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List Of New Drugs Approvals From 1-1-2006 To 12-2-2010

S.No Name Of Drug

Cefprozil Powder for oral suspension


1
(125mg/5ml)

2 Nebivolol (as HCl) 5mg + Valsartan 80mg

Combikit of Tamsulosin HCl 0.4mg M.R


3 capsule (10 no.) & Dutasteride Soft Gelatin
Capsule 0.5mg (10no.)

Alendronate Sodium (equiv. to Alendronic acid


4 70mg) + Cholecalciferol 70mcg (equiv. to 2800
I.U Vit.D) Tablet

5 Atenolol 50mg + HCTZ 25mg (addl. Strength)

Tamsulosin HCl (MR) 0.4mg + Dutasteride


6
0.5mg tablet

Erdosteine Powder for oral suspension


7
35mg/ml

8 Moxifloxacin Eye Ointment (5mg/gm)

9 Dexibuprofen Tablet (200mg/300mg/400mg)

10 Pegaptinib Sodium Injection (0.3mg).


11 Ciclesonide Inhaler 80/160mcg per actuation

Metoprolol Succinate equiv. to Metoprolol


12
Tartrate 50mg + Amlodipine (as besylate) 5mg

13 Doxofylline Tablet (400mg)

14 Zanamavir inhalation powder 5mg/blister

Testosterone Transdermal Spray


15
(12.5mg/spray) (addl. Lower strength)

Cefetamet Pivoxil Hcl oral suspension


16
250mg/ml

Voriconazole Powder for oral soluion


17
(40mg/ml)

18 Desflurane liquid for inhalation (240mg/bottle).

19 Aceclofenac 200mg (S.R) tablet

Tenofovir Disoproxil Fumarate (300mg) +


20
Emtricitabine (200mg) tablet

21 Levetiracetam Oral Solution (100mg/ml).

22 Atomoxetine 60mg capsule (Addl. Strength)


Diclofenac Sodium (75/50mg) as (E.C) +
23
Misoprostol 200mcg.

Fluorescein Sodium Solution for Injection


24
(100mg/ml)

25 Cefditeron (as pivoxil) 200mg tablet

26 Sodium Hyaluronate Cream 0.2%

27 Saquinavir (500mg) tablet (addl. Strength)

28 Eflornithine HCl Cream (139mg/gm)

Propionyl-L-Carnitine HCl Tablet (500mg) &


29
injection 300mg/vial

30 Tobramycin Inhalation solution (300mg/5ml)

31 Lactulose Enema (20%)

Haloperidol Tablet (0.5mg) (addl. Lower


32
strength)

Cholestyramine Powder for oral suspension


33
(4gm/sachet)

34 Doxofylline Syrup (20mg/ml)


35 Resperidone Tablet & Syrup (addl. Ind )

36 D-trans Fentantyl Transdermal patches

Pantoprazole (as Sodium) (E.C) 40mg +


37
Itopride (150mg) S.R

38 Oseltamivir formulation (additional indication)

39 Atazanavir (100/150/200mg)

40 Nicorandil E.R Tablet (10mg/20mg)

Amlodipine (as besylate) 5mg + HCTZ 12.5mg


41
Tablet

42 Nadifloxacin Gel 1%

Formoterol Fumarate (6mcg) + Fluticasone


43 Propionate (100/250/500mcg) dry powder
inhaler

44 Midazolam (as maleate) 7.5mg/15mg tablet

Olmesartan (as Medoxomil) 10mg (addl.


45
Strength)

Pregabalin Capsule 25/50/100/200mg (addl.


46
Strength)
Oxcarbazepine S.R 450mg/900mg (addl.
47
Strength).

48 Ciclesonide rotacaps (200/400mcg)

49 Itopride 150mg capsule (S.R)

Nevibolol (as HCl) 5mg + Amlodipine (as


50
besylate) 5mg/10mg

Levocetrizine 5mg + Ambroxol Hydrochloride


51
SR (75mg) tablet

52 Ibandronic Acid Tablet (150mg) addl. Strength

53 Zonisamide capsule 25/50mg (addl. Strength)

Perflutren liquid microsphere injectable


54
suspension

55 Cyclosporin Eye drops (0.1%) (addl. Strength)

Gatifloxacin (0.3%) + Prednisolone Acetate


56
(1%) eye drops

Amlodipine (as besylate) 5mg  + Metoprolol


57 Succinate equivalent to Metoprolol Tartrate
50mg.

Nadifloxacin (1%) + Miconazole Nitrate (2%) +


58
Mometasone Furoate (0.1%) Cream
Bemiparin Sodium Solution for
59
injection(5000/7500/10,000 I.U).

60 Icodextrin 7.5% peritoneal dialysis solution

Lamotrigin 200mg tablet (addl. Strength)


61
dispersible tablet (5mg/50mg/100mg/200mg

Amoxycillin 1000mg + Clavulanate Potassium


62
62.5mg E.R tablet

Lopinavir 200mg + Ritonavir 50mg Tablet


63
(addl. Strength)

64 Olopatadine Ophthalmic solution( 0.1%)

Ferrous ascorbate (equivalent to 50mg Iron) +


65
Folic acid 1.5mg.

66 Methyl Prednisolone Aceponate Cream (0.1%)

Aspirin 150mg + Clopidogrel (as bisulphate)


67
300mg tablet (addl. Strength)

68 Levofloxacin 0.5% Ear drops

Olmesartan 40mg + HCTZ 25mg tablet (addl.


69
Strength)

70 Buclizine HCl tablet (25mg) & Syrup 6mg/5ml


Ceftriaxone (as sodium) 250mg + Tazobactam
71
31.25 mg for injection (addl. Strength)

Bimatoprost 300mg + Timolol (as maleate)


72
5mg/ml eye drops

Mebeverine HCl 135mg + Isabgula husk


73
3.5gm sachet.

74 Solifenacin Succinate Tablet (5mg/10mg).

75 Zolpidem Tartrate E.R tablet (6.25mg/12.5mg).

76 Deferasirox dispersible tablet 125/250/500mg.

Vitamin C 500mcg + Zinc Citrate 2.2mg +


77
Selenium 60mcg tablet.

Lamivudine 40mg + Stavudine 10mg


78
dispersible tablet.

Levocetrizine 2.5/5mg + Ambroxol 30mg/5ml


79
of syrup

Cefixime 200mg + Pot. Clavulanate (125mg)


80
tablet

ISMN SR 30mg + Aspirin75/150mg tablet


81
(addl. Strength).

Clobestasol Propionate (0.05%) + Calcipotriol


82
Ointment (0.005%) Ointment.
83 Sodium Hyaluronate Injection (1%).

84 Forskolin Eye drop (1%).

85 Baclofen E.R capsule (30mg)

86 Amisulpiride Tablet (50/100/200mg)

87 Quetiapine S.R tablet 200/300mg.

88 Lumiracoxib Tablet (100/200/400mg).

Tenofovir Disoproxil Fumarate300mg +


89
Emtricitabin 200mg + Efavirenz 600mg tablet

90 Oxandrolone Tablet (2.5/10mg)

Erdosteine 150mg + Guaiphenesin 50mg +


91
Terbutaline 1.25mg per 5ml syrup

Rosiglitazone (as maleate)2mg +


92
Glibenclamide 5mg + MetFormin 500mg tablet 

93 L- Lysine Hcl Ointment (150mg/gm) 

Levocitirizine 2 Hcl 5mg+ Ambroxol Hcl SR


94 75mg + Pseudoephedrine Hcl 120mg SR
Capsules
Alprazolam SR 0.25mg + Sertraline (As Hcl)
95
25mg/50mg tablet

Dexibuprofen 200mg/300mg +Paracetamol


96
500mg tablet

ISMN SR 60mg + Metoprolol Succinate ER


97
25/50mg 

Aspirin 75mg / 150mg + Glycine 37.5mg/75mg


98
tablet

Combipack of 21 tablet of Quinin sulphate


99 600mg each & 8 capsule of Doxycycline (as
Hcl) 100mg each)

100 Pravastatin 40mg tablet (Additional strength)

Olanzapine powder For oral suspensian


101
(10mg/5ml)

Cefepem (as Hcl) 0.5/1gm + Amikacin (as


102
sulphate) 0.125/0.250gm Inj. 

Lamivudine 20mg + Nevirapine 35mg +


103
Stavudine 5mg tablet

Nadifloxacin (10mg/gm) + Mometasone


104
Furoate (1mg/gm) cream

Premetrexed(Disodium) powder For solution


105
For Inj. 500mg/vial

Gliclazide 40mg/80mg + MetFormin Hcl 500mg


106
+ Rosiglitazone 2mg tablet
107 Tiropramide Hcl (100mg) tablet

108 Eperisone Hcl (50mg ) tablet

109 Caroverine cap. 20mg & Inj. 40mg/2ml

110 Paclitaxel nanoparticle Inj. (20mg/ml)

111 Amoxycillin 250mg + Dicloxacillin 250mg cap.

112 Rifaximine 200mg tab.

113 Tigecycline powder For Inj. 50mg/vial 

114 Stavudine SR 100mg tablet

Cefixime (50mg/100mg) + Clavulanic acid


115
31.125mg/62.5mg per ml dry syrup & tablet

Ciclsonide 80mcg/160mcg + Formotorol 4.5mg


116
inhaler

Ciclsonide 100mcg/ 200mcg/400mcg +


117
Formotorol Fumarate 6mg rotacaps

118 Abacavir Sulphate syrup 20mg/ml


S(-) pantoprazole (as sodium) 20mg (E.C.) +
119
Domperidome SR 30mg tablet 

Cefadroxil 500mg + Clavulanic acid 125mg


120
tablet

Cefadroxil 250mg + Clavulanic acid 62.5mg


121
dispersible tablet

Cefadroxil 250mg + Clavulanic acid 62.5mg


122
per 5ml syrup

123 Human Insulin (r-DNA) Powder inhaler 

124 Fulvestrant Inj. 250mg/5ml prefilled syringe

125 S(-) Pantoprazole (as Sodium) Inj. 20mg/vial

126 Dasatinib tablet 20mg/50mg/70mg tablet 

127 Telbivudine 600mg tablet

128 Aprepitant cap (80mg/125mg) 

Telmisartan 40mg + Amlodipine (as Besylate)


129
5mg tablet

130 Gemifloxacin (as msylate) 320mg tablet


Ceftazidime 500mg /1000mg + Tazobactum
131 (as sodium) 62.5mg/125mg per vial for
injection

Cefepime (As Hcl) 500mg/1000mg +


132
Tazobactum (as Sodium) 62.5mg/125mg 

133 Paromomycin Inj. 375mg/ml

Cefixime 100mg + Cloxacillin (as Sodium)


134
500mg + Lactobacillus (45 million spore)tab.

Alprazolam Dispersible Tab.


135
0.125mg/0.25mg/0.50mg

136 Epinastine Hcl (0.05%) Opthlamic solution 

Levofloxacin tablet (250mg /500mg) & Infusion


137
5mg/ml (For additional indication)

138 Feracrylum 1% mouth gargle 10mg/ml

139 Aceclofenac Inj. (150mg/ml)

combipack of one cap. Of aprepitant .125mg &


140
two cap. Of aprepitant 80mg each (combipack)

Formoterol fumarate 6mcg + Fluficasone


141
propinate 50mcg/125mcg/250mcg MDI 

Amlodipine 25mg + Metoprolol 25mg


142
(additional lower strength)
143 Estrogen vaginal tablet 25mcg 

Esomeprazole 40mg (E.C.) + Itopride 150mg


144
SR Capsules

Cefixime 200mg + Cloxacillin 500mg (ER) +


145 Lactobacillus 90 million Spore tab. (additional
strength)

Cefixime dispersible tablet 400mg (new


146
dosage Form)

Trandalopril 1mg/2mg/4mg/2mg + Verapamil


147
(ER) 240mg/240mg/240mg/180mg

Ciclesonide 160mcg/320mcg cap. for


148
inhalation

149 Rabeprazole 20mg (EC) + Itopride SR 150mg

Metoprolol succinate 25mg /50mg ER + HCTZ


150
12.5mg 

Atorvastatin 5mg + Fenofibrate 160mg


151
(additional strength)

152 Aceclofenac Inj. 50mg/ml (additional strength)

153 Amisulpride 400mg tablet (additional strength)

Misoprostol tablet 25mcg/100mcg/200mcg


154
(additional strength indication
155 Atazanavir 150mg + Ritonavir 50mg capsules

Mebeverine Hcl 135mg + Chlordiazepoxide


156
5mg tablet

157 Ampicillin 250mg + Dicloxacillin 250mg tablet

Etoricoxib 10mg + Methyl Salicylate 100mg +


158 Mentol 50mg + Linseedoril 30mg per gm. of
Gel

Racecadotril dispersible tablet (10mg/30mg)


159
(new dosage Form)

160 Gabapentin ER 450/600/900mg tablet

Aceclofenac dispersible tablet 100mg (new


161
dosage form)

R-Ondansetron (As Hcl. Dihydrate) (1mg/ml)


162
injection

163 Torsemide 10mg + Amiloride 5mg tablets

164 Fexofenadine suspension (30mg/5ml)

165 Sildenafil Citrate 20mg Tablet

Pioglitazone 15mg/30mg + MetFormin ER


166
1000mg tablet (additional strength)
FluvAstatin Tablet (As calcium)
167
10mg/20mg/40mg (additional strength)

168 Halobetazol Propionate Cream (0.05%)

169 Eszopiclone tablet (1mg/2mg/3mg)

170 Diltiazem Hcl. 2% gel

171 Nalbuphine injection 10mg/20mg per ml.

172 Levonorgestrel 1.5mg tablets

Pantaprazole sodium 20mg/40mg Tablet (with


173
sodium bicarbonate As buffer)

levofloxacin (250mg/500mg) + ambroxol SR


174
75mg tablet

Testosterone cypionate (100mg/200mg) +


175
Cotton seed oil 736/566mg per ml injection

Rosiglitazone 1mg + Metofmin Hcl 500mg


176
tablet (additional strength)

Loteprednol Etabonate 5mg + Tobramycine


177
3mg per ml ophthalmic solution

Amlodipine (As besylate) 5mg + Metoprolol


178
(As succinate) ER 25mg (additional strength)
Glibeneclamide 5mg + MetFormin SR 850mg
179
tablet (additional strength)

180 Aceclofenac injection (150mg/3ml)

Metoprolol (As succinate) 50mg/25mg ER) +


181 Amlodipine 5mg/2.5mg tablet (For additional
indication)

Ramipril 10mg + HCTZ 12.5mg tablet


182
(additional strength)

Amlodipine (As besylate) 5mg/5mg/10mg +


183
valsartan 80mg/160mg/160mg tablet

184 Glatiramer Acetate injection (20mg/ml)

Baclofen ER (GRS) Capsule 45mg/60mg


185
(additional strength)

Amlodipine (As besylate )5mg/10mg +


186
Perindopril 4mg tablet

187 Olopatadine Hcl. Tablet 2.5mg/5mg

Metoprolol (As succinate) ER 25mg/50mg +


188
Ramipril 2.5mg/5mg

Rabeprazole Sodium 20mg/10mg with sodium


189
bicarbonate As buffer

Ciclesonide 160mcg/320mcg + Formoterol


190 Fumarate (12mcg) (Dry powder inhaler
additional strength)
191 Moxonidine tablet 0.2mg/0.3mg/0.4mg

Ceftriaxone (As sodium) 125mg/250mg +


192 Sulbactam (As sodium) 62.5mg/125mg For
injection (additional strength)

Quetiapine (As fumarate) SR 400mg tablet


193
(additional strength)

194 Cabergoline 1mg tablet (additional strength)

Levofloxacin Oral Solution (each 240ml bottle


195
contains Levofloxacin 125mg/5ml.)

196 Clindamycin 1% + Isotretinoin 0.05% gel

197 Estradiol topical emulsion 2.5mg/gm

Levosalbutamol MDI (50mcg/actuation) & Dry


198 Powder inhaler (100mcg/capsule) (New
Dosage Form)

Polonosetron (As Hcl.) For Injection


199
0.25mg/5ml

200 Cifixime 200mg + Erdosteine 300mg Capsules

201 Aminophylline CR 225/350mg

Etoricoxib 10mg + Methyl salicylate 20mg per


202
gm. of cream
203 Eberconazole cream (1%)

204 ISMN 60mg Sr + Atenolol 50mg/100mg

205 Levonorgestrel 0.03mg tablet

206 Bortezomib 2mg/vial (additional pack size)

Comb kit of two capsule of Azaranari 150mg


207
each + 1 tablet of Ritonavir 100mg)

Mecobalamine 500mcg + Alpha Lipoic acid


208
100mg soft gelatin capsule

Propofol 10mg + Lignocaem 1mg per ml


209
injection

210 Ezetimibe 10mg + Fenofibrate 160mg tablet

Methylprednisolone Acrponate topical solution


211
0.1%

Citicoline  (750mg) tablet (additional


212 strength),  syrup 500mg/5ml (new dosage
Form) (not For children)

213 Ertapenem For injection (1gm/vial)

Letrozole 2.5mg tablet (for additional


214
indication)
Quetiapine SR Tablets 50mg ( additional
215
strength)

Metoprolol (As succinate) 25mg + Amlodipine


216
(As besylate) 5mg (additional strength)

Sunitinib Maleate Capsules


217
12.5mg/25mg/50mg

Comb pack of 1 bottle of ciprofloxacin Injection


218 (200mg/100ml) & 1 bottle of Ornidazole
injection 500mg/100ml)

219 Aprepitant 40mg capsules (additional strength)

Olopatadime Ophthalmic solution (0.2%)


220
(additional Strength)

Combi pack of 1 tablet of Residronate sodium


221 (35mg) + 6 tablet of calcium carbonate
equivalent to 500mg calcium each

222 Levocetirizem 2Hcl. Dispersible tablet (2.5mg)

Amlodipine (As besylate) 10mg + Perindopril


223
8mg tablets (additional strength)

224 Etodolac ER tablets 400mg/500mg

225 Levosulpiride tablet (25mg)

226 Rimonabant tablet 20mg


227 Lactitol monohydrate Syrup 66.67/100ml

S(-) Metoprolol (As succinate) 25mg + S(-)


228
Amlodipine (As besylate 2.5/5mg

229 Amlexanox Oral PAste (5%)

Lenalidomide capsule
230
(5mg/10mg/15mg/25mg)

Cefotaxim (As sodium) 0.5mg/1gm +


231 Sulbactam (As sodium) 250mg/500mg
injection (for additional indication)

232 Lornoxicam tablet 4mg/ 8mg

233 Atenolol 25mg/50mg + Indapamide SR 1.5mg

Livetiracetam conc.  for infusion 100mg/ml


234
(new dosage form)

235 Eplerstat tablet 50mg

236 Citicoline tablet 200mg (additional strength)

237 Varenicline (As tartrate) 0.5mg/1mg tablets

238 Azithromycin eye drops 1%


239 Ciclesonide Nasal Spray 50mcg/spray

Ceftazidime 500mg/1000mg + Sulbactam (As


240
Sodium) 250mg/500mg For injection

241 Isotretinoin  0.05% + Erythromycin 2% gel

242 Aliskiren Tablet 150mg/300mg

Glimepiride 1mg/2mg. + Metformin SR


243
1000mg tablet (additional strength)

Cefditorene pivoxil dispersible tablet


244
(30mg/50mg) (New Dosage form for children)

Dexrabeprazole sodium Enteric Coated tablet


245
5mg/10mg

246 Renolazine Extend ReleAse tablet (500mg)

Phenytoin sodium ER capsules (300mg) (New


247
dosage form)

Alfuzocin Hcl. ER (10mg) + Dutasteride 0.5mg


248
tablet

Cefepime injection 500mg/1gm/2gm (For


249
additional indication)

250 Tranexamic acid mouthwash (50mg/ml)


Deflazocort oral suspension (6mg/5ml) (new
251
Dosage Form)

Tolterodine tartrate ER 4mg + Tamsulocin Hcl.


