For seborrhoic dermatitis For the treatment of systemic candidiasis, mucosal candidiasis, prevention of fungal infections in patients with malignancy Anti-fungal Antineoplastic Respiratory tract infections Ophthalmological diagnostic agent Neuroleptic agent Anti-psychotic Topical cormosteroide Hypnotic Lipid lowering agent 22.12.99 18.07.08 08-10-2003 16-09-2005 28.09.06 21-07-2005 08-06-2006
18.08.08
497. 498. 499. 500. 501.
27.08.08 19.01.07 Jun-78 03/1979 to 07/ 1981 22-02-2005
502.
Fluconazole Dispersible tablets 50mg
22.04.08
503. 504. 505. 506. 507. 508. 509. 510.
Fluconazole Gel (0.5%) Fludarabine Phosphate IV Inj. Flumequine (Vet) Fluorescein Sodium Solution for Injection (100mg/ml) Flupenthixol Fluphenozine Decanoate Fluprednydine 21- acetate Flurazepam
12-08-2004 26.06.99 1985-87 02-03-2006 Jan-77 1969 1974 Dec. 1977 1985-87
26

511. 512. 513. 514. 515. 516. 517. Flurbiprofen Flutamide Fluvastatin Sodium FluvAstatin Tablet (As calcium) 10mg/20mg/40mg (additional strength) Fluvoxamine Maleate Fondaparinax Sodium Fondaparinax Sodium injection (Additional Indication) Formoterol Fumarate (6mcg) + Fluticasone Propionate (100/250/500mcg) dry powder inhaler Formoterol fumarate 6mcg + Fluficasone propinate 50mcg/125mcg/250mcg MDI Forskolin Eye drop (1%). Fosinopril Sodium Fosphenytoin Sod. Fulvestrant Inj. 250mg/5ml prefilled syringe Fusagurgin Futraful5fluorociracil Gabapentin 100mg + methylcobalamin 500mcg tablets (Additional Strength) Gabapentin ER 450/600/900mg tablet Gabapentin SR 600mg tablets Gadobenate (Dimeglumine IV Injection) Gadoversetamide Injection Ganciclovir Garason Eye drops/ Oint. Gatanthamine HCl Tab./ Inj. NSAID Oral anti-cancer drug Lipid Lowering Agent As approved Antidepressant LMWH Treatment of acute coronary syndrome (ACS) with and without ST-segment elevation For Asthma & COPD For Asthma & COPD For open angle glaucoma Antihypertensive Anti-Epileptic Anti Cancer Fungal antibiotic Anti-cancer Same as Approved For naturopathic pain & partial Seizures As adjunctive therapy in the treatment of partial seizures of epilepsy MRI Contrast Medium MRI Contrast Medium Antiviral Ophthalmic drug 03/1979 to 07/ 1981 1985-87 25-11-2003 29.01.07 21.02.2000 22-10-2003 28.01.08
518. 519. 520. 521. 522. 523. 524. 525. 526. 527. 528. 529. 530. 531. 532. 533.
10-05-2006 14.10.06 27-07-2006 10.01.2002 01.10.2002 30.08.06 Jan-77 Jun-77 24.01.08 15.12.06 30.01.08 07.03.2003 04.06.2003 05.04.2000 Nov. 1977
Neurotropic/ Psychotropic drug Dec. 1978
27

534. 535. 536. Gatifloxacin Gatifloxacin (0.3%) + Prednisolone Acetate (1%) eye drops Gatifloxacin (200mg) +Ornidazole (500mg) tablet Gatifloxacin (as sequihydrate)-3mg + Flurbiprofen sod.-0.3mg/ml eye drops. Gatifloxacin 0.3% + Ketorolac Tramthamine 0.4% eye Drop Gatifloxacin Eye Ointment (1%) Gefitinib Gemcitabine (1.4 gm/vial) Gemifloxacin (as msylate) 320mg tablet Gemtuzumab Genirelix Glatiramer Acetate injection (20mg/ml) Glibenclamide Antibacterial For Ophthalmic use 03.10.2001 02-06-2006
537.
538. 539. 540. 541. 542. 543. 544. 545. 546. 547. 548. 549. 550. 551. 552. 553. 554. 555. 556.
For diarrhoea of mixed 06-06-2005 infection in adults For reduction of post-operative inflammatory conditions of 29-11-2007 eye, when bacterial infection exists. For reduction of part operative 24.07.08 inflammatory condition of eyes Ophthalmic use Anti-cancer Anti-cancer Antibiotic For Myeloid Leukemia Antigonadotropin releasing hormone (fertility drug) Multiple sclerosis Oral anti-diabetic 06-10-2004 17-02-2004 01-09-2004 30.08.06 12.09.2002 08.10.2001 21.02.07 1969 1974 15.02.07 22.08.06 27-04-2005 22.01.99 08.06.07 1975 76 Oct. 1978 03/1979 to 07/ 1981 05.07.2000
Glibeneclamide 5mg + MetFormin SR 850mg As approved tablet (additional strength) Gliclazide 40mg/80mg + MetFormin Hcl Ant- diabetic 500mg + Rosiglitazone 2mg tablet Gliclazide M.R. (30mg/60mg) + Metformin For type-II diabetes HCl (500mg) ER Tablet Glimepiride Glimepiride 1mg/2mg. + Metformin SR 1000mg tablet (additional strength) Glipizidex Glucagon Inj. Glycopyrrolate Granisetron Antidiabetic agent As approved Oral hypoglycaemc agent Hypoglycaomic agent Anaesthetic agent Antiemetic For the treatment of productive cough accompanied by phlegm
Guaiphenesin ER Tablet (600mg)
28.08.08
28

557. 558. 559. 560. 561. Gugulipid Haemodialysis Powder/Liquid Form containing citrate Halcinonide Halobetasol 0.05% + Salicylic acid 6% Ointment (additional Strength) Halobetasol 0.05% + Clotrimazole 1.0% cream Halobetasol 0.5mg + Miconazole 20mg per gram Cream Halobetasol Propionate (0.5mg) + Salicylic Acid 30mg per gm of ointment. Halobetazol Propionate Cream (0.05%) Halofuginone Haloperidol Tablet (0.5mg) (addl. Lower strength) Hepatitis B Vaccine (Recombinant Div) Human Insulin Human Insulin (r-DNA) Powder inhaler Human Recombinant Granulocyte Colony Stimulating Factor Inj. Hyaluronic Acid Salt 25mg + Cross-Linked Hyaluronic acid 25mg per ml in prefilledsyringe Hydrocortisone 17- Butyrate Lipid lowering agent For use for patients being treated by hemodialysis Topical cream For the treatment of plaque psoriasis For the treatment of steroid responsive fungal infections including eczema and psoriasis For steroid responsive dermatoses associated with superficial fungal infection of skin For plaque psoriasis. Corticosteroid responsive dermatomes Vet. Poultry feed additive As approved earlier. Vaccine Anti-diabetic For type-I & Type-2 Diabetes Haemopoietic stimulant, antineutropenic For intradermal implantation and facial soft tissue agumentation Topical Corticosteroid 1985-87 31.01.08 1975 76 14.05.08 04.01.08
562.
31.01.08
563. 564. 565. 566. 567. 568. 569. 570. 571. 572.
01-08-2007. 02.02.07 03/1979 to 07/ 1981 30-03-2006 1985-87 1985-87 30.08.06 29.06.2001 30.01.08 1985-87
573.
Hydroquinone 2% + Tretinoin 0.025% (w/w) Momentasone 0.10% Gel
For short term intermittent treatment of moderate to severe melasma of the face in the 31.01.08 presence of measures for sun avoidance including use of sun screen Antacid Same as Approved Antineoplastic agent For pain management in patients suffering with 1985-87 31.01.08 1969 1974 31.03.08
574. 575. 576. 577.
Hydrotalacite Hydroxychloroquine 400mg tablets (Additional Strength) Hydroxyurea Hylan GF 20 Injection (Synvisc) (Additional Indication)
29

osteoarthritis of the knee, hip, shoulder and ankle 578. 579. 580. 581. 582. 583. Hyoscine-N-Butylbromide (10mg) + Paracetamol 500mg Tablet Ibandronic Acid Inj ( 1 mg/ml) Ibandronic Acid Tablet (150mg) addl. Strength Ibopamine HCl Ibuprofen Icodextrin 7.5% peritoneal dialysis solution For spasmodic pain For Anti-Cancer Same as approved. Opthalmic Non-steroidal anti-rheumatic compound For peritoneal dialysis For improvement of neurologic symptoms, disorders of activitis of daily living and functional disorder associated with acute ischemic stroke. Anti-cancer Anticancer Anti-hypertensive Anti-Bacterial For warts in adults Anti-Rabbles Anti-hypertensive duiretic Antiviral (Anti-HIV) Bursal Disease Vaccine Vaccine (Vet.) For patients with essential fatty acid deficiencies Contrast Medium X-ray contrast medium Contrast medium X-ray contrast medium 08-12-2005 18-05-2004 25-05-2006 03-10-2003 1969 1974 08-06-2006
584.
Idaravone Injection (1.5mg/ml).
26-07-2007.
585. 586. 587. 588. 589. 590. 591. 592. 593. 594. 595. 596. 597. 598. 599.
Ifosfamide Imatinib Mesylate Imidapril Imipenem +Cilastatin Imiquimod Cream 5% w/w Inactivated Rabbies Vaccine (Human Dipoid Cell) Indapamide hemihydrate Indinavir Sulphate Infectious Bursal Disease Vaccine Inactivated Influenza Vaccine Inactivated Intralipid 30% Iobitridol Iohexpl Sterile Solution Iomeprol Iopamidol Sterile Solution
Sept. 1978 09.12.2001 23-02-2004 25-07-2003 28-12-2004 03/1979 to 07/ 1981 Oct. 1978 01.02.2001 1985-87 1985-87 12-05-2005 17.10.2001 1985-87 05.10.2000 1985-87
30

