LIST OF DRUGS APPROVED DURING 2006
S.No Name Of Drug Pharmacological Classification Date of Approval
1 Cefprozil Powder for oral suspension (125mg/5ml) Antibiotic 6/1/2006
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 1/2/2006
5 Atenolol 50mg + HCTZ 25mg (addl. Strength) For hypertension 3/2/2006
6 Tamsulosin HCl (MR) 0.4mg + Dutasteride 0.5mg tablet For BPH 6/2/2006
7 Erdosteine Powder for oral suspension 35mg/ml For chronic obstructive bronchitis 6/2/2006
8 Moxifloxacin Eye Ointment (5mg/gm)  For ophthalmic use. 6/2/2006
9 Dexibuprofen Tablet (200mg/300mg/400mg) For OA, RA & ankylosing spondylitis 6/2/2006
10 Pegaptinib Sodium Injection (0.3mg).   For neovascular (wet) age related macular degeneration. 6/2/2006
11 Ciclesonide Inhaler 80/160mcg per actuation For persistent Asthma 6/2/2006
12 Metoprolol Succinate equiv. to Metoprolol Tartrate 50mg + Amlodipine (as besylate) 5mg For hypertension 7/2/2006
13 Doxofylline Tablet (400mg) For bronchial asthma & COPD. 8/2/2006
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 2/3/2006
25 Cefditeron (as pivoxil) 200mg tablet Anti-biotic 3/3/2006
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. 4/4/2006
36 D-trans Fentantyl Transdermal patches For pain 5/4/2006
37 Pantoprazole (as Sodium) (E.C) 40mg + Itopride (150mg) S.R For GERD 8/4/2006
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 10/5/2006
43 Formoterol Fumarate (6mcg) + Fluticasone Propionate (100/250/500mcg) dry powder inhaler For Asthma & COPD 10/5/2006
44 Midazolam (as maleate) 7.5mg/15mg tablet   For insomnia 10/5/2006
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 2/6/2006
56 Gatifloxacin (0.3%) + Prednisolone Acetate (1%) eye drops For Ophthalmic use 2/6/2006
57 Amlodipine (as besylate) 5mg  + Metoprolol Succinate equivalent to Metoprolol Tartrate 50mg. For hypertension 5/6/2006
58 Nadifloxacin (1%) + Miconazole Nitrate (2%) + Mometasone Furoate (0.1%) Cream For dermatoses 6/6/2006
59 Bemiparin Sodium Solution for injection(5000/7500/10,000 I.U). For deep vein thrombosis 8/6/2006
60 Icodextrin 7.5% peritoneal dialysis solution For peritoneal dialysis 8/6/2006
61 Lamotrigin 200mg tablet (addl. Strength) dispersible tablet (5mg/50mg/100mg/200mg Anti-epileptic 8/6/2006
62 Amoxycillin 1000mg + Clavulanate Potassium 62.5mg E.R tablet Anti-biotic 8/6/2006
63 Lopinavir 200mg + Ritonavir 50mg Tablet (addl. Strength) Anti-HIV 8/6/2006
64 Olopatadine Ophthalmic solution( 0.1%) For allergic conjunctivitis 8/6/2006
65 Ferrous ascorbate (equivalent to 50mg Iron) + Folic acid 1.5mg. For iron deficiency anemia 8/6/2006
66 Super Oxidized Solution (containing Water 99.9% with salts like sodium hypochlorite, hypochlorous acid, hydrogen peroxide ozone, chlorine chloride, sodium hydroxide, sodium carbonate and sodium chloride) For use as cleaning and debriding agents in wounds management & care. 12/06/2006