252
ER 0.4mg tablet

Omeprazole 20mg/40mg + Sodium


253
Bicarbonate 1100mg capsules

Dexrabeprazole Sodium E. coated tablet


254
5mg/10mg.

255 Cefepime Injection (New indication)

256 Phenytoin Sodium E.R (300mg)

257 Tranexamic acid Mouth Wash (50mg/ml)

Deflazacort Oral Suspension (6mg/5ml) (New


258
dosage form)

Tolterodine Tartrate 4mg (ER) + Tamsulosin


259
HCL 0.4mg Capsule.

Omeprazole (E.coated) 40mg + Sodium


260
Bicarbonate 1100mg capsule.

Mebeverine HCl prolonged release capsule


261
(200mg).

Azithromycin 500mg + Ambroxol S.R (75mg)


262
Tablet.
263 Pholcodiene Syrup (4mg/5ml).

Exenatide Injection -pre-filled pen


264
(250mcg/ml).

Moxifloxacin HCL (0.5%) + Ketorolac


265
Tromethamine 0.5% Ophthalmic Solution.

Levofloxacin (15mg) + Prednisolone Acetate


266
10mg per ml eye drops.

Loteprednol Etabonate (0.5%) + Levofloxacin


267
(1.5%) Eye drops.

Clotrimazole (10mg) + Methyl-prednisolone


268
aceponate 1mg/gm of cream.

Capecitabin Tablet (150mg/500mg). (for


269
additional indication).

270 Rifabutin Capsule (150mg).

271 Lapatinib (as Ditosylate) (250mg) Tablet.

Levocetirizine Di-HCl mouth dissolving tablets


272
(5mg) (new dosage form).

273 Idaravone Injection (1.5mg/ml).

Diclofenac Sodium (75mg/ml) Injection (addl.


274
Strength).
Cefpodoxime (as Proxetil) (100mg/200mg) +
275
Clavulanic acid (62.5/125mg) tablet.

Atorvastatin (40mg) + Ezetimibe (10mg) Tablet


276
(addl. Strength).

Cefepime (250mg) + Tazobactam (31.25mg)


277
Injection (addl. Strength).

278 VSL # 3 (Probiotic Blend) sachet

279 Sorafenib (as Tosylate) (200mg) Tablet. 

Methylcobalamin (500mcg) + Alpha Lipoic Acid


280 (100mg) + Pyridoxine (3mg) + Folic acid
(1.5mg) Soft Gelatin Capsule.

Halobetasol Propionate (0.5mg) + Salicylic


281
Acid 30mg per gm of  ointment.

Combipack of 12 tablet of Artesunate (50mg)


each + 3 tablet of each containing Sulfadoxine
282
(500mg) + Pyrmethamine (25mg) Tablet.
(Addl. Strength)

Omeprazole (20mg/40mg)+Sod. Bicarbonate-


283
600mg+ Mg.Hydroxide-700mg .chew tab.

Deferasirox dispersible tablet (400mg) (addl.


284
Strength).

285 Tegafur (100mg) + Uracil (224mg) capsule.

286 Bortezomib Injection (additional indication)


Amlodipine (5mg) + Nebivolol (5mg) tablet
287
(addl. Strength).

Ceftazidine (2gm) + Sulbactam (1gm)


288 Injection  ( addl. strength for additional
indication).

Polyethylin Glycol 400 (0.4%) + Propylene


289
Glycol (0.3%).

Resperidone E.R. (long-acting) injection


290
(12.5mg/vial) (addl. strength).

Levocetirizine Di-HCl syrup (2.5mg/5ml) (for


291
use in children 2 years and above).

292 R-Sibutramine Capsule (2.5mg/5mg)

Cefuroxime Axetil (250mg) + Clavulanic Acid


293
(125mg) Tablet.

Sulphur Hexafluoride Powder and solvent for


294
dispersion for injection (45mcg/ml).

Ondansetron orally disintegrating tablet


295
(4mg/8mg) (additional dosage form)

Cefuroxime Axetil (250mg) + Clavulanic acid


296
(125mg) tablet.

Cefuroxime-125/250/500mg +Clav.Acid-
297
31.25/62.5/125mg

298 Amiodarone Injection (additional Indication).


Risedronate Sodium tablet (35mg) (additional
299
indication)

Sucralfate (70mg ) + Metronidazole (10mg) +


300
Povidone Iodine (50mg) per gram of Ointment.

301 Levetiracetam Tablet (addl. indication)

Combipack of two tablet of chloroquine


302 phosphate (250mg) each + 14 tablet of
Proguanil HCl (100mg) each

Paclitaxel (protein bound particle) for injectable


303 suspension (paclitaxel (100mg) + Albumin
Human 900mg per 20ml.

Olmesartan Medoxomil (20mg) + Amlodipine


304
Besylate (5mg) Tablet.

Atorvastatin Calcium (10mg ) + Ramipril


305
(2.5mg/5mg) tablet

Omeprazole(20mg) + Sodium bicarbonate


306
(1100mg) tablet (addl. strength).

Moxifloxacin HCl (5mg) + Prednisolone


307
Acetate (10mg)per ml. (eye drops)

Methylcobalamine (500mcg) + Alpha Lipoic


acid (100mg) + Pyridoxine HCl (1.5mg) +
308
Thiamine (2mg) +  Calcium Picolinate (200mg)
tablet.

Satranidazole (300mg) + Ofloxacin (200mg)


309
Tablet.

Methylcobalamin 500mcg+beta carotine-


310 10.33mg+alpha lipoic acid 100mg+B6
1.5mg+B1 2mg & Cr.polynicotinate.
Calcium Pidolate equivalent to Calcium 500mg
311
+ Vit-D3 250 IU

312 Etizolam Tablet (0.5mg/1mg).

313 Oxaprozine Tablet (600mg)

314 Prulifloxacin (600mg) Tablet.

315 Cilostazole E.R Tablet (100mg/200mg).

Atorvastatin Calcium (10mg) + Fenofibrate


316
(145mg) (addl. strength)

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

Miglitol (50mg) + Metformin HCl SR (500mg)


318
tablet.

Mupirocin (2%) + Methylprednisolone


319
Aceponate (0.1%) Cream.

Methyl cobalamine 500mcg+folic


acid1.5mg+B5-5mg,+Zn.sulphate
320 25mg+Cr.Polynicotinate 200mcg+selenium-
65mcg+inositol-1.5mg + alpha lipoic acid –
100mg capsule
Methylcobalamine 500mcg+folic acid1.5mg+
321 alpha lipoic acid –300mg +Benfetiamin-50mg.
capsule

Methyl prednisolone aceponate-1mg + salicylic


322
acid-50mg ointment
Propanol 50gm+povidone iodine-1gm in 100ml
323
solution

Propanol-18 gm+Ethenol(100%)-45gm in
324
100ml solution

325 Voglibose disp.tab.0.2mg/0.3mg

Ceftriaxone –2gm+ Tazobactum 250mg for


326
injection

Methylprednisolone aceponate-1mg +
327
Mupirocin-20mg. cream

Citicholine(as Sod.)-200mg/500mg/750mg
328
granules per sachet.

329 Butarphenol tartrate 10mg/ml nasal spray

330 Deferasirox 100mg dis.tablet(addl. strength)

Methyl cobalamine 500mcg+folic


acid1.5mg+B6-3mg,+Zn.sulphate
331
61.8mg+Ca.Pantothenate 10mg+
Niacinamide-50mg +chrimium-50mcg capsule

Methylcobalamine 500mcg+folic acid 1.5mg+


332 alpha lipoic acid –100mg +B6-3mg+Thiamine
10mg capsule

Doxophylline-400mg+Salbutamol(as sulphate)-
333
2mg/4mg Tablets

Gatifloxacin (as sequihydrate)-3mg +


334
Flurbiprofen sod.-0.3mg/ml eye drops.
335 Sertanidazole-300mg+ Ofloxacin-200mg tablet

Zoledronic acid 5mg/100ml solution for


336
infusion (addl. indication).

Olmesartan medoximil-20mg + Ramipril-5mg.


337
tablet

Levosulpiride Tablet (50mg/100mg) (addl.


338
strength for addl. indication).

Combipack of 12 Artesunate –50mg tablets &


339
6 Mefloquin-250mg tablets

Pregabalin-75mg/150mg +Methylcobalamine
340
500mcg cap

341 Doxycycline-100mg +L.bacillus spores-5 billion

Cefprozil 250mg/500mg+Clav. Acid-62.5mg


342
/125mg. tab

Dextrometharpahan HBr-
343 10mg+Chlorphenaramine maleate-2mg /5ml
syrup.

344 Lornoxicam 8mg /2ml inj.

345 Apomorphine HCL-2mg/3mg Sublingual tablet.

Escitlopram (as oxalate)10mg + Clonazepam-


346
0.5mg tablet (addl. Strength).
347 Doxophylline injection-10mg /ml

Me-salicylate 30% + Menthol 10% + camphor


348
4% Cream

Voglibose 0.2mg/0.3mg tablet (Mouth


349
dissolving)

Hydroxychloroquine 400mg tablets (Additional


350
Strength)

ISMN 30mg SR + Metoprolol Succinate


351 equivalent to metoprolol tartrate 25mg/50mg
tablets (Additional Strength)

352 Halobetasol 0.05% + Clotrimazole 1.0% cream

353 Citicholine Syrup 750mg/5ml

Levodopa 200mg + Carbidopa 50mg C.R.


354
tablet

355 Nanocrystalline Silver Gel 0.002%

356 Cinitapride (as hydrogen tartrate) 1mg tablet

Tenofovir disoproxil fumarate 300mg +


357
Lamivudine 300mg tablet

Cefixime 200mg/100mg + Lactic acid bacillus


358
2.5 billion spores tablet & dispersible tablet
D-Trans Fentanyl Metrix system (12mcg/hr.)
359
(Additional Strength)

Ceftazidime 500mg + Tobramycin 60mg per


360
vial (Injection)

Atazanavir 300mg capsules (Additional


361
strength)

Ertapenem for injection 1gm/vial (additional


362
indication)

363 Vildagliptin Tablets 50mg/100mg

Atorvastatin 10mg + Aspirin 75/150mg


364
Capsules

Smatriptan (as succinate ) 50mg + Naproxen


365
sodium 550mg  tablets

Sodium Valproate 666mg + valproic acid


366 290mg equivalent  as sodium valproate
1000mg C.R. tablet (Additional Strength)

Cefepime (as hydrochloride)


367 2000/1000/500mg + Sulbactam (as sodium)
1000/500/250mg per vial of injection

Paclitaxel Nanoparticle Solution for Injection


368
20mg/ml (Additional indication)

369 Sorafenib tablets 200mg (Additional Indication)

Zanamavir inhalation powder 5mg/blister


370
(Additional Indication)
Mycophenolate Mofetil Capsule
371 250mg, 500mg & Oral suspension 200mg/ml
(Additional Indication)
Combikit  4 tablets of Alendronate sodium
trihydrate equivalent to Alendronic acid 70mg
372 each + 24 tablets of Calcium carbonate
1250mg (equivalent to 500mg Calcium) +
cholecalciferol-250IU

373 Aceclofenac injection 150mg/ml

Atorvastatin 10mg + Fenofibrate 80mg tablet


374
(Additional Indication)

Sodium Valproate 499.5mg + Valproic acid


375 217.5mg equivalent  as sodium valproate-
750mg CR tablet (Additional Strength)

Diclofenac 50mg + Serratiopeptidase 10mg


376
enteric coated tablet

Gabapentin 100mg + methylcobalamin


377
500mcg tablets (Additional Strength)

Cefpirome (as sulphate) 500/1000mg/2000mg


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

Metformin HCl ER 500mg  + Fenofibrate


379
80mg/160mg tablet

Salicylic acid 10mg/20mg (Foaming facewash


380
solution)

381 Ozagrel Hcl. Tablets 100mg/200mg

Rivastigmine transdermal patch (each patch of


382 5m2, 10m2,15m2 & 20m2 contain
Rivastigmine base 9/18/27/36mg respectively
Daptomycin powder for concentrate for
383
solution for infusion (350mg/500mg per vial)

Dextromethorphan Orodispersible strip


384
5.5mg/11mg

Diclofenac sodium 50mg + Dicyclomine HCl


385
20mg per ml of injection

Travoprost 40mcg + Timolol (as Maleate) 5mg


386
per ml of eye drops

Amoxicillin 250mg/125mg + Cloxacillin


387 250mg/125mg + Lactic Acid Bacillus 1.7 Billion
spores

Amoxicillin 250mg + Lacto- Bacillus 1.7 billion


388
Spores

Amoxycillin 250mg + Cloxacillin 250mg +


389
Lactobacillus 2 billion spores capsules

Tiotropium (as Tiotropium Bromide


Monohydrate) 18mcg + Formoterol Fumarate
390
Dihydro. 12mcg + Ciclesomide 400mcg per
capsules

Metoprolol Succinate Equivalent to Metoprolol


391 Tartrate [ER 25/50mg] + Atorvastatin (As
calcium ) 10mg tablets

Levocetrizine Di HCl Dispersible tablet


392
5mg/10mg (New Dosage form)

Oseltamivir 30mg & 45mg Capsules


393
(Additional Strength)

Fondaparinax Sodium injection (Additional


394
Indication)
395 Camostat Mesylate tablets 100mg

Hyaluronic Acid Salt 25mg + Cross-Linked


396
Hyaluronic acid 25mg per ml in prefilledsyringe

397 Ursodeoxycholic acid tablets 600mg

Dalteparin Sodium Injection(Additional


398
Indication)

Beclomethasone Dipropionate 0.25mg +


399 Econazole 10mg + Neomycin 5mg per gm
of  Cream

Exenatide injection (Each 2ml vial contains-


400 Exenatide 5mcg/10mcg per 0.2ml ) (Additional
Strength)

Diclofenac Sodium 50mg + Paracetamol


401
500mg  tablets

402 Gabapentin SR 600mg tablets

Memantine 5mg /10mg + Donepezil 5mg


403
Tablets

404 Doxifluridine Capsules 100mg/200mg

Haemodialysis Powder/Liquid Form containing


405
citrate

Carmustine (polifeprosan 20 with carmustine


406
Implant (Wafer)
407 Cimetropium Bromide tablet 50mg

408 CyclobenzaprineHcl. Tablets 5mg/10mg

409 Sertaconazole Nitrate Cream 2%,

Cefpodoxime 50mg + Clavulanic acid 31.25mg


410 dispersible tablet & dry syrup (Additional
strength)

Darifenacin (as hydrobromide) 7.5mg/15mg


411
ER tablets

Amoxycillin 125mg/250mg/500mg +
412
Lactobacillus 1.66 billion Spores (Capsules)

Halobetasol 0.5mg + Miconazole 20mg per


413
gram Cream

Montelucast 10mg + Levocetirizine 5mg film


414
coated tablets

Hydroquinone 2% + Tretinoin 0.025% (w/w)


415
Momentasone 0.10% Gel

Phenylephrine 5mg + Chlorpheniramine


maleate 0.5mg + Paracetamol 125mg +
416
sodium citrate 60mg + Menthol 1mg (per 5ml)
Syrup

Diclofenac Sodium 100mg (SR Pellets) +


417 Rabeprazole Sodium 20mg (E.C Pellets)
Capsules

Ciclesonide 160mcg/320mcg/Formoterol
418
12mcg + Tiotropium 18mcg Dry powder inhaler
VSL # (Combination of lactic acid bacteria
419
(VSL # 3)

420 Clostimethate Sodium of 1,00,000IU Injection

Ramipril 5mg + HCTZ 12.5mg tablets


421
(Additional Strength)

422 Metronidazole CR tablet 600mg

423 Quetiapine fumarate SR tablets

Atorvastatin Calcium 80mg tablets (Additional


424
Strength)

Euphorbia Prostrata Dry Extract (ethanolic


425
80% (v/v) (35-70) :100mg tablet

426 Amtolmetin Guacil tablets 600mg

Brimonidine Tartrate Opthalmic solution 0.1%


427 (with purite as preservation 0.0005%)
(additional strength)

428 Methoxsalen USP-20mg Tablet

Cefditoren pivoxil 400mg tablets (Additional


429
Strength)

Doxofylline ER tablets 400mg/800mg (addl.


430
Strength)
Betamethasone 0.05% +Miconazole 2%
431
Cream

Premetrxed disodium injection 100mg/vial


432
(Additional Strength)

Omeprazole 20mg/40mg + Sodium


433 bicarbonate 1680mg per sachet powder for
oral suspension

ISMN 30mg SR + Atenolol 50mg tablets


434
(Additional Strength)

Temozolamide capsules 140mg/180mg (Addl.


435
Strength)

Amisulpiride 300mg tablets (Additional


436
Strength)

437 Nifedipine SR Tablets 10mg/20mg

Ambroxol HCl. 15mg + Guiphenesin 50mg +


438 Terbutalin sulphate 1.25mg + Menthol 2.5mg
per 5 ml of syrup

Ambroxol HCl 30mg + Guaiphenesin 100mg +


439
Terbutaline sulphate 2.5mg per 10ml  Syrup

440 Boswellia Serrata 0.05gm/gm of  Cream

441 Etoricoxib injection 90mg/ml

Drospirenone 3mg + Ethinyl estradiol 0.02mg


442
tablets (Additional Strength)
Nimesulide 100mg ER + Levocetirizine HCl
443
5mg Tablets

Dexketoprofen (as  Trometamol ) tablets


444
12.5mg/25mg

445 Nepafenac Opthalmic suspension (1mg/ml)

Hylan GF 20 Injection (Synvisc) (Additional


446
Indication)

447 Docetaxel injection conc.

Methylcobalamin 1000mcg + Pyridoxine Hcl IP


448 100mg + Nicotinamide IP 100mg + D-
Panthenol IP 50mg per 2 ml of injection

Lamivudine 20mg + Stavudine 5mg dispersible


449
tablets (Additional Sgtrength)

450 Nicardipine Hcl. Injection 2.5mg/ml

Diclofenac Potassium 50mg +


451 Serratiopeptidase (as enteric coated pellets)
15mg capsules (Additional Strength)

452 Diacerin 50mg + Aceclofenac 100mg tablets

Rabeprazole sodium Enteric coated pellets


453
15.4% w/w (20mg/129.83mg)

Live freeze-dried lactic acid bacteria and


454
bifidobacteria capsules
Miltefosin Capsule 10mg/50mg (Additional
455
Indication)

456 Silver Wound Dressing

Diacerin 50mg + Glucosamine sulphate 500mg


457
tablets.