600. 601. 602. 603. 604. 605. 606. 607. 608. 609. 610. 611. 612. 613. 614. Ioxitolmic acid Irbesartan ISMN 30mg SR + Atenolol 50mg tablets (Additional Strength) ISMN 30mg SR + Metoprolol Succinate equivalent to metoprolol tartrate 25mg/50mg tablets (Additional Strength) ISMN 60mg Sr + Atenolol 50mg/100mg ISMN SR 30mg + Aspirin75/ 150mg tablet (addl. Strength). ISMN SR 60mg + Metoprolol Succinate ER 25/50mg Isometamedium Chloride Isopropyl Unoprostone Isosorbide Mononitrate Isotretinoin 0.05% + Erythromycin 2% gel Isotretinoin Gel (0.05%) Isotretinoin Soft Gel Cap. Itopiride Capsules Itopride 150mg capsule (S.R) Contrast medium Antihypertensive Same as Approved Same as Approved For angina pectoris Same as approved For angina & Hypertension Anti-arrhythmic agent Ophthalmic Anti-anginal For acne For acne For Acne vulgaris Gastro Prokinetic Agent For GERD For the treatment of chronic stable anginapectoris in patients with normal sinus rhythm who have a contraindication or intolerance for Beta-blockers Anthelmintic (Vet) Non-barbiturate anaesthetic Oral anti-fungal agent NSAID Ophthalmic For the reduction of post operative inflammatory conditions of the eye Apr-77 26.06.2000 19.03.08 02.01.08 23.03.07 20-07-2006 10.08.06 Jan-77 25-11-2003 1985-87 08.06.07 11-10-2004 21.06.2002 09.05.2002 22-05-2006
615.
Ivabradine (Hcl.) 5mg/7.5mg Tablets
03.07.08
616. 617. 618. 619. 620. 621.
Ivermecting Ketamine Ketoconazole Ketoprofen Ketorolac Tromethamine 0.4% Eye drops (addl. Strength) Ketorolac Tromethamine 4mg + Gatifloxacin 3mg Eye Drops
1985-87 1969 1974 1985-87 03/1979 to 07/ 1981 20-09-2005 24.07.08
31

622. 623. 624. 625. 626. 627. 628. 629. 630. 631. 632. 633. 634. 635. 636. Ketorolac Tromethamine 5mg + Ofloxacin 3mg/ml Eye drops L- Lysine Hcl Ointment (150mg/gm) Labetolol HCl Lactitol monohydrate Syrup 66.67/100ml Lactitol Sachet (10gm/20gm). Lactulose Enema (20%) Lamivudine (40mg) +Nevirapine (70mg +Stavudine (10mg) (in 5ml) powder for suspension Lamivudine (40mg) +Stavudine (10mg/5ml) reconstituted solution Lamivudine 20mg + Nevirapine 35mg + Stavudine 5mg tablet Lamivudine 20mg + Stavudine 5mg dispersible tablets (Additional Sgtrength) Lamivudine 30/60mg + Stavudine 6mg/12mg + Nevirapine 50mg/100mg dispersible tablet Lamivudine 40mg + Stavudine 10mg dispersible tablet. Lamotrigin 200mg tablet (addl. Strength) dispersible tablet (5mg/50mg/100mg/200mg Lamotrigine S.R. tablet 50 mg/100 mg/200 mg Lanine Diacemper killed,canine Hepatitis Leptospira Parovirous Vaccine Lansoprazole for injection 30mg/vial Lanthanum Carbonate Chewable tablet (250mg/500mg) Ophthalmic For wounds of various etiology Anti-hypertensive agent For constipation For the treatment of constipation. For constipation & hepatic encepthalopathy Anti-HIV. For HIV infection Anti HIV Same as Approved For pediatric patients with HIV infection For HIV infection Anti-epileptic Anti-Epileptic Vaccine (Vet.) For short term treatment of errosive esophagitis when patients are unable to take the oral formulation For the treatment of hyperphosphatemia. In combination with capecitabine it is indicated in patients with advanced or metastatic breast cancer whose tumour overexpress HER2 and who have received prior therapy including trastuzumab. Anti-cancer Anti-parkinsonism drug For alcoholic liver disease, drug induced hepatitis 07-12-2005 08.08.06 1985-87 14.05.07 21-11-2005 28-03-2006 28-01-2005 08-04-2005 11.08.06 01.04.08 14-06-2005 12-07-2006 08-06-2006 26-08-2004 1985-87
637.
28.04.08
638.
09-11-2005
639.
Lapatinib (as Ditosylate) (250mg) Tablet.
24-07-2007.
640. 641. 642.
L-Asparginase L-Dihydroxyphenylalanlne Lecithin Liquid (each 5 ml contains lecithin 500mg equivalent to essential phospholipids
1969 1974 1969 1974 14.05.08
32

250mg 643. Leflunomide Anti-rheumatoid Arthritis For transfusion dependent anemia due to myalodysplastic syndrom Associated with deletion 5q cytogenic abnormality In combination with dexamethasone for the treatment of multiple myeloma patients who have received at least one prior therapy Antihypertensive For induction of ovulation in anovulatory infertility ( additional indication) As adjunctive therapy in treatment of partial onset seizures in adults with epilepsy. Anti-epileptic Anti-epileptic 01.10.2001
644.
Lenalidomide capsule (5mg/10mg/15mg/25mg)
16.05.07
645.
Lenalidomide Capsule 5mg/10mg/15mg/25mg (Additional Indication) Lercanidine HCl Letrozole 2.5mg tablet (for additional indication) Levetiracetam (250mg,500mg, 750mg) Tablets Levetiracetam Oral Solution (100mg/ml) Levetiracetam Oral Solution (100mg/ml).
22.04.08
646. 647.
07.05.2002 10.04.07
648.
04-04-2005
649. 650.
22-09-2005 24-02-2006
651.
Levetiracetam Tablet (addl. indication)
652. 653. 654. 655. 656.
Levocetirizem 2Hcl. Dispersible tablet (2.5mg) Levocetirizine Di-HCl mouth dissolving tablets (5mg) (new dosage form). Levocetirizine Di-HCl syrup (2.5mg/5ml) (for As approved. use in children 2 years and above). Levocetirizine Syrup (2.5mg/5ml) Levocetrizine
(i) As monotherapy in partial 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 09-10-2007. of age with Juvenile myoclonic epilepsy. In primary generalised tonic-clonic seizures in adults and adolescents from 12 years of age with idiopathic generalised epilepsy. For allergic rhinitis & chronic 08.05.07 urticaria For the treatment of allergic 25-07-2007. rhinitis and chronic urticaria. 26-09-2007. 13-01-2005 12.12.2002
For allergic rhinitis & urticaria Anti-Histaminic
33

657. 658. 659. 660. Levocetrizine 2.5/5mg + Ambroxol 30mg/5ml of syrup Levocetrizine 5mg + Ambroxol Hydrochloride SR (75mg) tablet Levocetrizine Di HCl Dispersible tablet 5mg/10mg (New Dosage form) Levocitirizine 2 Hcl 5mg+ Ambroxol Hcl SR 75mg + Pseudoephedrine Hcl 120mg SR Capsules Levodopa (50mg/100mg/150mg) + Carbidopa (12.5mg/25mg/37.5mg + Entacapone (200mg) tablet Levodopa 200mg + Carbidopa 50mg C.R. tablet Levodopat Carbidopa Levodropropizine oral suspension (30mg/5ml) Levofloxacin (15mg) + Prednisolone Acetate 10mg per ml eye drops. levofloxacin (250mg/500mg) + ambroxol SR 75mg tablet Levofloxacin 0.5% Ear drops Levofloxacin Oph. Solu. (1.5%) 15mg/ml. (Addl. Strength). Levofloxacin Ophthalmic Solution (0.5%) Levofloxacin Oral Solution (each 240ml bottle contains Levofloxacin 125mg/5ml.) Levofloxacin tablet (250mg /500mg) & Infusion 5mg/ml (For additional indication) Levonorgestrel 0.03mg tablet Levonorgestrel 1.5mg tablets Levosalbutamol MDI (50mcg/actuation) & Dry Powder inhaler (100mcg/capsule) (New Dosage Form) Levosalbutamol rotacaps (100 mcg/capsule) & inhaler (50 mcg /actuation) Levosalbutamol Tablet 1 mg/2mg & Syrup 1 mg/5 ml. Levosulpiride tablet (25mg) For productive cough For production cough For allergic rhinitis & chronic urticaria For SAR, PAR & Chronic idiopathic urticatia For Parkinsons disease For Parkinson's Disease Anti-parkinsonism drug For non-productive cough in adults For post-operative steriod responsive inflammatory ocular conditions when ocular bacterial infections or a risk of bacterial infection exists. For lower respiratory tract infection in adult For otitis media Ophthalmic For susceptible bacterial conjunctivitis Antibiotic (For adult use only) For prostatitis For control of fertility For emergency contraceptive As approved For obstructive airway disease. For Obstructive airway disease For G.I. problem like fanatical dyspepsia, nausea, vomiting and diabetic gAstroperisis 20-07-2006 24-05-2006 28.01.08 09.08.06
661. 662. 663. 664.
25-07-2005 08.01.08 Dec.1983 25-02-2005
665.
11-07-2007.
666. 667. 668. 669. 670. 671. 672. 673. 674. 675. 676. 677.
08.02.07 27-06-2006 16-12-2005 04-03-2005 07.03.07 26.09.06 23.03.07 07.02.07 16.03.07 20-10-2004 16-07-2004 10.05.07
34

