| S.No |
Name Of
Drug |
Pharmacological
Classification |
Date of
Approval |
| 1 |
Cefprozil Powder for oral suspension (125mg/5ml) |
Antibiotic |
06/01/2006 |
| 2 |
Nebivolol (as HCl) 5mg + Valsartan 80mg |
For hypertension |
17/01/2006 |
| 3 |
Combikit of Tamsulosin HCl 0.4mg M.R capsule (10 no.) &
Dutasteride Soft Gelatin Capsule 0.5mg (10no.) |
For BPH |
19/01/2006 |
| 4 |
Alendronate Sodium (equiv. to Alendronic acid 70mg) +
Cholecalciferol 70mcg (equiv. to 2800 I.U Vit.D) Tablet |
For osteoporosis |
01/02/2006 |
| 5 |
Atenolol 50mg + HCTZ 25mg (addl. Strength) |
For hypertension |
03/02/2006 |
| 6 |
Tamsulosin HCl (MR) 0.4mg + Dutasteride 0.5mg tablet |
For BPH |
06/02/2006 |
| 7 |
Erdosteine Powder for oral suspension 35mg/ml |
For chronic obstructive bronchitis |
06/02/2006 |
| 8 |
Moxifloxacin Eye Ointment (5mg/gm) |
For ophthalmic use. |
06/02/2006 |
| 9 |
Dexibuprofen Tablet (200mg/300mg/400mg) |
For OA, RA & ankylosing spondylitis |
06/02/2006 |
| 10 |
Pegaptinib Sodium Injection (0.3mg). |
For neovascular (wet) age related macular degeneration. |
06/02/2006 |
| 11 |
Ciclesonide Inhaler 80/160mcg per actuation |
For persistent Asthma |
06/02/2006 |
| 12 |
Metoprolol Succinate equiv. to Metoprolol Tartrate 50mg +
Amlodipine (as besylate) 5mg |
For hypertension |
07/02/2006 |
| 13 |
Doxofylline Tablet (400mg) |
For bronchial asthma & COPD. |
08/02/2006 |
| 14 |
Zanamavir inhalation powder 5mg/blister |
For influenzae |
13/02/2006 |
| 15 |
Testosterone Transdermal Spray (12.5mg/spray) (addl. Lower
strength) |
For replacement therapy in males with Testosterone deficiency. |
15/02/2006 |
| 16 |
Cefetamet Pivoxil Hcl oral suspension 250mg/ml |
Anti-biotic |
16/02/2006 |
| 17 |
Voriconazole Powder for oral soluion (40mg/ml) |
Anti-fungal |
21/02/2006 |
| 18 |
Desflurane liquid for inhalation (240mg/bottle). |
For induction & maintenance of anaesthesia. |
22/02/2006 |
| 19 |
Aceclofenac 200mg (S.R) tablet |
NSAID |
22/02/2006 |
| 20 |
Tenofovir Disoproxil Fumarate (300mg) + Emtricitabine (200mg)
tablet |
For HIV-1 infection |
23/02/2006 |
| 21 |
Levetiracetam Oral Solution (100mg/ml). |
Anti-epileptic |
24/02/2006 |
| 22 |
Atomoxetine 60mg capsule (Addl. Strength) |
For ADHD |
27/02/2006 |
| 23 |
Diclofenac Sodium (75/50mg) as (E.C) + Misoprostol 200mcg. |
For OA & RA |
28/02/2006 |
| 24 |
Fluorescein Sodium Solution for Injection (100mg/ml) |
Ophthalmological diagnostic agent |
02/03/2006 |
| 25 |
Cefditeron (as pivoxil) 200mg tablet |
Anti-biotic |
03/03/2006 |
| 26 |
Sodium Hyaluronate Cream 0.2% |
For leg ulcer, diabetic ulcer etc. |
16/03/2006 |
| 27 |
Saquinavir (500mg) tablet (addl. Strength) |
Anti-AIDS |
20/03/2006 |
| 28 |
Eflornithine HCl Cream (139mg/gm) |
For reduction of unwanted facial hair in women. |
22/03/2006 |
| 29 |
Propionyl-L-Carnitine HCl Tablet (500mg) & injection
300mg/vial |
Chronic congestive heart failure |
22/03/2006 |
| 30 |
Tobramycin Inhalation solution (300mg/5ml) |
For chronic pulmonary infection cystic fibrosis. |
22/03/2006 |
| 31 |
Lactulose Enema (20%) |
For constipation & hepatic encepthalopathy |
28/03/2006 |
| 32 |
Haloperidol Tablet (0.5mg) (addl. Lower strength) |
As approved earlier. |
30/03/2006 |
| 33 |
Cholestyramine Powder for oral suspension (4gm/sachet) |
For hypercholesterolaemia |
30/03/2006 |
| 34 |
Doxofylline Syrup (20mg/ml) |
For bronchial asthma & COPD. |
30/03/2006 |
| 35 |
Resperidone Tablet & Syrup (addl. Ind ) |
Acute mania & mixed episode in bipolar-I disorder. |
04/04/2006 |
| 36 |
D-trans Fentantyl Transdermal patches |
For pain |
05/04/2006 |
| 37 |
Pantoprazole (as Sodium) (E.C) 40mg + Itopride (150mg) S.R |
For GERD |
08/04/2006 |
| 38 |
Oseltamivir formulation (additional indication) |
For Prophylaxis of influenzae in adult and children >14 years
of age |
24/04/2006 |
| 39 |
Atazanavir (100/150/200mg) |
Anti-HIV in adults. |
24/04/2006 |
| 40 |
Nicorandil E.R Tablet (10mg/20mg) |
Angina Pectoris |
24/04/2006 |
| 41 |
Amlodipine (as besylate) 5mg + HCTZ 12.5mg Tablet |
For hypertension |
24/04/2006 |
| 42 |
Nadifloxacin Gel 1% |
Acne vulgaris |
10/05/2006 |
| 43 |
Formoterol Fumarate (6mcg) + Fluticasone Propionate
(100/250/500mcg) dry powder inhaler |
For Asthma & COPD |
10/05/2006 |
| 44 |
Midazolam (as maleate) 7.5mg/15mg tablet |
For insomnia |
10/05/2006 |
| 45 |
Olmesartan (as Medoxomil) 10mg (addl. Strength) |
Anti-hypertensive |
18/05/2006 |
| 46 |
Pregabalin Capsule 25/50/100/200mg (addl. Strength) |
Same as approved. |
19/05/2006 |
| 47 |
Oxcarbazepine S.R 450mg/900mg (addl. Strength). |
Anti-epileptic |
19/05/2006 |
| 48 |
Ciclesonide rotacaps (200/400mcg) |
For Asthma |
19/05/2006 |
| 49 |
Itopride 150mg capsule (S.R) |
For GERD |
22/05/2006 |
| 50 |
Nevibolol (as HCl) 5mg + Amlodipine (as besylate) 5mg/10mg |
For hypertension |
24/05/2006 |
| 51 |
Levocetrizine 5mg + Ambroxol Hydrochloride SR (75mg) tablet |
For production cough |
24/05/2006 |
| 52 |
Ibandronic Acid Tablet (150mg) addl. Strength |
Same as approved. |
25/05/2006 |
| 53 |
Zonisamide capsule 25/50mg (addl. Strength) |
Same as approved. |
25/05/2006 |
| 54 |
Perflutren liquid microsphere injectable suspension |
For diagnostic use |
31/05/2006 |
| 55 |
Cyclosporin Eye drops (0.1%) (addl. Strength) |
For Ophthalmic use |
02/06/2006 |
| 56 |
Gatifloxacin (0.3%) + Prednisolone Acetate (1%) eye drops |
For Ophthalmic use |
02/06/2006 |
| 57 |
Amlodipine (as besylate) 5mg + Metoprolol Succinate equivalent to Metoprolol Tartrate 50mg. |
For hypertension |
05/06/2006 |
| 58 |
Nadifloxacin (1%) + Miconazole Nitrate (2%) + Mometasone Furoate
(0.1%) Cream |
For dermatoses |
06/06/2006 |
| 59 |
Bemiparin Sodium Solution for injection(5000/7500/10,000 I.U). |
For deep vein thrombosis |
08/06/2006 |
| 60 |
Icodextrin 7.5% peritoneal dialysis solution |
For peritoneal dialysis |
08/06/2006 |
| 61 |
Lamotrigin 200mg tablet (addl. Strength) dispersible tablet
(5mg/50mg/100mg/200mg |
Anti-epileptic |
08/06/2006 |
| 62 |
Amoxycillin 1000mg + Clavulanate Potassium 62.5mg E.R tablet |
Anti-biotic |
08/06/2006 |
| 63 |
Lopinavir 200mg + Ritonavir 50mg Tablet (addl. Strength) |
Anti-HIV |
08/06/2006 |
| 64 |
Olopatadine Ophthalmic solution( 0.1%) |
For allergic conjunctivitis |
08/06/2006 |
| 65 |
Ferrous ascorbate (equivalent to 50mg Iron) + Folic acid 1.5mg. |
For iron deficiency anemia |
08/06/2006 |
| 66 |
Methyl Prednisolone Aceponate Cream (0.1%) |
For atopic dermatitis |
15/06/2006 |
| 67 |
Aspirin 150mg + Clopidogrel (as bisulphate) 300mg tablet (addl.