Clostridium Botulinum type-A toxin


458
haemagglutinin complex (Additional Indication)

459 Fluconazole Dispersible tablets 50mg

Lenalidomide Capsule 5mg/10mg/15mg/25mg


460
(Additional Indication)

Sitagliptin ( As Phosphate) 50mg + Metformin


461
Hcl. 500mg/1000mg Film coated tablets

462 Lansoprazole for injection 30mg/vial

463 Naproxen Suspension 125mg/5ml

Sevelamer Carbonate 400mg/800mg tablets &


464
sachet 400mg/800mg

Rabeprazole Sodium (With Sodium


465
bicarbonate as buffer) 10mg/20mg tablets

Pantoprazole Sodium (With Sodium


466
bicarbonate as buffer) 20mg/40mg tablets
Cefdinir 250mg dispersible tablets & oral
467
suspension 250mg/5ml

468 Pregabalin capsules (Addl. Indication)

Pregabalin 75mg/150mg + Methylcobalamin


469
750mcg capsules (Additional Strength)

Aliskiren 150/150/300/300mg + HCTZ


470
12.5/25/12.5/25mg tablets

Desmoprission lyophilisate Oral tablets


471
60mcg/120mcg/240mcg per tablets

Losartan Potassium 25mcg + Amlodipine (as


472
besylate) 5mg tablets. (Additional Strength)

Lecithin Liquid (each 5 ml contains lecithin


473 500mg equivalent to essential phospholipids
250mg

Halobetasol  0.05% + Salicylic acid 6%


474
Ointment (additional Strength)

Benzoyl Peroxide Medicated  Solution (each


475 textured pad contains 4.5%/6.5%/8.5% of
solution

476 Deflazocort 24mg  tablets (Additional strength)

Sodium Chondroitin sulfate 40mg + sodium


477 Hyaluronate 30mg per ml Intraocular Injection
(additional strength)

Esomeprazole (with Sodium bicarbonate as


478
buffer) 20mg/40mg tablets
Telmisartan 40 mg + Atorvastatin (as calcium)
479
10 mg  Tablets

Milnacipran Hcl. 25mg/50mg equivalent to


480 Milnacipran free base 21.77 or 43.55 mg.
tablet.

Metolazone 2.5mg + Losartan Potassium


481
25mg/50mg tablets

482 Metolazone 2.5mg + Ramipril 2.5mg/5mg

Doxercalciferol 0.5mcg/2.5mcg Soft Gelatin


483
capsules

484 Acebrophylline capsules 100mg

485 Sofalcone Capsule (100mg/50mg)

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

Diclofenac Sodium 50mg + Codeine


487
Phosphate 50mg tablets

Sodium Hyaluronate injectable gel (each


488 0.6ml. 1ml pre filled syringe contains, sodium
Hyaluronate 20mg/ml, 22.5mg/ml

Amphotericin B Lipid suspension injection


489
(25mg/vial) with lipid suspension

Dexrabeprazole 10mg (EC) + Domperidone


490
30mg SR Capsules
Thiocolchicoside 4mg/8mg +
491
Ketoprofen 50mg/100mg tablets

Cefotaxime sodium + Sulbactam sodium for


492
injection (Additional Indication)

Artemether 40mg/80mg + Lumefantrine


493
240mg/480mg tablets (additional Strength)

494 Ivabradine (Hcl.) 5mg/7.5mg Tablets

Amino Acid, Glucose Parentral Solution


495
(Solution for intravenous infusion)

Temoporfin 1mg/ml Injection (Additional


496
Strength)

Pazufloxacin Mesylate i.v. infusion


497
300mg/100ml & 500mg/100ml

Metoprolol ER + Amlodipine tablets (Additional


498
Indication)

Fenofovir Disoproxil fumarate 300mg +


499
Lamivudine 300mg + Efavirenz 600mg tablets

Vildagliptin 50mg/50mg/50mg + Metformin Hcl


500
500mg +850mg +1000mg tablets

501 Testosterone Undecanoate 250mg/ml Injection

502 Abatacept powder for injection 250mg/vial


503 Actarit 100mg Tablets

Tenofovir Fumarate 300mg + Lamivudine


504
300mg + Efavirenz 600mg Tablets

Bacillus Clausii Spores (2 Billion) Capsules


505
(additional dosage form)

Gatifloxacin 0.3% + Ketorolac Tramthamine


506
0.4% eye Drop

Ketorolac Tromethamine 4mg + Gatifloxacin


507
3mg Eye Drops

Cefadroxyl (as monohydrate) 125mg +


508 Clavulanic acid (as potassium) 31.25 per 5ml
Syrup (Additional strength)

Doxercalciferol (0.5/ 2.5mcg) Soft Gelatin


509
Capsule (Additional Indication)

Artemether + Lumefantrine Dispersible tablet


510
(40/80mg + 240/480mg ) (Additional Strength)

Ceftazidime + Tobramycin  injection (1gm +


511
120mg) (Additional Strength)

512 Olopatadine Nasal Spray (0.6%)

513 Loxoprofen Sodium tablet (60mg)

514 Dexibuprofen Suspension 50mg/5ml


515 Bromfenac Sodium Eye Drop (0.09%)

Ceftriaxone + Sulbactam injection (Additional


516
Indication)

517 Citicoline Chewable tablet (500mg)

Ambroxol + loratadine + Guaifenesin Syrup


518
(30mg + 5mg + 50mg per 5ml)

Ferrous Ascorbate + Folic Acid + Zinc FC


519
Tablets (100mg + 1.5 mg + 22.5 mg)

Cyclobenzaprine 7.5mg tablets (Additional


520
Strength)

S-Metoprolol Succinate Oral Solution (Each Ml


521 contains: S-Metoprolol Succinate 9.5mg equal
to S-Metoprolol Tartrate 10mg)

Doxorubicin HCl Pegylated Liposomal Injection


522
(20/50MG) (Additional Indication)

Povidone Iodine Sachet (containing


523 Effervescent Granules) Each 2gm Sachet
contains: 175mg (available iodine 17.5mg)

Sodium Chondroitin Sulphate + Sodium


524 Hyaluronate injection (40mg + not more than
17mg per ml) 

Metolazone + Spironolactone FC Tablets


525
(2.5/5mg + 50mg)

526 Tretinoin Microsphere Gel (0.1% W/V)


527 Misoprostol 50Mcg tablet (Additional Strength)

Ferrous Ascorbate + Folic Acid Suspension


528 (Equiv. to elemental iron 30mg + 550mcg per
5ml) (New Dosage Form)

529 Guaiphenesin ER Tablet (600mg)

530 Clopidogrel 300mg Tablet (addl. Strength)

Capecitabine 150/500mg Tablets (addl.


531
Indication)

Lopinavir + Ritonavir (100 + 25mg) Tablets


532
(additional strength)

Ixabepilone lyophilized powder inj. 15mg/45mg


533
per vial

Halometasone (as monohydrate ) 0.05%


534
Cream 

Calcium and Magnesium 24% (Veterinary)


535
injectable solution. 

Telmisartan + Ramipril (40mg + 2.5mg )


536
Tablets (Additional Strength)

Drotaverine + Aceclofenac (80mg + 100mg)


537
Tablets

Losartan + Chlorthalidone (25/25/50/50mg +


538
6.25/12.5/6.25/12.5mg) Tablets
Olmesartan + Ramipril (5mg + 40mg) tablets
539
(Additional Strength)

Fluconazole + Zinc Pyrethrone (Each 30/60ml


540
bottle contains: 2% + 1%) Lotion

541 Citicoline CR Tab 1000mg

542 Montelukast Suspension 5mg/5ml

543 Etoricoxib roll on Topical Solution 1% v/v

Risedronate Sodium 150mg Tablet (Additional


544
Strength)

545 Levosulpiride Inj. 25mg/ml, 2ml 

546 Paliperidone ER Tablet 3mg / 6mg / 9mg

Ceftiofur Crystalline free acid Suspension equi


547
to Ceftiofur ---- 200 mg(veterinary)

Ceftiofur HCl Suspension(as HCl salt)


548
----500mg (veterinary)

Ceftiofur HCl Suspension (as HCl salt)


549
----125mg (veterinary)

550 Nitrofurantoin SR Tab. 100mg


551 Tolperisone HCl Tablet 50 / 100 / 150mg 

552 Etoricoxib + PCM (60mg + 500mg) Tablets 

553 Citicoline Oral Drops

Paracetamol + Meloxicam + Benzyl Alcohol +


554 Lignocaine (5mg/ml + 150mg/ml + 1% + 1% )
Injection

Calcium (as Calcium Citrate Malate) +


555 Colecalciferol (as Colecalciferol Concentrate) +
Folic Acid (250mg + 100IU + 50mcg) Tablets

Artemether + Lumefantrine (80mg +


556
480mg/5ml) Dry syrup

Cabergoline 1mg Tablets (Additional


557
indication)

Pemetrexed disodium500mg / 100mg powder


558
for sol. (Addl.indication )

Tylvalosin tartrate oral soluble granules Sachet


559
62.5% w/w (Veterinary)

Bortezomib inj.3.5mg/vial (Additional


560
Indication)

561 Sertaconazole Nitrate Vaginal Tab.500mg

562 Fosfomycin Tromethamine Sachet 3gms


Ixabepilone lyophilized powder (additional
563
Indication)

564 Eprosartan Mesylate 400 mg / 600mg Tablets

565 Tretinoine Gel as Micro Sphere 0.04% % 0.1%

Hydroxychloroquine Sulphate (Additional


566
indication )

Budesonide + Formoterol (80/160mcg +


567 4.5mcg) Inhalational Powder (Additional
Indication)

Azithromycin + Dexamethasone (10mg + 1mg)


568
Eye Drops

Diclofenac + Thiocolchicoside (50mg (EC) +


569
8mg) Capsules

570 Adapalene 0.1% + Benzoyl Peroxide 2.5% gel

571 Aceclofenac Roll - On 1%

572 Citicoline Troches 200/500mg

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

Calcitriol + Calcium + Zinc (0.25mcg + 200mg


574
+ 7.5mg) Capsules
Atazanavir + Ritonavir(300mg + 100mg) FC
575
Tablets

576 Timolol Maleate SR Eye Drops 5.0mg / ml

Rosuvastatin Calcium tablets 5/10/20/40mg


577
(Addl. Indication)

Paclitaxel inj.30/100/300mg vial (Addl.


578
Indication)

Montelucast + Desloratidine(10mg + 5mg) FC


579
Tablets

Amlodipine + Metoprolol (2.5/5 mg + 25/50mg


580
(ER))Tablets

581 Losartan + HCTZ (100 mg + 25 mg) Tablets

582 Phenyramidol HCl tablet 400mg

583 Salicylic Acid + Coal Tar (3% + 1%) Solution

Salicylic Acid + Coal Tar + Precipitated


584
Sulphur (3% + 1% + 3%) Ointment

Thiocolchicoside + Etoricoxib(4mg + 60 mg)


585
FC Tablets

Tamsulosin + Tolterodine (0.4mg MR Pellets +


586
2mg/4mg ER Pellets) Capsules
Calcium Hypochlorite 4gm Sachet (Calcium
587 Hypochlorite 0.542% Other Ingredients:
99.458%)

Sumatriptan + Naproxen (50mg + 275mg)


588
Tablets

Amoxycillin + Clavulanic acid(1gm + 62.5mg )


589
FC Tablets

Buprenorphine + Naloxone (2 mg/0.4mg +


590
0.5/0.1 mg) Tablets

Atorvastatin + Metformin(10mg + 500mg SR)


591
Tablets

Pemetrexed disodium 500mg / 100mg powder


592
for sol. (Addl. Indication)

593 Magnesuim Valproate Tablet 200mg/400mg

Ursodeoxycholic Acid 300/600 SR Tablets


594
(Additional Strength)

Rifampicin + INH + Piperine (200mg + 300mg


595
+ 10mg ) Capsules

Rifampicin +Piperine (200mg + 10mg )


596
Capsules

Amphotericin B Lipid suspension 50mg/ vial


597
(Addl. Strength)

598 Desmopressin Acetate tablet 0.1/0.2 mg


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

600 Lamotrigine MR Tablets 50/100mg

Levosulpride Injection 25mg/2ml (Additional


601
Strength)

602 Cyclobenzaprine HCl ER Capsule 15/30mg

Docetaxel injection concentrate 80mg/2ml,


603
20mg/0.5ml (Additional Indication )

Salicylic Acid + Cetyl Alcohol + Stearyl Alcohol


604
(2% + 2.65% + 0.26%) Lotion

605 Azathioprine 25mg Tablets

606 Paracetamol solution for infusion 10mg/ml

Gemifloxacin + Ambroxol (320mg + 75mg SR)


607
FC Tablets

Ceftazidime + Sulbactam (500/1000mg +


608
250/500mg) Injection

Paracetamol + Phenylephrine Hydrochloride


609 (Each 6gm Sachet contains: 500mg + 10mg)
Sachet

Carboinoxamine Maleate + Ammonium


610 Chloride + Sodium Citrate (Each 5 ml contains:
2 mg + 120 mg + 120 mg) syrup
Diclofenac + Thiocolchicoside (50 mg + 4 mg)
611
Capsules

Zoledronic Acid Injection 5mg/100ml (Addl.


612
Indication)

613 Misoprostol Tablet 600mcg

614 Acebrophylline Syrup 10mg/ ml

Selamectin Tropical solution (for verterinary


615
use.) 60mg/120mg per ml

Methylcobalamin1500mcg + Calcium 200mg


616 + Calcitriol 0.25mcg + Folic Acid1.5mg +
Pyridoxine3mg Capsules

Metoprolol tartrate tablets 50 mg (Addl.


617
Indication)

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

Mycophenolate mofetil Capsules 250mg,
619 Tablets 500mg, Oral suspension 200mg/ml
(addl. Indication)

Liquid Paraffin1.25ml + Milk of Magnesia


620
3.75ml + Sodium Picosulphate 3.33mg per 5ml

Ranolazine 1000mg ER Tabs (Additional


621
Strength)

Hyaluronic acid (cross linked) Pre-filled syringe


622
18mg/0.6ml and 24mg/0.8ml
Caspofungin acetate Injection (Addl.
623
Indication)

Micafungin ( as sodium) Powder for solution


624
for infusion 50mg / vial

625 Loteprednol Etabonate Nasal spray 0.1% w/v

626 Rasagiline (as mesylate ) Tablet 0.5mg/1mg

Nicotine Polacrilex Gum 2mg & 4mg (Addl.


627
Indication)

Closantel Injection100mg/ ml
628
(forverterinary use.)

Lornoxicam 4mg + Paracetamol 500mg film


629
coated tablets

Cetrimide15% w/v + Chlorhexidine Gluconate


630 7.5% v/v + Isopropyl Alcohol 7.5% v/v
Concentrate Solution

Ketoconazole 2% w/v + Prepared Coal Tar 2%


631
w/v (I.P. 1966) Solution

Doripenem (as monohydrate) Injection


632
250mg/500mg

633 Halobetasol Scalp Approved 0.05% w/v

634 Nicotine (as Polacrilex) Lozenges 2mg & 4mg


635 Tranexamic Acid Tab SR 750mg

636 Betahistine Mesilate Tablet 6mg/12mg

Abatacept Injection 250mg/vial (Addl.


637
Indication)

Anidulafungin Injection (Lyophilized powder)


638
50mg/100mg per vial

Hydroquinone 2%+ Tretinoin 0.05% +
639
Hydrocortisone1%Cream

Doxyphylline 400 mg + Terbutaline 5mg


640
tablets

Hydroquinone 20mg + Tretinoin 0.25mg +


641
Fluocinolone Acetonide 0.1mg per gm Cream

642 Ketoconazole 2% + Zinc Pyrithone 1% Lotion

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

Glibenclamide 5mg + Pioglitazone 15mg +
644
Metformin500mg film coated tablets

Aceclofenac 100mg + Tizanidine 2mg film


645
coated tablets

Octinoxate 7.5% + Avobenzone 3% +
646
Oxybenzone 3% + Titanium dioxide 2% lotion
Cetrizine 5/10mg + Ambroxol 30mg per 5ml
647
syrup

648 Lidocaine Lozenges 200/300mg

649 Calamine 8% + Liquid Paraffin10% lotion

650 Nifedipine 0.3% + Lidocaine1.5% cream

Quinapril 20mg + HCTZ 25mg film coated


651
tablet

Levodopa 100/100/250
652 + Carbidopa10/25/25mg mouth dissolving
tablet

653 Paliperidone ER Tablets 1.5mg

654 Losartan 100mg+ HCTZ 25 mg tablet

655 Darunavir(as ethanolate) Tablet 300mg

656 Ropivacaine HCl Inj.2/5/7.5/10mg

Butaphosphan 100g + Methyl
657 Hydroxybenzoate 1gm + Cyanocobalamin50
gm Oral powder (Veterinary Drug)

Fluticasone furoate Nasal spray 27.5mcg per


658
spray
Octinoxate 7.5% + Avobenzone 2% +
659 Oxybenzone 3% + Octocrylene 3%+ Zinc
Oxide 2% lotion

Omeprazole 20/40mg + Sodium Bicarbonate


660
600mg+ Magnesium Hydroxide 700mg sachet

Ambroxol 30mg + Levo salbutamol
661
1mg+Guiphenesin 50mg /5ml syrup

662 Montelucast 4 mg+ Levocetrizine 2.5 mg tablet

663 Surgical Sealant

Lidocaine Patch 700mg in aqueous base. (50


664
mg per gram adhesive)

665 Bimatoprost Opthalmic solution 0.03%

Trabectedin powder for concentrate for


666
solution for infusion 1 mg/ vial

Acebrophylline Syrup 10mg/ml (Additional


667
Indication)

668 Mesalamine PR Tablets 1.2gm

Mycophenolate Mofetil Tablets 750mg
669
Additional Strength

670 Ketorolac Tromethamine Gel 2%w/w


Theophylline 400mg SR + Montelukast10mg
671
Tablet

Hyaluronic Acid Sodium Salt 0.2 gm + Silver


672
Sulfadiazine 1.0 gm/25 gm tube 

Hyaluronic Acid Sodium Salt 50 mg + Silver


673 Sulfadiazine 1.0 gm/ 100 gm gauze
pads impregneted with cream.

674 Telmisartan 80mg + Amlodipine 5mg tablet

675 Hyaluronic Acid Sodium Salt

(i) Each 15gm tube contains: HyaluronicAcid


676
Sodium Salt 0.2gm/100gm

(ii) Sterile Gauze Pads impregnated with


cream: Each gauze pad
677
contains HyaluronicAcid Sodium Salt
50/100mg

Abatacept Injection 250mg/vial  (additional
678
indication)

679 Cetrizine 10 mg + Ambroxol 75 mg SR Tablet

Ciclesonide 200mcg + Formoterol 6mcg
680
+Tiotropium 9mcg MDI

Each film coated bilayred tablet contains:


681 Metoprolol 25mg/50mg + Chlorthalidone
12.5mg

Milnacipran 25/50mg Caps      (Addl.
682
Indication)
683 Lornoxicam SR 16mg Tabs

Palonosetron Hcl 0.075mg IV Inj (Addl.
684
Strength)

Each film coated bilayred tablet contains:


685 Metoprolol 25mg/50mg + Chlorthalidone 6.25
mg /12.5mg

686 Albendazole 400 mg + Ivermectin 6 mg tablet  

Decitabine Lyophilized powder for injection


687
50mg/20ml vial

688 Retapamulin Ointment 1%

Each ml contains Calamine 15% w/v + Zinc


oxide 5% w/v + Bentonite 3%
689
w/v+Glycerin 5%w/v + Sodium citrate 0.05 %
Each 1000 ml of emulsion contains: Medium
w/v lotion
chain triglycerides 100 gm + Soya oil 80 gm +
Omega-3  acid triglycerides 20 gm + egg
690 lecithin 12 gm + Glycerl 25 gm + Sodium
oleate 0.30 gm + Alpha -tocopherol 0.20 gm
+ Ascorbypalmitate0.30 gm + Sodium
hydroxide
Sertaconazole Nitrate Powder 2% w/w &
691
Lotion 2% w/v

Amlodipine Tablets 5mg/10mg  (additional


692
indication)

Clindamycin Phosphate Inj. 150mg/ml &


693 Clindamycin HCl Capsules 150mg/300mg
(additional indication)

Each 15 gm sachet contains: Lactulose 10 gm


694
+ Ispaghula husk 3.50 gm granules
695 Sucralose

CarvedilolTablets 3.125/6.25/12.5/25mg (additi
696
onal indication)

Dexketoprofen 12.5 mg/25 mg + Paracetamol


697
500 mg film coated tablets

698 Pregabalin SR Tablet 150/300mg

699 Guaiphenesin ER Tablet 1200mg

700 Everolimus 5/10mg Tablets (Addl. Indication)

701 Nimesulide ER 200mg

702 ( Additional Indication)

Palonesetron Injection 0.25mg/5ml (Additional


703
Indication)

Bendamustine Hydrochloride Lyophilized
704
powder Injection 100mg/ vial

705 Caffeine(as  Citrate)       10mg / ml Injection

Perindopril arginine 2.5mg/5mg/10mg  film
706
coated tablet
Each gm contains: Halobetasol 0.05% w/w
707
+ Mupirocin 2.0 % w/w gel

Mometasone 0.1 % + Fusidic acid 2%
708
cream/ointment

Thiocolchicoside 8 mg + Etoricoxib 60 mg
709
tablets

Methadone Hydrochloride 5mg/10mg per ml


710
syrup;  5mg/ 10mg/ 20mg / 40mg  tablet

711 Trospium Chloride  film coated tablet 20mg

Arformoterol (as Tartrate ) 15mcg / 2ml


712
Inhalation Solution

Zolmitriptan...5.0% w/v   Benzalkonium
713
Chloride NF ... 0.01% w/v        Nasal spray

Dexmedetomidine ( as HCl) 100mcg /ml


714
Injection

715 Levetiracetam SR Tablet 500/750/1000mg

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


716
filled syringe (20mg/ml)

Yttrium-90 Microspheres Injection (Yttrium-


717
90...3GBq (at the time of calibration) per vial)

718 Luliconazole Cream 1%
Magnesium Valporate Prolonged release
719
tablet 600mg

720 Tenofovir Disoproxil Fumerate 300mg

Bosentan (as monohydrate) Tablets


721
62.5/125mg

722 Lornoxicam 12 mg SR (additional strength)

Azithromycin SR Granules for oral


723
suspension  2000mg

Metoprolol 50/50/25
724 mg  + Atorvastatin20/10/10
mg  + Ramipril 10/5/2.5 mg capsules

725 Methyl Phenidate ER Tablet 10/20/30mg

726 Dasatinib Tablets 100mg (addl. Strength)

727 Voglibose 0.2 mg  + Metformin 500mg Tablets

728 Milnacipran 100mg (additional Strength)

729 Rifaximin 400mg (additional Indication)

Nevirapine tablet 50 mg for oral suspension


730
mg
Desvenlafaxine (as Succinate) ER
731
Tablets 50mg/100mg

732 Posaconazole Oral Suspension 40mg/ml

Caffeine Citrate 20mg / ml (equivalent to 10mg


733 of Caffeine base) Oral Solution (Addl. Dosage
form)

Amphotericin B Emulsion 5mg/ml (Addl.


734
Indication)

735 Hydroxy ethyl starch 10% Solution for infusion

736 Naratriptan (as HCl)  Tablets 1/ 2.5mg

Colistimethate Sodium powder for solution for


737 injection/infusion 500000IU and 2000000IU
(additional Strength)

Simvastatin 20 mg + Ramipril 5mg  + Atenolol


738 50 mg + HCTZ 12.5 mg + Aspirin 100 mg (EC
Pellets) Capsules

Colistimethate Sodium powder for solution for


739
inhalation 500000IU/1000000IU/2000000IU

740 Ramipril MR capsule 10mg

741 Abacavir Sulfate Tablet 60mg

Zoledronic Acid Solution for Infusion Addl.


742
Indication
Sumatriptan 85 mg + Naproxen 500 mg
743
Tablets

Aceclofenac(100mg) + Thiocolchicoside ( 8
744
mg) tablets

Oxcarbazepine 150/300/600mg Tablet (Addl.


745
Indication

Ofloxacin 2mg + Ornidazole 5 mg  per ml


746
Infusion

747 Clozapine Tablet200mg (Addl. Strength)

Oxymetazoline Hydrochloride Nasal


748
Spray50mcg/0.05%w/w

749 Enoxaparin Sodium Injection (Addl.Indication)

750 Fluvoxamine Maleate100/150mg ER Tablets

Lidocaine Lozenges 200/300mg (Addl.


751
Indication)

Risperidone long acting injection (Addl.


752
Indication)

753 Exemestane 25mg Tablet (Addl. Indication)

Artesunate (25/50/100mg) + Amodiaquine


754
(67.5 mg/135/270mg) bilayerd Tablets 
Ezetimibe 10 mg + Fenofibrate 145 mg Film
755
coated tablets 
Buprenorphine Transdermal Patch Each
Transdermal Patch having an area
of  6.25cm², 12.5cm², and 25cm²contains:
756 Buprenorphine…5mg/10mg/20mg having
release rate of 5mcg, 10mcg, 20mcg
Buprenorphine per hour respectively(over a
period of 7 days). 
757  Trospium Chloride ER Capsules 60 mg 

Metoclopramide (as HCl) 200mg / 400mg per


758
ml Intranasal Solution 

Isosorbibe 20 mg  + Hydralazine 37.5 mg


759
tablets 

Cefixime 200 mg + Dicloxacillin ER 500 mg


760
Tablets 

761 Chlorthalidone Tablet 6.25mg               

Cefovecin( as sodium) 80mg/ ml Lyophilised


762
powder for injection (Veterinary)              
Imidacloprid 10% + Moxidectin 1.0% &
2.5%   Topical solution
(Veterinary)           Each pippette
763 contains:                             (a) 0.4ml, 1.0ml,
2.5ml, 4ml of 10% Imidacloprid and 1.0%
moxidectin             (b) 0.4ml, 0.8ml of 10%
Imidacloprid a
Isoflupredone AcetateSuspension for Injection
764
(2mg per ml) ( For Veterinary) 

765 Saxagliptin (as HCl) 2.5mg/ 5mg Tablets 

Calcipotriol Gel
766 0.005%                       (additional dosage
form) 
Lamotrigine MR Tablets 150mg (Addl.
767
Strength) 

Metoprolol Tartrate ER Tablet


768 75mg                                                 (additional
strength) 

Valganciclovir Powder for Oral Solution


769
50mg/ml 

770 Dexketoprofen Trometamol Gel 12.5mg/gm 

Donepezil Hydrochloride Orodispersible Tablet


771
5mg/10mg 

Dexketoprofen Trometamol Injection


772
50mg/2ml 

Bromocriptine Mesylate Tablet IP 0.8mg,


773
(additional Indication) 

774 Levosulpride ER Tablet 100/150/200mg 

Ambroxol 30 mg+ Terbutaline 2.5 mg +


775 Guaiphenesin 100mg + Menthol 2.5 mg per 5
ml syrup 

Propofol 10 mg+ Lignocaine 2.5 mg per ml


776
injection 

Mecobalamin 750 mg + Pyridoxine


777 Hydrochloride1.5 mg + Nicotinamide 45 mg
tablets 

Olmesartan (20/40mg )+  Atorvastatin


778
5/10/20mg film coated tablets 
Deltamethrin (0.50% m/v) and Piperonyl
779
Butoxide  (2.0% m/v) per ml Pour–On Solution

Glucosamine sulphate potassium chloride 500


780
mg + Ibuprofen IP 200mg film coated Tablets

Methylcobalamin 1500 mcg + Gabapentin SR


781
600 mg film coated tablets

782 Propofol 1% for injection (Additional Indication)

Rupatadine 10 mg + Montelukast 10 mg
783
Tablets

Eperisone 50 mg + Paracetamol 500 mg


784
Tablets

785 Lafutidine Tablets ....5mg/10mg. 

Ramosetron Hydrochloride Tablets 2.5mcg,


786
5mcg, 0.1mg & Injecton 0.3mg /2ml 

787 Tadalafil tablet 20 mg (Additional Indication)

Flurbiprofen Sodium 0.03% Ophthalmic


788
solution USP

Dexmedetomidine HCl Injection (Additional


789
Indication)

Paliperidone ER tablet 12 mg (Additional


790
Strength)
1) Triticum Vulgare Topical Cream      Each
791
100gm of cream contains:

Aqueous extract of Triticum Vulgare (dry


792
residue 200mg / 100ml) ..... 15gm

793 2-phenoxyethanol Eur. Ph.....1gm 

2) Triticum Vulgare Vaginal Pessary Each


794
3.5gm of vaginal pessary contains:

Aqueous extract of Triticum Vulgare (dry


795
residue 200mg/ 100ml) .....0.60gm

796 2-phenoxyethanol Eur. Ph.....0.04gm

797 Febuxostat Tablets 80mg / 120mg

Euphorbia Prostrata Dry Extract :100mg tablet


798
(addl. Indication)

Euphorbia Prostrata dry extract ethanolic


799
80%v/v[(35-70):1] cream 1% w/w

Lactobacillus Rhammnosus 1 billion cells +


800 Saccharomyces Boulardi 125 mg + Zinc
Enriched yeast 20 mg sachets & capsules 

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


801
topical solution

802 Diacerein Modified Release Capsule 100mg


Amlodipine 5mg/10mg/5mg/10mg/10mg +
Valsartan
803 160mg/160mg/160mg/160mg/320mg +
Hydrochlorothizide
12.5mg/12.5mg/25mg/25mg/25mg Tablets 

804 Maraviroc Tablets 150mg/300mg.

S (+) Etodolac 150/200/300mg + Paracetamol


805
500/500/500mg Tablets

Tacrolimus Granules for oral suspension 0.2/1


806
mg per sachet

807 Rifaximin Dispersible Tablet 200mg

Prednisolone Sodium Phosphate Orally


808
Disintegrating Tablet 10/15/30mg

809 Cinitapride Hydrogen Tartrate ER Tablet 3mg

810 Sevelamer Carbonate (Additional Indication)

Oxcarbazepine Tablets (Additional


811
Indication)150/300/600 mg

812 Ketoprofen plaster 30 mg (7cm X 10 cm)

813 Acipimox Capsules 250mg.

814 Amisulpiride SR Tablet 100 mg

Mycophenolate Sodium Enteric coated tablet


815
540 mg (Additional Strength)
Loteprednol etabonate 0.5% w/v +
816
Moxifloxacin 0.5% w/v opthalmic Suspension

817 Ropinirole ER tablet 2/4/8mg

Diclofenac Diethyl amine transdermal patch


818
100 mg/37.5 sq cm (Additional Strength)

Lornoxicam ER Tablet 8 mg (Additional


819
Strength)

820 Flurbiprofen plaster 20 mg (7cm X 10cm)

Carvedilol Phosphate ER tablet


821
10/20/40/80mg

Halometasone monohydrate  0.05% w/w +


822
Fusidic acid 2.00% w/w cream

Glimepiride 1/2 mg + Metformin 500 mg +


823
Atorvastatin 10 mg tablets

Betahistine Di hydrochloride CR capsule


824
24/32/48mg

825 Gefitinib tab 250mg (Additional Indication)

826 Midazolam Hcl Syrup 2mg/ml

827 Guaiphenasin Syrup 133mg/5ml


828 Balofloxacin Tablet 100mg

Xylometazoline 0.5 mg + Ipratropium 0.6 mg


829
Nasal spray

830 Doxofylline 400 mg + Ambroxol 30 mg Tablets

831 Ribavirin Capsules 200mg (Addl. Strength)

Formoterol 6 mcg + Mometasone furoate


832 100/200/400mcg Metered dose Inhaler & Dry
Powder Inhalation

833 Chlorohexidine Gluconate Gel 0.2%

834 Chlorohexidine Gluconate Mouth wash 0.1%

Ferrous ascorbate 100mg + Folic acid 1.1 mg


835 tablet and Omega-3-fatty acid 200mg capsules
combikit 

836 Sphaeranthus Indicus Extract Tablets 700mg

837 Febuxostat 40mg Additional Strength

Dexamethasone Intravitreal Implant 0.7mg (in


838
solid polymer drug delivery system)

Buclizine Hcl 25mg Tablet (Additional


839
Indication)
Pemetrexed Disodium 500mg/100mg Powder
840
for Injection (additional indication)

Levobetaxolol HCl Opthalmic Suspension


841
0.5%

Sarpogrelate Hydrochloride film coated Tablets


842
100mg

Propanol 1-ol 18gm + Ethanol 100%


843
45gm/100ml solution

Aliskiren 150/160mg + Valsartan 300/320mg


844
tablets

Piroxicam 20mg tab& Paracetamol 500mg tab


845
combikit  
Soybean oil 60gm + Triglycerides (medium
chain) 50gm + olive oil  purified fish oil 30gm +
dl-alpha-tocopherol 163-225mg + glycerol
846
(anhydrous) 25gm + Egg lecithin 12gm +
sodium hydroxide (to approx pH 8) + sodium
pleate 0.3mg emulsion for infusion in 100
Raltegravir (as Potassium) film coated Tablets
847
400mg 

848 Deflazacort Tablet 18mg (Additional Strength)

Pregabalin SR Tablet 75mg (Additional


849
Strength)

850 Rivaroxaban film coated Tablets 10mg

Cinnarizine 20mg + Dimenhydrinate 40mg


851
tablets  
852 Lipid Based Amphotericin-B  Gel 0.1%

Sodium Hyaluronate Injectable Gel 14mg/ml,


853
18mg/ml, 25.5mg/ml (Additional Strength)

854 Milnacipran Hcl 12.5mg (Addl. Strength)

855 Ropinirole 6mg ER Tablets (Addl. Strength)

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


856
Indication)

Pregabalin SR 75/150/300mg +
857
Methylcobalamin 1500mcg tablets  

Ivabradine Hcl Tablets 5/7.5mg (Additional


858
Indication)

Paracetamol Solution for Infusion (10mg/ml) in


859
50ml (Additional Packsize)

Ketorolac Tromethamine Ophthalmic Solution


860
0.45%

Cytarabine Injection 100mg Additional


861
Packsize (20ml)

Olopatadine Hcl Nasal Spray 0.6% w/w


862
(Additional Indication)
Sodium chloride 6.80gm + Potassium chloride
0.30 gm + Calcium chloride dihydrate
0.37gm  + Magnesium chloride  hexahydrate
863
0.20gm + Sodium acetate trihydrate 3.27gm +
L-malic acid 0.67gm in 1000ml solution for
infusion  
Chemically Modified Sodium Hyaluronate
864 and           Caboxymethylcellulose Absorbable
Adhesion Barrier.

Lornoxicam 4mg/4mg + Thiocolchicoside


865
4mg/8mg tablets 

Cefixime 100mg/200mg + Cloxacillin


866
500mg/500mg tablets 

Celecoxib Mouth Dissolving Tablet


33 50/100/200 mg
Propofol 2% w/v Injection
34 (additionalStrength)
Spironolactone 25mg + Furosemide 20mg
tablets

35
Olopatadine5mg + Ambroxol30mg tablets 
36
Methylcobalamin750mcg +
Pregabalin75/150mg + Vitamin B61.5mg +
Folic acid0.75mg + Benfothiamine7.5mg
capsules
37
Calcium acetate 435mg + Magnesium
carbonate 235mg tablets

38
Dicyclomine2.5mg + Dried Aluminimum
Hydroxide200mg + Light Magnesium
Oxide100mg + Simethicone 20mg per 5ml
suspension.

39
Sertaconazole 2% w/v+ Zinc Pyrithione 1%
40 w/v Shampoo
Faropenam Sodium Extended Release
Tablet 225/300/450 mg

41
Amlodipine5mg + Ramipril10mg/5mg
42 Tablets (additional strength)
Doxofylline MR Tablet 650 mg
43
Lidocaine7.5mg + Prilocaine2.5mg per
44 acutation spray
Pramipexole Di HCl monohydrate ER
45 Tablet 0.375/0.75/1.5/3/4.5 mg
Drosperinone 3mg + Ethinyl
Estradiol0.02mg tablets 
46
Miglitol 25 mg + Metformin 500mg tablets
47
Propranolol 40mg (SR Pellets) + Fluarizine
48 5mg/10mg capsules 
Citicholine 500mg + Piracetam 400mg
49 Tablets 
Diclofenac 50mg + Chlorzoxazone500mg
Tablets
50
Mecobalamin 750 mcg + Pyridoxine 1.5mg
+ Nicotinamide 45 mg + Benfotiamine
150mg Tablets
51
Etoricoxib 1%+ Menthol 5% Spray 
52
Pantoprazole 40mg + Cinitapride (ER) 3mg
Capsules
53
Atorvastatin 20mg + Ramipril 2.5mg/5mg
54 Capsules 
Lamotrigine Orodispersible Tablet 12.5
55 mg(additional strength)
Trabectedin powder for Conc. solution for
infusion (Additional Indication)

56
Lornoxicam 8mg/8mg + Thiocolchicoside
57 4mg/8mg Tablets 
Diclofenac sodium SR Tablet 150 mg

58
Magnesium Valproate CR Tablet 200/
59 300/400/ 500 mg (additonal strength)
Lidocaine 2.5% w/w+Prilocaine 2.5% w/w
60 Gel
Nicotinic Acid and Laropiprant Modified
Release Tablets: Nicotinic Acid.........1000
mg

Laropiprant...........20mg 

61
Pantoprazole Mouth Dissolving Tablet
20/40 mg
62
Praziquntel 175mg + Pyrantel 504mg +
63 Febental 525mg Tablets 
Difluprednate Opthalmic Emulsion 0.05%
64 w/v
Tolperisone Hcl SR 450mg Tablets
65
S(-)Metoprolol 25mg/50mg (ER) +
Atorvastatin (IR)10mg tablets 
66
Atorvastatin10mg + Ramipril 5mg + Aspirin
(EC pellets) 75mg/150mg + Metoprolol (ER
tablets) 25mg Capsules
67
Lamotrigine 25mg Modified Release
68 Tablet (Addl. Strength)
Imatinib Mesylate 100/400mg Tablets
(Addl. Indication)
69
Azithromycin SR Granules for Oral
70 Suspension 1gm (Addl. Strength)
Gemfibrozil Capsule USP & Gemfibrozil
Tablet USP 200mg/600mg (Addl.
Indication)
71
Ibuprofen 400mg + Chlorzoxazone 500mg
Tablets
72
Doxophylline (SR) 400mg/800mg +
73 Montelukast 10mg/10mg Tablets 
Dronedarone( as Hydrochloride) film
coated tablet .... 400 mg. 