678. 679. 680. 681. 682. 683. 684. Levosulpiride Tablet (50mg/100mg) (addl. strength for addl. indication). Lidoflazin Linezolid Linezolid (600 mg) Tablet Lithini Carbonate Lithium Carbonate ER (450mg) tablet Live freeze-dried lactic acid bacteria and bifidobacteria capsules Livetiracetam conc. for infusion 100mg/ml (new dosage form) For depression and schizophrenia in adults. Coronary Vasodilator Antibacterial For Osteomyelitis in adults Esychstric Drug Anti-Depression 12/06/07 1969 1974 04.10.2001 30-05-2004 1969 1974 28-06-2004
685.
686. 687. 688. 689.
Lomustine Loperamide Lopinavir 200mg + Ritonavir 50mg Tablet (addl. Strength) Lorazepam
For the treatment of irritable 10.04.08 bowel syndrome As adjunctive therapy in partial onset seizures in adults with epilepsy when oral 21.05.07 administration is temporarily not feasible 03/1979 to Anti-cancer 07/ 1981 Anti-diarrhoeat agent Anti-HIV Psychiatric drug For Short-term treatment of mild to moderate pain, when oral administration is inappropriate(i.e after dental surgery) For Osteoarthritis rheumatoid arthritis Same as Approved 1975 76 08-06-2006 1969 1974
690.
Lornoxicam 8mg /2ml inj.
12/11/07
691. 692.
Lornoxicam tablet 4mg/ 8mg Losartan Potassium 25mcg + Amlodipine (as besylate) 5mg tablets. (Additional Strength)
21.05.07 14.05.08
693.
694. 695.
696.
For post-operative steriod responsive inflammatory Loteprednol Etabonate (0.5%) + Levofloxacin ocular conditions when ocular (1.5%) Eye drops. bacterial infections or a risk of bacterial infection exists. Loteprednol Etabonate 5mg + Tobramycine For steroid responsive 3mg per ml ophthalmic solution inflammatory ocular condition Corticosteroid, ophthalmic Loteprednol Etabonate Ophtalmic Sol. anti-inflammatory For the symptomatic treatment of pain and inflammation Loxoprofen Sodium tablet (60mg) condition in patients with osteoarthritis
12-07-2007.
14.02.07 15.03.2002
14.08.08
35

697. 698. 699. 700. 701. 702. 703. 704. 705. 706. 707. 708. 709. 710. 711. 712. 713. 714. 715. 716. 717. 718. 719. 720. Lumiracoxib Tablet (100/200/400mg). Luprostiol Mebendazole Mebeverine HCl Mebeverine Hcl 135mg + Chlordiazepoxide 5mg tablet Mebeverine HCl 135mg + Isabgula husk 3.5gm sachet. Mebeverine HCl prolonged release capsule (200mg). Mecobalamine 500mcg + Alpha Lipoic acid 100mg soft gelatin capsule Mecobalamine E.R. tablet (1500mcg) Medroxy Progesterone Acetate (Tab. only) Mefanamic acid Meglumine gadoteric Meglumine locarmate Meloxicam Meloxicam Inj. (Vet) Memantine 5mg /10mg + Donepezil 5mg Tablets Memantine HCl tablet 5 mg/10 mg. Menesin Sodium Merckenzyme Meropenem Inj. Mesalazine SR Me-salicylate 30% + Menthol 10% + camphor 4% Cream Mesterolone Metadoxine For OA, RA acute pain & primary dysmenorrhoea Prostaglandin (Vet) Broad spectrum anthelmintic Misculocropic spasmolytic For IBS Irritable bowel syndrome For irritable bowel syndrome For diabetic neuropathy For neuropathic pain Gynaecclogical disorders Analgesic with antiinflammatory agent Contrast media X-ray contrast media NSAID NSAID For moderate to severe Alzheimer's disease For dementia of Alzheimers type Coccidiosis (Vet) Enzyme Beta-lactum Antibiotic Bowel disease(inflammatory) For temporary relief from pain, swelling & inflammation due to musculoskeletal disorder Oral androgen For Hepatic Disorder 01-08-2006 1985-87 1969 1974 1969 1974 12.12.06 06-07-2006 19-06-2007. 02.04.07 19-07-2005 1985-87 1975 76 16.10.2002 1969 1974 16.02.99 02.04.2002 31.01.08 19-07-2004 1985-87 May-77 08.01.2002 04.04.2002 29.11.07 1969 1974 24-10-2003
36

721. 722. Metaxalone Metaxalone (400mg) + Diclofenac Potassium (50mg) tablet Metformin HCl ER 500mg + Fenofibrate 80mg/160mg tablet Metformin Oral Solution (100mg/ml) Methimazole Tablet ( 5mg/10mg) Methotrexate Topical gel (1%) Addl. Strength Muscle Relaxant For acute painful musculoskeletal condition in adult For the treatment of Type-II diabetes associated with mixed dyslipidemia For type-II diabetes mellitus For hyperthyroidism. Psoriasis. 1:- For repigmentation of idiopathic vitiligo alongwith phototherapy. 2:- For symptomatic control of severe, recalcitrant, disabling psoriasis in conjunction with phototherapy Peripheral Neuropathy 08.10.2002 22-02-2005
723. 724. 725. 726.
25.01.08 04-03-2005 22-12-2005 25-11-2005
727.
Methoxsalen USP-20mg Tablet
07.03.08
728.
Methyl Cobalamin Methyl cobalamine 500mcg+folic acid1.5mg+B5-5mg,+Zn.sulphate 25mg+Cr.Polynicotinate 200mcg+selenium65mcg+inositol-1.5mg + alpha lipoic acid 100mg capsule Methyl cobalamine 500mcg+folic acid1.5mg+B6-3mg,+Zn.sulphate 61.8mg+Ca.Pantothenate 10mg+ Niacinamide-50mg +chrimium-50mcg capsule Methyl Prednisolone Aceponate Cream (0.1%) Methyl prednisolone aceponate-1mg + salicylic acid-50mg ointment Methyl prenisolone Methylcobalamin (500mcg) + Alpha Lipoic Acid (100mg) + Pyridoxine (3mg) + Folic acid (1.5mg) Soft Gelatin Capsule. Methylcobalamin 1000mcg + Pyridoxine Hcl IP 100mg + Nicotinamide IP 100mg + DPanthenol IP 50mg per 2 ml of injection Methylcobalamin 500mcg+beta carotine10.33mg+alpha lipoic acid 100mg+B6 1.5mg+B1 2mg & Cr.polynicotinate. Methylcobalamine (500mcg) + Alpha Lipoic acid (100mg) + Pyridoxine HCl (1.5mg) + Thiamine (2mg) + Calcium Picolinate
13-02.2002
729.
For Vitamins and mineral deficiency states.
31-10-2007
730.
For Vitamins and mineral deficiency patients.
29-11-2007
731. 732. 733. 734.
For atopic dermatitis For treatment of psoriasis Corticosteriod For diabetic neuropathy.
15-06-2006 19-11-2007 Mar-78 31-07-2007.
735.
For peripheral neuropathy For adult patients with diabetic neuropathy. For diabetic neuropathy.
31.03.08
736.
18-10-2007.
737.
16-10-2007.
37

(200mg) tablet. Methylcobalamine 500mcg+folic acid 1.5mg+ alpha lipoic acid 100mg +B63mg+Thiamine 10mg capsule Methylcobalamine 500mcg+folic acid1.5mg+ alpha lipoic acid 300mg +Benfetiamin50mg. Capsule Methylphenidate HCl (18, 36, 54 mg) E.R. tablet Methylprednisolone aceponate-1mg + Mupirocin-20mg. cream Methylprednisolone Acrponate topical solution 0.1% Methylsulphadiazine Metoclopramide Metolazone Metolazone 2.5mg + Losartan Potassium 25mg/50mg tablets
738.
For diabetic neuropathy
29-11-2007
739. 740. 741. 742. 743. 744. 745.
For diabetic neuropathy For ADHD For the treatment of atopic dermatitis Atopic dermatitis (eczema) inflammatory and allergic skin reaction Sulpha Drug Anti-emetic Diuretic For hypertension in patients whose blood pressure is not adequately controlled in monotherapy For the treatment of oedema associated with congestive heart failure, cirrhosis and nephritic syndrome For essential hypertension in adult patients whose blood pressure is not adequately controlled on monotherapy As approved
13-11-2007 08-12-2004 21-11-2007 04.04.07 1969 - 1974 1975 76 23.04.2003
746.
28.05.08
747.
Metolazone + Spironolactone FC Tablets (2.5/5mg + 50mg)
25.08.08
748.
Metolazone 2.5mg + Ramipril 2.5mg/5mg Metoprolol (As succinate) 25mg + Amlodipine (As besylate) 5mg (additional strength) Metoprolol (As succinate) 50mg/25mg ER) + Amlodipine 5mg/2.5mg tablet (For additional indication) Metoprolol (As succinate) ER 25mg/50mg + Ramipril 2.5mg/5mg Metoprolol ER + Amlodipine tablets (Additional Indication) Metoprolol succinate 25mg /50mg ER + HCTZ 12.5mg Metoprolol Succinate equiv. to Metoprolol Tartrate 50mg + Amlodipine (as besylate) 5mg Metoprolol Succinate Equivalent to Metoprolol Tartrate [ER 25/50mg] +
28.05.08
749.
10.04.07
750. 751. 752. 753. 754. 755.
Angina pectoris in adults Essential hypertension For coronary artery disease/ischaemic lheartt disease Anti hypertensive For hypertension For the treatment of patient with both essential
20.02.07 26.02.07 16.07.08 30.11.06 07-02-2006 28.01.08
38

