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LIST OF DRUGS APPROVED DURING 2005

S.No Name Of Drug Pharmacological Classification       Date of Approval
267

 Centbucridine (0.5%) + Feracrylem (3%)

 For hemorrhoid & anal fissure

11-01-2005
268

 Atenolol (25mg, 50mg) + HCTZ (12.5mg)

 Anti-Hypertensive

13-01-2005
269

 Levocetirizine Syrup (2.5mg/5ml)

 For allergic rhinitis & urticaria

13-01-2005
270

 Pitavastatin (1mg/2mg) Tablet

 Lipid Lowering agent

14-01-2005
271

 Ofloxacin (200mg) + Ornidazole (500mg)

 For diarrhea of mixed infection

20-01-2005
272

 Bacillus calusii spores suspension (2billion/5ml vial)

 For alteration of intestinal bacterial flora

28-01-2005
273

 Lamivudine (40mg) +Nevirapine (70mg  +Stavudine (10mg) (in 5ml) powder for  suspension

 Anti-HIV.

28-01-2005
274

 Diflorasone Diacetate Cream (0.5mg/gm)

 For corticosteroid responsive dermatoses

08-02-2005
275 Etonogestrel (11.7mg) + Ethinylestradiol (2.7mg) Contraceptive rings For Contraceptive in women 15-02-2005
276 Metaxalone (400mg) + Diclofenac Potassium (50mg) tablet For acute painful musculoskeletal condition in adult 22-02-2005
277 Tranexamic Acid (500mg) + Mefenamic acid (250mg) tablet For primary dysmenorrhoea and pain associated with menorrhagia in women 22-02-2005
278 Fluconazole (2%) + Zinc Pyrethione (1%) suspension For seborrhoic dermatitis 22-02-2005
279 Azelaic acid Cream (15%) For the treatment of inflammatory papules and pustules of mild to moderate rosacea 23-02-2005
280 Levodropropizine oral suspension (30mg/5ml) For non-productive cough in adults 25-02-2005
281 Duloxetine HCl (60mg) tablet (additional strength)   28-02-2005
282 Desloratadine (2.5mg) + Ambroxol (30mg) +Guiphenasine (50mg) + Menthol 1mg/5ml Syrup For productive cough 02-03-2005
283  Levofloxacin Ophthalmic Solution (0.5%)  For susceptible bacterial conjunctivitis

 04-03-2005

284 Metformin Oral Solution (100mg/ml) For type-II diabetes mellitus

04-03-2005

285 Tirofiban (0.25mg/ml injection)

(additional strength)

For acute coronary syndrome including patients undergoing PTCA or atherectomy

09-03-2005

286 Omeprazole (20mg)

Enteric coated + Domperidone (30mg)  (S.R.) capsule

For GERD not responding to Omeprazole. 10-03-2005
287 Stavudine powder for suspension For HIV-1 infusion 11-03-2005
288 Erdosteine (150mg/300mg) Capsules For chronic obstructive bronchitis

 

11-03-2005

289 Tazarotene (1mg) +Mometasone Furoate (1mg) per gram cream For plaque psoriasis

01-04-2005

290 Levetiracetam (250mg,500mg,

750mg)  Tablets

As  adjunctive therapy in treatment of partial onset seizures in adults with epilepsy.

04-04-2005

291 Esomeprazole Sodium For injection For GERD in patients with esophagitis and/or severe symptoms of reflux as an alternative to oral therapy when oral intake is not appropriate

04-04-2005

292 Rupatadine (10mg) tablet For perinial allergic rhinitis

05-04-2005 

293 Acesulfame Potassium As sweetener in pharmaceutical preparation

05-04-2005

294 Buprenorphine (0.4mg) + Naloxone (0.1mg) sublingual tablet For opioid dependence

06-04-2005

295 Lamivudine (40mg) +Stavudine (10mg/5ml) reconstituted solution For HIV infection

08-04-2005

296 S(-) Metoprolol Succinate S.R. tablets (equivalent to S(-) Metoprolol Tartrate 12.5mg/25mg/50mg) For Hypertension

15-04-2005

297 R(-) Ondansetron (2mg/4mg) tablet For chemotherapeutic induced nausea and vomiting

15-04-2005

298 Balanced salt intra ocular irrigating solution enriched with glutathione Dextrose, bicarbonate For intraocular irrigating during intraocular surgical procedures