74
Dosulepin Hcl Tablet 25mg/75mg
75 (Additional Indication)
Prasugrel (as Hydrochloride) film coated
tablet ....5 mg / 10mg. 

76
tablet ....5 mg / 10mg. 

76
Tofisopam uncoated tablet JP... 50/100mg
77
78 Zotepine tablet ....25/50/100mg
Armodafinil uncoated
tablet ..50/150/250mg

79
Indacaterol ( as Maleate ) Inhalation
Powder Hard Capsules ….. ...150/300mcg

80
Ranolazine ER Tablets 750mg (Additional
81 Strength)
Tacrolimus Capsules 3mg (Additional
82 Strength)
Cefixime 100mg/200mg + Ofloxacin
83 100mg/200mg Tablets
Liquid paraffin 6% + White soft paraffin
15%w/v Cream 

84
Levosimendan Injection 2.5mg / ml

85

FOR DCGI APPROVAL CONTACT shahbaz@meherpharma.com, Mob-0091-9818131498, B-6/151, Sec-3


Approvals From 1-1-2006 To 12-2-2010

Pharmacological Classification       Date of Approval

Antibiotic 6/1/2006

For hypertension 17/01/2006

For BPH 19/01/2006

For osteoporosis 1/2/2006

For hypertension 3/2/2006

For BPH 6/2/2006

For chronic obstructive bronchitis 6/2/2006

 For ophthalmic use. 6/2/2006

For OA, RA & ankylosing spondylitis 6/2/2006

  For neovascular (wet) age related macular


6/2/2006
degeneration.
For persistent Asthma 6/2/2006

For hypertension 7/2/2006

For bronchial asthma & COPD. 8/2/2006

For influenzae   13/02/2006 

For replacement therapy in males with Testosterone


15/02/2006
deficiency.

Anti-biotic 16/02/2006

Anti-fungal 21/02/2006

For induction & maintenance of anaesthesia. 22/02/2006

NSAID 22/02/2006

For HIV-1 infection 23/02/2006

Anti-epileptic 24/02/2006

For ADHD 27/02/2006


For OA & RA 28/02/2006

Ophthalmological diagnostic agent 2/3/2006

Anti-biotic 3/3/2006

For leg ulcer, diabetic ulcer etc. 16/03/2006

Anti-AIDS 20/03/2006

For reduction of unwanted facial hair in women. 22/03/2006

Chronic congestive heart failure 22/03/2006

For chronic pulmonary infection cystic fibrosis. 22/03/2006

For constipation & hepatic encepthalopathy 28/03/2006

As approved earlier. 30/03/2006

For hypercholesterolaemia 30/03/2006

For bronchial asthma & COPD. 30/03/2006


Acute mania & mixed episode in bipolar-I disorder. 4/4/2006

For pain 5/4/2006

For GERD 8/4/2006

For Prophylaxis of influenzae in adult and children


24/04/2006
>14 years of age

Anti-HIV in adults. 24/04/2006

Angina Pectoris 24/04/2006

For hypertension 24/04/2006

 Acne vulgaris 10/5/2006

For Asthma & COPD 10/5/2006

  For insomnia 10/5/2006

Anti-hypertensive 18/05/2006

Same as approved. 19/05/2006


Anti-epileptic 19/05/2006

For Asthma 19/05/2006

For GERD   22/05/2006 

For hypertension 24/05/2006

For production cough 24/05/2006

Same as approved. 25/05/2006

Same as approved. 25/05/2006

For diagnostic use 31/05/2006

For Ophthalmic use 2/6/2006

For Ophthalmic use 2/6/2006

For hypertension 5/6/2006

For dermatoses 6/6/2006


For deep vein thrombosis 8/6/2006

For peritoneal dialysis 8/6/2006

Anti-epileptic 8/6/2006

Anti-biotic 8/6/2006

Anti-HIV 8/6/2006

For allergic conjunctivitis 8/6/2006

For iron deficiency anemia 8/6/2006

For atopic dermatitis 15/06/2006

As loading dose for prevention of in-stent restenosis


22/06/2006
in PCI

For otitis media 27/06/2006

Anti-hypertensive 28/06/2006

As appetite stimulant 28/06/2006


Anti-biotic 5/7/2006

For reduction of IOP 5/7/2006

Irritable bowel syndrome 6/7/2006

For overactive bladder with urge urinary


6/7/2006
incontinence urgency & urinary frequency

For insomnia 10/7/2006

For chronic iron overload due to blood transfusion 10/7/2006

For vitamin C deficiency 12/7/2006

For HIV infection 12/7/2006

For productive cough 20/07/2006

Anti-biotic 20/07/2006

Same as approved 20/07/2006

For plaque psoriasis 20/07/2006


For OA 26/07/2006

For open angle glaucoma 27/07/2006

For spasticity 1/8/2006

For schizophrenic disorder 1/8/2006

For psychotic disorder 1/8/2006

For OA, RA acute pain & primary dysmenorrhoea 1/8/2006

For HIV-1 infection 1/8/2006

To promote weight gain 4/8/2006

Mucolytic 8/8/2006

Anti Diabetic 8/8/2006

For wounds of various etiology 8/8/2006

For SAR, PAR & Chronic idiopathic urticatia  9/8/2006


For Panic disorder with or without agoraphobia 9/8/2006

For RA, OA & ankolysing spondylosis 10/8/2006

For angina & Hypertension 10/8/2006

For prevention of acute coronary syndrome in


10/8/2006
patients with CAD prophylaxis against stroke

For P. Falciparam malaria 10/8/2006

 As Approved 10/8/2006

For schizophrenia in adults 11/8/2006

Antibiotic 11/8/2006

Anti HIV 11/8/2006

For mixed infection of skin  17/08/2006

Anti Cancer 21/08/2006

Ant- diabetic 22/08/2006


For abdominal spasmodic pain, colics of
22/08/2006
hepatobilliary track, abdominal colics

For neck-shoulder orm  syndrome scapula hum oral


23/08/2006
per arthritis and low back pain

For abdominal pain & tinnitus in adult 23/08/2006

For metastatic breast cancer 23/08/2006

Anti biotic 28/08/2006

For infections diarrhea in adults 28/08/2006

For skin & skin structure infection & intra abdominal


28/08/2006
infection

Anti HIV 29/08/2006

Antibiotic 29/08/2006

Anti asthratic 29/08/2006

 Anti asthmatic 29/08/2006

For HIV Infection 29/08/2006


FOR GERD 30/08/2006

Antibiotic 30/08/2006

Antibiotic 30/08/2006

Antibiotic 30/08/2006

For type-I & Type-2 Diabetes 30/08/2006

Anti Cancer 30/08/2006

For  peptic ulcer, GERD & Zollinger Ellison


30/08/2006
Syndrome

For chronic hepatitis B infection 30/08/2006

For chronic hepatitis B infection 30/08/2006

For chemotherapy induced nausea & vomiting 30/08/2006

For essential hypertension 30/08/2006

Antibiotic 30/08/2006
Antibiotic 30/08/2006

Antibiotic 30/08/2006

For visceral leishmaniasis (Kalaazar) 30/08/2006

Antibiotic 31/08/2006

For anxiety 20/09/2006

For allergic conjunctivitis 22/09/2006

For prostatitis 26/09/2006

As hacmostatic agent in dental surgery 28/09/2006

For pain in post operative & post traumatic cases 28/09/2006

  As Approved 10/10/2006

For Asthma & COPD 14/10/2006

1/11/2006
For atropic viginitis 2/11/2006

For GERD 13/11/2006

 Antibiotic 14/11/2006

Antibiotic 22/11/2006

 Anti hypertensive 23/11/2006

Anti asthmatic 28/11/2006

For GERD 28/11/2006

Anti hypertensive 30/11/2006

 As Approved 1/12/2006

 As Approved 1/12/2006

 As Approved 1/12/2006

For cervical ripening, prevention of post partum


haemorrhage & First trimester of aboration with 8/12/2006
mifepristone
Anti HIV 12/12/2006

For IBS 12/12/2006

Antibiotic 13/12/2006

For acute Musculoskeletal pain 14/12/2006

For diarrhea 15/12/2006

For naturopathic pain & partial Seizures 15/12/2006

  As Approved 21/12/2006

Chemotherapy induced nausea & vomiting 12.01.07

Edema Associated with congestive heart failure &


17.01.07
hypertension

SeAsonal allergic rhinitis & chronic idiopathic


19.01.07
urticaria

For pulmonary osterial hypertension 23.01.07

As approved 23.01.07
As approved 29.01.07

Corticosteroid responsive dermatomes 02.02.07

For insomnia 07.02.07

For anal fissure 07.02.07

For moderate to severe pain 07.02.07

For emergency contraceptive 07.02.07

For gAstric ulcer, duodenal ulcer, Z. E Syndrome,


07.02.07
GERD

For lower respiratory tract infection in adult 08.02.07

For testosterone deficiency (i) primary


hypogonadism (ii) Hypogonadotropine 08.02.07
hypogonadism

As approved 08.02.07

For steroid responsive inflammatory ocular condition 14.02.07

As approved 14.02.07
As approved 15.02.07

For short term treatment of pain due to post


19.02.07
operative and post traumatic cAses

Angina pectoris in adults 20.02.07

As approved 20.02.07

Essential hypertension 21.02.07

Multiple sclerosis 21.02.07

As approved 22.02.07

For hypertension 23.02.07

Allergic nAsal inflammation hives, itching with skin


26.02.07
diseAses

Essential hypertension 26.02.07

For Duodenal ulcer, G.U, Z.E.S. & GERD 26.02.07

As approved 27.02.07
For hypertension 27.02.07

As approved 01.03.07

As approved 05.03.07

For Hyperprolactinemia 06.03.07

Antibiotic (For adult use only) 07.03.07

For acne 08.03.07

Vasomotor symptoms Associated with menopause 16.03.07

As approved 16.03.07

Chemotherapy induced nausea & Vomiting 20.03.07

Acute Exacerbation of chronic bronchitis 21.03.07

Asthma, COPD, Bronchitis 21.03.07

Acute Musenlosleteal pain 21.03.07


Dermatophyte infection of skin such As T-corporis,
22.03.07
T-c, T-Pedis

For angina pectoris 23.03.07

For control of fertility 23.03.07

As approved 28.03.07

For HIV infection 02.04.07

For diabetic neuropathy 02.04.07

For induction of anesthesia 04.04.07

For combined hypertipidemia 04.04.07

Atopic dermatitis (eczema) inflammatory and allergic


04.04.07
skin reaction

As approved 10.04.07

Antibiotic 10.04.07

For induction of ovulation in anovulatory infertility


10.04.07
( additional indication)
As approved 10.04.07

As approved 10.04.07

For G.I. Stromal tumor, advanced renal cell


10.04.07
carcinoma

Antibiotic 20.04.07

Prevention of post-operative nausea & vomiting


24.04.07
(additional indication)

As approved 24.04.07

For osteoporosis in postmenopausal women 01.05.07

For allergic rhinitis & chronic urticaria 08.05.07

As approved 07.05.07

For osteoarthritis & rheumatoid arthritis 09.05.07

For G.I. problem like fanatical dyspepsia, nausea,


10.05.07
vomiting and diabetic gAstroperisis

For Obese Patients BMI≥ 30kg/m2 or overweight


patients BMI≥ 27kg/m2 with Associated risk factors 11.05.07
such As type-I diabetes or dyslipidemia
For constipation 14.05.07

For essential hypertension 16.05.07

For apthous ulcers in people with normal immune


16.05.07
system

For transfusion dependent anemia due to


myalodysplastic syndrom Associated with deletion 16.05.07
5q cytogenic abnormality

For surgical prophylaxis (additional indication) 18.05.07

For Osteoarthritis  rheumatoid arthritis 21.05.07

For essential hypertension 21.05.07

As adjunctive therapy in partial onset seizures in


adults with epilepsy when oral administration is 21.05.07
temporarily not feasible

For abnormality of vibration sense and abnormal


change in heart rate associated with diabetic 25.05.07
peripheral neuropathy

As approved 25.05.07

As an aid to smoking cessation treatment in adults 29.05.07

Conjunctivitis 06.06.07
For seasonal & perennial allergic rhinitis in adults,
08.06.07
adolescents aged ≥ 12 years

Antibiotic 08.06.07

For acne 08.06.07

For hypertension 08.06.07

As approved 08.06.07

As approved 08.06.07

For Duodenal ulcer, Gastric ulcer & GERD 13.06.07

For Chronic Angina 14.06.07

For control of generalized toni-clonic and treatment


& prevention of seizures occurring during or 14.06.07
following neurosurgery

For BPH in men with enlarged prostate 14.06.07

For bacterial meningitis in children 14.06.07

For prevention of oral hemorrhage in anticoagulant


15.06.07
treated patients undergoing oral surgery
As approved 15.06.07

For BPH with overactive bladder 15.06.07

For duodenal ulcer, gastric ulcer & GERD 15.06.07

For duodenal ulcer, gastric ulcer and GERD. 13-06-2007.

For bacterial meningitis in children. 14-06-2007.

For control of generalised tonic-clonic (grand-mal)


and prevention and treatment of seizures occuring 14-6-2007.
during or following neurosurgery.

For prevention of oral hemorrhage in anticoagulant


15.6.2007.
treated patients undergoing oral surgery.

For asthma, rheumatoid arthritis when


15-06-2007.
glucocorticosteriod therapy is warranted.

For BPH with overaction bladder in Adults only. 15-06-2007.

For gastric ulcer, duodenal ulcer and GERD. 18-6-2007.

For irritable bowel syndrome 19-06-2007.

For RTI caused by susceptible organisms in adults. 05-07-2007.


For symptomatic relief of dry ticklish and
06-07-2007.
unproductive coughs in children above 1 years.

For adjunctive therapy to improve glycemic


control  in patients with Type-II diabetes mellitus,
who have not achieved adequate glycemic control 06-07-2007.
with Metformin, a sulfonyl urea or a combination of
metformin and sulfonylurea.

For reduction of post-operative inflammatory


11-07-2007.
conditions of the eyes.

For post-operative steriod responsive inflammatory


ocular conditions when ocular bacterial infections or 11-07-2007.
a risk of bacterial infection exists.

For post-operative steriod responsive inflammatory


ocular conditions when ocular bacterial infections or 12-07-2007.
a risk of bacterial infection exists.

For fungal infection of skin associated with


12-7-2007.
inflammation.
(i). First line treatment of advanced gastric cancer in
combination with platinum based regimen.(ii).
Treatment of patients with locally advanced or
16-07-2007.
metastatic breast cancer in combination with
docetaxel following failure of cytotoxic
chemotherapy.
For treatment of pulmonary T.B only in patients co-
infected with HIV. (It should never be used as a
16-07-2007.
substitute to Rifampicin in T.B patients without HIV
co-infection).
In combination with capecitabine it is indicated in
patients with advanced or metastatic breast cancer
whose tumour overexpress HER2 and who have 24-07-2007.
received prior therapy including trastuzumab.

For the treatment of allergic rhinitis and chronic


25-07-2007.
urticaria.

For improvement of neurologic symptoms, disorders


of activitis of daily living and functional disorder 26-07-2007.
associated with acute ischemic stroke.

For management of painful conditions in post-


operative cases, rheumatoid arthritis and 30-07-2007.
osteoarthritis. 
For LRTI, URTI and UTI. 30-07-2007.

As approved. 30-07-2007.

As approved. 30-07-2007.

For rotavirus diarrhoea in children. 31-07-2007.

For advanced renal cell carcinoma. 31-07-2007.

For diabetic neuropathy. 31-07-2007.

For plaque psoriasis. 01-08-2007.

As Approved 01-08-2007.

For duodenal, gastric ulcer, GERD, and erosive


1/8/2007
esophagitis,

As approved 17-08-2007.

For first line treatment of metastatic colorectal


22-08-2007.
cancer in combination with calcium folinate.

For the treatment of patients with mantle cell


lymphoma who have received at least one prior 05-09-2007.
therapy.
As approved. 06-09-2007.

For serious abdominal infection. 06-09-2007.

For temprory relief of dryness, irritation burning,


stinging, grittiness or foreign body sensation caused 18-9-2007.
due to environmental factors.

As approved. 25-09-2007.

As approved. 26-09-2007.

As an adjunctive therapy for the management of


obesity including weight loss and maintenance of
26-09-2007.
weight loss in pateints whose BMI is 30Kg/m2 or
higher.

For adult patients with infection caused susceptible


micro-organisms including S.aureus viz UTI, upper 27-09-2007.
and lower RTI and gonoccoccal urethritis.

For diagnostic use in echocardiography doppler of


28-09-2007.
macrovasculature an doppler of microvasculature.

For chemotherapy induced nausea and vomiting 28-09-2007.

For UTI, URTI and LRTI and gonococcal urethritis. 05-10-2007.

For adult patients with infection caused by


susceptible microbs,including s.aureus.(e.g- 5/10/2007
UTI,Upper&lower RTI & gonococcal urethrities)

For cardiopulmonary resuscitation in the event of


cardiac arrest related to ventricular fibrilation 05-10-2007.
resistant to external electric shock.
For osteoporosis in men at high risk of fracture. 08-10-2007.

For infected wounds and ulcers. 09-10-2007.

(i)             (i) As monotherapy in partial onset


seizures with or without secondary generalisation in
patients with 16 years of age with newly diagnosed 09-10-2007.
epilepsy. (ii)        As adjunctive therapy in myoclonic
seizures in adults and adolescents from 1

For drug resistant malaria. 10-10-2007.

For breast cancer after failure of combination


chemotherapy for metastatic disease or relapse 11-10-2007.
within 6 months of adjuvant chemotherapy.

For mild to moderate hypertension. 15-10-2007.

For treatment of patients with both hypertension and


15-10-2007.
hypercholesterolemia.

As approved. 15-10-2007.

For inflammation after ocular surgery and where a


16-10-2007.
risk of bacterial ocular infection exists.

For diabetic neuropathy. 16-10-2007.

For diarrhoea of mixed infection in adults. 18-10-2007.

For adult patients with diabetic neuropathy. 18-10-2007.


For osteoporosis and calcium deficiency state. 23-10-2007.

For anxiety disorder associated with depression. 29-10-2007.

For relief of signs and symptoms of osteoarthritis,


30-10-2007.
rheumatoid arthritis.

For acute uncomplicated lower urinary tract infection


(simple cystitis), complicated lower UTI, acute 30-10-2007.
exacerbation of chronic bronchitis.

 For management intermittent claudication. 30-10-2007.

As Approved 30-10-2007.

As adjunct to diet and exercise to improve glycemic


30-10-2007.
control in patients with type-II diabetes.

For adult with Type-II diabetes mellitus where simple


drug therapy, diet and exercise do not result in 31-10-2007.
adequate glycemic control.

For atopic dermatitis. 31-10-2007.

For Vitamins and mineral deficiency states. 31-10-2007

For diabetic neuropathy 13-11-2007

For treatment of psoriasis 19-11-2007


For surgical & hygenic hand disinfection. 19-11-2007

          -do- 19-11-2007

As Approved 20-11-2007

As Approved 21-11-2007

For the treatment of atopic dermatitis 21-11-2007

As Approved 26-11-2007

For management of pain in patients using opioid


26-11-2007
analgesics.

