List of Approved Drug for Marketing in India
(from 01.01.2011 to 30.12.2011)
S.No |
Name Of Drug | Indication | Date of issue |
1 |
Alpha Lipoic Acid USP 100mg + Methylcobalamin 1500mcg + Vitamin B6 IP 3mg + Folic Acid IP 1.5mg + Benfotiamine 50mg + Biotin USP 5mg + Chromium Picolinate USP Eq. to Chromuim 200mcg Capsule | For the treatment of diabetic neuropathy | 03.01.11 |
2 |
Ropinirole ER Tablet 1 mg. (Additional Strength) | Same as approved | 04.01.11 |
3 |
Erlotinib HCl Tablet 150 mg (Additional Indication) |
Monotherapy for the Maintenance Treatment of Patients with locally advanced metastatic non-small lung cancer whose disease has not progressed after four cycles of Platinum based First Line Chemotherapy. | 04.01.11 |
4 |
Moxifloxacin HCl BP 0.5% w/v + Bromfenac Sodium 0.09% w/v Eye drop | For the reduction of post operative inflammatory conditions of the eye | 05.01.11 |
5 |
Ferrous Ascorbate 100mg + Folic Acid IP 1.5mg + Cyanocobalamin IP 15mcg + Zinc Sulphate Monohydrate Eq. to Elemental Zinc 22.5mg Tablet | For the treatment of iron deficiency anaemia | 05.01.11 |
6 |
S (+) Etodolac 300mg +Thiocolchicoside 8mg Tablet | For the treatment of patients with acute painful musculoskeletal conditions | 05.01.11 |
7 |
Beclomethasone Dipropionate IP 100mcg + Formoterol Fumarate Dihydrate BP Eq. to Formoterol Fumarate 6 mcg Metered Dose Inhaler | For the treatment of bronchial asthma where use of inhaled corticosteroid therapy found appropriate | 05.01.11 |
8 |
Amlodipine Besilate IP Eq. to Amlodipine 5mg + Indapamide USP SR 1.5mg Tablet | For the treatment of mild to moderate hypertension | 05.01.11 |
9 |
Metformin HCl IP 500mg + Alpha Lipoic Acid USP 200mg Tablet | For the treatment of patients with diabetic polyneuropathy | 05.01.11 |
10 |
Spironolactone IP 25mg + Furosemide IP 40mg Tablet | Additional strength | 05.01.11 |
11 |
Bicalutamide Tablet 150 mg.(Additional Strength and Indication) | Indicated either alone or as adjuvant to radical Prostatetomy or radiotherapy in Patients with Locally advanced Prostate cancer at High risk for disease Progression. | 05.01.11 |
12 |
Paracetamol Chewable Tablet 500 mg. ( Additional Dosage Form) |
Same as approved | 05.01.11 |
13 |
Methylcobalamin 500mcg + Folic Acid IP 1.5mg + Zinc Sulphate IP 25mg + Chromium Polynicotinate 200mcg + Selenium as Sodium Selenite USP 65 mcg + Inositol 100mg + Alpha Lipoic Acid 50mg + Streptococcus faecalis 30 Millions (30 lakh) + Clostridium butyricum 2 Million (20 lakh) + Bacillus mesentericus 1 Million (10 lakh) + Lactic acid bacillus 50 Million (500lakh) Capsule | For Vitamins and Minerals deficiency states in adult patients | 11.01.11 |
14 |
Dextromethorphan Extended Release Oral Suspension 30 mg per 5 ml | For the Relief of Persistent Dry irritating cough in adult patients Only. | 17.01.11 |
15 |
Hydroquinone USP 2% w/w + Tretinoin USP 0.025% w/w + Allantoin USP 1%w/w Gel | For treatment of hyper pigmentry disorders | 31.01.11 |
16 |
Paracetamol Fast Release Tablet 500mg (Additional Dosage Form) | Same as approved | 10.02.11 |
17 |
Each bowel preparatory kit contains: One enteric coated tablet Biscodyl IP 5mg & One sachet of powder for reconstitution contains: Polyethylene glycol 3350NF: 210gm + Sodium Bicarbonate IP 2.86gm + Sodium Chloride IP 5.6gm + Potassium Chloride IP 0.74gm |
For bowel cleansing prior to colonoscopy in adult patients only | 11.02.11 |
18 |
Ferric Carboxymaltose equivalent to elemental Iron…50mg/ml Injection | For the treatment of iron deficiency in adults when oral iron preparations are ineffective or cannot be used. | 11.02.11 |
19 |
Pidotimod Tablet 400 mg/800 mg & Oral Solution 400 mg/800 mg per 7ml | For infections of the respiratory system in secondary and primary immunodeficiency with alteration in maturation of T cells in adults only. | 11.02.11 |
20 |
Ursodeoxycholic Acid Suspension 125mg/5ml and 250 mg /5ml. | For the treatment of patients with chronic cholestatic liver disease. | 11.02.11 |
21 |
Iloperidone Tablets 1mg/2mg/4mg/6mg/8mg /10mg/12mg | For the acute treatment of adults with schizophrenia. | 17.02.11 |
22 |