Strength) |
As loading dose for prevention of in-stent restenosis in PCI |
22/06/2006 |
| 68 |
Levofloxacin 0.5% Ear drops |
For otitis media |
27/06/2006 |
| 69 |
Olmesartan 40mg + HCTZ 25mg tablet (addl. Strength) |
Anti-hypertensive |
28/06/2006 |
| 70 |
Buclizine HCl tablet (25mg) & Syrup 6mg/5ml |
As appetite stimulant |
28/06/2006 |
| 71 |
Ceftriaxone (as sodium) 250mg + Tazobactam 31.25 mg for
injection (addl. Strength) |
Anti-biotic |
05/07/2006 |
| 72 |
Bimatoprost 300mg + Timolol (as maleate) 5mg/ml eye drops |
For reduction of IOP |
05/07/2006 |
| 73 |
Mebeverine HCl 135mg + Isabgula husk 3.5gm sachet. |
Irritable bowel syndrome |
06/07/2006 |
| 74 |
Solifenacin Succinate Tablet (5mg/10mg). |
For overactive bladder with urge urinary incontinence urgency
& urinary frequency |
06/07/2006 |
| 75 |
Zolpidem Tartrate E.R tablet (6.25mg/12.5mg). |
For insomnia |
10/07/2006 |
| 76 |
Deferasirox dispersible tablet 125/250/500mg. |
For chronic iron overload due to blood transfusion |
10/07/2006 |
| 77 |
Vitamin C 500mcg + Zinc Citrate 2.2mg + Selenium 60mcg tablet. |
For vitamin C deficiency |
12/07/2006 |
| 78 |
Lamivudine 40mg + Stavudine 10mg dispersible tablet. |
For HIV infection |
12/07/2006 |
| 79 |
Levocetrizine 2.5/5mg + Ambroxol 30mg/5ml of syrup |
For productive cough |
20/07/2006 |
| 80 |
Cefixime 200mg + Pot. Clavulanate (125mg) tablet |
Anti-biotic |
20/07/2006 |
| 81 |
ISMN SR 30mg + Aspirin75/150mg tablet (addl. Strength). |
Same as approved |
20/07/2006 |
| 82 |
Clobestasol Propionate (0.05%) + Calcipotriol Ointment (0.005%)
Ointment. |
For plaque psoriasis |
20/07/2006 |
| 83 |
Sodium Hyaluronate Injection (1%). |
For OA |
26/07/2006 |
| 84 |
Forskolin Eye drop (1%). |
For open angle glaucoma |
27/07/2006 |
| 85 |
Baclofen E.R capsule (30mg) |
For spasticity |
01/08/2006 |
| 86 |
Amisulpiride Tablet (50/100/200mg) |
For schizophrenic disorder |
01/08/2006 |
| 87 |
Quetiapine S.R tablet 200/300mg. |
For psychotic disorder |
01/08/2006 |
| 88 |
Lumiracoxib Tablet (100/200/400mg). |
For OA, RA acute pain & primary dysmenorrhoea |
01/08/2006 |
| 89 |
Tenofovir Disoproxil Fumarate300mg + Emtricitabin 200mg +
Efavirenz 600mg tablet |
For HIV-1 infection |
01/08/2006 |
| 90 |
Oxandrolone Tablet (2.5/10mg) |
To promote weight gain |
04/08/2006 |
| 91 |
Erdosteine 150mg + Guaiphenesin 50mg + Terbutaline 1.25mg per
5ml syrup |
Mucolytic |
08/08/2006 |
| 92 |
Rosiglitazone (as maleate)2mg + Glibenclamide 5mg + MetFormin
500mg tablet |
Anti Diabetic |
08/08/2006 |
| 93 |
L- Lysine Hcl Ointment (150mg/gm) |
For wounds of various etiology |
08/08/2006 |
| 94 |
Levocitirizine 2 Hcl 5mg+ Ambroxol Hcl SR 75mg + Pseudoephedrine
Hcl 120mg SR Capsules |
For SAR, PAR & Chronic idiopathic urticatia |
09/08/2006 |
| 95 |
Alprazolam SR 0.25mg + Sertraline (As Hcl) 25mg/50mg tablet |
For Panic disorder with or without agoraphobia |
09/08/2006 |
| 96 |
Dexibuprofen 200mg/300mg +Paracetamol 500mg tablet |
For RA, OA & ankolysing spondylosis |
10/08/2006 |
| 97 |
ISMN SR 60mg + Metoprolol Succinate ER 25/50mg |
For angina & Hypertension |
10/08/2006 |
| 98 |
Aspirin 75mg / 150mg + Glycine 37.5mg/75mg tablet |
For prevention of acute coronary syndrome in patients with CAD
prophylaxis against stroke |
10/08/2006 |
| 99 |
Combipack of 21 tablet of Quinin sulphate 600mg each & 8
capsule of Doxycycline (as Hcl) 100mg each) |
For P. Falciparam malaria |
10/08/2006 |
| 100 |
Pravastatin 40mg tablet (Additional strength) |
As Approved |
10/08/2006 |
| 101 |
Olanzapine powder For oral suspensian (10mg/5ml) |
For schizophrenia in adults |
11/08/2006 |
| 102 |
Cefepem (as Hcl) 0.5/1gm + Amikacin (as sulphate) 0.125/0.250gm
Inj. |
Antibiotic |
11/08/2006 |
| 103 |
Lamivudine 20mg + Nevirapine 35mg + Stavudine 5mg tablet |
Anti HIV |
11/08/2006 |
| 104 |
Nadifloxacin (10mg/gm) + Mometasone Furoate (1mg/gm) cream |
For mixed infection of skin |
17/08/2006 |
| 105 |
Premetrexed(Disodium) powder For solution For Inj. 500mg/vial |
Anti Cancer |
21/08/2006 |
| 106 |
Gliclazide 40mg/80mg + MetFormin Hcl 500mg + Rosiglitazone 2mg
tablet |
Ant- diabetic |
22/08/2006 |
| 107 |
Tiropramide Hcl (100mg) tablet |
For abdominal spasmodic pain, colics of hepatobilliary track,
abdominal colics |
22/08/2006 |
| 108 |
Eperisone Hcl (50mg ) tablet |
For neck-shoulder orm syndrome scapula hum oral per arthritis and low back pain |
23/08/2006 |
| 109 |
Caroverine cap. 20mg & Inj. 40mg/2ml |
For abdominal pain & tinnitus in adult |
23/08/2006 |
| 110 |
Paclitaxel nanoparticle Inj. (20mg/ml) |
For metastatic breast cancer |
23/08/2006 |
| 111 |
Amoxycillin 250mg + Dicloxacillin 250mg cap. |
Anti biotic |
28/08/2006 |
| 112 |
Rifaximine 200mg tab. |
For infections diarrhea in adults |
28/08/2006 |
| 113 |
Tigecycline powder For Inj. 50mg/vial |
For skin & skin structure infection & intra abdominal
infection |
28/08/2006 |
| 114 |
Stavudine SR 100mg tablet |
Anti HIV |
29/08/2006 |
| 115 |
Cefixime (50mg/100mg) + Clavulanic acid 31.125mg/62.5mg per ml
dry syrup & tablet |
Antibiotic |
29/08/2006 |
| 116 |
Ciclsonide 80mcg/160mcg + Formotorol 4.5mg inhaler |
Anti asthratic |
29/08/2006 |
| 117 |
Ciclsonide 100mcg/ 200mcg/400mcg + Formotorol Fumarate 6mg
rotacaps |
Anti asthmatic |
29/08/2006 |
| 118 |
Abacavir Sulphate syrup 20mg/ml |
For HIV Infection |
29/08/2006 |
| 119 |
S(-) pantoprazole (as sodium) 20mg (E.C.) + Domperidome SR 30mg
tablet |
FOR GERD |
30/08/2006 |
| 120 |
Cefadroxil 500mg + Clavulanic acid 125mg tablet |
Antibiotic |
30/08/2006 |
| 121 |
Cefadroxil 250mg + Clavulanic acid 62.5mg dispersible tablet |
Antibiotic |
30/08/2006 |
| 122 |
Cefadroxil 250mg + Clavulanic acid 62.5mg per 5ml syrup |
Antibiotic |
30/08/2006 |
| 123 |
Human Insulin (r-DNA) Powder inhaler |
For type-I & Type-2 Diabetes |
30/08/2006 |
| 124 |
Fulvestrant Inj. 250mg/5ml prefilled syringe |
Anti Cancer |
30/08/2006 |
| 125 |
S(-) Pantoprazole (as Sodium) Inj. 20mg/vial |
For peptic ulcer, GERD
& Zollinger Ellison Syndrome |
30/08/2006 |
| 126 |
Dasatinib tablet 20mg/50mg/70mg tablet |
For chronic hepatitis B infection |
30/08/2006 |
| 127 |
Telbivudine 600mg tablet |
For chronic hepatitis B infection |
30/08/2006 |
| 128 |
Aprepitant cap (80mg/125mg) |
For chemotherapy induced nausea & vomiting |
30/08/2006 |
| 129 |
Telmisartan 40mg + Amlodipine (as Besylate) 5mg tablet |
For essential hypertension |
30/08/2006 |
| 130 |
Gemifloxacin (as msylate) 320mg tablet |
Antibiotic |
30/08/2006 |
| 131 |
Ceftazidime 500mg /1000mg + Tazobactum (as sodium) 62.5mg/125mg
per vial for injection |
Antibiotic |
30/08/2006 |
| 132 |
Cefepime (As Hcl) 500mg/1000mg + Tazobactum (as Sodium)
62.5mg/125mg |
Antibiotic |
30/08/2006 |
| 133 |
Paromomycin Inj. 375mg/ml |
For visceral leishmaniasis (Kalaazar) |
30/08/2006 |
| 134 |
Cefixime 100mg + Cloxacillin (as Sodium) 500mg + Lactobacillus
(45 million spore)tab. |
Antibiotic |
31/08/2006 |
| 135 |
Alprazolam Dispersible Tab. 0.125mg/0.25mg/0.50mg |
For anxiety |
20/09/2006 |
| 136 |
Epinastine Hcl (0.05%) Opthlamic solution |
For allergic conjunctivitis |
22/09/2006 |
| 137 |
Levofloxacin tablet (250mg /500mg) & Infusion 5mg/ml (For
additional indication) |
For prostatitis |
26/09/2006 |
| 138 |
Feracrylum 1% mouth gargle 10mg/ml |
As hacmostatic agent in dental surgery |
28/09/2006 |
| 139 |
Aceclofenac Inj. (150mg/ml) |
For pain in post operative & post traumatic cases |
28/09/2006 |
| 140 |
combipack of one cap. Of aprepitant .125mg & two cap. Of
aprepitant 80mg each (combipack) |
As Approved |
10/10/2006 |
| 141 |
Formoterol fumarate 6mcg + Fluficasone propinate
50mcg/125mcg/250mcg MDI |
For Asthma & COPD |
14/10/2006 |
| 142 |
Amlodipine 25mg + Metoprolol 25mg (additional lower strength) |
|
01/11/2006 |
| 143 |
Estrogen vaginal tablet 25mcg |
For atropic viginitis |
02/11/2006 |
| 144 |
Esomeprazole 40mg (E.C.) + Itopride 150mg SR Capsules |
For GERD |
13/11/2006 |
| 145 |
Cefixime 200mg + Cloxacillin 500mg (ER) + Lactobacillus 90
million Spore tab. (additional strength) |
Antibiotic |
14/11/2006 |
| 146 |
Cefixime dispersible tablet 400mg (new dosage Form) |