67 Methyl Prednisolone Aceponate Cream (0.1%) For atopic dermatitis 15/06/2006 
68 Aspirin 150mg + Clopidogrel (as bisulphate) 300mg tablet (addl. Strength) As loading dose for prevention of in-stent restenosis in PCI 22/06/2006 
69 Levofloxacin 0.5% Ear drops For otitis media 27/06/2006 
70 Olmesartan 40mg + HCTZ 25mg tablet (addl. Strength) Anti-hypertensive 28/06/2006 
71 Buclizine HCl tablet (25mg) & Syrup 6mg/5ml As appetite stimulant 28/06/2006 
72 Ceftriaxone (as sodium) 250mg + Tazobactam 31.25 mg for injection (addl. Strength) Anti-biotic 5/7/2006
73 Bimatoprost 300mg + Timolol (as maleate) 5mg/ml eye drops For reduction of IOP 5/7/2006
74 Mebeverine HCl 135mg + Isabgula husk 3.5gm sachet. Irritable bowel syndrome 6/7/2006
75 Solifenacin Succinate Tablet (5mg/10mg). For overactive bladder with urge urinary incontinence urgency & urinary frequency 6/7/2006
76 Zolpidem Tartrate E.R tablet (6.25mg/12.5mg). For insomnia 10/7/2006
77 Deferasirox dispersible tablet 125/250/500mg. For chronic iron overload due to blood transfusion 10/7/2006
78 Vitamin C 500mcg + Zinc Citrate 2.2mg + Selenium 60mcg tablet. For vitamin C deficiency 12/7/2006
79 Lamivudine 40mg + Stavudine 10mg dispersible tablet. For HIV infection 12/7/2006
80 Levocetrizine 2.5/5mg + Ambroxol 30mg/5ml of syrup For productive cough 20/07/2006 
81 Cefixime 200mg + Pot. Clavulanate (125mg) tablet Anti-biotic 20/07/2006 
82 ISMN SR 30mg + Aspirin75/150mg tablet (addl. Strength). Same as approved 20/07/2006 
83 Clobestasol Propionate (0.05%) + Calcipotriol Ointment (0.005%) Ointment. For plaque psoriasis 20/07/2006 
84 Sodium Hyaluronate Injection (1%). For OA 26/07/2006 
85 Forskolin Eye drop (1%). For open angle glaucoma 27/07/2006 
86 Baclofen E.R capsule (30mg) For spasticity 1/8/2006
87 Amisulpiride Tablet (50/100/200mg) For schizophrenic disorder 1/8/2006
88 Quetiapine S.R tablet 200/300mg. For psychotic disorder 1/8/2006
89 Lumiracoxib Tablet (100/200/400mg). For OA, RA acute pain & primary dysmenorrhoea 1/8/2006
90 Tenofovir Disoproxil Fumarate300mg + Emtricitabin 200mg + Efavirenz 600mg tablet For HIV-1 infection 1/8/2006
91 Oxandrolone Tablet (2.5/10mg) To promote weight gain 4/8/2006
92 Erdosteine 150mg + Guaiphenesin 50mg + Terbutaline 1.25mg per 5ml syrup Mucolytic 8/8/2006
93 Rosiglitazone (as maleate)2mg + Glibenclamide 5mg + MetFormin 500mg tablet  Anti Diabetic 8/8/2006
94 L- Lysine Hcl Ointment (150mg/gm)  For wounds of various etiology 8/8/2006
95 Levocitirizine 2 Hcl 5mg+ Ambroxol Hcl SR 75mg + Pseudoephedrine Hcl 120mg SR Capsules For SAR, PAR & Chronic idiopathic urticatia  9/8/2006
96 Alprazolam SR 0.25mg + Sertraline (As Hcl) 25mg/50mg tablet For Panic disorder with or without agoraphobia 9/8/2006