As Approved 28-11-2007

For Vitamins and mineral deficiency patients. 29-11-2007

For diabetic neuropathy 29-11-2007

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

For reduction of post-operative inflammatory


29-11-2007
conditions of eye ,when bacterial infection exists.
For treatment of diarrhoea of mixed infection in
29-11-2007
adults patients.

Post-menopausal osteoporosis. 6-12-2007.

For treatment of essential hypertention. 6/12/2007

For depression and schizophrenia in adults. 6/12/2007

For drug resistant P.falciparum malaria infection. 6/12/2007

For the treatment of adult patients with peripheral


10/12/2007
neuropathy.

For adult patients prone to intrabdominal bacterial


11/12/2007
infection & Antibiotic associated diarrhoea

For the treatment of adult patients with upper&lower


11/12/2007
RTI, Skin & Skin structure infection

For the temporary relief of cough due to throat


11/12/2007
irritation, sneezing & ruunning nose.

For Short-term treatment of mild to moderate pain,


when oral administration is inappropriate(i.e after 11/12/2007
dental surgery)

For erectile dysfunction in adult men. 11/12/2007

For comobid depression and anxiety disorder. 12/12/2007


For bronchial asthama & COPD in adult patients,
31-12-2007
when oral therapy is in approriate.

For temporary relief from pain, swelling &


29.11.07
inflammation due to musculoskeletal disorder

For improvement of  parantial hyperphemia in


diabetis mellitus only. When diet and/or exercise or
oral, hypoglyceamic drug or insulin preparation in 28.12.07
addition to diet and or exercise do not result in
adequate glycemic control.

Same as Approved 31.01.08

Same as Approved 02.01.08

For the treatment of steroid responsive fungal


04.01.08
infections including eczema and psoriasis

For the treatment of disturbance of consciousness


resulting from head injuries, brain operation and 04.01.08
acute stage of cerebral infarction in adults only

For Parkinson's Disease 08.01.08

For the treatment of burns and wound infections 04.01.08

For the treatment of gastroesophageal reflux


disease and functional inconveniences of the 04.01.08
gastrointestinal motility

For the treatment of adult patients with HIV infection 07.01.08

For the treatment of Urinary tract infections,


respiratory tract infections, biliary tract infections in
07.01.08
adult patients prone to antibiotic associated
diarrhoea
Same as Approved 07.01.08

For the treatment of lower respiratory tract infection


08.01.08
caused by pseudomonas aeruginosa

Same as approved 08.01.08

For the prophylaxis of surgical site infections


15.01.08
following elective colorectal surgery

As an adjunct to diet and exercise to improve


glycemic control in patients with type-II diabetes 18.01.08
mellitus

For the treatment of dyslipidemia associated with


atherosclerotic arterial disease with risk of
18.01.08
myocardial infarction, stroke or peripheral vascular
disease

For the treatment of acute migraine 22.01.08

Same as Approved 24.01.08

For serious CRTI, uncomplicated and complicated


UTI, Uncomplicated  skin & skin structure, infection
24.01.08
acute exacerbation of chronic bronchitis &
intraabdominal infection.

Ovarian cancer, non-small cell lung cancer and AIDS


22.01.08
related Kaposis Sarcoma

For hepatocellular Carcenoma 22.01.08

For prophylaxes and treatment of both influenza A &


B in adults and children (greater than or equal to 5 22.01.08
years)
For the prophylaxis of acute organ rejection in
23.01.08
patients receiving allogeneic hepatic transplantation

For the treatment of osteoporosis in post-


23.01.08
menopausal women

For short term treatment of pain due to post


23.01.08
operative and post traumatic cases

For the treatment of uncomplicated and complicated


UTI, uncomplicated skin and skin structure
25.01.08
infections, and complicated intra-abdominal
infections

Same as Approved 24.01.08

For the treatment of acute pain in adults 24.01.08

Same as Approved 24.01.08

For the treatment of infection caused by sensitive


organisms viz. lower RTI, complicated UTI, 24.01.08
Septicemia, bacteremia

For the treatment of Type-II diabetes associated with


25.01.08
mixed dyslipidemia

For the treatment of acne vulgaris 28.01.08

For the treatment of bronchial asthma 28.01.08

For the treatment of patients with mild to moderately


severe dementia of the Alzheimer type and dementia 28.01.08
associated with Parkinsons disease
For the treatment of complicated skin and skin
structure infections and for staphylococus aureus 28.01.08
bloodstream infections (bacteremia)

For the relief of persistent dry irritating cough in adult


28.01.08
patients only

For the treatment of acute colicky pain in adults 28.01.08

For decrease of intraocular pressure in patients with


open angle glaucoma or ocular hypertension, who
28.01.08
are insufficiently responsive to topical beta blockers
or prostaglandin analogues

For RTI, SRS of tissue infection, bons & joint


infection, ENT infection in adults prone to antibiotic 30.01.08
associated diarrhoea

For RTI, SRS of tissue infection, bons & joint


infection, ENT infection in adults prone to antibiotic 31.01.08
associated diarrhoea

For the treatment of lower RTI, skin & soft tissue


bone & joint infections, ENT infections in adult 30.01.08
patients prone to antibiotic associated diarrhoea

As 3rd line treatment of sever cases of COPD when


monotherapy and second line therapy with two drugs 31.01.08
do not respond adequately

For the treatment of patient with both essential


28.01.08
hypertension and hypercholesterolemia

For allergic rhinitis & chronic urticaria 28.01.08

Same as Approved 28.01.08

Treatment of acute coronary syndrome (ACS) with


28.01.08
and without ST-segment elevation
For remission of acute symptoms of chronic
29.01.08
pancreatitis and post-operative reflux esophagitis

For intradermal implantation and facial soft tissue


30.01.08
agumentation

For the treatment of patients with chronic cholestatic


30.01.08
liver disease

For the extended treatment of symptomatic venous


thromboembolism (VTE) proximal deep thrombosis
30.01.08
(DVT) and/or pulmonary embolism (PE), to reduce
the recurrence of VTE in patients with cancer

For the topical treatment of bacterial and fungal


30.01.08
infections

For adjunctive therapy to improve glycemic control in


patients with type-II diabetes mellitus, who have not
achieved adequate glycemic control with metformin, 30.01.08
a sulfonylurea or a combination of metformin and a
sulfonylureas
For the symptomatic treatment of acute pain and
inflammation in patients with osteoarthritis, 30.01.08
rheumatoid arthritis and ankylosing spondylitis

As adjunctive therapy in the treatment of partial


30.01.08
seizures of epilepsy

For moderate to severe Alzheimer's disease 31.01.08

For carcinoma of the stomach, colon, rectum, breast,


31.01.08
uterine, cervix and bladder

For use for patients being treated by hemodialysis 31.01.08

1:- In newly diagnosed high-grade malignant glioma


patients as an adjunct to surgery and radiation. 2:- In
31.01.08
recurrent glioblastoma multiforme patients as an
adjunct to surgery
For the treatment of irritable bowel syndrome 31.01.08

As adjunct to rest and physical therapy for relief of


muscle spasm associated with acute painful 31.01.08
musculoskeletal conditions

For the topical treatment of the superficial mycosis


31.01.08
like dermatophytosis

Same as Approved 31.01.08

For the treatment of overactive bladder with


symptoms of urge urinary incontinence, urgency and 31.01.08
frequency

For the treatment of respiratory tract infection, skin


and soft tissue infections & antibiotics associated 31.01.08
diarrhoea in adult patients

For steroid responsive dermatoses associated with


31.01.08
superficial fungal infection of skin

For the treatment of allergic rhinitis in adults only 31.01.08

For short term intermittent treatment of moderate to


severe melasma of the face in the presence of
31.01.08
measures for sun avoidance including use of sun
screen

For the treatment of common cold and cough


31.01.08
associated with fever

For treatment of painful inflammatory conditions


31.01.08
associated with gastroduodenal ulcers

As third line treatment of severe cases of COPD,


when monotherapy and second line therapy with two 31.01.08
drugs do not respond adequately
For the treatment of irritable bowel syndrome 31.01.08

For the treatment of serious infection caused Gram-


Ve bacteria including LRTI, UTI, where commonly
31.01.08
used anti bacterial agent may be infective because
of bacterial resistance

Same as Approved 20.02.08

For the treatment of amoebiasis, urogenital


21.02.08
trichomoniasis & giardiasis

for the additional indication "acute manic episode


21.02.08
associated with bipolar disorder

additional Strength (it should not be used routinely


because of increased risk of adverse events.  It
25.02.08
should be reserved for patients who are considered
to be at higher risk after careful risk assessment

For the treatment of haemorrhoid 29.02.08

For the treatment of osteoarthritis & rheumatoid


07.03.08
arthritis

For lowering of IOP in patients with open angle


07.03.08
glaucoma occular hypertension

1:- For repigmentation of idiopathic vitiligo alongwith


phototherapy. 2:- For symptomatic control of severe,
07.03.08
recalcitrant, disabling psoriasis in conjunction with
phototherapy

Same as Approved 11.03.08

For the treatment of bronchial asthma & COPD in


12.03.08
adults
For the treatment of steroid responsive dermatoses
associated with superficial fungal infections of the 12.03.08
skin

Same as Approved 12.03.08

For gastric ulcer, duodenal ulcer, and GERD 12.03.08

Same as Approved 19.03.08

Same as Approved 31.03.08

Same as Approved 20.03.08

For the treatment of essential hypertension 24.03.08

For symptomatic relief of bronchospasm in bronchial


26.03.08
asthma and chronic bronchitis

For the symptomatic relief of bronchospasm in


26.03.08
bronchial asthma & chronic bronchitis

For the treatment of mild to moderate psoriasis 28.03.08

For short term use in acute painful condition in


28.03.08
adults only

 Oral contraceptive in women 28.03.08


For symptomatic treatment of acute rhinosinusitis 28.03.08

For the treatment of mild to moderate pain, such as


28.03.08
dental pain, dysmenorrhoea & musculoskeletal pain

For the treatment of pain and inflammation


31.03.08
associated with cataract surgery

For pain management in patients suffering with


31.03.08
osteoarthritis of the knee, hip, shoulder and ankle

For additional indication "advanced gastric


adenocarcinoma, locally advanced squamous cell
carcinoma of head & neck,  Harmone refraetory 31.03.08
metastatic prostrate cancer, locally advanced or
metastatic breast cancer

For peripheral neuropathy 31.03.08

Same as Approved 01.04.08

For short-term treatment of hypertension when oral


07.04.08
therapy is not feasible or not desirable

For the treatment of acute pain in adults 08.04.08

For the treatment of adult patients with osteoarthritis


11.04.08
of knee and or hip joints

Same as Approved 16.04.08

For the treatment of irritable bowel syndrome 10.04.08


Treatment of cutaneous leishmaniasis 16.04.08

As an antimicrobial barrier for management of partial


thickness burns, incisions, skin grafts, donor sites,
16.04.08
lacerations, abrasions and Stage I-IV dermal ulcers
(vascular, venous, pressure and diabetic)

For the treatment of adult patients with osteoarthritis


21.04.08
of knee and hip joints

For focal spasticity, including the treatment of arm


symptoms associated with focal spasticity in 22.04.08
conjunction with physiotherapy

For the treatment of systemic candidiasis, mucosal


candidiasis, prevention of fungal infections in 22.04.08
patients with malignancy

In combination with dexamethasone for the


treatment of multiple myeloma patients who have 22.04.08
received at least one prior therapy

As an adjunct to diet & exercise to improve glycemic


28.04.08
control in patients with type-two  diabetes mellitus

For short term treatment of errosive esophagitis


28.04.08
when patients are unable to take the oral formulation

For the treatment of RA in children 5 years of age


28.04.08
and above

For control of serum phosphorus in patients with


28.04.08
chronic kidney disease on dialysis

For the treatment of gastric ulcer, duodenal ulcer,


28.04.08
Zollinger Ellison Syndrome and GERD

For the treatment of gastric ulcer, duodenal ulcer,


28.04.08
Zollinger Ellison Syndrome and GERD
For the treatment of community acquired
pneumonia, acute exacerabation of chronic
29.04.08
bronchitis, uncomplicated skin and skin structure
infection, Pharyngitis/tonsillitis

management of fibromyalgia syndrome 29.04.08

Same as Approved 08.05.08

For the treatment of essential hypertension in adult


patients whose blood pressure is not adequately 08.05.08
controlled on monotherapy .

For diabetes insipidus and noctural emuresis 08.05.08

Same as Approved 14.05.08

For alcoholic liver disease, drug induced hepatitis 14.05.08

For the treatment of plaque psoriasis 14.05.08

For the topical treatment of acne vulgaris 14.05.08

Same as Approved 14.05.08

For use as a surgical aid in anterior segments


procedure including catract extraction & intra-ocular 14.05.08
lens implantation

For the treatment of GERD, gastric and duodenal


14.05.08
ulcer, Zollinger-Ellison syndrome
For coexisting essential hypertension &
22.05.08
hyperlipidemia

For the treatment of adult patients with major


22.05.08
depressive disorder

For hypertension in patients whose blood pressure is


28.05.08
not adequately controlled in monotherapy

For essential hypertension in adult patients whose


blood pressure is not adequately controlled on 28.05.08
monotherapy

For the treatment of secondary hyperthyroidism in


29.05.08
patients with chronic kidney disease on dialysis

For the treatment of adult patients with chronic


29.05.08
obstructive pulmonary disease and bronchial asthma

For the treatment of gastric ulcer and management


of gastric mucosal lesions (erosion, hemorrhage,
02.06.08
redness or edema) associated with acute gastritis or
acute exacerbation of chronic gastritis

For the relief of pain and inflammation in patients


02.06.08
with rheumatoid arthritis and osteoarthritis

For the treatment of adult patients with signs &


02.06.08
symptoms of acute painful conditions

For intradermal implantation and facial soft tissue


03.06.08
augmentation

For invasive fungal infection in patients who are


refractory to or intolerant of conventional 03.06.08
amphotericin B therapy

For the treatment of Gastroeasophageal Reflux


Disease (GERD) in patients not responding to 09.06.08
dexrabeprazole alone
For acute low back pain & other musculoskeletal
11.06.08
painful and inflammatory condition in adults

For the treatment of lower respiratory tract infection


24.06.08
in children

Same as Approved 24.06.08

For the treatment of chronic stable anginapectoris in


patients with normal sinus rhythm who have a 03.07.08
contraindication or intolerance for Beta-blockers

Indicated to meet daily requirement of nitrogen


(amino acids), energy (glucose) for patients needing 08.07.08
parentral Nutrition

Same as Approved 08.07.08

For the treatment of RTI, UTI and abdominal


09.07.08
infections in adults

For coronary artery disease/ischaemic lheartt


16.07.08
disease

18.07.08

For the treatment of type_II diabetes mellitus when


single drug therapy alongwith diet, exercise do not 21.07.08
result in adequate glycemic control

For Testosterone replacement therapy of male


hypogonadism when testosterone dificiency has
22.07.08
been confirmed by clinical feature or biochemical
tests
For adult patients with severe active rheumatoid
arthritis who had an inadequate response to one
22.07.08
more DMARDs such as methotixate or TNF
antagonists
For the treatment of rheumatoid arthritis patients 22.07.08

For the treatment of HIV infection in adults 23.07.08

Same as Approved 23.07.08

For reduction of part operative inflammatory


24.07.08
condition of eyes

For the reduction of post operative inflammatory


24.07.08
conditions of the eye

Same as Approved 25.07.08

For the treatment of secondary hyperparathyroidism


in patients with stage 3 or stage 4 chronic kidney 05.08.08
disease

Same as approved 05.08.08

Same as approved 05.08.08

For the relief of the symptoms of seasonal allergic


05.08.08
rhinitis in patients 12 years of age and older

For the symptomatic treatment of pain and


14.08.08
inflammation condition in patients with osteoarthritis

For the treatment of mild to moderate pain, reduction


14.08.08
of fever
For the treatment of postoperative inflammation &
reduction of postoperative ocular pain in patients
who have undergone cataract extraction
for the treatment of acute bacterial otitis media, skin
& soft structure infections, UTI, uncomplicated
gonorrhoea, pelvic inflammatory disease, bacterial
14.08.08
septicemia, bone and joint infections, intra
abdominal infections, meningitis, surgical
prophylaxis
For the treatment of disturbance of consciousness
as resulting from head injuries , brain operation and 18.08.08
acute stage of cerebral infraction in adult only

For the treatment of productive cough 18.08.08

For the treatment of iron deficiency anaemia 18.08.08

Same as approved 18.08.08

For the treatment of haemo-dynamically stably


patients with definite or suspected acute Myocardial 19.08.08
Infarction to reduce cardio-vascular mortality.
In combination with bortezumab  for the treatment of
progressive multiple myeloma in patients who have
received at least one prior therapy and who have 23.08.08
already undergone or are unsuitable for bone
marrow transplant
As mouthwash for oral hygeine in various
oropharyngeal conditions, surgery, dental infections, 25.08.08
and halitosis

Same as approved 25.08.08

For the treatment of oedema associated with


congestive heart failure, cirrhosis and nephritic 25.08.08
syndrome

For topical treatment of acne vulgaris 26.08.08


Same as approved 26.08.08

Same as approved 27.08.08

For the treatment of productive cough accompanied


28.08.08
by phlegm

As approved 02.09.08

For the treatment of patients with metastatic


02.09.08
colorectal cancer

For the treatment of patients with HIV infection 08.09.08

in combination with capecitabine for the treatment of


patients with metastatic or locally advanced breast
cancer resistant to treatment with an anthracycline 13.09.08
and a taxane, or whose cancer is taxane resistant
and for whom further anthracycline therapy is c
For the relief of inflammatory and pruritic
manifestation of non-infected corticosteroid 13.09.08
responsive dermatoses like eczema

For the treatment of milk fever, hypocalcaemia


tetanies and disorders of calcium metabolism in 13.09.08
dairy cattle.

for the treatment of essential hypertension  15.09.08

For the treatment of adult patients with muscular


15.09.08
pain associated with spasm

For the treatment of mild to moderate hypertension


in adult patients whose blood pressure is not 15.09.08
adequately controlled by monotherapy
for the treatment of essential hypertension  15.09.08

For the treatment of seborrhoeic dermatitis 15.09.08

For the treatment of patients with serious cerebral


injuries of vascular traumatic nature with or without
loss of consciousness & for treatment of 16.09.08
degenerative damages & chronic cerebral vascular
injuries in senile dementia.
For the treatment of Prophylaxis & chronic treatment
of Asthma in Pediatrics patients 12 months of age &
older./ For relieving symptoms of seasonal allergic 16.09.08
rhinitis in Pediatric patients 2 years of age & older &
perennial allergic rhinitis in Pediatric P

For the treatment of pain, swelling & inflammatory


16.09.08
conditions due to arthritis.