Antibiotic |
22/11/2006 |
| 147 |
Trandalopril 1mg/2mg/4mg/2mg + Verapamil (ER)
240mg/240mg/240mg/180mg |
Anti hypertensive |
23/11/2006 |
| 148 |
Ciclesonide 160mcg/320mcg cap. for inhalation |
Anti asthmatic |
28/11/2006 |
| 149 |
Rabeprazole 20mg (EC) + Itopride SR 150mg |
For GERD |
28/11/2006 |
| 150 |
Metoprolol succinate 25mg /50mg ER + HCTZ 12.5mg |
Anti hypertensive |
30/11/2006 |
| 151 |
Atorvastatin 5mg + Fenofibrate 160mg (additional strength) |
As Approved |
01/12/2006 |
| 152 |
Aceclofenac Inj. 50mg/ml (additional strength) |
As Approved |
01/12/2006 |
| 153 |
Amisulpride 400mg tablet (additional strength) |
As Approved |
01/12/2006 |
| 154 |
Misoprostol tablet 25mcg/100mcg/200mcg (additional strength
indication |
For cervical ripening, prevention of post partum haemorrhage
& First trimester of aboration with mifepristone |
08/12/2006 |
| 155 |
Atazanavir 150mg + Ritonavir 50mg capsules |
Anti HIV |
12/12/2006 |
| 156 |
Mebeverine Hcl 135mg + Chlordiazepoxide 5mg tablet |
For IBS |
12/12/2006 |
| 157 |
Ampicillin 250mg + Dicloxacillin 250mg tablet |
Antibiotic |
13/12/2006 |
| 158 |
Etoricoxib 10mg + Methyl Salicylate 100mg + Mentol 50mg +
Linseedoril 30mg per gm. of Gel |
For acute Musculoskeletal pain |
14/12/2006 |
| 159 |
Racecadotril dispersible tablet (10mg/30mg) (new dosage Form) |
For diarrhea |
15/12/2006 |
| 160 |
Gabapentin ER 450/600/900mg tablet |
For naturopathic pain & partial Seizures |
15/12/2006 |
| 161 |
Aceclofenac dispersible tablet 100mg (new dosage form) |
As Approved |
21/12/2006 |
| 162 |
R-Ondansetron (As Hcl. Dihydrate) (1mg/ml) injection |
Chemotherapy induced nausea & vomiting |
12.01.07 |
| 163 |
Torsemide 10mg + Amiloride 5mg tablets |
Edema Associated with congestive heart failure &
hypertension |
17.01.07 |
| 164 |
Fexofenadine suspension (30mg/5ml) |
SeAsonal allergic rhinitis & chronic idiopathic urticaria |
19.01.07 |
| 165 |
Sildenafil Citrate 20mg Tablet |
For pulmonary osterial hypertension |
23.01.07 |
| 166 |
Pioglitazone 15mg/30mg + MetFormin ER 1000mg tablet (additional
strength) |
As approved |
23.01.07 |
| 167 |
FluvAstatin Tablet (As calcium) 10mg/20mg/40mg (additional
strength) |
As approved |
29.01.07 |
| 168 |
Halobetazol Propionate Cream (0.05%) |
Corticosteroid responsive dermatomes |
02.02.07 |
| 169 |
Eszopiclone tablet (1mg/2mg/3mg) |
For insomnia |
07.02.07 |
| 170 |
Diltiazem Hcl. 2% gel |
For anal fissure |
07.02.07 |
| 171 |
Nalbuphine injection 10mg/20mg per ml. |
For moderate to severe pain |
07.02.07 |
| 172 |
Levonorgestrel 1.5mg tablets |
For emergency contraceptive |
07.02.07 |
| 173 |
Pantaprazole sodium 20mg/40mg Tablet (with sodium bicarbonate As
buffer) |
For gAstric ulcer, duodenal ulcer, Z. E Syndrome, GERD |
07.02.07 |
| 174 |
levofloxacin (250mg/500mg) + ambroxol SR 75mg tablet |
For lower respiratory tract infection in adult |
08.02.07 |
| 175 |
Testosterone cypionate (100mg/200mg) + Cotton seed oil 736/566mg
per ml injection |
For testosterone deficiency (i) primary hypogonadism (ii)
Hypogonadotropine hypogonadism |
08.02.07 |
| 176 |
Rosiglitazone 1mg + Metofmin Hcl 500mg tablet (additional
strength) |
As approved |
08.02.07 |
| 177 |
Loteprednol Etabonate 5mg + Tobramycine 3mg per ml ophthalmic
solution |
For steroid responsive inflammatory ocular condition |
14.02.07 |
| 178 |
Amlodipine (As besylate) 5mg + Metoprolol (As succinate) ER 25mg
(additional strength) |
As approved |
14.02.07 |
| 179 |
Glibeneclamide 5mg + MetFormin SR 850mg tablet (additional
strength) |
As approved |
15.02.07 |
| 180 |
Aceclofenac injection (150mg/3ml) |
For short term treatment of pain due to post operative and post
traumatic cAses |
19.02.07 |
| 181 |
Metoprolol (As succinate) 50mg/25mg ER) + Amlodipine 5mg/2.5mg
tablet (For additional indication) |
Angina pectoris in adults |
20.02.07 |
| 182 |
Ramipril 10mg + HCTZ 12.5mg tablet (additional strength) |
As approved |
20.02.07 |
| 183 |
Amlodipine (As besylate) 5mg/5mg/10mg + valsartan
80mg/160mg/160mg tablet |
Essential hypertension |
21.02.07 |
| 184 |
Glatiramer Acetate injection (20mg/ml) |
Multiple sclerosis |
21.02.07 |
| 185 |
Baclofen ER (GRS) Capsule 45mg/60mg (additional strength) |
As approved |
22.02.07 |
| 186 |
Amlodipine (As besylate )5mg/10mg + Perindopril 4mg tablet |
For hypertension |
23.02.07 |
| 187 |
Olopatadine Hcl. Tablet 2.5mg/5mg |
Allergic nAsal inflammation hives, itching with skin diseAses |
26.02.07 |
| 188 |
Metoprolol (As succinate) ER 25mg/50mg + Ramipril 2.5mg/5mg |
Essential hypertension |
26.02.07 |
| 189 |
Rabeprazole Sodium 20mg/10mg with sodium bicarbonate As buffer |
For Duodenal ulcer, G.U, Z.E.S. & GERD |
26.02.07 |
| 190 |
Ciclesonide 160mcg/320mcg + Formoterol Fumarate (12mcg) (Dry
powder inhaler additional strength) |
As approved |
27.02.07 |
| 191 |
Moxonidine tablet 0.2mg/0.3mg/0.4mg |
For hypertension |
27.02.07 |
| 192 |
Ceftriaxone (As sodium) 125mg/250mg + Sulbactam (As sodium)
62.5mg/125mg For injection (additional strength) |
As approved |
01.03.07 |
| 193 |
Quetiapine (As fumarate) SR 400mg tablet (additional strength) |
As approved |
05.03.07 |
| 194 |
Cabergoline 1mg tablet (additional strength) |
For Hyperprolactinemia |
06.03.07 |
| 195 |
Levofloxacin Oral Solution (each 240ml bottle contains
Levofloxacin 125mg/5ml.) |
Antibiotic (For adult use only) |
07.03.07 |
| 196 |
Clindamycin 1% + Isotretinoin 0.05% gel |
For acne |
08.03.07 |
| 197 |
Estradiol topical emulsion 2.5mg/gm |
Vasomotor symptoms Associated with menopause |
16.03.07 |
| 198 |
Levosalbutamol MDI (50mcg/actuation) & Dry Powder inhaler
(100mcg/capsule) (New Dosage Form) |
As approved |
16.03.07 |
| 199 |
Polonosetron (As Hcl.) For Injection 0.25mg/5ml |
Chemotherapy induced nausea & Vomiting |
20.03.07 |
| 200 |
Cifixime 200mg + Erdosteine 300mg Capsules |
Acute Exacerbation of chronic bronchitis |
21.03.07 |
| 201 |
Aminophylline CR 225/350mg |
Asthma, COPD, Bronchitis |
21.03.07 |
| 202 |
Etoricoxib 10mg + Methyl salicylate 20mg per gm. of cream |
Acute Musenlosleteal pain |
21.03.07 |
| 203 |
Eberconazole cream (1%) |
Dermatophyte infection of skin such As T-corporis, T-c, T-Pedis |
22.03.07 |
| 204 |
ISMN 60mg Sr + Atenolol 50mg/100mg |
For angina pectoris |
23.03.07 |
| 205 |
Levonorgestrel 0.03mg tablet |
For control of fertility |
23.03.07 |
| 206 |
Bortezomib 2mg/vial (additional pack size) |
As approved |
28.03.07 |
| 207 |
Comb kit of two capsule of Azaranari 150mg each + 1 tablet of
Ritonavir 100mg) |
For HIV infection |
02.04.07 |
| 208 |
Mecobalamine 500mcg + Alpha Lipoic acid 100mg soft gelatin
capsule |
For diabetic neuropathy |
02.04.07 |
| 209 |
Propofol 10mg + Lignocaem 1mg per ml injection |
For induction of anesthesia |
04.04.07 |
| 210 |
Ezetimibe 10mg + Fenofibrate 160mg tablet |
For combined hypertipidemia |
04.04.07 |
| 211 |
Methylprednisolone Acrponate topical solution 0.1% |
Atopic dermatitis (eczema) inflammatory and allergic skin
reaction |
04.04.07 |
| 212 |
Citicoline (750mg) tablet
(additional strength), syrup 500mg/5ml
(new dosage Form) (not For children) |
As approved |
10.04.07 |
| 213 |
Ertapenem For injection (1gm/vial) |
Antibiotic |
10.04.07 |
| 214 |
Letrozole 2.5mg tablet (for additional indication) |
For induction of ovulation in anovulatory infertility (
additional indication) |
10.04.07 |
| 215 |
Quetiapine SR Tablets 50mg ( additional strength) |
As approved |
10.04.07 |
| 216 |
Metoprolol (As succinate) 25mg + Amlodipine (As besylate) 5mg
(additional strength) |
As approved |
10.04.07 |
| 217 |
Sunitinib Maleate Capsules 12.5mg/25mg/50mg |
For G.I. Stromal tumor, advanced renal cell carcinoma |
10.04.07 |
| 218 |
Comb pack of 1 bottle of ciprofloxacin Injection (200mg/100ml)
& 1 bottle of Ornidazole injection 500mg/100ml) |
Antibiotic |
20.04.07 |
| 219 |
Aprepitant 40mg capsules (additional strength) |
Prevention of post-operative nausea & vomiting (additional
indication) |
24.04.07 |
| 220 |
Olopatadime Ophthalmic solution (0.2%) (additional Strength) |
As approved |
24.04.07 |
| 221 |
Combi pack of 1 tablet of Residronate sodium (35mg) + 6 tablet