Atorvastatin (As calcium ) 10mg tablets 756. 757. 758. 759. 760. 761. 762. 763. Metoprolol Tarterate Metronidazole CR tablet 600mg Mexiletine HCl Mianserine HCl Miconazole Midazolam (as maleate) 7.5mg/15mg tablet Midazolam Maleate Bulk Mifepristone hypertension and hypercholesterolemia Antihypertensive For the treatment of amoebiasis, urogenital trichomoniasis & giardiasis Anti-Arrhythmic agent Anti-depressant Topical anti-fungal antibacterial agent For insomnia Anesthetic Progesterone Antagonist For adult with Type-II diabetes mellitus where simple drug therapy, diet and exercise do not result in adequate glycemic control. Anti-Diabetic For the treatment of adult patients with major depressive disorder Cardiotonic Treatment of cutaneous leishmaniasis For Kalazar Antidepressant Antiulcer agent For cervical ripening, prevention of post partum haemorrhage & First trimester of aboration with mifepristone Same as approved Antiallergic Vaccine Mar-82 21.02.08 1985-87 1985-87 1969 1974 10-05-2006 05-07-2005 13.02.2002
764.
Miglitol (50mg) + Metformin HCl SR (500mg) tablet.
31-10-2007.
765. 766. 767. 768. 769. 770. 771.
Miglitol Tablet 25 mg/50 mg/100 mg Milnacipran Hcl. 25mg/50mg equivalent to Milnacipran free base 21.77 or 43.55 mg. tablet. Milrinone Lactate Inj. Miltefosin Capsule 10mg/50mg (Additional Indication) Miltefosine Mirtazapine Misoprostol Misoprostol tablet 25mcg/100mcg/200mcg (additional strength indication
18-08-2004 22.05.08 17.05.99 16.04.08 15.03.2002 14.02.2001 21.06.2001
772.
08.12.06
773. 774. 775.
Misoprostol 50Mcg tablet (Additional Strength) Mizolastine MMR Vaccine
26.08.08 15.03.2002 Feb. 1983
39

776. 777. 778. Moclobemide Modafinil Montelucast 10mg + Levocetirizine 5mg film coated tablets Montelukast Granules (4mg/pack) Antidepressant For sleeping disorder For the treatment of allergic rhinitis in adults only For Prophylaxis and chronic treatment of asthma in adult and pediatric patients of 12 months age and older Antiasthmatic (Leukotriene Receptor Antagonist) Prokinetic agent, GERD Antibacterial For Ophthalmic use. For bacterial conjunctivitis For ophthalmic use. For reduction of post-operative inflammatory conditions of the eyes. For inflammation after ocular surgery and where a risk of bacterial ocular infection exists. For hypertension For atopic dermatitis. Immunosuppressant For the prophylaxis of acute organ rejection in patients receiving allogeneic hepatic transplantation NSAID 28.07.2000 15-12-2003 31.01.08
779.
17-05-2005
780. 781. 782. 783. 784. 785. 786.
Montelukast Sodium Mosapride Moxifloxacin Moxifloxacin (0.5%) + Dexamethasone Phosphate (0.1%) Eye drops Moxifloxacin Eye drops (0.5%) Moxifloxacin Eye Ointment (5mg/gm) Moxifloxacin HCL (0.5%) + Ketorolac Tromethamine 0.5% Ophthalmic Solution. Moxifloxacin HCl (5mg) + Prednisolone Acetate (10mg)per ml. (eye drops) Moxonidine tablet 0.2mg/0.3mg/0.4mg Mupirocin (2%) + Methylprednisolone Aceponate (0.1%) Cream. Mycophenolate Mofetil Mycophenolate Mofetil Capsule 250mg, 500mg & Oral suspension 200mg/ml (Additional Indication) Nabumetone
13.02.2002 12.03.2001 26.06.2001 24-11-2005 26-08-2004 06-02-2006 11-07-2007.
787.
16-10-2007.
788. 789. 790.
27.02.07 31-10-2007. 07.02.99
791.
23.01.08
792. 793. 794. 795. 796.
18.05.99 06-06-2006 17.08.06 28.03.2002 10-05-2006
Nadifloxacin (1%) + Miconazole Nitrate (2%) For dermatoses + Mometasone Furoate (0.1%) Cream Nadifloxacin (10mg/gm) + Mometasone For mixed infection of skin Furoate (1mg/gm) cream Nadifloxacin Cream Nadifloxacin Gel 1% Antibacterial; antiacne Acne vulgaris
40

797. 798. 799. 800. 801. 802. 803. 804. 805. 806. 807. 808. 809. 810. 811. 812. 813. 814. 815. 816. 817. 818. 819. Nadolol Nafarelin Acetate Nalbuphine injection 10mg/20mg per ml. NalidixicAcid Nanocrystalline Silver Gel 0.002% Naproxen Suspension 125mg/5ml Natamycin Nateglinide Nebivolol (as HCl) 5mg + Valsartan 80mg Nebivolol HCl Nelfinavir 625mg tablet (addl.strength) Nelfinavir Mesylate Neotame Nepafenac Opthalmic suspension (1mg/ml) Netilimicin Sulphate Nevibolol (as HCl) 5mg + Amlodipine (as besylate) 5mg/10mg Nevirapine Nicardipine Hcl. Injection 2.5mg/ml Nicergoline Nicofuranose Nicorandil E.R Tablet (10mg/20mg) Nifedipine SR Tablets 10mg/20mg Niflumic acid Anti-hypertensive agent Antiendometriotic agent; gonadotropin inhibitor For moderate to severe pain Chemotherapeutic Agent For the treatment of burns and wound infections For the treatment of RA in children 5 years of age and above Trichomonial agent Antidiabetic For hypertension Antihypertensive For HIV patients Anti-HIV Sweetening Agent For the treatment of pain and inflammation associated with cataract surgery Aminoglycoside antibiotic For hypertension Anti HIV 1985-87 17.03.99 07.02.07 1969 1974 04.01.08 28.04.08 03/1979 to 07/ 1981 01.05.2002 17-01-2006 12.07.2002 20-05-2005 02.07.2001 22-04-2004 31.03.08 1985-87 24-05-2006 06.03.2000
For short-term treatment of hypertension when oral therapy 07.04.08 is not feasible or not desirable Peripacral Vasadilator Vasodilator Angina Pectoris For the treatment of essential hypertension Anti-inflammatory agent 1985-87 1969 1974 24-04-2006 24.03.08 1975 76
41

820. 821. 822. 823. 824. 825. 826. 827. 828. 829. 830. 831. 832. 833. 834. 835. 836. 837. 838. 839. 840. 841. 842. 843. 844. Nimesulide 1% + Methyl Salicylate 5%. Nimesulide 100mg ER + Levocetirizine HCl 5mg Tablets Nimesulide Injection (100 mg/ml) (Veterinary) Nimesulide Injection 75mg/ml. Nimorazole Nimustine HCl Nitazoxanide Nitazoxanide (500mg) + Ofloxacin (200mg) Tablet Nitrazepam Nitroglycerin Inj. Nitroglycerin Ointment Norethisterone Enanthate Inj. Norfloxacin Nova-T Obtained from streptomyceVirginies (Virginiamycin) Octy.lonium Bromide Ofloxacin (200mg) + Ornidazole (500mg) Olanzapine Olanzapine powder For oral suspensian (10mg/5ml) Olmesartan (as Medoxomil) 10mg (addl. Strength) Olmesartan 40mg + HCTZ 25mg tablet (addl. Strength) Olmesartan medoximil-20mg + Ramipril5mg. tablet Olmesartan Medoxomil (20mg) + Amlodipine Besylate (5mg) Tablet. Olmesartan Medoxomil (5mg/20mg/40mg) Tablet Olopatadime Ophthalmic solution (0.2%) (additional Strength) Aerosol For local application in acute pain. For symptomatic treatment of acute rhinosinusitis Veterinary use For short-term treatment of post-operative pain. Anti-trichomoniasis Anti-cancer Anti-Diarrhoeal For urogenital infection in adults. Hypnotic Cardiac drug Anti-anginal drug Injectable Contraceptives Anti-bacterial IUD (Contraceptive) Vet. Antibiotic Irritable bowel syndrome For diarrhea of mixed infection Antipsychotic For schizophrenia in adults Anti-hypertensive Anti-hypertensive For treatment of essential hypertention. For mild to moderate hypertension. Anti-hypertension As approved 16-09-2005 28.03.08 08-10-2004 28-06-2004 Sep. 1977 1985-87 17-03-2004 30-06-2005 1969 1974 1985-87 Jan. 1982 1985-87 1985-87 1985-87 1975 76 12.12.2000 20-01-2005 27.01.2000 11.08.06 18-05-2006 28-06-2006 12/06/07 15-10-2007. 21-07-2005 24.04.07
42

845. 846. Allergic nAsal inflammation hives, itching with skin diseAses For allergic conjunctivitis For the relief of the symptoms of seasonal allergic rhinitis in patients 12 years of age and older As approved. For GERD not responding to Omeprazole. For duodenal, gastric ulcer, GERD, and erosive esophagitis, For gastric ulcer, duodenal ulcer and GERD. For duodenal ulcer, gastric ulcer & GERD For gastric ulcer, duodenal ulcer, and GERD Anti-ulcer For chemotherapy induced nausea and vomiting Anti-obesity For influenzae Same as Approved For Prophylaxis of influenzae in adult and children >14 years of age To promote weight gain For relief of signs and symptoms of osteoarthritis, rheumatoid arthritis. Antiepileptic Anti-epileptic Anti-epileptic Vet. anthelmintic
Olopatadine Hcl. Tablet 2.5mg/5mg Olopatadine Ophthalmic solution (0.1%)
26.02.07 08-06-2006
847. Olopatadine Nasal Spray (0.6%) 848. 849. 850. 851. 852. 853. 854. 855. 856. 857. 858. 859. 860. 861. 862. 863. 864. 865. Omeprazole (20mg) + Sodium bicarbonate (1100mg) tablet (addl. strength). Omeprazole (20mg) Enteric coated + Domperidone (30mg) (S.R.) capsule Omeprazole (20mg/40mg) +Sod. Bicarbonate-600mg+ Mg.Hydroxide-700mg .chew tab. Omeprazole (E.coated) 40mg + Sodium Bicarbonate 1100mg capsule. Omeprazole 20mg/40mg + Sodium Bicarbonate 1100mg capsules Omeprazole 20mg/40mg + Sodium bicarbonate 1680mg per sachet powder for oral suspension Omeprazole Powder for suspension (20mg/Sachet) Ondansetron orally disintegrating tablet (4mg/8mg) (additional dosage form) Orlistat (120 mg) Capsule Oseltamivir (as phosphate) Capsule (75mg) & oral suspension (12mg/ml) Oseltamivir 30mg & 45mg Capsules (Additional Strength) Oseltamivir formulation (additional indication) Oxandrolone Tablet (2.5/10mg) Oxaprozine Tablet (600mg) Oxcarbazepine Oxcarbazepine S.R 450mg/900mg (addl. Strength). Oxcarbazepine S.R. (150mg/300mg/600mg) Tablet Oxibendazole
05.08.08
15-10-2007. 10-03-2005 08/01/07 18-6-2007. 15.06.07 12.03.08 30-11-2005 28-09-2007. 27-10-2004 25-10-2005 28.01.08 24-04-2006 04-08-2006 30-10-2007. 30.10.2001 19-05-2006 08-09-2005 1975 76
43