26-04-2005

299 Gliclazide M.R. (30mg/60mg)+

Metformin HCl (500mg) ER Tablet

For type-II diabetes

27-04-2005

300 Drosperinone (3mg) + Ethinylestradiol (0.035mg tablet) Oral Contraceptive

11-05-2005

301 Simvastatin (10/20mg) + Ezetimibe (10mg) Tab For primary Hypercholesterolemia

 

11-05-2005

302 Ramipril (5mg) + Telmisartan (40mg) tablet For Hypertension

11-05-2005

303 Intralipid 30% For patients with essential fatty acid deficiencies

12-05-2005

304 Montelukast Granules (4mg/pack) For Prophylaxis and chronic treatment of asthma in adult and pediatric patients of 12 months age and older

17-05-2005

305 Bortezomib for injection (3.5mg/vial) For the treatment of myeloma patients

18-05-2005

306 Nelfinavir 625mg tablet (addl.strength) For HIV patients

20-05-2005

 

307 Sevelamer (400mg/800mg) tablet For control of serum phosphorus in patients with chronic kidney disease and hemodialysis.

20-05-2005

308 S(-)Pantoprazole (10mg/20mg) tablet For gastric ulcer, duodenal ulcer & GERD

20-05-2005

309 Tazarotene (0.05%) + Mometasone Furoate (0.1%) Cream (addl.strength) For Plaque psoriasis

24-05-2005

310 R (-) Ondansetron oral Solution (1mg/5ml) For Chemotherapy induced nausea and vomiting

24-05-2005

311 Gatifloxacin (200mg) +Ornidazole (500mg) tablet For diarrhoea of mixed infection in adults

06-06-2005

312 Combikit of 2 tablet of Stavudine (40mg) + Lamivudine (150mg) each  & 1 tablet of Efavirenz (600mg) For HIV infection in adults

07-06-2005

313 Combikit of 2 tablet of Lamivudine (150mg) + Zidovudine (300mg) each and 1 tablet of Egavirenz (600mg) For HIV infection in adults

07-06-2005

314 Aceclofenac gel 1.5% alongwith linseed oil, menthol, Salicylate, Capsaicin For pain, swelling etc

08-06-2005

315 Emtricitabine (200mg) capsule For HIV infection in adults

09-06-2005

316   Eplerenone Tablet (25mg/50mg)

For hypertension

10-06-2005

317 Strontium Ranelate Granules (2gm/Sachet) For post-menopausal women with Osteoporosis

14-06-2005

318 Lamivudine 30/60mg + Stavudine 6mg/12mg + Nevirapine 50mg/100mg dispersible tablet For pediatric patients with HIV infection

14-06-2005

319 Nitazoxanide (500mg) + 
Ofloxacin  (200mg) Tablet
For urogenital infection in  adults. 30-06-2005
320 Midazolam Maleate Bulk Anesthetic 05-07-2005
321 Calcium Polycarbophil  (500mg) Tablet IBS 06-07-2005
322 FDC of  Papain + Urea Ointment For debriment of necrotic tissues. 11-07-2005
323 Testosterone Gel 1%.