of calcium carbonate equivalent to 500mg calcium each |
For osteoporosis in postmenopausal women |
01.05.07 |
| 222 |
Levocetirizem 2Hcl. Dispersible tablet (2.5mg) |
For allergic rhinitis & chronic urticaria |
08.05.07 |
| 223 |
Amlodipine (As besylate) 10mg + Perindopril 8mg tablets
(additional strength) |
As approved |
07.05.07 |
| 224 |
Etodolac ER tablets 400mg/500mg |
For osteoarthritis & rheumatoid arthritis |
09.05.07 |
| 225 |
Levosulpiride tablet (25mg) |
For G.I. problem like fanatical dyspepsia, nausea, vomiting and
diabetic gAstroperisis |
10.05.07 |
| 226 |
Rimonabant tablet 20mg |
For Obese Patients BMI≥ 30kg/m2 or overweight patients
BMI≥ 27kg/m2 with Associated risk factors such As type-I diabetes or
dyslipidemia |
11.05.07 |
| 227 |
Lactitol monohydrate Syrup 66.67/100ml |
For constipation |
14.05.07 |
| 228 |
S(-) Metoprolol (As succinate) 25mg + S(-) Amlodipine (As
besylate 2.5/5mg |
For essential hypertension |
16.05.07 |
| 229 |
Amlexanox Oral PAste (5%) |
For apthous ulcers in people with normal immune system |
16.05.07 |
| 230 |
Lenalidomide capsule (5mg/10mg/15mg/25mg) |
For transfusion dependent anemia due to myalodysplastic syndrom
Associated with deletion 5q cytogenic abnormality |
16.05.07 |
| 231 |
Cefotaxim (As sodium) 0.5mg/1gm + Sulbactam (As sodium)
250mg/500mg injection (for additional indication) |
For surgical prophylaxis (additional indication) |
18.05.07 |
| 232 |
Lornoxicam tablet 4mg/ 8mg |
For Osteoarthritis rheumatoid arthritis |
21.05.07 |
| 233 |
Atenolol 25mg/50mg + Indapamide SR 1.5mg |
For essential hypertension |
21.05.07 |
| 234 |
Livetiracetam conc. for
infusion 100mg/ml (new dosage form) |
As adjunctive therapy in partial onset seizures in adults with
epilepsy when oral administration is temporarily not feasible |
21.05.07 |
| 235 |
Eplerstat tablet 50mg |
For abnormality of vibration sense and abnormal change in heart
rate associated with diabetic peripheral neuropathy |
25.05.07 |
| 236 |
Citicoline tablet 200mg (additional strength) |
As approved |
25.05.07 |
| 237 |
Varenicline (As tartrate) 0.5mg/1mg tablets |
As an aid to smoking cessation treatment in adults |
29.05.07 |
| 238 |
Azithromycin eye drops 1% |
Conjunctivitis |
06.06.07 |
| 239 |
Ciclesonide Nasal Spray 50mcg/spray |
For seasonal & perennial allergic rhinitis in adults,
adolescents aged ≥ 12 years |
08.06.07 |
| 240 |
Ceftazidime 500mg/1000mg + Sulbactam (As Sodium) 250mg/500mg For
injection |
Antibiotic |
08.06.07 |
| 241 |
Isotretinoin 0.05% +
Erythromycin 2% gel |
For acne |
08.06.07 |
| 242 |
Aliskiren Tablet 150mg/300mg |
For hypertension |
08.06.07 |
| 243 |
Glimepiride 1mg/2mg. + Metformin SR 1000mg tablet (additional
strength) |
As approved |
08.06.07 |
| 244 |
Cefditorene pivoxil dispersible tablet (30mg/50mg) (New Dosage
form for children) |
As approved |
08.06.07 |
| 245 |
Dexrabeprazole sodium Enteric Coated tablet 5mg/10mg |
For Duodenal ulcer, Gastric ulcer & GERD |
13.06.07 |
| 246 |
Renolazine Extend ReleAse tablet (500mg) |
For Chronic Angina |
14.06.07 |
| 247 |
Phenytoin sodium ER capsules (300mg) (New dosage form) |
For control of generalized toni-clonic and treatment &
prevention of seizures occurring during or following neurosurgery |
14.06.07 |
| 248 |
Alfuzocin Hcl. ER (10mg) + Dutasteride 0.5mg tablet |
For BPH in men with enlarged prostate |
14.06.07 |
| 249 |
Cefepime injection 500mg/1gm/2gm (For additional indication) |
For bacterial meningitis in children |
14.06.07 |
| 250 |
Tranexamic acid mouthwash (50mg/ml) |
For prevention of oral hemorrhage in anticoagulant treated
patients undergoing oral surgery |
15.06.07 |
| 251 |
Deflazocort oral suspension (6mg/5ml) (new Dosage Form) |
As approved |
15.06.07 |
| 252 |
Tolterodine tartrate ER 4mg + Tamsulocin Hcl. ER 0.4mg tablet |
For BPH with overactive bladder |
15.06.07 |
| 253 |
Omeprazole 20mg/40mg + Sodium Bicarbonate 1100mg capsules |
For duodenal ulcer, gastric ulcer & GERD |
15.06.07 |
| 254 |
Dexrabeprazole Sodium E. coated tablet 5mg/10mg. |
For duodenal ulcer, gastric ulcer and GERD. |
13-06-2007. |
| 255 |
Cefepime Injection (New indication) |
For bacterial meningitis in children. |
14-06-2007. |
| 256 |
Phenytoin Sodium E.R (300mg) |
For control of generalised tonic-clonic (grand-mal) and
prevention and treatment of seizures occuring during or following
neurosurgery. |
14-6-2007. |
| 257 |
Tranexamic acid Mouth Wash (50mg/ml) |
For prevention of oral hemorrhage in anticoagulant treated
patients undergoing oral surgery. |
15.6.2007. |
| 258 |
Deflazacort Oral Suspension (6mg/5ml) (New dosage form) |
For asthma, rheumatoid arthritis when glucocorticosteriod
therapy is warranted. |
15-06-2007. |
| 259 |
Tolterodine Tartrate 4mg (ER) + Tamsulosin HCL 0.4mg Capsule. |
For BPH with overaction bladder in Adults only. |
15-06-2007. |
| 260 |
Omeprazole (E.coated) 40mg + Sodium Bicarbonate 1100mg capsule. |
For gastric ulcer, duodenal ulcer and GERD. |
18-6-2007. |
| 261 |
Mebeverine HCl prolonged release capsule (200mg). |
For irritable bowel syndrome |
19-06-2007. |
| 262 |
Azithromycin 500mg + Ambroxol S.R (75mg) Tablet. |
For RTI caused by susceptible organisms in adults. |
05-07-2007. |
| 263 |
Pholcodiene Syrup (4mg/5ml). |
For symptomatic relief of dry ticklish and unproductive coughs
in children above 1 years. |
06-07-2007. |
| 264 |
Exenatide Injection -pre-filled pen (250mcg/ml). |
For adjunctive therapy to improve glycemic control in patients with Type-II diabetes mellitus,
who have not achieved adequate glycemic control with Metformin, a sulfonyl
urea or a combination of metformin and sulfonylurea. |
06-07-2007. |
| 265 |
Moxifloxacin HCL (0.5%) + Ketorolac Tromethamine 0.5% Ophthalmic
Solution. |
For reduction of post-operative inflammatory conditions of the
eyes. |
11-07-2007. |
| 266 |
Levofloxacin (15mg) + Prednisolone Acetate 10mg per ml eye
drops. |
For post-operative steriod responsive inflammatory ocular
conditions when ocular bacterial infections or a risk of bacterial infection
exists. |
11-07-2007. |
| 267 |
Loteprednol Etabonate (0.5%) + Levofloxacin (1.5%) Eye drops. |
For post-operative steriod responsive inflammatory ocular
conditions when ocular bacterial infections or a risk of bacterial infection
exists. |
12-07-2007. |
| 268 |
Clotrimazole (10mg) + Methyl-prednisolone aceponate 1mg/gm of
cream. |
For fungal infection of skin associated with inflammation. |
12-7-2007. |
| 269 |
Capecitabin Tablet (150mg/500mg). (for additional indication). |
(i). First line treatment of advanced gastric cancer in
combination with platinum based regimen.(ii). Treatment of patients with
locally advanced or metastatic breast cancer in combination with docetaxel
following failure of cytotoxic chemotherapy. |
16-07-2007. |
| 270 |
Rifabutin Capsule (150mg). |
For treatment of pulmonary T.B only in patients co-infected with
HIV. (It should never be used as a substitute to Rifampicin in T.B patients
without HIV co-infection). |
16-07-2007. |
| 271 |
Lapatinib (as Ditosylate) (250mg) Tablet. |
In combination with capecitabine it is indicated in patients
with advanced or metastatic breast cancer whose tumour overexpress HER2 and who have
received prior therapy including trastuzumab. |
24-07-2007. |
| 272 |
Levocetirizine Di-HCl mouth dissolving tablets (5mg) (new dosage
form). |
For the treatment of allergic rhinitis and chronic urticaria. |
25-07-2007. |
| 273 |
Idaravone Injection (1.5mg/ml). |
For improvement of neurologic symptoms, disorders of activitis
of daily living and functional disorder associated with acute ischemic
stroke. |
26-07-2007. |
| 274 |
Diclofenac Sodium (75mg/ml) Injection (addl. Strength). |
For management of painful conditions in post-operative cases,
rheumatoid arthritis and osteoarthritis. |
30-07-2007. |
| 275 |
Cefpodoxime (as Proxetil) (100mg/200mg) + Clavulanic acid
(62.5/125mg) tablet. |
For LRTI, URTI and UTI. |
30-07-2007. |
| 276 |
Atorvastatin (40mg) + Ezetimibe (10mg) Tablet (addl. Strength). |
As approved. |
30-07-2007. |
| 277 |
Cefepime (250mg) + Tazobactam (31.25mg) Injection (addl.