866. 867. 868. 869. 870. 871. 872. Oxiconazole Oxolinic Acid Oxprenolol HCl Oxybutynine E.R. tablets Oxyfedrine Ozagrel Hcl. Tablets 100mg/200mg Ozothine Paclitaxel (protein bound particle) for injectable suspension (paclitaxel (100mg) + Albumin Human 900mg per 20ml. Paclitaxel nanoparticle Inj. (20mg/ml) Paclitaxel Nanoparticle Solution for Injection 20mg/ml (Additional indication) Pancuronium Bromide Pantaprazole sodium 20mg/40mg Tablet (with sodium bicarbonate As buffer) Pantoprazole (40mg) + Domperidone (20mg) ( 10mg IR + 10mg SR) Pantoprazole (as Sodium) (E.C) 40mg + Itopride (150mg) S.R Pantoprazole Sodium (With Sodium bicarbonate as buffer) 20mg/40mg tablets Parbendazole Parecoxib Inj. Paromomycin Inj. 375mg/ml Paroxetine Hydrochloride Parvo-virus Vaccine Pazufloxacin Mesylate i.v. infusion 300mg/100ml & 500mg/100ml Pegaptinib Sodium Injection (0.3mg). Antifungal Urinary anti-fungal antibacterial agent Beta-blocker For Neurogenic bladder disorder Coronary Vasodilator For the treatment of bronchial asthma Bronchodilator For breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. For metastatic breast cancer Ovarian cancer, non-small cell lung cancer and AIDS related Kaposis Sarcoma Non-polarising neuromuscular blocking agent For gAstric ulcer, duodenal ulcer, Z. E Syndrome, GERD GERD For GERD 17.01.2000 1969 1974 1969 1974 05-05-2004 1969 1974 28.01.08 1985-87
873.
11-10-2007.
874. 875. 876. 877. 878. 879. 880. 881. 882. 883. 884. 885. 886. 887.
23.08.06 22.01.08 1969 1974 07.02.07 23-12-2004 08-04-2006
For the treatment of gastric ulcer, duodenal ulcer, Zollinger 28.04.08 Ellison Syndrome and GERD Vet. Drug NSAID For visceral leishmaniasis (Kalaazar) Antidepressant Vaccine (Vet.) For the treatment of RTI, UTI and abdominal infections in adults For neovascular (wet) age related macular degeneration. 1969 1974 01.11.2002 30.08.06 04.10.2000 1985-87 09.07.08 06-02-2006
44

888. 889. 890. 891. 892. Pentoxiflyline Peplomycin Inj. Perflutren liquid microsphere injectable suspension Pergonal Inj. (FSH) Phenylephrine 2.5% Eye drops Phenylephrine 5mg + Chlorpheniramine maleate 0.5mg + Paracetamol 125mg + sodium citrate 60mg + Menthol 1mg (per 5ml) Syrup Phenytoin Sodium (300mg) tablet Vasodilator Anti-cancer For diagnostic use Fertility Drug Ophthalmic For the treatment of common cold and cough associated with fever Addl. Strength 1975 76 1985-87 31-05-2006 Oct. 1978 02-12-2005
893.
31.01.08
894.
05-08-2005
895.
896.
897.
For control of generalised tonic-clonic (grand-mal) and Phenytoin Sodium E.R (300mg) prevention and treatment of seizures occuring during or following neurosurgery. For control of generalized toniclonic and treatment & Phenytoin sodium ER capsules (300mg) (New prevention of seizures dosage form) occurring during or following neurosurgery For symptomatic relief of dry ticklish and unproductive Pholcodiene Syrup (4mg/5ml). coughs in children above 1 years. Pimcrolimus 10 mg/gm cream Pimozide Pindolol Pioglitazone 15mg/30mg + MetFormin ER 1000mg tablet (additional strength) Pioglitazone Hydrochloride Piperacillin - Tazobactam Inj. Piracetam Piroxicam Pitavastatin (1mg/2mg) Tablet Pollidacanol Inj. For atopic dermatitis Neuroleptic and anti-psychotic agent Beta-blocker As approved Antidiabetic Antibiotic Memory enhancer Anti-inflammatory Lipid Lowering agent Anti-scerosis
14-6-2007.
14.06.07
06-07-2007.
898. 899. 900. 901. 902. 903. 904. 905. 906. 907.
23-07-2004 1969 1974 1969 1974 23.01.07 17.10.2000 13.08.99 Dec. 1977 1985-87 14-01-2005 1985-87
45

908. 909. Polonosetron (As Hcl.) For Injection 0.25mg/5ml Polyestradiol Phosphate Inj. Chemotherapy induced nausea & Vomiting Anti-cancer For temprory relief of dryness, irritation burning, stinging, grittiness or foreign body sensation caused due to environmental factors. Sutures 20.03.07 1985-87
910.
Polyethylin Glycol 400 (0.4%) + Propylene Glycol (0.3%).
18-9-2007.
911. 912.
Polyglycolic Acid Poractant Povidone Iodine Sachet (containing Effervescent Granules) Each 2gm Sachet contains: 175mg (available iodine 17.5mg) Pramipexole Di-hydrochloride Tablet (0.125mg/0.25mg/0.5mg/1mg/1.5mg). Pravastatin Pravastatin 40mg tablet (Additional strength) Praziquantel Praziquental Prednimustine Tablets Prednisolone Stearoglycolate Pregabalin 75mg/150mg + Methylcobalamin 750mcg capsules (Additional Strength) Pregabalin capsule (75/150/300mg) Pregabalin Capsule 25/50/100/200mg (addl. Strength) Pregabalin capsules (Addl. Indication) Pregabalin-75mg/150mg +Methylcobalamine 500mcg cap Premetrexed(Disodium) powder For solution For Inj. 500mg/vial Premetrxed disodium injection 100mg/vial (Additional Strength) Procarbazine HCl Prooanidid
1969 1974
913.
For respiratory distress in 24.12.2002 preterm babies As mouthwash for oral hygeine in various oropharyngeal conditions, surgery, dental 25.08.08 infections, and halitosis For Parkinsons disease Lipid lowering agent As Approved Neurocysticerncosis Neurocystecercosis Anti-cancer Corticosteroid Same as Approved For neuropathic pain. Same as approved. management of fibromyalgia syndrome For the treatment of adult patients with peripheral neuropathy. Anti Cancer Same as Approved Anti-cancer 25-07-2005 20.12.2000 10.08.06 1985-87 1985-87 1985-87 1969 1974 08.05.08 25-11-2005 19-05-2006 29.04.08 12/10/07 21.08.06 12.03.08 03/1979 to 07/ 1981
914. 915. 916. 917. 918. 919. 920. 921. 922. 923. 924. 925. 926. 927. 928. 929.
Short acting IV non-barbiturate 1969 1974 anaesthetic

46

930. 931. 932. 933. 934. 935. Propafenone HCl Propanol 50gm+povidone iodine-1gm in 100ml solution Propanol-18 gm+Ethenol(100%)-45gm in 100ml solution Propionyl-L-Carnitine HCl Tablet (500mg) & injection 300mg/vial Propofol 10mg + Lignocaem 1mg per ml injection Prothionamide Anti-arrhythmic agent For surgical & hygenic hand disinfection. -doChronic congestive heart failure For induction of anesthesia Anti-Tuberculosis For acute uncomplicated lower urinary tract infection (simple cystitis), complicated lower UTI, acute exacerbation of chronic bronchitis. Tissue Culture Rabies Vaccin For BPH Anthelmentic As approved for the additional indication "acute manic episode associated with bipolar disorder Antipsychotic For psychotic disorder As approved Anti Hypertensive Oestrogenic steroid For Chemotherapy induced nausea and vomiting For chemotherapeutic induced nausea and vomiting Antiulcer; Proton pump inhibitor For GERD 1985-87 19-11-2007 19-11-2007 22-03-2006 04.04.07 1969 1974
936.
Prulifloxacin (600mg) Tablet.
30-10-2007.
937. 938. 939. 940.
Purlfied Chicken Embryo Cell (PCEC) Pygenum Africum PyrantelPamoate Quetiapine (As fumarate) SR 400mg tablet (additional strength) Quetiapine fumarate SR tablets
1985-87 30.07.2002 1969 1974 05.03.07
941.
21.02.08
942. 943. 944. 945. 946. 947. 948. 949. 950. 951.
Quetiapine Fumerate Quetiapine S.R tablet 200/300mg. Quetiapine SR Tablets 50mg ( additional strength) Quinapril Quinestrol R (-) Ondansetron oral Solution (1mg/5ml) R(-) Ondansetron (2mg/4mg) tablet Rabeprazole Rabeprazole 20mg (EC) + Itopride SR 150mg Rabeprazole Sodium (With Sodium bicarbonate as buffer) 10mg/20mg tablets
31.05.2002 01-08-2006 10.04.07 19.09.2002 1969 1974 24-05-2005 15-04-2005 27.12.2001 28.11.06
For the treatment of gastric ulcer, duodenal ulcer, Zollinger 28.04.08 Ellison Syndrome and GERD
47