As already approved  16.09.08

For the treatment of depression and schizophrenia in


26.09.08
adults when oral therapy is not possible

For the acute and maintenance treatment of


26.09.08
schizophrenia

For treatment of bovine respiratory disease (BRD,


Shipping fever, pneumonia) associated with
Mannhenia haemolytica, Pasteurella multocida, 26.09.08
andHistophilus somni in beef, non-lactating dairy,
and lactating dairy cattle
For treatment of sub clinical mastitis in dairy cattle at
the time of dry off asssociated with staphylococcus
26.09.08
aureus, Streptococcus dysgalactiae, and
Streptococcus uberis.
For treatment of clinical mastitis in lactating dairy
cattle asssociated with coagulase- negative
26.09.08
staphylococci, Streptococcus dysgalactiae, and
Escherichia coli.
For the treatment of acute uncomplicated urinary
tract infections (acute cystitis) caused by susceptible
26.09.08
strains of Escherichia coli or Staphylococcus
saprophyticus
For the relief of painful muscle spasms of the
26.09.08
skeletal musculature

For the short term use in acute painful and


30.09.08
inflammatory condition

For the treatment of disturbance of consciousness


resulting from head injuries, brain operation & acute 30.09.08
stage of cerebral infraction in adult.

Indicated for the treatment of mastitis, metritis,


pneumonia, pleuritis, fever and relieving of acute 30.09.08
pain in musculoskeletal disorders in animals

For the treatment of calcium and Vitamin D


deficiency states (pregnancy, lactation, growing 30.09.08
Children)

for the treatment of chloroquine resistant/multidrug


30.09.08
resitant on complicated malaria

For the treatment of hyperprolactinemia and


01.10.08
inhibition of lactation.

In combination with cisplatin is indicated for the first


line treatment of patients with locally advanced or
08.10.08
metastatic non-small cell lung cancer other than
predominantly squamous cell histology
For the prevention and treatment of mycoplasma
induced chronic respiratory disease in broilers and
breeders, the prevention and treatment of diseases 08.10.08
due to clostridium perfringens (necrotic enteritis, wet
litter, cholangiohepatitis), the prevention and t

Treatment of patients with multiple myeloma 09.10.08

For the treatment of vulvo-vaginal candidiasis in


09.10.08
women

For the treatment of uncomplicated urinary tract


infections (acute cystitis) in women due to
09.10.08
susceptible strains of E.Coli and Entreococcus
faecalis
As monotherapy for the treatment of metastatic or
locally advanced breast cancer in patients whose
tumors are resistant or refractory to cytotoxic
09.10.08
chemotherapy. Previous therapy should have
included as anthracycline, a taxane, and
capecitabine

For the treatment of essential hypertension 11.10.08

For topical treatment of Acne vulgaris. 14.10.08

For the treatment of systemic lupus erythematosus 17.10.08

Indicated in the regular treatment of patients with


moderate to severe COPD with frequent symptoms 17.10.08
and a history of exacerbations

For post operative steroid responsive inflammatory


ocular condition when bacterial ocular infections or a 21.10.08
risk of bacterial ocular infections exists.

For the treatment of acute inflammation conditions


21.10.08
associated with spasm in adults only

For the treatment of acne vulgaris 24.10.08

For the treatment of acute musculoskeletal pain in


24.10.08
patients

For the treatment of patients with serious cerebral


injuries of vascular traumatic nature with or without
loss of consciousness and for treatment of 31.10.08
degenerative damages and chronic cerebral
vascular injuries in senile dementia.
For acute and chronic schizophrenic disorders, in
which positive symptoms and or negative symptoms
03.11.08
are prominent, including patients characterised by
predominant negative symptoms.

For the treatment of hypocalcaemia and/or


04.11.08
osteoporosis
For the treatment of patients with HIV infection 04.11.08

For the treatment of elevated intraocular pressure in


patients with ocular hypertension or open angle 08.11.08
glaucoma.
1) As an adjunctive therapy to diet for the treatment
of adult patients with hypertriglyceridemia. 2)As an
adjunctive therapy to diet to slow the progression of 08.11.08
atherosclerosis in adult patients as part of a
treatment strategy to lower Total-C and LDL-C t

For the treatment of advanced gastric carcinoma 08.11.08

For the treatment of allergic rhinitis in adults only 10.11.08

Additional Lower Strength 10.11.08

Additional Strength 10.11.08

For the treatment of lumbago, integumental pain,


14.11.08
musculoskeletal pain

For scaling of seborrhea, seborrheic dermatitis,


17.11.08
psoriasis of scalp

For the treatment of psoriasis and fungal skin


17.11.08
infection

For the acute treatment of inflammatory


musculoskeletal disorders associated with painful 17.11.08
muscle spasm in adults.

Additional Lower Strength 17.11.08


For purification of contaminated ground water
23.11.08
sources.

Additional Lower Strength 24.11.08

For the treatment and management of patients with


community acquired pneumonia or acute bacterial 25.11.08
sinusitis due to beta lactamase producing pathogens

Additional Lower Strength 02.12.08

As adjunctive therapy to diet and exercise in patients


04.12.08
with diabetic dyslipidemia

As monotherapy for the second-line treatment of


patients with locally advanced or metastatic non-
04.12.08
small cell lung cancer other than predominantly
squamous cell histology
For the treatment of generalized or partial seizures
as monotherapy or adjunctive therapy. For the
treatment of maniac episodes associated with 04.12.08
bipolar disorders. For prophylaxis of migraine
headache in adults.
For the dissolution of Radiolucent collestral goll
stone, chronic cholestatic liver disease in particular
primary biliary cirrhosis, primary sclerosing 08.12.08
cholangitis & cholestasis associated with cyatic
fibrosis.

For the treatment of adult patients with pulmonary


11.12.08
tuberculosis

For the treatment of adult patients with pulmonary


11.12.08
tuberculosis

Additional Strength 12.12.08

For the treatment of cranial diabetes insipidus ,


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

For the treatment of bipolar I disorder. (addl.


17.12.08
Indication)

For the treatment of different Gastro intestinal


problems like functional dyspepsia, nausea, vomiting
17.12.08
& diabetic gastroparesis. For the treatment of
schizophrenia and depression in adults.

As an adjunct to rest and physical therapy for relief


of muscle spasm associated with acute, painful, 17.12.08
musculoskeletal conditions.

In combination with cisplatin and 5-fluorouracil is


indicated for the induction treatment of patients with
17.12.08
locally advanced squamous cell carcinoma of the
head and neck.

For the treatment of scaly dermatoses 18.12.08

Additional Strength 19.12.08

For short term treatment of moderate pain,


especially following surgery and for the short term
23.12.08
treatment of fever, when administration by i.v route
is clinically justified

Indicated for the treatment of lower respiratory tract


24.12.08
infections in adult patients

1. For LRTI infections, 2. for UTI - Complicated and


uncomplicated, 3. for bacterial septicemia, 4. for
bone and joint infections, 5. for gynaecologic 24.12.08
infections including endometritis, pelvic cellutitis, and
other infections of female genital tract, 6. f

For the treatment of fever associated with cold,


24.12.08
nasal congestion in adults

For symptomatic treatment of cough 24.12.08


Additional Lower Strength 24.12.08

For the treatement of osteoporosis in post-


menopausal women and in men who are at
07.01.09
increased risk offracture,including those with a
recent low-trauma hip fracture.

Addl. Strength 09.01.09

For the treatement of adult patients with chronic


obstructive pulmonarydisease(COPD) and bronchial 09.01.09
asthma.
(I) For the treatement and lasting prevention of
flea infestations,treatmentand control of flea allergy
dermatitis, prevention of
heartwormdisease,treatement and prevention of ear 09.01.09
mites in dogs and cats; (II) For the treatement and
prevention of sarcoptic mange,roundworms and for
control of tick infestations in dogs.
For the treatment of vitamin deficiency states in
14.01.09
adults

Adjunct to the treatement of Hyperthyroidism 14.01.09

For the treatment of secondary


hyperparathyroidism in patients with chronic kidney
14.01.09
diseases (CKD) on dialysis and for hypercalcemia in
patients with parathyroid carcinoma

For the prophylaxis of acute organ rejection in


23.01.09
patients recieving allogenic hepatic transplantation.

For symptomatic treatment of constipation in adults 29.01.09

Same as approved 31.01.09

For intradermal implantation and facial soft tissue


31.01.09
augmentation
For use in following: (I) Empirical therapy for
presumed fungal infections in
febrile neutropenic patients. (II) Treatment
of Candidemia and the following Candida infections:
Intra-abdominal abscesses, Peritonitis and Pleural
space infections. (II) Treatment of Candidemia and
31.01.09
the following Candida infections: Intra-abdominal
abscesses, Peritonitis and Pleural space infections.
For the treatment of patients withcandidemia, acute
(IV) Treatment of invasive Aspergillosis in patients
disseminated candidiasis, candida peritonitis,
who are refractory to or intolerant of other therapies
abscess and esophageal candidiasis. For the
(i.e, amphotericin B, lipid formulations of 31.01.09
prophylaxis of Candida infection in patients
amphotericin B, and/oritraconazole)
undergoing hematopoietic stem cell transplantation
(HSCT)
For prophylaxis and treatment of the nasal
31.01.09
symptoms of seasonal allergic rhinitis.

For the tratment of signs and symptoms of idiopathic


Parkinson's disease as intial monotherapy and as an 31.01.09
addition to levodopa.

To reduce the withdrawal symptoms, including


nicotine craving, associated with quitting the
03.02.09
smoking and quitting chewed tobacco
and guthka containing tobacco.

For the infestation of trematodes, nematodes,


cestodes and arthropods of domestic animals, 05.02.09
including milch and other food producing animals.

For the short term use in acute painful &


05.02.09
inflammatory conditions in adults

For cleansing of physically contaminated wounds


09.02.09
and for pre-operative disinfection

For the treatment of dandruff 09.02.09

For the treatment of nosocomial pneumonia in


16.02.09
adults.

For the relief of inflammatory


andpuritic manifestation of 18.02.09
corticosteroidrespensive dermatosis

To reduce the withdrawal symptoms, including


nicotine craving, associated with quitting the
18.02.09
smoking and quitting chewed tobacco
and guthka containing tobacco.
For the treatment of menorrhagia 20.02.09

For the treatment of dizziness and feeling of


dizziness resulting from Meniere's disease, 20.02.09
Meniere's syndrome and vertigo.

In moderately to severly active
rheumatoid arithritis in adults and may be used
20.02.09
as monotherapy or concomitantly with DMARD's
other than TNF antagonists

For the treatment of invasive candidiasis


including candidemia andesophageal candidiasis in 23.02.09
adult patients.

For the treatment of patients with skin


23.02.09
hyperpigmentation

For the treatment of asthma and chronic obstructive


23.02.09
pulmonary disease in adult patients only

For the treatment of melasma of face in adults 23.02.09

For the treatment of pityriasis and dandruff of the


23.02.09
scalp

For the treatment of HIV patients 23.02.09

As 3rd line treatment of type II diabetes mellitus


when diet, exercise and the single agents and the
23.02.09
second line therapy with two drugs do not result in
adequate glycemic control

For the treatment of acute low back pain in adult


23.02.09
patients only

As sunscreen lotion for prevention of sunburn skin 23.02.09


For the symptomatic relief of productive cough
associated with allergic rhinitis, when both anti- 23.02.09
histamine and mucolytic agents are desired

For single agent anesthesia in upper gastro


26.02.09
intestinal endoscopy.

As antipruritic and smoothening agent 26.02.09

For the treatment of anal fissures 26.02.09

For the treatment of mild to moderate hypertension


in adult patients (in whom combination therapy is
26.02.09
appropriate) who have been stabilized on the
individual components given in the same proportion

For the symptomatic symptoms of idiopathic


04.03.09
Parkinson's Disease

Addl. Strength 04.03.09

Additional higher strength 16.03.09

For the treatment of human immunodeficiency virus


(HIV) infection in antiretroviral treatment experienced
adult patients, such as those patients with HIV-1 19.03.09
strains resistant to more than one protease inhibitor
when co-administered with 100mg ritonavir, an

For the production of local or regionalanasthesia for


19.03.09
surgery and for acute pain management.

As vitamin and phosphorous supplement for


19.03.09
livestock, shirmp and fish.

For the treatment of symptoms of allergic rhinitis. 19.03.09


A sunscreen lotion for prevention of sunburn skin 19.03.09

Additional Strength 19.03.09

For the symptomatic relief of bronchospasm in


19.03.09
bronchial asthma & chronic bronchitis

Additional lower paedriatric dose 19.03.09

To be indicated for use in sealing suture lines along


26.03.09
arterial and venous reconstructions.

For the relief of pain associated with post-herpetic


26.03.09
neuralgia. It should be applied only to intact skin.

For the treatment of hypotrichosis of the eyelashes


by increasing their growth including length, thickness 30.03.09
and darkness.

For the treatment of patients with advanced soft


tissue sarcoma, after failure
30.03.09
of anthracyclines and ifosfamide, or who are
unsuited to recieve these agents.

For the treatment of children (age 6to 12years) with


chronic obstructive pulmonary disease(COPD) and 30.03.09
bronchial asthma.

For the induction of remission in patients with active,


30.03.09
mild to moderate ulcerative colitis.

Same as approved 31.03.09

For the treatment of muscle, joint and post-traumatic


31.03.09
stress.
For the treatment of patients with bronchial asthma 31.03.09

For the treatment of wound of differentetiology 31.03.09

Additional higher strength 31.03.09

For the treatment of wound of differentetiology 31.03.09

For reducing signs and symptoms of moderately


to severly active polyarticular juvenile idiopathic
arthritis/juvenile rheumatoid arthritis
10.04.09
inpediatric patients 6 years of age and older who
have had an inadequate response to one or more
DMARD's such as MTX
For symptomatic relief of productive cough
associated with allergic rhinitis, when both anti- 13.04.2009
histamine and mucolytic agents are desired

Indicated as third line treatment of severe


cases of  COPD, whenmonotherapy and second line 13.04.2009
therapy with two drugs do not respond adequately.

For the tretament of patients with mild


13.04.2009
to modrate essential hypertension

For the management of fibromylagia. 15.04.2009


For the symptomatic treatment of pain and
inflammation in patients of osteoarthritis & 25.04.2009
rheumatoid arthritis

Same as approved 25.04.2009

Additional strength 25.04.2009

For the treatment of intestinalhelminthes and


suppression ofmicrofilaraemia especially with 25.04.2009
bancrofti infections
For treatment of patients with myelodysplastic
syndromes (MDS) including previously treated and
untreated, de novo and secondary MDS of all
25.04.2009
French-American-British subtypes(refractory anemia,
refractoryanemia with ringed sideroblasts,
refractory anemia wi
For the topical treatment of bacterial skin and skin
structure infections:-Primary impetigo, secondarily
25.04.2009
infected traumatic lesions, secondarily infected
dermatoses.

For the tretament of pruritis and prickly heat 08.05.2009

For the supply of fats, including essential omega-6


fatty acids and omega-3 fatty acids, as part of a
parenteral nutrition regimen in adults  iforal or 14.05.2009
enteral nutrition is impossible,inadequte or
contraindicated.

For the topical treatment of the superficial fungal


02.05.2009
infections of the skin.

1. To reduce of fatal coronary heart disease and


non-fatal myocardial infarction, and to reduce the
risk of stroke.                                   2. To reduce the 02.05.2009
risk of coronary revascularization procedures and
the need for hospitalization due to an

Prophylaxis of infection in neck and head surgery 02.05.2009

For the treatment of chronic idiopathic constipation


16.05.2009
in adult patients only
for use as sweetner in drug formulations 09.05.2009

To reduce cardiovascular mortality in clinically stable


patients who have survived the acute phase of a
myocardial infarction and have a left ventricular 09.05.2009
ejection fraction of ≤ 40% (with or without
symptomatic heart failure)

For the treatment of Acute musculoskeletal pain 18.05.2009

For the treatment of peripheral neuropathic pain in


16.05.2009
adults

For the treatment of productive cough accompanied


16.05.2009
by Phlegm

Treatment of advance renal cell carcinoma 16.05.2009

Acute pain in Orthopaedic, ENT, Dental and Post


16.05.2009
Operative condition

For treatment of Post Operative Nausea & vomiting 16.05.2009

For the treatment of patients with chronic


16.05.09
lymphocytic leukemia.

For the short term treatment of apnoea of


prematurity of infants between 28 and < 33 weeks 16.05.09
gestational age.

For the treatment of arterial hypertension,


16.05.09
congestive heart failure and coronary artery disease.
For the topical treatment of inflammatory dermatitis
16.05.09
with secondrybacterial infection

For the treatment of dermatoses


wheresecondry bacterial and/or candidialinfection is 25.04.09
present

Additional strength 25.04.09

For the treatment of opioddependence and


28.05.09
in maintainencetreatment for opioid dependence.

For the treatment of overactive bladder with the


symptoms of urge urinary incontinence, urgency, 28.05.09
and urinary frequency.
For the long term, twice daily (morning and
evening) maintainence treatment of
bronchoconstriction in patients with chronic 29.05.09
obstructive pulmonary disease (COPD), including
chronic bronchitis and emphysema.

For the acute treatment of migraine with or without


29.05.09
aura in adults.

For sedation of initially and mechanically ventilated


patients during treatment in an intensive care 29.05.09
setting.

same as approved 2.05.2009

For the reduction of the frequency of relapses in


3.06.2009
patients with Relapsing-Remitting Multiple Sclerosis.

For the treatment of unresectablemetastatic


liver tumors from primary colorectal cancer with
3.06.2009
intra-hepatic artery chemotherapy (IHAC) of FUDR
(Floxuridine)

For the treatment of cutaneous mycosis viz. Tinea


3.06.2009
pedis, Tinea corporis, Tinea cruris.
1) For the treatment of generelized or partial
seizures as monothreapy or adjunctive threapy. 2)
For prophylaxis of migraine headache in adults. 3) 4.06.2009
For the treatment of manic episodes associated with
bi polar disorders

For the treatment of chronic Hepatitis B in adults 19.6.2009

For the treatment of pulmonary arterial hypertension


(WHO Group I) in patients with WHO Class III or IV
23.6.2009
symptoms, to improve excercise ability and decrease
the rate of clinical worsening.

same as approved 26.6.2009

for the treatment for mild to moderate susceptible


infection including RTI, uncomplicated skin/ skin 26.6.2009
structure, non gonococcal urethritis, cervicitis

As 2nd line treatment of patients with both essential


hypertension and hypercholesterolemia who are not
1.07.2009
adequately controlled by combination of an anti-
hypertensive with lipid lowering agent.

For the treatment of Attention Deficit Hyperactivity


10.07.2009
Disorder (ADHD)

same as approved 10.07.2009

As 2nd line treatment of type II Diabetes mellitus


when diet, exercise and the single agent do not 13.7.2009
result in adequate glycemic control.

same as approved 16.7.2009

For the treatment of hepatic encephalopathy 18.7.2009

For the treatment of HIV infection in combination


18.7.2009
with other anti retro viral agents
For the treatment of major depressive disorder
18.7.2009
(MDD)

For the treatment of oropharyngeal candidiasis,


including oropharyngeal candidiasis refractory
to itraconazoleand/orfluconazole.                                18.7.2009
            For prophylaxis of invasive Aspergillus and
Candida infections in patients, 13 years

same as approved 18.7.2009

Febrile Neutropenia in cancer patients 18.7.2009

For the treatment of imminent or manifest


18.7.2009
hypovolemia and shock.