97 Dexibuprofen 200mg/300mg +Paracetamol 500mg tablet For RA, OA & ankolysing spondylosis 10/8/2006
98 ISMN SR 60mg + Metoprolol Succinate ER 25/50mg  For angina & Hypertension 10/8/2006
99 Aspirin 75mg / 150mg + Glycine 37.5mg/75mg tablet For prevention of acute coronary syndrome in patients with CAD prophylaxis against stroke 10/8/2006
100 Combipack of 21 tablet of Quinin sulphate 600mg each & 8 capsule of Doxycycline (as Hcl) 100mg each) For P. Falciparam malaria 10/8/2006
101 Pravastatin 40mg tablet (Additional strength)  As Approved 10/8/2006
102 Olanzapine powder For oral suspensian (10mg/5ml) For schizophrenia in adults 11/8/2006
103 Cefepem (as Hcl) 0.5/1gm + Amikacin (as sulphate) 0.125/0.250gm Inj.  Antibiotic 11/8/2006
104 Lamivudine 20mg + Nevirapine 35mg + Stavudine 5mg tablet Anti HIV 11/8/2006
105 Nadifloxacin (10mg/gm) + Mometasone Furoate (1mg/gm) cream For mixed infection of skin  17/08/06
106 Premetrexed(Disodium) powder For solution For Inj. 500mg/vial Anti Cancer 21/08/06
107 Gliclazide 40mg/80mg + MetFormin Hcl 500mg + Rosiglitazone 2mg tablet Ant- diabetic 22/08/06
108 Tiropramide Hcl (100mg) tablet For abdominal spasmodic pain, colics of hepatobilliary track, abdominal colics 22/08/06
109 Eperisone Hcl (50mg ) tablet For neck-shoulder orm  syndrome scapula hum oral per arthritis and low back pain 23/08/06
110 Caroverine cap. 20mg & Inj. 40mg/2ml For abdominal pain & tinnitus in adult 23/08/06
111 Paclitaxel nanoparticle Inj. (20mg/ml) For metastatic breast cancer 23/08/06
112 Amoxycillin 250mg + Dicloxacillin 250mg cap. Anti biotic 28/08/06
113 Rifaximine 200mg tab. For infections diarrhea in adults 28/08/06
114 Tigecycline powder For Inj. 50mg/vial  For skin & skin structure infection & intra abdominal infection 28/08/06
115 Stavudine SR 100mg tablet Anti HIV 29/08/06
116 Cefixime (50mg/100mg) + Clavulanic acid 31.125mg/62.5mg per ml dry syrup & tablet Antibiotic 29/08/06
117 Ciclsonide 80mcg/160mcg + Formotorol 4.5mg inhaler Anti asthratic 29/08/06
118 Ciclsonide 100mcg/ 200mcg/400mcg + Formotorol Fumarate 6mg rotacaps  Anti asthmatic 29/08/06
119 Abacavir Sulphate syrup 20mg/ml For HIV Infection 29/08/06
120 S(-) pantoprazole (as sodium) 20mg (E.C.) + Domperidome SR 30mg tablet  FOR GERD 30/08/06
121 Cefadroxil 500mg + Clavulanic acid 125mg tablet Antibiotic 30/08/06
122 Cefadroxil 250mg + Clavulanic acid 62.5mg dispersible tablet Antibiotic 30/08/06
123 Cefadroxil 250mg + Clavulanic acid 62.5mg per 5ml syrup Antibiotic 30/08/06
124 Human Insulin (r-DNA) Powder inhaler  For type-I & Type-2 Diabetes 30/08/06
125 Fulvestrant Inj. 250mg/5ml prefilled syringe Anti Cancer 30/08/06
126 S(-) Pantoprazole (as Sodium) Inj. 20mg/vial For  peptic ulcer, GERD & Zollinger Ellison Syndrome 30/08/06
127