952. 953. 954. 955. 956. 957. 958. 959. 960. 961. 962. 963. 964. 965. 966. 967. 968. 969. 970. 971. Rabeprazole Sodium 20mg/10mg with sodium bicarbonate As buffer Rabeprazole sodium Enteric coated pellets 15.4% w/w (20mg/129.83mg) Rabeprazole Sodium Injection 20 Rabies Vaccine Inactivated Racecadotril Racecadotril dispersible tablet (10mg/30mg) (new dosage Form) Racecadotril Sachet (10 mg/30 mg) Raloxifene HCl Ramipril (5mg) + Telmisartan (40mg) tablet Ramipril 10mg + HCTZ 12.5mg tablet (additional strength) Ramipril 5mg + HCTZ 12.5mg tablets (Additional Strength) Ranitidine Rebamipide 100 mg tablet Reboxetine Renolazine Extend ReleAse tablet (500mg) Repaglinide Reproterol HCl Resperidone E.R. (long-acting) injection (12.5mg/vial) (addl. strength). Resperidone Tablet & Syrup (addl. Ind ) Retinoin For Duodenal ulcer, G.U, Z.E.S. & GERD Same as Approved For Gastric and Deudonal Ulcers & GERD Vaccine (Vet.) Antidiarrhoel For diarrhea Anti-diarrhoeal Menopausal osteoporosis For Hypertension As approved Same as Approved Anti-ulcer For gastric ulcer Anti-depressant For Chronic Angina Antidiabetic Bronchodilator As approved. Acute mania & mixed episode in bipolar-I disorder. Topical acne therapy For treatment of pulmonary T.B only in patients coinfected with HIV. (It should never be used as a substitute to Rifampicin in T.B patients without HIV co-infection). Anti-tubercular drug For infections diarrhea in adults 26.02.07 16.04.08 12-05-2004 1985-87 10.10.2001 15.12.06 18-05-2004 04.05.2001 11-05-2005 20.02.07 20.02.08 1985-87 28-07-2004 31.12.2002 14.06.07 23.03.2000 1985-87 25-09-2007. 04-04-2006 1969 1974
972.
Rifabutin Capsule (150mg).
16-07-2007.
973. 974.
Rifampicin Rifaximine 200mg tab.
1969 1974 28.08.06
48

For Obese Patients BMI 30kg/m2 or overweight patients BMI 27kg/m2 with Associated risk factors such As type-I diabetes or dyslipidemia For Osteoporosis
975.
Rimonabant tablet 20mg
11.05.07
976. 977. 978. 979.
Risedronate Sodium Risedronate Sodium tablet (35mg) (additional indication) Risperidone long-acting suspension for injection 25 mg/37.5 mg/50 mg per vial Rituximab Rivastigmine transdermal patch (each patch of 5m2, 10m2,15m2 & 20m2 contain Rivastigmine base 9/18/27/36mg respectively Rizapriptan Rofecoxib R-Ondansetron (As Hcl. Dihydrate) (1mg/ml) injection Ropinirole Rosiglitazone Rosiglitazone (as maleate) 2mg + Glibenclamide 5mg + MetFormin 500mg tablet Rosiglitazone 1mg + Metofmin Hcl 500mg tablet (additional strength) Rosiglitazone Maleate Rosoxacin Rosuvastatin
17-10-2003
For osteoporosis in men at high 08-10-2007. risk of fracture. For Schizophrenia Antineoplastic 26-08-2004 10.07.2000
980.
For the treatment of patients with mild to moderately severe dementia of the Alzheimer type 28.01.08 and dementia associated with Parkinsons disease Anti migrain NSAID Chemotherapy induced nausea & vomiting Dopamine Agonist (for Parkinson's Disease) Antidiabetic Anti Diabetic As approved Antidiabetic Antibacterial Lipid lowering Agent As an adjunctive therapy for the management of obesity including weight loss and maintenance of weight loss in pateints whose BMI is 30Kg/m2 or higher. For perinial allergic rhinitis Anti-hypertensive 27.02.2003 26.06.2000 12.01.07 03.12.2001 14.07.2000 08.08.06 08.02.07 28.06.2000 Jul-82 12-09-2003
981. 982. 983. 984. 985. 986. 987. 988. 989. 990.
991.
R-Sibutramine Capsule (2.5mg/5mg)
26-09-2007.
992. 993.
Rupatadine (10mg) tablet S (-) Amlodipine Besylate
05-04-2005 16.08.2002
49

For the treatment of haemodynamically stably patients with definite or suspected acute 19.08.08 Myocardial Infarction to reduce cardio-vascular mortality. For essential hypertension For Hypertension FOR GERD For peptic ulcer, GERD & Zollinger Ellison Syndrome For gastric ulcer, duodenal ulcer & GERD For the relief of pain and inflammation in patients with rheumatoid arthritis and osteoarthritis Bronchodilator Polypeptide hormone Antimalarial For the treatment of acne vulgaris Anti-AIDS Addl. Strength. Anti-cancer Anti-hypertensive Anthelmintic For diarrhoea of mixed infection in adults. Bone & Soft tissue infection Oral enzyme For the topical treatment of the superficial mycosis like dermatophytosis For treatment of diarrhoea of mixed infection in adults 16.05.07 15-04-2005 30.08.06 30.08.06 20-05-2005
994.
S-Metoprolol Succinate Oral Solution (Each Ml contains: S-Metoprolol Succinate 9.5mg equal to S-Metoprolol Tartrate 10mg) S(-) Metoprolol (As succinate) 25mg + S(-) Amlodipine (As besylate 2.5/5mg S(-) Metoprolol Succinate S.R. tablets (equivalent to S(-) Metoprolol Tartrate 12.5mg/25mg/50mg) S(-) pantoprazole (as sodium) 20mg (E.C.) + Domperidome SR 30mg tablet S(-) Pantoprazole (as Sodium) Inj. 20mg/vial S(-)Pantoprazole (10mg/20mg) tablet
995. 996. 997. 998. 999.
1000.
S(+) Etodolac ER tablets 200mg/300mg
02.06.08
1001. 1002. 1003.
Salbutamol Sulphate Salcalcitonin Salfametopyrazine
1969 1974 Jul-78 Jun-78 28.01.08 20-03-2006 25-07-2005 1969 1974 11-09-2003 1985-87 18-10-2007. 1985-87 1985-87 31.01.08 29-11-2007
1004. Salicylic acid 10mg/20mg (Foaming facewash solution) 1005. Saquinavir (500mg) tablet (addl. Strength) 1006. 1007. 1008. 1009. Saquinavir (as mesylate) 500mg Tablet Sarocolysin S-Atenolol Satranidazole
1010. Satranidazole (300mg) + Ofloxacin (200mg) Tablet. 1011. Septopal Heads & Chains 1012. 1013. Serratio Pepodase Sertaconazole Nitrate Cream 2%,
1014. Sertanidazole-300mg+ Ofloxacin-200mg tablet
50

patients. For control of serum 1015. phosphorus in patients with Sevelamer (400mg/800mg) tablet chronic kidney disease and hemodialysis. For control of serum 1016. Sevelamer Carbonate 400mg/800mg tablets & phosphorus in patients with sachet 400mg/800mg chronic kidney disease on dialysis 1017. Sibutramine Hydrochloride Appetite suppressant 1018. 1019. Sildenafil Citrate Sildenafil Citrate 20mg Tablet Male Erectile Dysfunction For pulmonary osterial hypertension As an antimicrobial barrier for management of partial thickness burns, incisions, skin grafts, donor sites, lacerations, abrasions and Stage I-IV dermal ulcers (vascular, venous, pressure and diabetic) For primary Hypercholesterolemia Immunosuppressant Aminoglycoside antibiotic As an adjunct to diet & exercise to improve glycemic control in patients with typetwo diabetes mellitus As adjunct to diet and exercise to improve glycemic control in patients with type-II diabetes. Antibacterial agent For the treatment of acute migraine For use as a surgical aid in anterior segments procedure including catract extraction & intra-ocular lens implantation Same as approved Anti-asthmatic Antibiotic
20-05-2005
28.04.08
23.12.99 08.01.2001 23.01.07
1020.
Silver Wound Dressing
16.04.08
1021. Simvastatin (10/20mg) + Ezetimibe (10mg) Tab 1022. Sirolimus 1023. Sismicln Sulphate Sitagliptin ( As Phosphate) 50mg + Metformin Hcl. 500mg/1000mg Film coated tablets Sitagliptin Tablet (25mg/50mg/100mg). Sliver Sulphadiazine
11-05-2005 15.07.2002 03/1979 to 07/ 1981 28.04.08
1024.
1025. 1026.
30-10-2007. 03/1979 to 07/ 1981 22.01.08
1027. Smatriptan (as succinate ) 50mg + Naproxen sodium 550mg tablets 1028. Sodium Chondroitin sulfate 40mg + sodium Hyaluronate 30mg per ml Intraocular Injection (additional strength) Sodium Chondroitin Sulphate + Sodium Hyaluronate injection (40mg + not more than 17mg per ml) Sodium Cromoglycate Sodium Fusidate
14.05.08
1029. 1030. 1031.
25.08.08 1969 1974 1969 1974
51