For replacement therapy in male with Testosterone deficiencies and hypogonadotropic hypogonadism

12-07-2005
324 Erlotinib Hydrochloride (25mg/100mg/150mg Tablet For metastatic non-small cell lung cancer. 13-07-2005
325 Chloroquine Phosphate eye drops (0.3mg/ml)   For dry eye syndrome 13-07-2005
326 Mecobalamine E.R. tablet (1500mcg) For neuropathic pain 19-07-2005
327  Olmesartan Medoxomil (5mg/20mg/40mg) Tablet  Anti-hypertension

 21-07-2005

328 Ursodeoxycholic Acid (500mg) S.R Tablet Addl. Strength

20-07-2005

329

FDC of Amlodipine (5mg) + Bisoprolol (2.5mg)

Anti-hypertension

21-07-2005

330

FDC of Ceftriaxone (500mg/100mg) + Tazobactum (12.5mg/62.5mg) Injection

Anti-bacterial 21-07-2005
331

Feropenem Sodium (150mg/200mg) Tablet

Anti-bacterial 21-07-2005
332 Levodopa (50mg/100mg/150mg) + Carbidopa (12.5mg/25mg/37.5mg + Entacapone (200mg) tablet For Parkinsonís disease

 25-07-2005

333 Saquinavir (as mesylate) 500mg Tablet Addl. Strength.

25-07-2005

334

Pramipexole Di-hydrochloride Tablet (0.125mg/0.25mg/0.5mg/1mg/1.5mg).

For Parkinsonís disease

25-07-2005

335 FDC of Atorvastatin (10mg) + Niacin (375mg/500mg E.R) Capsule For Hypercholesterolemia

26-07-2005

336 FDC of Levocetirizine (5mg) + Ambroxol (75mg S.R) Capsule Anti-histaminic & mucolytic

29-07-2005

337 FDC of Gabapentin (300mg) + Methylcobalamin (500mcg) Tablet For neuropathic pain in adults.

05-08-2005

338 Phenytoin Sodium (300mg) tablet Addl. Strength

05-08-2005

339 FDC of Calciptriol (50mcg) + Betamethasone Dipro (0.5mg/gm) Ointment For psoriasis vulgaris.

12-08-2005

340 FDC of Glimepiride (1mg/2mg) + Pioglitazone (15mg)+ Metformin (500mg E.R) Tablet Anti-diabetic

12-08-2005

341 Tenofovir Disoproxil Fumarate Tablet (300mg) Anti-HIV

17-08-2005

342 Sucralfate (7%) + Povidone Iodine (5%) Ointment Anti-infective

18-08-2005

343

Bivalirudin Injection  (250mg/vial)

Anti-coagulant in PTCA

25-08-2005

344

Efavirenz Oral Solution (30mg/ml)

Anti-AIDS

25-08-2005

345

Didanosine Powder for oral solution (2gm/4gm per bottles)

Anti-AIDS

26-08-2005

346

Sodium Valproate (750mg/1000mg) C.R. Tablet

Addl. Strength

26-08-2005

347

Oxcarbazepine S.R. (150mg/300mg/600mg) Tablet

Anti-epileptic

08-09-2005

348

Acitretin

For sever psoriasis in adults.

09-09-2005

349

Dried IVY Leaf Extract (0.7gm/100ml)

Cough Syrup

15-09-2005

350

Nimesulide 1% + Methyl Salicylate 5%.

Aerosol For local application in acute pain.

16-09-2005

351

Feracrylum (1%) +  Metronidazole 1%)

Antiseptic gel.

16-09-2005

352

FDC of Methylcobalamin (1500mcg E.R) + Pyridoxine (20mg) + Folic Acid (5mg) Tablet

For hyper-homocysteinemia

16-09-2005

353 Ketorolac Tromethamine 0.4% Eye drops (addl. Strength) Ophthalmic 20-09-2005
354 Levetiracetam Oral Solution (100mg/ml) Anti-epileptic 22-09-2005
355 Zinc (Gluconate) oral solution (20mg/5ml) For acute diarrhoea 05-10-2005
356

Trimebutine Maleate

For irritable bowel syndrome

10-10-2005

357

Enalapril (2.5mg/5mg) + HCTZ (12.5) Tablet (Addl. Strength)

For Hypertension 17-10-2005
358 Oseltamivir  (as phosphate) Capsule (75mg) & oral suspension (12mg/ml) For influenzae 25-10-2005
358 Cetirizine HCl drops (10mg/ml) Anti-histaminic 08-11-2005
359

Lanthanum Carbonate Chewable tablet (250mg/500mg)

For the treatment of hyperphosphatemia. 09-11-2005
360 Ambroxol HCl 75mg (S.R) + Desloratadine 5mg Capsule.