Strength). |
As approved. |
30-07-2007. |
| 278 |
VSL # 3 (Probiotic Blend) sachet |
For rotavirus diarrhoea in children. |
31-07-2007. |
| 279 |
Sorafenib (as Tosylate) (200mg) Tablet. |
For advanced renal cell carcinoma. |
31-07-2007. |
| 280 |
Methylcobalamin (500mcg) + Alpha Lipoic Acid (100mg) +
Pyridoxine (3mg) + Folic acid (1.5mg) Soft Gelatin Capsule. |
For diabetic neuropathy. |
31-07-2007. |
| 281 |
Halobetasol Propionate (0.5mg) + Salicylic Acid 30mg per gm
of ointment. |
For plaque psoriasis. |
01-08-2007. |
| 282 |
Combipack of 12 tablet of Artesunate (50mg) each + 3 tablet of
each containing Sulfadoxine (500mg) + Pyrmethamine (25mg) Tablet. (Addl.
Strength) |
As Approved |
01-08-2007. |
| 283 |
Omeprazole (20mg/40mg)+Sod. Bicarbonate-600mg+
Mg.Hydroxide-700mg .chew tab. |
For duodenal, gastric ulcer, GERD, and erosive esophagitis, |
1/8/2007 |
| 284 |
Deferasirox dispersible tablet (400mg) (addl. Strength). |
As approved |
17-08-2007. |
| 285 |
Tegafur (100mg) + Uracil (224mg) capsule. |
For first line treatment of metastatic colorectal cancer in
combination with calcium folinate. |
22-08-2007. |
| 286 |
Bortezomib Injection (additional indication) |
For the treatment of patients with mantle cell lymphoma who have
received at least one prior therapy. |
05-09-2007. |
| 287 |
Amlodipine (5mg) + Nebivolol (5mg) tablet (addl. Strength). |
As approved. |
06-09-2007. |
| 288 |
Ceftazidine (2gm) + Sulbactam (1gm) Injection ( addl. strength for additional
indication). |
For serious abdominal infection. |
06-09-2007. |
| 289 |
Polyethylin Glycol 400 (0.4%) + Propylene Glycol (0.3%). |
For temprory relief of dryness, irritation burning, stinging,
grittiness or foreign body sensation caused due to environmental factors. |
18-9-2007. |
| 290 |
Resperidone E.R. (long-acting) injection (12.5mg/vial) (addl.
strength). |
As approved. |
25-09-2007. |
| 291 |
Levocetirizine Di-HCl syrup (2.5mg/5ml) (for use in children 2
years and above). |
As approved. |
26-09-2007. |
| 292 |
R-Sibutramine Capsule (2.5mg/5mg) |
As an adjunctive therapy for the management of obesity including
weight loss and maintenance of weight loss in pateints whose BMI is 30Kg/m2 or higher. |
26-09-2007. |
| 293 |
Cefuroxime Axetil (250mg) + Clavulanic Acid (125mg) Tablet. |
For adult patients with infection caused susceptible
micro-organisms including S.aureus viz UTI, upper and lower RTI and
gonoccoccal urethritis. |
27-09-2007. |
| 294 |
Sulphur Hexafluoride Powder and solvent for dispersion for
injection (45mcg/ml). |
For diagnostic use in echocardiography doppler of
macrovasculature an doppler of microvasculature. |
28-09-2007. |
| 295 |
Ondansetron orally disintegrating tablet (4mg/8mg) (additional
dosage form) |
For chemotherapy induced nausea and vomiting |
28-09-2007. |
| 296 |
Cefuroxime Axetil (250mg) + Clavulanic acid (125mg) tablet. |
For UTI, URTI and LRTI and gonococcal urethritis. |
05-10-2007. |
| 297 |
Cefuroxime-125/250/500mg +Clav.Acid-31.25/62.5/125mg |
For adult patients with infection caused by susceptible
microbs,including s.aureus.(e.g-UTI,Upper&lower RTI & gonococcal
urethrities) |
5/10/2007 |
| 298 |
Amiodarone Injection (additional Indication). |
For cardiopulmonary resuscitation in the event of cardiac arrest
related to ventricular fibrilation resistant to external electric shock. |
05-10-2007. |
| 299 |
Risedronate Sodium tablet (35mg) (additional indication) |
For osteoporosis in men at high risk of fracture. |
08-10-2007. |
| 300 |
Sucralfate (70mg ) + Metronidazole (10mg) + Povidone Iodine
(50mg) per gram of Ointment. |
For infected wounds and ulcers. |
09-10-2007. |
| 301 |
Levetiracetam Tablet (addl. indication) |
(i)
(i) As monotherapy in partial onset seizures with or without secondary
generalisation in patients with 16 years of age with newly diagnosed
epilepsy. (ii) As adjunctive therapy in myoclonic
seizures in adults and adolescents from 1 |
09-10-2007. |
| 302 |
Combipack of two tablet of chloroquine phosphate (250mg) each +
14 tablet of Proguanil HCl (100mg) each |
For drug resistant malaria. |
10-10-2007. |
| 303 |
Paclitaxel (protein bound particle) for injectable suspension
(paclitaxel (100mg) + Albumin Human 900mg per 20ml. |
For breast cancer after failure of combination chemotherapy for
metastatic disease or relapse within 6 months of adjuvant chemotherapy. |
11-10-2007. |
| 304 |
Olmesartan Medoxomil (20mg) + Amlodipine Besylate (5mg) Tablet. |
For mild to moderate hypertension. |
15-10-2007. |
| 305 |
Atorvastatin Calcium (10mg ) + Ramipril (2.5mg/5mg) tablet |
For treatment of patients with both hypertension and
hypercholesterolemia. |
15-10-2007. |
| 306 |
Omeprazole(20mg) + Sodium bicarbonate (1100mg) tablet (addl.
strength). |
As approved. |
15-10-2007. |
| 307 |
Moxifloxacin HCl (5mg) + Prednisolone Acetate (10mg)per ml. (eye
drops) |
For inflammation after ocular surgery and where a risk of
bacterial ocular infection exists. |
16-10-2007. |
| 308 |
Methylcobalamine (500mcg) + Alpha Lipoic acid (100mg) +
Pyridoxine HCl (1.5mg) + Thiamine (2mg) + Calcium Picolinate (200mg) tablet. |
For diabetic neuropathy. |
16-10-2007. |
| 309 |
Satranidazole (300mg) + Ofloxacin (200mg) Tablet. |
For diarrhoea of mixed infection in adults. |
18-10-2007. |
| 310 |
Methylcobalamin 500mcg+beta carotine-10.33mg+alpha lipoic acid
100mg+B6 1.5mg+B1 2mg & Cr.polynicotinate. |
For adult patients with diabetic neuropathy. |
18-10-2007. |
| 311 |
Calcium Pidolate equivalent to Calcium 500mg + Vit-D3 250 IU |
For osteoporosis and calcium deficiency state. |
23-10-2007. |
| 312 |
Etizolam Tablet (0.5mg/1mg). |
For anxiety disorder associated with depression. |
29-10-2007. |
| 313 |
Oxaprozine Tablet (600mg) |
For relief of signs and symptoms of osteoarthritis, rheumatoid
arthritis. |
30-10-2007. |
| 314 |
Prulifloxacin (600mg) Tablet. |
For acute uncomplicated lower urinary tract infection (simple
cystitis), complicated lower UTI, acute exacerbation of chronic bronchitis. |
30-10-2007. |
| 315 |
Cilostazole E.R Tablet (100mg/200mg). |
For management
intermittent claudication. |
30-10-2007. |
| 316 |
Atorvastatin Calcium (10mg) + Fenofibrate (145mg) (addl.