1032. Sodium Hyaluronate 0.1% eye drops (addl. Strength) 1033. Sodium Hyaluronate Cream 0.2% 1034. 1035. Sodium Hyaluronate injectable gel (each 0.6ml. 1ml pre filled syringe contains, sodium Hyaluronate 20mg/ml, 22.5mg/ml Sodium Hyaluronate Injection (1%). Ophthalmic use. For leg ulcer, diabetic ulcer etc. For intradermal implantation and facial soft tissue augmentation For OA Anti-cataract preparation X-ray contrast medium Addl. Strength Same as Approved 10-11-2005 16-03-2006 03.06.08 26-07-2006 1975 76 1969 1974 26-08-2005 24.01.08
1036. Sodium Hydroxy oxopyrido Phynoxazine Carboxylate 1037. Sodium Meglumin Iothalamate 1038. Sodium Valproate (750mg/1000mg) C.R. Tablet Sodium Valproate 499.5mg + Valproic acid 1039. 217.5mg equivalent as sodium valproate750mg CR tablet (Additional Strength) Sodium Valproate 666mg + valproic acid 1040. 290mg equivalent as sodium valproate 1000mg C.R. tablet (Additional Strength)
Same as Approved For the treatment of gastric ulcer and management of gastric mucosal lesions (erosion, hemorrhage, redness or edema) associated with acute gastritis or acute exacerbation of chronic gastritis For overactive bladder with urge urinary incontinence urgency & urinary frequency For the treatment of burns, varicose, ulcers For advanced renal cell carcinoma. For hepatocellular Carcenoma Beta-blocker Anti-gonorrheal agent For HIV infection For HIV-1 infusion Anti HIV For post-menopausal women with Osteoporosis
24.01.08
1041.
Sofalcone Capsule (100mg/50mg)
02.06.08
1042.
Solifenacin Succinate Tablet (5mg/10mg).
06-07-2006 1969 1974 31-07-2007. 22.01.08 Aug. 1978 1985-87 11-11-2005 11-03-2005 29.08.06 14-06-2005
1043. Solution of solic benzoic & salicy acid in acqueous propylene alcohol, malic acid 1044. Sorafenib (as Tosylate) (200mg) Tablet. 1045. Sorafenib tablets 200mg (Additional Indication) 1046. Sotalol 1047. Spectinomycin
1048. Stavudine 10mg+Lamivudine 40mg+ Nevirapine 70mg dispersible tablet 1049. Stavudine powder for suspension 1050. 1051. Stavudine SR 100mg tablet Strontium Ranelate Granules (2gm/Sachet)
52

1052. Sucralfate (7%) + Povidone Iodine (5%) Ointment Sucralfate (70mg) + Metronidazole (10mg) + 1053. Povidone Iodine (50mg) per gram of Ointment. 1054. Sucralfote 1055. 1056. Sufentanil Citrate Sulphadoxine Anti-infective For infected wounds and ulcers. Anti-ulcer Anesthetic Agent Anti-malarial drug For diagnostic use in echocardiography doppler of macrovasculature a doppler of microvasculature. Antipsychotic Abortificiant For G.I. Stromal tumor, advanced renal cell carcinoma Veterinary drug Immuno-modulator For organ rejection For Erectile Dysfunction Anti-cancer For BPH For BPH Anti-Acne For Plaque psoriasis For plaque psoriasis For first line treatment of metastatic colorectal cancer in combination with calcium folinate. For irritable bowel syndrome For chronic hepatitis B infection 18-08-2005 09-10-2007. 1985-87 17-12-2003 03/1979 to 07/ 1981 28-09-2007.
1057. Sulphur Hexafluoride Powder and solvent for dispersion for injection (45mcg/ml). 1058. 1059. Sulpiride Sulprostone Inj.
26.10.99 1985-87 10.04.07 Sep. 1977 10-03-2003 21-05-2004 11-09-2003 03/1979 to 07/ 1981 04.04.2002 06-02-2006 12.09.2003 24-05-2005 01-04-2005
1060. Sunitinib Maleate Capsules 12.5mg/25mg/50mg 1061. Suramin Inj. 1062. 1063. 1064. 1065. 1066. Tacrolimus Ointment TacrolimusCapsule (0.5mg/1mg/5 mg) Tadalafil Tamoxifen Citrate Tamsulosin HCl
1067. Tamsulosin HCl (MR) 0.4mg + Dutasteride 0.5mg tablet 1068. Tazarotene 1069. Tazarotene (0.05%) + Mometasone Furoate (0.1%) Cream (addl.strength) 1070. Tazarotene (1mg) +Mometasone Furoate (1mg) per gram cream 1071. Tegafur (100mg) + Uracil (224mg) capsule.
22-08-2007.
1072. 1073.
Tegaserod Maleate Telbivudine 600mg tablet
01.11.2002 30.08.06
53

1074. Telmisartan Antihypertensive For coexisting essential hypertension & hyperlipidemia For essential hypertension Same as Approved Same as Approved Antineoplastic For HIV-1 infection For the treatment of adult patients with HIV infection Anti-HIV For HIV-1 infection For the treatment of HIV infection in adults Anti-asthmatic drug For Osteoporosis Anti-Tuberculosis drug Anti-cancer drug For testosterone deficiency (i) primary hypogonadism (ii) Hypogonadotropine hypogonadism For replacement therapy in male with Testosterone deficiencies and hypogonadotropic hypogonadism For replacement therapy in males with testosterone deficiency. For replacement therapy in males with Testosterone deficiency. Oral androgan For Testosterone replacement therapy of male hypogonadism when testosterone dificiency 25.11.2002 22.05.08 30.08.06 08.07.08 31.03.08 17.01.2000 23-02-2006 07.01.08 17-08-2005 01-08-2006 23.07.08 03/1979 to 07/ 1981 04-09-2003 03/1979 to 07/ 1981 1969 1974
1075. Telmisartan 40 mg + Atorvastatin (as calcium) 10 mg Tablets 1076. Telmisartan 40mg + Amlodipine (as Besylate) 5mg tablet 1077. Temoporfin 1mg/ml Injection (Additional Strength) 1078. Temozolamide capsules 140mg/180mg (Addl. Strength) 1079. Temozolomide 1080. Tenofovir Disoproxil Fumarate (300mg) + Emtricitabine (200mg) tablet 1081. Tenofovir disoproxil fumarate 300mg + Lamivudine 300mg tablet 1082. Tenofovir Disoproxil Fumarate Tablet (300mg) 1083. Tenofovir Disoproxil Fumarate300mg + Emtricitabin 200mg + Efavirenz 600mg tablet 1084. Tenofovir Fumarate 300mg + Lamivudine 300mg + Efavirenz 600mg Tablets 1085. Terbutaline Sulphate 1086. 1087. 1088. Teriparatide Terizidone Testolactone
1089. Testosterone cypionate (100mg/200mg) + Cotton seed oil 736/566mg per ml injection
08.02.07
1090.
Testosterone Gel 1%.
12-07-2005
1091.
Testosterone Spray (25mg)
29-11-2005
1092. Testosterone Transdermal Spray (12.5mg/spray) (addl. Lower strength) 1093. Testosterone Undecanoate
15-02-2006 1985-87 22.07.08
1094. Testosterone Undecanoate 250mg/ml Injection
54

has been confirmed by clinical feature or biochemical tests Pre-Synaptic monoamine depleting agent Broad spectrum anthelmintic For Leprosy For acute low back pain & other musculoskeletal painful and inflammatory condition in adults Vet. Anthelmintic Mercks Disease Vaccine Anticancer Immunomodulator (for chronic Hepatitis-B) Anti-Epileptic Respiratory disease in Poultry (Vet.) Anti-inflammatory For skin & skin structure infection & intra abdominal infection Glaucoma Nasal Decongestant Trichomona agent As 3rd line treatment of sever cases of COPD when monotherapy and second line therapy with two drugs do not respond adequately Anti asthematic For acute coronary syndrome including patients undergoing PTCA or atherectomy Anti-Platelet For abdominal spasmodic pain, colics of hepatobilliary track, abdominal colics
1095. 1096. 1097.
Tetrabenazine Tetramisole HCl Thalidomide
10.03.99 1969 1974 12.08.2002
1098. Thiocolchicoside 4mg/8mg + Ketoprofen 50mg/100mg tablets 1099. 1100. 1101. 1102. 1103. 1104. 1105. 1106. 1107. 1108. 1109. Thiophanate THV (Turkey Herpex Virus) Inn. Thymogen Inj. Thymosin Alfa-1 Inj. Tiagabine HCl tablet (2/ 4 /12 /16 mg) Tiamulin Hydrogen Fumarate Tiaprofenic Acid Tigecycline powder For Inj. 50mg/vial Timolol Maleate Tinazoline Eulk Tinidazole
11.06.08
1969 1974 1969 1974 12.02.2002 17.01.2001 14-05-2004 1985-87 1985-87 28.08.06 1985-87 1985-87 1969 1974
Tiotropium (as Tiotropium Bromide 1110. Monohydrate) 18mcg + Formoterol Fumarate Dihydro. 12mcg + Ciclesomide 400mcg per capsules 1111. 1112. 1113. 1114. Tiotropium Bromide Tirofiban (0.25mg/ml injection) (additional strength) Tirofiban HCl I.V Tiropramide Hcl (100mg) tablet
31.01.08
16.04.2003 09-03-2005 12.08.2003 22.08.06
55

1115. 1116. 1117. Tizanidine SR Tobramycin Tobramycin Inhalation solution (300mg/5ml) Multiple Sclerosis Antibiotic For chronic pulmonary infection cystic fibrosis. For BPH with overaction bladder in Adults only. For BPH with overactive bladder Overactive Bladder Antiepileptic Antineoplastic Diuretic Edema Associated with congestive heart failure & hypertension Anti hypertensive Anti-Hypertensive Antifibrinolytic For primary dysmenorrhoea and pain associated with menorrhagia in women For prevention of oral hemorrhage in anticoagulant treated patients undergoing oral surgery. For prevention of oral hemorrhage in anticoagulant treated patients undergoing oral surgery Adjunct in angioplasty Antineoplastic For decrease of intraocular pressure in patients with open angle glaucoma or ocular hypertension, who are insufficiently responsive to topical beta blockers or prostaglandin analogues 06.02.2002 1985-87 22-03-2006 15-06-2007. 15.06.07 13.09.2001 23.08.99 15.06.99 09.06.2003 17.01.07 23.11.06 03-10-2003 06.03.2002 22-02-2005
1118. Tolterodine Tartrate 4mg (ER) + Tamsulosin HCL 0.4mg Capsule. 1119. Tolterodine tartrate ER 4mg + Tamsulocin Hcl. ER 0.4mg tablet 1120. Tolterodine-L-Tartrate 1121. 1122. 1123. 1124. Topiramate Topotecan Hydrochloride Torsamide Torsemide 10mg + Amiloride 5mg tablets
1125. Trandalopril 1mg/2mg/4mg/2mg + Verapamil (ER) 240mg/240mg/240mg/180mg 1126. Trandolapril 1127. Tranexamic Acid
1128. Tranexamic Acid (500mg) + Mefenamic acid (250mg) tablet 1129.
Tranexamic acid Mouth Wash (50mg/ml)
15.6.2007.
1130.
Tranexamic acid mouthwash (50mg/ml)
15.06.07
1131. 1132.
Trapidil Trastuzumab
11.05.2000 10.07.2000
1133. Travoprost 40mcg + Timolol (as Maleate) 5mg per ml of eye drops
28.01.08
56