For the acute treatment of migraine with or without


18.7.2009
aura in adults.

same as approved 20.7.2009

For secondary prevention of coronoryheart


disease/stroke in patients where use of such 21.7.2009
combination is appropriate

Treatment by inhalation of Pseudomonas


aeruginosa lung infection in patients with cystic 28.7.2009
fibrosis

For the treatment of hypertension/ cardiac failure


30.7.2009
and myocardial infarction

For the treatment of HIV-1 infection in combination


1.08.2009
with other antiretroviral agents

Prevention of clinical fractures after hip fracture in


1.08.2009
men and women
Additional Strength  for the treatment of migraine 3.08.2009

For the treatment of acute inflammation conditions


3.08.2009
associated with spasm in adults only

Treatment of generalized tonic-clonic seizures in


13.08.2009
adults and children

for the treatment of diarrhoea of mixed infection in


17.08.2009
adult patients

Indicated in the management of Schizophrenic


19.08.2009
patients

Is indicated for the relief of stuffy,running nose


associated with colds and influenza, also post nasal 19.08.2009
drip, sinusitis.

Treatment of acute ST-segment elevation


myocardial infarction including patients to be
19.08.2009
managed medically or with subsequent percuaneous
coronary intervention (PCI)

For the treatment of obsessive compulsive disorder


19.08.2009
(OCD)and depression

For single agent anesthesia in procedure involving


the introduction of instrument & tubes into 19.08.2009
respiratory tract.

Indicated as monotherapy or as adjunctive therapy


in lithium  or valproate for the maintenance treatment 29.08.2009
of Bipolar-1 disorder.
Indicated for adjuvant treatment of Post Menopausal
Women with estrogen receptor positive early breast
cancer who have received two-three year of
29.08.2009
tamoxifen and are switched to exemestane for
completion of total of five years of adjuvant hormonal
therapy.
For the treatment of uncomplicated malaria due to
01.09.2009 
plasmodium falciparum strain in various age groups 
For the treatment of combined hyperlipidemia in
01.09.2009 
patients with normal hepatic and renal function 

For the treatment of severe opioid responsive


painconditions which are not adequately responding 03.09.09 
to non-opioid analgesics.For Hospital supply only. 

For the treatment of overactive bladder with the


symptoms of urge urinary incontinence, urgency and  04.09.2009
urinary frequency.

For the treatment of nausea and vomiting.  09.09.09 

For the treatment of heart failure as an adjunct to


standard therapy in patients to improve survival, to
18.09.2009 
prolong time to hospitalization for heart failure and to
improve patients reported functional status. 

For the treatment of adult patients with Upper and


Lower respiratory tract infections, skin and soft 22.09.2009 
tissue infections 

For the treatment of mild to moderate hypetension.  03.10.09 

For the treatment of skin bacterial infections in dogs


03.10.09 
and cats. 

For the treatment and prevention of flea infestations,


prevention of heartworm disease and treatment of
03.10.09 
infections with gastrointestinal nematodes in dogs
and cats. 
For the glucocorticoid, anti-inflammatory or
supportive therapy to cattle suffering from conditions
such as: (1) Overwhelming infections with severe
03.10.09 
toxicity. (2)  Bovine ketosis.(3)  Musculoskeletal
conditions.(4)  Shock.(5) Parturient paresis
As an adjunct
(supportive to diet
stress and exercise
therapy to improve
for milk fever). 
glycemic control in adults with type-2 diabetes
mellitus. (It should not be used for the treatment of 24.10.09 
type 1 diabetes mellitus or diabetic ketoacidosis, as
it would not be effective in these settings. 

For the treatment of moderate plaque psoriasis in


3.10.2009 
adults 
same as approved  3.10.2009 

same as approved  3.10.2009 

For the treatment of cytomegalovirus (CMV) retinitis


in AIDS patients and for prevention of CMV disease 9.10.2009 
in solid organ transplant patients at high risk 

For the painful and inflammatory conditions


associated with joints, tendons, ligaments and 13.10.2009 
muscle 

For the treatment of mild to moderate severe


15.10.2009 
Alzheimer's Dementia 

Symptomatic treatment of acute pain of moderate to


severe intensity, when oral administration is not
22.10.2009 
appropriate such as post-operative pain, renal colic
and low back pain. 

Indicated as an adjunct to diet and exercise to


improve glycemic control in adults with type 2 22.10.2009 
diabetes mellitus. 

For the treatment of depression and schizophrenia in


27.10.2009 
adults 

Additional strength  27.10.2009 

Additional strength  27.10.2009 

For the treatment of diabetic neuropathy  27.10.2009 

For the treatment of co-existing essential


27.10.2009 
hypertension and hyperlipidemia in adult patients 
Ready to use pour-on for cattle, sheep and goats.  1.
For use in Cattle to control ticks, stable flies, horn
flies, cattle louse flies and nuisance flies e.g. house
29.10.2009
flies, to kill lice and protection against blackflies. 2.
For use in sheep and goats for controlling Karoo
paralysis, bont- legged and red-legged ticks
For the treatment of adult patients with osteoarthritis
03.11.2009
of knee and/or hip joints

Additional strength  4.11.2009

1. For conscious sedation for surgical and diagnostic


procedures 2. for sedation of ventilated patients 5.11.2009
receiving intensive care

For the management of seasonal allergic rhinitis


10.11.2009
(SAR)

For improvement of mytonic conditions caused by


neck shoulder arm syndrome , scapulhumeral 10.11.2009
periarthritis and low back pain in adult patients only 
For the treatment of: • gastric ulcers, duodenal
ulcers and stromal ulcers • gastric mucosal lesions
(erosion, hemorrhage, redness or edema) 11.11.2009
associated with acute gastritis and acute
1. Tablets 0.1mg
exacerbation & Injection
of chronic 0.3-- for the prevention
gastritis.
and treatment of gastrointestinal symptoms (nausea
and vomiting) associated with emetogenic
11.11.2009
cancer chemotherapy.2. Tablets 2.5mcg & 5mcg---
for the treatment of diarrhoea predominant irritable
bowel syndrome.

For the treatment of pulmonary arterial hypertension 14.11.2009

for the reduction of post-operative inflammatory


14.11.2009
condition

Sedation of non-intubated patients prior to and/or


14.11.2009
during surgical and other procedure

Same as approved 14.11.2009


1) Triticum Vulgare Cream is indicated for the
14.11.2009
treatment of ulcers and bed sores.

2) Triticum Vulgare Vaginal Pessary is indicated for


the treatment of phlogistic and dystrophic disorders
of the female genital tract. 

For treatment of chronic hyperuricemia in conditions


where urate depression has already occured
14.11.2009
(including a history, or presence of tophus and /or
gouty arthritis).

For the treatment of 3° and 4° haemorrhoids (Addl.


14.11.2009
Indication).

For the treatment of 1° and 2° internal haemorrhoids. 14.11.2009

For the treatment of acute diarrhoea in children  4.11.2009

For the local application in relieving pain in acute low


17.11.2009
backache, tendonitis, tenosinovitis and sprains

Symptomatic treatment of osteoarthritis of knee &


20.11.2009
hip
For the treatment of essential hypertension  24.11.2009

For the treatment of patients infected with CCR5-


25.11.2009
trophic HIV-1.

For the symptomatic treatment of acute pain and


inflammation in patients with osteoarthritis, 25.11.2009
rheumatoid arthritis and ankylosing spondylitis

Prophylaxis of transplant rejection in kidney, liver or


26.11.2009
heart allograft recipient

For infections diarrhoea in adults 26.11.2009

Indicating for condition required Glucocorticoids


activity including collagen disease, allergic disease 26.11.2009
and hypersensitive reaction

For the treatment of gastroesophageal reflux


disease (GERD) and functional inconveniences of 26.11.2009
the gastrointestinal motility

for control of serum phosphorus in patients with


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

Monotherapy in the treatment of partial seizures in


26.11.2009
children ages 4-16 

for the relief of musculoskeletal pain & inflammation 11.12.2009

As adjunctive therapy to diet and weight loss in the


26.11.2009
treatment of type IIa, IIb and IV lipid disorders.

Same as approved 27.11.2009

Same as approved 29.10.2009


For the treatement of post operative steriod
responsive inflammatory ocular infections or risk of 1.12.2009
bacterial ocular infections exists 

for the treatment of signs & symptoms of idiopathic


3.12.2009
Parkinson's disease

same as approved 4.12.2009

same as approved 11.12.2009

for the relief of pain & inflammation due to


rheumatoid arthritis , osteoarthritis and allied 11.12.2009
disorder

1. Mild to severe chronic heart failure. 2. Left


ventricular dysfunction following myocardial 11.12.2009
infarction in clinically stable patients 3. hypertension

For the treatment of acute and chronic infected


15.12.2009
eczematous dermatitis

For the treatment of type II diabetes mellitus


17.12.2009
associated with dyslipidemia 

indicated in the treatment of Menier's syndrome,


characterized by unilateral or bilateral tinnitus, 17.12.2009
vertigo, sensorineural hearing loss

Indicated for the first line treatment of patients with


locally advanced or metastatic non small cell lung
18.12.2009
cancer (NSLC) who have activating mutationof the
EGFRTK".

For selection,anxiolysis and amnesia prior to


diagnostic, therapeutic or endoscopic procedure or 18.12.2009
before induction of anesthesia.

For the treatment of productive cough accompanied


18.12.2009
by phlegm
for the treatment of uncomplicated urinary tract
22.12.2009
infectins (such as cystitis and urethritis)

For symptomatic treatment of nasal congestion with


23.12.2009
running nose (rhinorrhea)

For the treatment of patients with bronchial asthma


and COPD, when use of both the drug is 23.12.2009
appropriate 

Indicated in combination with peg interferon alpha-


2b for the treatment of naïve adult patients with
24.12.2009
chronic hepatitis C with clinically stable HIV co-
infection.

For the treatment of patients with bronchial asthma


and COPD, where the use of combination is found 30.12.2009
appropriate 

For the prevention of Plaque and treatment of


30.12.2009
gengivitis.

For the prevention of Plaque and treatment of


30.12.2009
gengivitis.

For iron, folic acid & omega-3-fatty acid deficiency   8.1.10

For the management of psoriasis. 8.1.10

Same As approved 16.1.10

For the treatment of macular edema following


16.1.10
branch retinal vein occlusion (CRVO)

For the Symptomatic treatment of various allergic


conditions (rhinitis, conjunctivitis and urticaria) and 16.1.10
for prevention and treatment of motion sickness
Indicated as a monotherapy for the maintenance
treatment of locally advanced or metastatic Non
Small Cell Lung Cancer (NSCLC) other than
16.1.10
predominantly squamous cell histology in patients
whose disease has not progressed immediately
following platinum-base
For lowering of intraoccular pressure in patients with
chronic open-angle glaucoma or occular 16.1.10
hypertension.

For the improvement of ischemic symptoms


including ulcer, associated with chronic arterial 16.1.10
occlusion.

For hygenic and surgical hand disinfection 18.1.10

For the treatment of hypertension  19.1.10

For treatment of fever and pain associated with


acute upper respiratory tract inflammation, acute
musculoskeletal disorders, pain after operative 19.1.10
intervetion and following trauma, chronic condition
like rheumatoid arthritis, osteoarthritis etc for short t

Total parenteral nutrition following major abdominal,


19.1.10
major thoracic or major urological surgery 

In combination with other anti retroviral agents


for  the treatment of human immunodeficiency virus
(HIV-1) infection in treatment experienced patients 27.1.10
with evidence of HIV-1 replication despite ongoing
retroviral therapy.

Same as approved 30.1.10

Same as approved 30.1.10

For the prevention of venous thromboembolism in


patients (VTE) in adult patients undergoing hip or 30.1.10
knee replacement surgery.

For the treatment of vertigo 3.2.10


Indicated in the treatment of cutaneous and
mucocutaneous mycotic infections caused by 5.2.10
candida (Monilia) species.

Same as approved 6.2.10

Same as approved 6.2.10

Same as approved 6.2.10

(1)  Enforcement of suture and staple lines in lung


resection
procedures.                                    (2)Patients
6.2.10
undergoing cardiac surgery to prevent or reduce the
incidence, severity and extend of post surgical
adhesion formation.              
For the treatment of adult patients with peripheral
9.2.10
neuropathy
 For Symptomatic Treatment of chronic stable
angina pectoris in coronary artery disease patients
with normal sinus rhythm, indicated in combination
10.2.10
with beta-blockers in patients inadequately
controlled with an optimal beta-blocker dose and
whose heart ra

Same as approved 10.2.10

Indicated for the treatment of pain and inflammation


10.2.10
following cataract surgery.

In combination with other approved anticancer drugs


is indicated for remission induction in acute non-
lymphocytic leukemia of adults and children.  It has 10.2.10
also been found useful in the treatment of acute
lymphocytic leukemia and the blast phase of chronic

For the relief of the symptoms of seasonal allergic


10.2.10
rhinitis in patients 6 years of age and older.

Replacement of extracellular fluid losses in case of


isotonic dehydration, especially if acidosis is being 11.2.10
imminent or present 
As an adjunct in abdominal or pelvic surgery for
reducing the incidence, extent and severity of 11.2.10
postoperative adhesions at the site of placement.

For the treatment of patients with acute painful


12.2.10
musculoskeletal conditions

For the treatment of adult patients with upper &


lower respiratory tract infections, skin and soft tissue 12.2.10
infections

For the Treatment of Osteoarthritis and 25-Feb-10


Rheumatoid Arthritis
Same as Approved 27-Feb-10

For treatment of resistant oedema associated 5/3/2010


with secondary hyperaldosteronism; resistant
hypertension, chronic cardic failure and hepatic
cirrhosis

For the management of cough in adult patients 5/3/2010


only 
For the treaetment of painful diabetic 5/3/2010
neuropathy in adults only 

For the management of hyperphosphatemia in 5/3/2010


adults patients with renal failure being treated
with dialysis (hemodialysis or peritoneal dialysis

For the treatment of the symptoms of 5/3/2010


functional gastrointestinal disorders like
irratible bowel syndrome, functional dyspepsia,
peptic ulcers., GERD which includes smooth
muscle spasm, flatulence, abdominal
distension, hyperacdity, gastric distress, bloting
etc.

For the treatment in adults patients with 5/3/2010


dandruff/seborrheic dermatitis of the scalp
For the Treatment of respiratory tract 8/3/2010
infections, urinary tract infection, skin and skin
structure infections and gynaecological
infections

For the treatment of hypertension only 10/3/2010

For the treatment of Bronchial Asthma and 11/3/2010


COPD in Adults
For the treatment of adult male patients with 12/3/2010
premature ejaculation
For the treatment of the sign and symptoms of 13/3/2010
idiopathic parkinsons disease
For the treatment of symptoms of premenstrual 16/3/2010
dysphoric disorders (PMDD) in women
(additional indication)
Additional Strength 16/3/2010

For the prophylaxis of migraine 16/3/2010

For the treatment of acute stroke  16/3/2010

For the treatment of acute inflammation 16/3/2010


conditions associated with spasm in adults only

For the treatment of diabetic neuropathy in 16/3/2010


adults

For the topical treatment of acute 16/3/2010


musculoskeletal pain
For the treatment of patients suffering from 17/3/2010
non-ulcer dyspepsia (NUD) or
gasteroesophageal reflux disease (GERD)
Additional higher strength 17/3/2010

Same as Approved 20/3/2010

In combination with pegylated liposomal 20/3/2010


doxorubicin, it is indicated for the treatment of
patients with relapsed platinum- sensitive
ovarian cancer
Additional higher strength 23/3/2010

For the treatment of rheumatoid arthritis, 26/3/2010


osteoarthritis, ankylosing
spondilytis,gout,painful post perative pain
following dental surgery etc.

Same as Approved  26/3/2010

Additional higher Strength 26/3/2010

1. For the treatment of dyslipidaemia, 26/3/2010


particularly in patients with combined mixed
dyslipidaemia (characterised by elevated levels
of LDL-cholesterol and triglycerides and low
HDl-cholesterol) and in patients with primary
hypercholesterolemia (heterozygous familial
and non-familial).

2. In combination with HMG-CoA reductase


inhibitors (statins), when cholesterol lowering
effect of HMG-CoA reductase inhibitor
monotherapy is inadequate. It can be used as
monotherapy only in patients in whom HMG-
CoA reductase inhibitors are considered
inappropriate or not tolerated. Diet or other
non-pharmacological treatments (e.g. exercise,
weight reduction) should be continued during
therapy.

For the treatment of gastric ulcer, duodenal 30/3/2010


ulcer & gastroesophageal reflux disease (GERD).

For the treatment of mixed infections with 30/3/2010


roundworms and tapeworms in dogs 
For the treatment of inflammation and pain  30/3/2010
associated with ocular surgery. 
For the relief of painful muscle spasms of the 31/3/2010
skeletal muscualture.
For the treatment of patients with both 4/1/2010
essential hypertension and
hypercholesterolemia
For secondary prophylaxis of ischemic heart 5/4/2010
disease in patients where use of such
combinations in appropriate 
Same as Approved 5/4/2010

Adjuvant treatment of adult patients following 5/4/2010


resection of gastro-intestinal stromal tumours
(GIST)

Same as Approved 5/4/2010

For the treatment of other dyslipidemias: (a) 5/4/2010


Fredrickson Types III and V.(b) Associated with
diabetes.(C) Associated with xanthomata.

For the short term treatment of 7/4/2010


musculoskeletal pain associated with
inflammation and spasm in adults only
For the treatment of bronchial asthma in adults 7/4/2010

To reduce the risk of cardiovascular 8/4/2010


hospitalization in patients with paroxysmal or
persistent atrial fibrillation (AF) or atrial flutter
(AFL), with a recent episode of AF/AFL and
associated cardiovascular risk factors (i.e., age >
70, hypertension, diabetes, prior
cerebrovascular accident, left atrial diameter >
50mm or left ventricular ejection fraction [LVEF]
< 40%), who are in sinus rhythm or who will be
cardioverted.

For the treatment of chronic pain. 8/4/2010

To reduce the rate of thrombotic cardiovascular 13/4/2010


(CV) events (including stent thrombosis) in
patients with acute coronary syndrome (ACS)
who are to be managed with percutaneous
coronary intervention (PCI) as follows:
• Patients with unstable angina (UA) or non-ST-
elevation myocardial infarction (NSTEMI). 

• Patients with ST-elevation myocardial


infarction (STEMI) when managed with primary
or delayed PCI.

For the treatment of anxiety and depression. 13/4/2010

For the treatment of schizophrenia 15/4/2010


To improve wakefulness in patients with 23/4/2010
excessive sleepiness associated with treated
obstructive sleep apnea (OSA), shift work sleep
disorder (SWD) or narcolepsy.

For maintenance bronchodilator treatment of 24/4/2010


airflow obstruction in adult patients with
chronic obstructive pulmonary disease (COPD).

Same as Approved 24/4/2010

Same as approved 24/4/2010

For the treatment of patients with typhoid fever 26/4/2010


and urinary tract infection in adults 
For symptomatic relief of dermatological 29/4/2010
condition associated with dry skin including
atopic dermatitis, eczema, pruritus, ichthyosis,
xerosis, psoriasis

For the short term treatment of acutely 30/4/2010


decompensated chronic heart failure (ADHF) in
situations where conventional therapy is not
sufficient and in cases where ionotropic support
is considered appropriate.

T shahbaz@meherpharma.com, Mob-0091-9818131498, B-6/151, Sec-3, Rohini, Near Jaipur Golden Hospital

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