strength) |
As Approved |
30-10-2007. |
| 317 |
Sitagliptin Tablet (25mg/50mg/100mg). |
As adjunct to diet and exercise to improve glycemic control in
patients with type-II diabetes. |
30-10-2007. |
| 318 |
Miglitol (50mg) + Metformin HCl SR (500mg) tablet. |
For adult with Type-II diabetes mellitus where simple drug
therapy, diet and exercise do not result in adequate glycemic control. |
31-10-2007. |
| 319 |
Mupirocin (2%) + Methylprednisolone Aceponate (0.1%) Cream. |
For atopic dermatitis. |
31-10-2007. |
| 320 |
Methyl cobalamine 500mcg+folic acid1.5mg+B5-5mg,+Zn.sulphate
25mg+Cr.Polynicotinate 200mcg+selenium-65mcg+inositol-1.5mg + alpha lipoic
acid –100mg capsule |
For Vitamins and mineral deficiency states. |
31-10-2007 |
| 321 |
Methylcobalamine 500mcg+folic acid1.5mg+ alpha lipoic acid
–300mg +Benfetiamin-50mg. capsule |
For diabetic neuropathy |
13-11-2007 |
| 322 |
Methyl prednisolone aceponate-1mg + salicylic acid-50mg ointment |
For treatment of psoriasis |
19-11-2007 |
| 323 |
Propanol 50gm+povidone iodine-1gm in 100ml solution |
For surgical & hygenic hand disinfection. |
19-11-2007 |
| 324 |
Propanol-18 gm+Ethenol(100%)-45gm in 100ml solution |
-do- |
19-11-2007 |
| 325 |
Voglibose disp.tab.0.2mg/0.3mg |
As Approved |
20-11-2007 |
| 326 |
Ceftriaxone –2gm+ Tazobactum 250mg for injection |
As Approved |
21-11-2007 |
| 327 |
Methylprednisolone aceponate-1mg + Mupirocin-20mg. cream |
For the treatment of atopic dermatitis |
21-11-2007 |
| 328 |
Citicholine(as Sod.)-200mg/500mg/750mg granules per sachet. |
As Approved |
26-11-2007 |
| 329 |
Butarphenol tartrate 10mg/ml nasal spray |
For management of pain in patients using opioid analgesics. |
26-11-2007 |
| 330 |
Deferasirox 100mg dis.tablet(addl. strength) |
As Approved |
28-11-2007 |
| 331 |
Methyl cobalamine 500mcg+folic acid1.5mg+B6-3mg,+Zn.sulphate
61.8mg+Ca.Pantothenate 10mg+ Niacinamide-50mg +chrimium-50mcg capsule |
For Vitamins and mineral deficiency patients. |
29-11-2007 |
| 332 |
Methylcobalamine 500mcg+folic acid 1.5mg+ alpha lipoic acid
–100mg +B6-3mg+Thiamine 10mg capsule |
For diabetic neuropathy |
29-11-2007 |
| 333 |
Doxophylline-400mg+Salbutamol(as sulphate)-2mg/4mg Tablets |
For treatment of Bronchial asthma in adults |
29-11-2007 |
| 334 |
Gatifloxacin (as sequihydrate)-3mg + Flurbiprofen sod.-0.3mg/ml
eye drops. |
For reduction of post-operative inflammatory conditions of eye
,when bacterial infection exists. |
29-11-2007 |
| 335 |
Sertanidazole-300mg+ Ofloxacin-200mg tablet |
For treatment of diarrhoea of mixed infection in adults
patients. |
29-11-2007 |
| 336 |
Zoledronic acid 5mg/100ml solution for infusion (addl.
indication). |
Post-menopausal osteoporosis. |
6-12-2007. |
| 337 |
Olmesartan medoximil-20mg + Ramipril-5mg. tablet |
For treatment of essential hypertention. |
6/12/2007 |
| 338 |
Levosulpiride Tablet (50mg/100mg) (addl. strength for addl.
indication). |
For depression and schizophrenia in adults. |
6/12/2007 |
| 339 |
Combipack of 12 Artesunate –50mg tablets & 6 Mefloquin-250mg
tablets |
For drug resistant P.falciparum malaria infection. |
6/12/2007 |
| 340 |
Pregabalin-75mg/150mg +Methylcobalamine 500mcg cap |
For the treatment of adult patients with peripheral neuropathy. |
10/12/2007 |
| 341 |
Doxycycline-100mg +L.bacillus spores-5 billion |
For adult patients prone to intrabdominal bacterial infection
& Antibiotic associated diarrhoea |
11/12/2007 |
| 342 |
Cefprozil 250mg/500mg+Clav. Acid-62.5mg /125mg. tab |
For the treatment of adult patients with upper&lower RTI,
Skin & Skin structure infection |
11/12/2007 |
| 343 |
Dextrometharpahan HBr-10mg+Chlorphenaramine maleate-2mg /5ml
syrup. |
For the temporary relief of cough due to throat irritation,
sneezing & ruunning nose. |
11/12/2007 |
| 344 |
Lornoxicam 8mg /2ml inj. |
For Short-term treatment of mild to moderate pain, when oral
administration is inappropriate(i.e after dental surgery) |
11/12/2007 |
| 345 |
Apomorphine HCL-2mg/3mg Sublingual tablet. |
For erectile dysfunction in adult men. |
11/12/2007 |
| 346 |
Escitlopram (as oxalate)10mg + Clonazepam-0.5mg tablet (addl.
Strength). |
For comobid depression and anxiety disorder. |
12/12/2007 |
| 347 |
Doxophylline injection-10mg /ml |
For bronchial asthama & COPD in adult patients, when oral
therapy is in approriate. |
31-12-2007 |
| 348 |
Me-salicylate 30% + Menthol 10% + camphor 4% Cream |
For temporary relief from pain, swelling & inflammation due
to musculoskeletal disorder |
29.11.07 |
| 349 |
Voglibose 0.2mg/0.3mg tablet (Mouth dissolving) |
For improvement of parantial hyperphemia in diabetis mellitus only. When diet and/or
exercise or oral, hypoglyceamic drug or insulin preparation in addition to
diet and or exercise do not result in adequate glycemic control. |
28.12.07 |
| 350 |
Hydroxychloroquine 400mg tablets (Additional Strength) |
Same as Approved |
31.01.08 |
| 351 |
ISMN 30mg SR + Metoprolol Succinate equivalent to metoprolol
tartrate 25mg/50mg tablets (Additional Strength) |
Same as Approved |
02.01.08 |
| 352 |
Halobetasol 0.05% + Clotrimazole 1.0% cream |
For the treatment of steroid responsive fungal infections
including eczema and psoriasis |
04.01.08 |
| 353 |
Citicholine Syrup 750mg/5ml |
For the treatment of disturbance of consciousness resulting from
head injuries, brain operation and acute stage of cerebral infarction in
adults only |
04.01.08 |
| 354 |
Levodopa 200mg + Carbidopa 50mg C.R. tablet |
For Parkinson's Disease |
08.01.08 |
| 355 |
Nanocrystalline Silver Gel 0.002% |
For the treatment of burns and wound infections |
04.01.08 |
| 356 |
Cinitapride (as hydrogen tartrate) 1mg tablet |
For the treatment of gastroesophageal reflux disease and
functional inconveniences of the gastrointestinal motility |
04.01.08 |
| 357 |
Tenofovir disoproxil fumarate 300mg + Lamivudine 300mg tablet |
For the treatment of adult patients with HIV infection |
07.01.08 |
| 358 |
Cefixime 200mg/100mg + Lactic acid bacillus 2.5 billion spores
tablet & dispersible tablet |
For the treatment of Urinary tract infections, respiratory tract
infections, biliary tract infections in adult patients prone to antibiotic
associated diarrhoea |
07.01.08 |
| 359 |
D-Trans Fentanyl Metrix system (12mcg/hr.) (Additional Strength) |
Same as Approved |
07.01.08 |
| 360 |
Ceftazidime 500mg + Tobramycin 60mg per vial (Injection) |
For the treatment of lower respiratory tract infection caused by
pseudomonas aeruginosa |
08.01.08 |
| 361 |
Atazanavir 300mg capsules (Additional strength) |
Same as approved |
08.01.08 |
| 362 |
Ertapenem for injection 1gm/vial (additional indication) |
For the prophylaxis of surgical site infections following
elective colorectal surgery |
15.01.08 |
| 363 |
Vildagliptin Tablets 50mg/100mg |
As an adjunct to diet and exercise to improve glycemic control
in patients with type-II diabetes mellitus |
18.01.08 |
| 364 |
Atorvastatin 10mg + Aspirin 75/150mg Capsules |
For the treatment of dyslipidemia associated with
atherosclerotic arterial disease with risk of myocardial infarction, stroke
or peripheral vascular disease |
18.01.08 |
| 365 |
Smatriptan (as succinate ) 50mg + Naproxen sodium 550mg tablets |
For the treatment of acute migraine |
22.01.08 |
| 366 |
Sodium Valproate 666mg + valproic acid 290mg equivalent as sodium valproate 1000mg C.R. tablet
(Additional Strength) |
Same as Approved |
24.01.08 |
| 367 |
Cefepime (as hydrochloride) 2000/1000/500mg + Sulbactam (as
sodium) 1000/500/250mg per vial of injection |
For serious CRTI, uncomplicated and complicated UTI,
Uncomplicated skin & skin
structure, infection acute exacerbation of chronic bronchitis &
intraabdominal infection. |
24.01.08 |
| 368 |
Paclitaxel Nanoparticle Solution for Injection 20mg/ml
(Additional indication) |
Ovarian cancer, non-small cell lung cancer and AIDS related
Kaposis Sarcoma |
22.01.08 |
| 369 |
Sorafenib tablets 200mg (Additional Indication) |
For hepatocellular Carcenoma |
22.01.08 |
| 370 |
Zanamavir inhalation powder 5mg/blister (Additional Indication) |
For prophylaxes and treatment of both influenza A & B in
adults and children (greater than or equal to 5 years) |
22.01.08 |
| 371 |
Mycophenolate Mofetil Capsule 250mg, 500mg & Oral suspension 200mg/ml
(Additional Indication) |
For the prophylaxis of acute organ rejection in patients