1134. 1135. 1136. 1137. 1138. 1139. 1140. 1141. 1142. 1143. 1144. 1145. 1146. 1147. 1148. 1149. 1150. 1151. 1152. Travoprost Eye drops (40mcg/ml) Trazadone Tretinoin Microsphere Gel (0.1% W/V) Trichloromethiazide Trifluperidol HCl Triflusal Trimebutine Maleate Trimetazidine dihydrochloride Trimethoprim & Sulphamethoxazole Trimethoprim & Sulfamoxole Trimethoprim & Sulphadoxine Trofosfamide Trolamine Cream (0.67%) Tylosin Tartrate Uroklnase for Inj. Urovison Inj. Ursodeoxycholic Acid (500mg) S.R Tablet Ursodeoxycholic acid S.R. Capsule (450mg) Ursodeoxycholic acid tablets 600mg For glaucoma & ocular hypertension. Anti-depressant For topical treatment of acne vulgaris Diuretic Neuroleptic Agent Platelet Aggregation Inhibitor For irritable bowel syndrome Cardiac drug Bactericidal Chemotherapeutic agent Chemotherapeatic agent Chemotherapeutic agent Anti-cancer drug For Topical use Vet. Antimicrobial Thrombolytic Contrast Media Addl. Strength For dissolution of gall stones For the treatment of patients with chronic cholestatic liver disease Muscle relaxant, Neuromuscular, Blocking agent Anti-viral NSAID For CMV 08-12-2005 1985-87
26.08.08 Dec. 1978 1969 1974 17.01.2001 10-10-2005 03/1979 to 07/ 1981 1969 1974 1975 76 1969 1974 1975 76 20-03-2004 03/1979 to 07/ 1981 May-82 Dec. 1978 20-07-2005 01-12-2004 30.01.08 1985-87 25.09.2002 01.08.2002 20-11-2003
1153. 1154. 1155. 1156.
Vacuranium Bromide Inj. Valacyclovir Valdecoxib Valgancyclovir
57

1157. 1158. 1159. Valsartan Varenicline (As tartrate) 0.5mg/1mg tablets Venlafaxine Hydrochloride Antihypertensive As an aid to smoking cessation treatment in adults Antidepressant For the treatment of type_II diabetes mellitus when single drug therapy alongwith diet, exercise do not result in adequate glycemic control As an adjunct to diet and exercise to improve glycemic control in patients with type-II diabetes mellitus Vasodilator Antineoplastic aggregation inhibitor Anti-pychotic For vitamin C deficiency Anti-diabetic For improvement of parantial hyperphemia in diabetis mellitus only. When diet and/or exercise or oral, hypoglyceamic drug or insulin preparation in addition to diet and or exercise does not result in adequate glycemic control. As Approved Anti-fungal Anti-fungal For the treatment of irritable bowel syndrome For rotavirus diarrhoea in children. Diuretic Anti-diarrhoeal agent Antiasthmatic (Leukotriene Receptor Antagonist) 10.12.2001 29.05.07 18.09.2000
1160. Vildagliptin 50mg/50mg/50mg + Metformin Hcl 500mg +850mg +1000mg tablets
21.07.08
1161.
Vildagliptin Tablets 50mg/100mg
18.01.08
1162. 1163. 1164.
Vimpocetine Vinorelbin Tartrate Inj. Vinpocetin
13.05.2002 17.01.2001 01.08.2003 12-07-2006 17-11-2005
1165. Vitamin C 500mcg + Zinc Citrate 2.2mg + Selenium 60mcg tablet. 1166. Voglibose (0.2mg/0.3mg) Tablet
1167. Voglibose 0.2mg/0.3mg tablet (Mouth dissolving)
28.12.07
1168.
Voglibose disp.tab.0.2mg/0.3mg
20-11-2007 21-02-2006 09-09-2004 31.01.08 31-07-2007. 03/1979 to 07/ 1981 1969 - 1974 03.12.2001
1169. Voriconazole Powder for oral soluion (40mg/ml) 1170. Voriconazole Tablet (50 mg/200 mg) Infusion (200 mg/vial) 1171. VSL # (Combination of lactic acid bacteria (VSL # 3) 1172. VSL # 3 (Probiotic Blend) sachet 1173. 1174. 1175. Xipamid Yeast tannic acid compound Zafirlukast
58

1176. 1177. Zaleplon Zanamavir inhalation powder 5mg/blister Sedative-Hypnotic For influenzae For prophylaxes and treatment of both influenza A & B in adults and children (greater than or equal to 5 years) For acute diarrhoea For Schizophrenia Anti-psychotic Post-menopausal osteoporosis. For Hypercalcaemia Sedative-Hypnotic For insomnia Anti-epileptic Same as approved. Antimaniac & antischizoprenic 17.01.2002 13-02-2006
1178. Zanamavir inhalation powder 5mg/blister (Additional Indication) 1179. 1180. Zinc (Gluconate) oral solution (20mg/5ml) Ziprasidone HCl
22.01.08
05-10-2005 18.03.2002 03-09-2004 6-12-2007. 05.11.2001 28.05.99 10-07-2006 21-12-2005 25-05-2006 29.07.99
1181. Ziprasidone powder for injection (after reconstitution 20 mg/ml) 1182. Zoledronic acid 5mg/100ml solution for infusion (addl. indication). 1183. Zolendronic Acid 1184. Zolpidem
1185. Zolpidem Tartrate E.R tablet (6.25mg/12.5mg). 1186. Zonisamide (100mg) capsule 1187. 1188. Zonisamide capsule 25/50mg (addl. Strength) Zuclopenthixol Acetate
59

List of Drugs Approved by DCGI 1969 To Aug 2008 Alfa

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List of Drugs Approved by DCGI During Jan -1969 to Aug- 2008

Date of Approval 1975 76 22.03.2002 29.08.06

Abatacept powder for injection 250mg/vial

Acebrophylline capsules 100mg

7. 8. 9. 10. 11. 12. 13. 14. 15.

16. 17. 18. 19.

Aceclofenac injection 150mg/ml Acesulfame Potassium Acitretin Actarit 100mg Tablets

23.01.08 05-04-2005 09-09-2005 22.07.08

List of Drugs Approved by DCGI During Jan -1969 to Aug- 2008

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

29. 30. 31. 32. 33. 34.

08.06.07 20.09.06 09.08.06 09.05.2002 1969 - 1974

35. 36. 37. 38. 39. 40.

18.08.08 26.03.08 10-11-2005 26.03.08 1985-87 03/1979 to 07/ 1981

List of Drugs Approved by DCGI During Jan -1969 to Aug- 2008

Amiodarone Injection (additional Indication).

Anti-Fungal Anti-amcabic Anti-capressant

25-11-2003 1985-87 1985-87

List of Drugs Approved by DCGI During Jan -1969 to Aug- 2008

Amoxicillin 250mg + Lacto- Bacillus 1.7 billion Spores

Dec. 1978 08-06-2006

71. 72. 73. 74. 75. 76. 77. 78. 79.

List of Drugs Approved by DCGI During Jan -1969 to Aug- 2008

05.08.08 24.06.08 1985-87 22-06-2006

Atorvastatin 10mg + Aspirin 75/150mg Capsules

Atorvastatin 10mg + Fenofibrate 80mg tablet (Additional Indication)

List of Drugs Approved by DCGI During Jan -1969 to Aug- 2008

Atorvastatin Calcium 80mg tablets (Additional Strength)

104. 105. 106. 107. 108. 109.

111. 112. 113. 114. 115. 116. 117. 118. 119.

05-07-2007. 06.06.07 01.11.2002 01-09-2004 1985-87 28-01-2005 23.07.08 01-08-2006 22.02.07

List of Drugs Approved by DCGI During Jan -1969 to Aug- 2008

133. 134. 135. 136. 137. 138. 139. 140.

List of Drugs Approved by DCGI During Jan -1969 to Aug- 2008

Bortezomib Injection (additional indication)

148. 149. 150. 151.

28.03.08 18.05.99 25-11-2005 07.03.08

152. Bromfenac Sodium Eye Drop (0.09%)

153. 154. 155. 156. 157. 158. 159. 160. 161.

List of Drugs Approved by DCGI During Jan -1969 to Aug- 2008

Camostat Mesylate tablets 100mg

Capecitabin Tablet (150mg/500mg). (For additional indication).

177. 178. 179. 180. 181.

Capecitabine Captopril Carbadox Carbenicillin Sodium Carbenoxolene Sodium

12.10.2000 1985-87 1975 76 1969 1974 1969 1974

List of Drugs Approved by DCGI During Jan -1969 to Aug- 2008

Carmustine (polifeprosan 20 with carmustine Implant (Wafer)

187. 188. 189. 190. 191. 192. 193. 194.

23.08.06 23-12-2005 30.08.06 30.08.06 30.08.06 25.07.08 1985-87 10.10.2001

Cefdinir 250mg dispersible tablets & oral suspension 250mg/5ml

196. 197. 198. 199. 200.

27-05-2004 03-03-2006 11.03.08 08.06.07 11.08.06

List of Drugs Approved by DCGI During Jan -1969 to Aug- 2008

215. 216. 217. 218.

22.11.06 18.05.07 1985-87 24.06.08

List of Drugs Approved by DCGI During Jan -1969 to Aug- 2008

220. 221. 222.

30-07-2007. 31.01.08 10-01-2003

224. 225. 226. 227.

22-06-2004 06-01-2006 05.08.08 30.08.06

231. Ceftriaxone + Sulbactam injection (Additional Indication)

List of Drugs Approved by DCGI During Jan -1969 to Aug- 2008