For relief of productive cough.

10-11-2005
361 Sodium Hyaluronate 0.1% eye drops (addl. Strength) Ophthalmic use. 10-11-2005
362 FDC of S-Metoprolol Succinate Tartrate  equivalent to Metoprolol Tartrate (E.R) 25/50mg + HCTZ (12.5mg) Tablet.   For essential hypertension 11-11-2005
363 Stavudine 10mg+Lamivudine 40mg+ Nevirapine 70mg dispersible tablet For HIV infection 11-11-2005
364 Voglibose (0.2mg/0.3mg) Tablet  Anti-diabetic

17-11-2005

365

Lactitol Sachet (10gm/20gm).

For the treatment of constipation.

21-11-2005

366

Aspirin Bolus (Vet.) 6gm/bolus)

For Veterinary use.

21-11-2005

367

Domperidone (10mg) + Activaed dimethicone (125mg) chewable tablet

For dyspepsia, colicy pain & GERD. 22-11-2005
368

Moxifloxacin (0.5%) + Dexamethasone Phosphate (0.1%) Eye drops

For Ophthalmic use. 24-11-2005
369 Pregabalin capsule (75/150/300mg) For neuropathic pain.

 25-11-2005

370 Methotrexate Topical gel (1%)  Addl. Strength Psoriasis.

25-11-2005

371

Brimonidine Tartrate (2mg/1.5mg) + Timolol (as HCl) 5mg/ml.

Ophthalmic

25-11-2005

372

Testosterone Spray (25mg)

For replacement therapy in males with testosterone deficiency.

29-11-2005

373 Omeprazole Powder for suspension (20mg/Sachet) Anti-ulcer

30-11-2005

374 Doxazosin (as Mesylate) 4mg/8mg E.R. Tablet For hypertension

30-11-2005

375 Amlodipine (as besylate) 5mg + Bisoprolol 5mg Tablet (Addl. Strength) For hypertension

30-11-2005

376 FDC of Olmesartan Medoxomil (20mg/40mg/40mg) + HCTZ(12.5mg/12.5mg/25mg) For essential hypertension

02-12-2005

377 Phenylephrine 2.5% Eye drops Ophthalmic

02-12-2005

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

05-12-2005

379 Ketorolac Tromethamine 5mg + Ofloxacin 3mg/ml Eye drops Ophthalmic

07-12-2005

380

Hyoscine-N-Butylbromide (10mg) + Paracetamol 500mg Tablet

For spasmodic pain

08-12-2005

381

Amlodipine (as besylate ) 5mg + Losartan Pot. 50mg

For hypertension

08-12-2005

382

Travoprost Eye drops (40mcg/ml)

For glaucoma & ocular hypertension.

08-12-2005

383

Ceftriaxone (as sodium) (500mg/1000mg) + Sulbactam (as sodium) (250mg/500mg) powder for injection.

For LRTI

08-12-2005

384

Atomoxetine (as HCl) Sachet (10/18/25/40mg)

For ADHD

15-12-2005

385

Levofloxacin Oph. Solu. (1.5%) 15mg/ml. (Addl. Strength).

Ophthalmic

16-12-2005

386

Zonisamide (100mg) capsule

Anti-epileptic

21-12-2005

387

Methimazole Tablet ( 5mg/10mg)

For hyperthyroidism.

22-12-2005

388

Caspofungin Acetate injection (50mg/70mg per vial).

For invasive candidiasis fungal infection.

23-12-2005