receiving allogeneic hepatic transplantation |
23.01.08 |
| 372 |
Combikit 4 tablets of
Alendronate sodium trihydrate equivalent to Alendronic acid 70mg each + 24
tablets of Calcium carbonate 1250mg (equivalent to 500mg Calcium) +
cholecalciferol-250IU |
For the treatment of osteoporosis in post-menopausal women |
23.01.08 |
| 373 |
Aceclofenac injection 150mg/ml |
For short term treatment of pain due to post operative and post
traumatic cases |
23.01.08 |
| 374 |
Atorvastatin 10mg + Fenofibrate 80mg tablet (Additional
Indication) |
For the treatment of uncomplicated and complicated UTI,
uncomplicated skin and skin structure infections, and complicated
intra-abdominal infections |
25.01.08 |
| 375 |
Sodium Valproate 499.5mg + Valproic acid 217.5mg equivalent as sodium valproate- 750mg CR tablet
(Additional Strength) |
Same as Approved |
24.01.08 |
| 376 |
Diclofenac 50mg + Serratiopeptidase 10mg enteric coated tablet |
For the treatment of acute pain in adults |
24.01.08 |
| 377 |
Gabapentin 100mg + methylcobalamin 500mcg tablets (Additional
Strength) |
Same as Approved |
24.01.08 |
| 378 |
Cefpirome (as sulphate) 500/1000mg/2000mg + Sulbactam (as sodium
) 250mg/500mg/1000mg powder for injection |
For the treatment of infection caused by sensitive organisms
viz. lower RTI, complicated UTI, Septicemia, bacteremia |
24.01.08 |
| 379 |
Metformin HCl ER 500mg +
Fenofibrate 80mg/160mg tablet |
For the treatment of Type-II diabetes associated with mixed
dyslipidemia |
25.01.08 |
| 380 |
Salicylic acid 10mg/20mg (Foaming facewash solution) |
For the treatment of acne vulgaris |
28.01.08 |
| 381 |
Ozagrel Hcl. Tablets 100mg/200mg |
For the treatment of bronchial asthma |
28.01.08 |
| 382 |
Rivastigmine transdermal patch (each patch of 5m2, 10m2,15m2
& 20m2 contain Rivastigmine base 9/18/27/36mg respectively |
For the treatment of patients with mild to moderately severe
dementia of the Alzheimer type and dementia associated with Parkinsons
disease |
28.01.08 |
| 383 |
Daptomycin powder for concentrate for solution for infusion
(350mg/500mg per vial) |
For the treatment of complicated skin and skin structure
infections and for staphylococus aureus bloodstream infections (bacteremia) |
28.01.08 |
| 384 |
Dextromethorphan Orodispersible strip 5.5mg/11mg |
For the relief of persistent dry irritating cough in adult
patients only |
28.01.08 |
| 385 |
Diclofenac sodium 50mg + Dicyclomine HCl 20mg per ml of
injection |
For the treatment of acute colicky pain in adults |
28.01.08 |
| 386 |
Travoprost 40mcg + Timolol (as Maleate) 5mg per ml of eye drops |
For decrease of intraocular pressure in patients with open angle
glaucoma or ocular hypertension, who are insufficiently responsive to topical
beta blockers or prostaglandin analogues |
28.01.08 |
| 387 |
Amoxicillin 250mg/125mg + Cloxacillin 250mg/125mg + Lactic Acid
Bacillus 1.7 Billion spores |
For RTI, SRS of tissue infection, bons & joint infection,
ENT infection in adults prone to antibiotic associated diarrhoea |
30.01.08 |
| 388 |
Amoxicillin 250mg + Lacto- Bacillus 1.7 billion Spores |
For RTI, SRS of tissue infection, bons & joint infection,
ENT infection in adults prone to antibiotic associated diarrhoea |
31.01.08 |
| 389 |
Amoxycillin 250mg + Cloxacillin 250mg + Lactobacillus 2 billion
spores capsules |
For the treatment of lower RTI, skin & soft tissue bone
& joint infections, ENT infections in adult patients prone to antibiotic
associated diarrhoea |
30.01.08 |
| 390 |
Tiotropium (as Tiotropium Bromide Monohydrate) 18mcg +
Formoterol Fumarate Dihydro. 12mcg + Ciclesomide 400mcg per capsules |
As 3rd line treatment of sever cases of COPD when monotherapy
and second line therapy with two drugs do not respond adequately |
31.01.08 |
| 391 |
Metoprolol Succinate Equivalent to Metoprolol Tartrate [ER
25/50mg] + Atorvastatin (As calcium ) 10mg tablets |
For the treatment of patient with both essential hypertension
and hypercholesterolemia |
28.01.08 |
| 392 |
Levocetrizine Di HCl Dispersible tablet 5mg/10mg (New Dosage
form) |
For allergic rhinitis & chronic urticaria |
28.01.08 |
| 393 |
Oseltamivir 30mg & 45mg Capsules (Additional Strength) |
Same as Approved |
28.01.08 |
| 394 |
Fondaparinax Sodium injection (Additional Indication) |
Treatment of acute coronary syndrome (ACS) with and without
ST-segment elevation |
28.01.08 |
| 395 |
Camostat Mesylate tablets 100mg |
For remission of acute symptoms of chronic pancreatitis and
post-operative reflux esophagitis |
29.01.08 |
| 396 |
Hyaluronic Acid Salt 25mg + Cross-Linked Hyaluronic acid 25mg
per ml in prefilledsyringe |
For intradermal implantation and facial soft tissue agumentation |
30.01.08 |
| 397 |
Ursodeoxycholic acid tablets 600mg |
For the treatment of patients with chronic cholestatic liver
disease |
30.01.08 |
| 398 |
Dalteparin Sodium Injection(Additional Indication) |
For the extended treatment of symptomatic venous thromboembolism
(VTE) proximal deep thrombosis (DVT) and/or pulmonary embolism (PE), to
reduce the recurrence of VTE in patients with cancer |
30.01.08 |
| 399 |
Beclomethasone Dipropionate 0.25mg + Econazole 10mg + Neomycin
5mg per gm of Cream |
For the topical treatment of bacterial and fungal infections |
30.01.08 |
| 400 |
Exenatide injection (Each 2ml vial contains- Exenatide
5mcg/10mcg per 0.2ml ) (Additional Strength) |
For adjunctive therapy to improve glycemic control in patients
with type-II diabetes mellitus, who have not achieved adequate glycemic
control with metformin, a sulfonylurea or a combination of metformin and a
sulfonylureas |
30.01.08 |
| 401 |
Diclofenac Sodium 50mg + Paracetamol 500mg tablets |
For the symptomatic treatment of acute pain and inflammation in
patients with osteoarthritis, rheumatoid arthritis and ankylosing spondylitis |
30.01.08 |
| 402 |
Gabapentin SR 600mg tablets |
As adjunctive therapy in the treatment of partial seizures of
epilepsy |
30.01.08 |
| 403 |
Memantine 5mg /10mg + Donepezil 5mg Tablets |
For moderate to severe Alzheimer's disease |
31.01.08 |
| 404 |
Doxifluridine Capsules 100mg/200mg |
For carcinoma of the stomach, colon, rectum, breast, uterine,
cervix and bladder |
31.01.08 |
| 405 |
Haemodialysis Powder/Liquid Form containing citrate |
For use for patients being treated by hemodialysis |
31.01.08 |
| 406 |
Carmustine (polifeprosan 20 with carmustine Implant (Wafer) |
1:- In newly diagnosed high-grade malignant glioma patients as
an adjunct to surgery and radiation. 2:- In recurrent glioblastoma multiforme
patients as an adjunct to surgery |
31.01.08 |
| 407 |
Cimetropium Bromide tablet 50mg |
For the treatment of irritable bowel syndrome |
31.01.08 |
| 408 |
CyclobenzaprineHcl. Tablets 5mg/10mg |
As adjunct to rest and physical therapy for relief of muscle
spasm associated with acute painful musculoskeletal conditions |
31.01.08 |
| 409 |
Sertaconazole Nitrate Cream 2%, |
For the topical treatment of the superficial mycosis like
dermatophytosis |
31.01.08 |
| 410 |
Cefpodoxime 50mg + Clavulanic acid 31.25mg dispersible tablet
& dry syrup (Additional strength) |
Same as Approved |
31.01.08 |
| 411 |
Darifenacin (as hydrobromide) 7.5mg/15mg ER tablets |
For the treatment of overactive bladder with symptoms of urge
urinary incontinence, urgency and frequency |
31.01.08 |
| 412 |
Amoxycillin 125mg/250mg/500mg + Lactobacillus 1.66 billion
Spores (Capsules) |
For the treatment of respiratory tract infection, skin and soft
tissue infections & antibiotics associated diarrhoea in adult patients |
31.01.08 |
| 413 |
Halobetasol 0.5mg + Miconazole 20mg per gram Cream |
For steroid responsive dermatoses associated with superficial
fungal infection of skin |
31.01.08 |
| 414 |
Montelucast 10mg + Levocetirizine 5mg film coated tablets |
For the treatment of allergic rhinitis in adults only |
31.01.08 |
| 415 |
Hydroquinone 2% + Tretinoin 0.025% (w/w) Momentasone 0.10% Gel |
For short term intermittent treatment of moderate to severe
melasma of the face in the presence of measures for sun avoidance including
use of sun screen |
31.01.08 |
| 416 |
Phenylephrine 5mg + Chlorpheniramine maleate 0.5mg + Paracetamol
125mg + sodium citrate 60mg + Menthol 1mg (per 5ml) Syrup |
For the treatment of common cold and cough associated with fever |
31.01.08 |
| 417 |