Dasatinib tablet 20mg/50mg/70mg tablet 

For the treatment of adults with chronic accelerated or myeloid or lymphoid blast phase chronic myeloid leukemai (CML)

30/08/06
128 Telbivudine 600mg tablet For chronic hepatitis B infection 30/08/06
129 Aprepitant cap (80mg/125mg)  For chemotherapy induced nausea & vomiting 30/08/06
130 Telmisartan 40mg + Amlodipine (as Besylate) 5mg tablet For essential hypertension 30/08/06
131 Gemifloxacin (as msylate) 320mg tablet Antibiotic 30/08/06
132 Ceftazidime 500mg /1000mg + Tazobactum (as sodium) 62.5mg/125mg per vial for injection Antibiotic 30/08/06
133 Cefepime (As Hcl) 500mg/1000mg + Tazobactum (as Sodium) 62.5mg/125mg  Antibiotic 30/08/06
134 Paromomycin Inj. 375mg/ml For visceral leishmaniasis (Kalaazar) 30/08/06

135

Cefixime 100mg + Cloxacillin (as Sodium) 500mg + Lactobacillus (45 million spore)tab. Antibiotic 31/08/06

136

Alprazolam Dispersible Tab. 0.125mg/0.25mg/0.50mg For anxiety 20/09/06

137

Epinastine Hcl (0.05%) Opthlamic solution  For allergic conjunctivitis 22/09/06

138

Levofloxacin tablet (250mg /500mg) & Infusion 5mg/ml (For additional indication) For prostatitis 26/09/06

139

Feracrylum 1% mouth gargle 10mg/ml As hacmostatic agent in dental surgery 28/09/06

140

Aceclofenac Inj. (150mg/ml) For pain in post operative & post traumatic cases 28/09/06

141

combipack of one cap. Of aprepitant .125mg & two cap. Of aprepitant 80mg each (combipack)   As Approved 10/10/2006
142 Formoterol fumarate 6mcg + Fluficasone propinate 50mcg/125mcg/250mcg MDI  For Asthma & COPD 14/10/06
143 Amlodipine 25mg + Metoprolol 25mg (additional lower strength)   1/11/2006
144 Estrogen vaginal tablet 25mcg  For atropic viginitis 2/11/2006
145 Esomeprazole 40mg (E.C.) + Itopride 150mg SR Capsules For GERD 13/11/06
146 Cefixime 200mg + Cloxacillin 500mg (ER) + Lactobacillus 90 million Spore tab. (additional strength)  Antibiotic 14/11/06
147 Cefixime dispersible tablet 400mg (new dosage Form) Antibiotic 22/11/06
148 Trandalopril 1mg/2mg/4mg/2mg + Verapamil (ER) 240mg/240mg/240mg/180mg  Anti hypertensive 23/11/06
149 Ciclesonide 160mcg/320mcg cap. for inhalation Anti asthmatic 28/11/06
150 Rabeprazole 20mg (EC) + Itopride SR 150mg For GERD 28/11/06
151 Metoprolol succinate 25mg /50mg ER + HCTZ 12.5mg  Anti hypertensive 30/11/06
152 Atorvastatin 5mg + Fenofibrate 160mg (additional strength)  As Approved 1/12/2006
153 Aceclofenac Inj. 50mg/ml (additional strength)  As Approved 1/12/2006
154 Amisulpride 400mg tablet (additional strength)  As Approved 1/12/2006
155 Misoprostol tablet 25mcg/100mcg/200mcg (additional strength indication For cervical ripening, prevention of post partum haemorrhage & First trimester of aboration with mifepristone 8/12/2006
156 Atazanavir 150mg + Ritonavir 50mg capsules Anti HIV 12/12/2006
157 Mebeverine Hcl 135mg + Chlordiazepoxide 5mg tablet For IBS 12/12/2006
158 Ampicillin 250mg + Dicloxacillin 250mg tablet Antibiotic 13/12/06
159 Etoricoxib 10mg + Methyl Salicylate 100mg + Mentol 50mg + Linseedoril 30mg per gm. of Gel For acute Musculoskeletal pain 14/12/06
160 Racecadotril dispersible tablet (10mg/30mg) (new dosage Form) For diarrhea 15/12/06
161 Gabapentin ER 450/600/900mg tablet For naturopathic pain & partial Seizures 15/12/06
162 Aceclofenac dispersible tablet 100mg (new dosage form)   As Approved 21/12/06