Diclofenac Sodium 100mg (SR Pellets) + Rabeprazole Sodium 20mg
(E.C Pellets) Capsules |
For treatment of painful inflammatory conditions associated with
gastroduodenal ulcers |
31.01.08 |
| 418 |
Ciclesonide 160mcg/320mcg/Formoterol 12mcg + Tiotropium 18mcg
Dry powder inhaler |
As third line treatment of severe cases of COPD, when
monotherapy and second line therapy with two drugs do not respond adequately |
31.01.08 |
| 419 |
VSL # (Combination of lactic acid bacteria (VSL # 3) |
For the treatment of irritable bowel syndrome |
31.01.08 |
| 420 |
Clostimethate Sodium of 1,00,000IU Injection |
For the treatment of serious infection caused Gram-Ve bacteria
including LRTI, UTI, where commonly used anti bacterial agent may be
infective because of bacterial resistance |
31.01.08 |
| 421 |
Ramipril 5mg + HCTZ 12.5mg tablets (Additional Strength) |
Same as Approved |
20.02.08 |
| 422 |
Metronidazole CR tablet 600mg |
For the treatment of amoebiasis, urogenital trichomoniasis &
giardiasis |
21.02.08 |
| 423 |
Quetiapine fumarate SR tablets |
for the additional indication "acute manic episode
associated with bipolar disorder |
21.02.08 |
| 424 |
Atorvastatin Calcium 80mg tablets (Additional Strength) |
additional Strength (it should not be used routinely because of
increased risk of adverse events. It
should be reserved for patients who are considered to be at higher risk after
careful risk assessment |
25.02.08 |
| 425 |
Euphorbia Prostrata Dry Extract (ethanolic 80% (v/v) (35-70)
:100mg tablet |
For the treatment of haemorrhoid |
29.02.08 |
| 426 |
Amtolmetin Guacil tablets 600mg |
For the treatment of osteoarthritis & rheumatoid arthritis |
07.03.08 |
| 427 |
Brimonidine Tartrate Opthalmic solution 0.1% (with purite as
preservation 0.0005%) (additional strength) |
For lowering of IOP in patients with open angle glaucoma occular
hypertension |
07.03.08 |
| 428 |
Methoxsalen USP-20mg Tablet |
1:- For repigmentation of idiopathic vitiligo alongwith
phototherapy. 2:- For symptomatic control of severe, recalcitrant, disabling
psoriasis in conjunction with phototherapy |
07.03.08 |
| 429 |
Cefditoren pivoxil 400mg tablets (Additional Strength) |
Same as Approved |
11.03.08 |
| 430 |
Doxofylline ER tablets 400mg/800mg (addl. Strength) |
For the treatment of bronchial asthma & COPD in adults |
12.03.08 |
| 431 |
Betamethasone 0.05% +Miconazole 2% Cream |
For the treatment of steroid responsive dermatoses associated
with superficial fungal infections of the skin |
12.03.08 |
| 432 |
Premetrxed disodium injection 100mg/vial (Additional Strength) |
Same as Approved |
12.03.08 |
| 433 |
Omeprazole 20mg/40mg + Sodium bicarbonate 1680mg per sachet
powder for oral suspension |
For gastric ulcer, duodenal ulcer, and GERD |
12.03.08 |
| 434 |
ISMN 30mg SR + Atenolol 50mg tablets (Additional Strength) |
Same as Approved |
19.03.08 |
| 435 |
Temozolamide capsules 140mg/180mg (Addl. Strength) |
Same as Approved |
31.03.08 |
| 436 |
Amisulpiride 300mg tablets (Additional Strength) |
Same as Approved |
20.03.08 |
| 437 |
Nifedipine SR Tablets 10mg/20mg |
For the treatment of essential hypertension |
24.03.08 |
| 438 |
Ambroxol HCl. 15mg + Guiphenesin 50mg + Terbutalin sulphate
1.25mg + Menthol 2.5mg per 5 ml of syrup |
For symptomatic relief of bronchospasm in bronchial asthma and
chronic bronchitis |
26.03.08 |
| 439 |
Ambroxol HCl 30mg + Guaiphenesin 100mg + Terbutaline sulphate
2.5mg per 10ml Syrup |
For the symptomatic relief of bronchospasm in bronchial asthma
& chronic bronchitis |
26.03.08 |
| 440 |
Boswellia Serrata 0.05gm/gm of Cream |
For the treatment of mild to moderate psoriasis |
28.03.08 |
| 441 |
Etoricoxib injection 90mg/ml |
For short term use in acute painful condition in adults only |
28.03.08 |
| 442 |
Drospirenone 3mg + Ethinyl estradiol 0.02mg tablets (Additional
Strength) |
Oral contraceptive in
women |
28.03.08 |
| 443 |
Nimesulide 100mg ER + Levocetirizine HCl 5mg Tablets |
For symptomatic treatment of acute rhinosinusitis |
28.03.08 |
| 444 |
Dexketoprofen (as Trometamol ) tablets 12.5mg/25mg |
For the treatment of mild to moderate pain, such as dental pain,
dysmenorrhoea & musculoskeletal pain |
28.03.08 |
| 445 |
Nepafenac Opthalmic suspension (1mg/ml) |
For the treatment of pain and inflammation associated with
cataract surgery |
31.03.08 |
| 446 |
Hylan GF 20 Injection (Synvisc) (Additional Indication) |
For pain management in patients suffering with osteoarthritis of
the knee, hip, shoulder and ankle |
31.03.08 |
| 447 |
Docetaxel injection conc. |
For additional indication "advanced gastric adenocarcinoma,
locally advanced squamous cell carcinoma of head & neck, Harmone refraetory metastatic prostrate
cancer, locally advanced or metastatic breast cancer |
31.03.08 |
| 448 |
Methylcobalamin 1000mcg + Pyridoxine Hcl IP 100mg + Nicotinamide
IP 100mg + D-Panthenol IP 50mg per 2 ml of injection |
For peripheral neuropathy |
31.03.08 |
| 449 |
Lamivudine 20mg + Stavudine 5mg dispersible tablets (Additional
Sgtrength) |
Same as Approved |
01.04.08 |
| 450 |
Nicardipine Hcl. Injection 2.5mg/ml |
For short-term treatment of hypertension when oral therapy is
not feasible or not desirable |
07.04.08 |
| 451 |
Diclofenac Potassium 50mg + Serratiopeptidase (as enteric coated
pellets) 15mg capsules (Additional Strength) |
For the treatment of acute pain in adults |
08.04.08 |
| 452 |
Diacerin 50mg + Aceclofenac 100mg tablets |
For the treatment of adult patients with osteoarthritis of knee
and or hip joints |
11.04.08 |
| 453 |
Rabeprazole sodium Enteric coated pellets 15.4% w/w
(20mg/129.83mg) |
Same as Approved |
16.04.08 |
| 454 |
Live freeze-dried lactic acid bacteria and bifidobacteria
capsules |
For the treatment of irritable bowel syndrome |
10.04.08 |
| 455 |
Miltefosin Capsule 10mg/50mg (Additional Indication) |
Treatment of cutaneous leishmaniasis |
16.04.08 |
| 456 |
Silver Wound Dressing |
As an antimicrobial barrier for management of partial thickness
burns, incisions, skin grafts, donor sites, lacerations, abrasions and Stage
I-IV dermal ulcers (vascular, venous, pressure and diabetic) |
16.04.08 |
| 457 |
Diacerin 50mg + Glucosamine sulphate 500mg tablets. |
For the treatment of adult patients with osteoarthritis of knee
and hip joints |
21.04.08 |
| 458 |
Clostridium Botulinum type-A toxin haemagglutinin complex
(Additional Indication) |
For focal spasticity, including the treatment of arm symptoms
associated with focal spasticity in conjunction with physiotherapy |
22.04.08 |
| 459 |
Fluconazole Dispersible tablets 50mg |
For the treatment of systemic candidiasis, mucosal candidiasis,
prevention of fungal infections in patients with malignancy |
22.04.08 |
| 460 |
Lenalidomide Capsule 5mg/10mg/15mg/25mg (Additional Indication) |
In combination with dexamethasone for the treatment of multiple
myeloma patients who have received at least one prior therapy |
22.04.08 |
| 461 |
Sitagliptin ( As Phosphate) 50mg + Metformin Hcl. 500mg/1000mg
Film coated tablets |
As an adjunct to diet & exercise to improve glycemic control
in patients with type-two diabetes
mellitus |
28.04.08 |
| 462 |
Lansoprazole for injection 30mg/vial |
For short term treatment of errosive esophagitis when patients
are unable to take the oral formulation |
28.04.08 |
| 463 |
Naproxen Suspension 125mg/5ml |
For the treatment of RA in children 5 years of age and above |
28.04.08 |
| 464 |
Sevelamer Carbonate 400mg/800mg tablets & sachet 400mg/800mg |
For control of serum phosphorus in patients with chronic kidney
disease on dialysis |
28.04.08 |
| 465 |
Rabeprazole Sodium (With Sodium bicarbonate as buffer) 10mg/20mg
tablets |
For the treatment of gastric ulcer, duodenal ulcer, Zollinger
Ellison Syndrome and GERD |
28.04.08 |
| 466 |
Pantoprazole Sodium (With Sodium bicarbonate as buffer)
20mg/40mg tablets |
For the treatment of gastric ulcer, duodenal ulcer, Zollinger
Ellison Syndrome and GERD |
28.04.08 |
| 467 |
Cefdinir 250mg dispersible tablets & oral suspension
250mg/5ml |
For the treatment of community acquired pneumonia, acute
exacerabation of chronic bronchitis, uncomplicated skin and skin structure
infection, Pharyngitis/tonsillitis |
29.04.08 |
| 468 |
Pregabalin capsules (Addl. Indication) |
management of fibromyalgia syndrome |
29.04.08 |
| 469 |
|