Calf lung surfactant Intratracheal Suspension containing Phospholipids.... 35mg (containing 26 mg phosphatidylcholine of which 16mg is disaturated phosphatidylcholine) Proteins....0.65mg (including 0.26mg of surfactant associated proteins B) per ml |
(a). As a prophylaxis therapy for premature infants <29 weeks of gestational age at significant risk for Respiratory Distress Syndrome (RDS). (b). For the treatment of infants <72 hours of age with RDS (confirmed by clinical and radiologic findings) and requiring endotrachteal intubation. |
17.02.11 |
23 |
Baclofen ER Capsule 10 mg/50 mg. |
Same as approved | 17.02.11 |
24 |
Dexketoprofen Trometamol ER Tablet 50 mg (Additional Strength) | Same as approved | 21.02.11 |
25 |
Gatifloxacin Eye drop 5 mg/ml | For the treatment of bacterial conjunctivitis caused by susceptible strains | 21.02.11 |
26 |
Paclitaxel Injection 30mg/100 mg/300 mg (additional Indication) | Advanced squmous cell carcinoma of Head and Neck SCCHN: |
24.02.11 |
27 |
Eslicarbazepine Acetate Tablets 200mg/400mg/600mg/800mg | As an adjunctive therapy in adults with partial-onset seizures with or without secondary generalisation. | 07.03.11 |
28 |
Ketoprofen Plaster |
For the Relief of Musculoskeletal pain and Inflammation. | 09.03.11 |
29 |
Meropenem IP 1000mg + Sulbactam sodium USP 500mg injection | For the treatment of lower respiratory tract infection caused by gram negative bacteria in adults only | 15.03.11 |
30 |
Dasatinib 20mg/50mg/70mg (Additional Indication) | Treatment of newly Diagnosed Adults with Chronic Myeloid Leukaemia (CML) in Chronic Phase. | 16.03.11 |
31 |
Adenosylcobalamin 15mcg + Ferrous Ascorbate 100mg + Folic Acid IP 1.5mg + Zinc Sulphate USP Eq. to Elemental Zinc 22.5mg tablet | For the treatment of iron deficiency anaemia in adults only | 21.03.11 |
32 |
Tioconazole Vaginal Gel 65mg per gm | For the local treatment of vulvo vaginal candidiasis in adult patients. | 22.03.11 |
33 |
Aspirin (EC Tablets) 75mg/75mg/150mg +Rosuvastatin (Granules) 5mg/10mg/10mg Capsules | For the treatment of dyslipidemia associated with arthersclerotic arterial disease with risk of Myocardial infarction, stroke or peripheral vascular disease. | 30.03.11 |
34 |
Ilaprazole Tablets 5mg/10mg | For the treatment of duodenal ulcer in adults only. | 05.04.11 |
35 |
Asenapine Maleate Sublingual Tablets 5mg/10mg | For acute treatment of schizophrenia in adults only. | 07.04.11 |
36 |
Cefpodoxime IP 100mg/200mg +Ofloxacin IP 100mg/200mg Tablets | For the Treatment of Lower and upper respiratory tract infection and Typhoid fever in adults only | 16.04.11 |
37 |
Tapentadol Hydrochloride Tablets 50mg/75mg/100mg | For relief of moderate to severe acute pain in adults 18 years of age or older. | 18.04.11 |
38 |
Cefixime Trihydrate IP Eq. to Anhydrous Cefixime 100mg/200mg + Ofloxacin IP 100mg/200mg Dispersible Tablet (Additional dosage form ) |
Same as approved | 20.04.11 |
39 |
S-Bupivacaine Hydrochloride Injection 2.5mg/5mg/7.5mg per ml | For surgical anaesthesia in adults for epidural (including caesarean section), intrathecal, peripheral nerve block. | 28.04.11 |
40 |
Dexketoprofen 50mg + Dicyclomine 20mg per 2ml Injection | For the treatment of acute colicky pain in adult patients | 28.04.11 |
41 |
Gatifloxacin 0.3% + Loteprednol Etabonate 0.5% + Benzalkonium Chloride 0.01% w/v Opthalmic suspension | For Post-Operative Steroid repulsive inflammatory Ocular conditions when Ocular bacterial infections or a risk of bacterial infection exists | 19.05.11 |
42 |
Diclofenac Colestyramine 145.6 mg corresponding to 75mg Diclofenac Sodium Capsules. | For the treatment of acute arthritis (including attacks of gout), chronic arthritis especially rheumatoid arthritis (chronic polyarthritis), ankylosing spondylitis (Morbus Bechterew) and other inflammatory, rheumatoid syndromes of vertebral column. | 19.05.11 |
43 |
Brinzolamide Ophthalmic Suspension 1%w/v | For the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma. | 26.05.11 |
44 |
Besifloxacin Ophthalmic Suspension 0.6% w/v | For the treatment of bacterial conjunctivitis. | 31.05.11 |
45 |
Diclofenac (as EC Tablets) 25mg + Paracetamol 325 mg Capsule (Additional Strength) |
Same as approved | 31.05.11 |
46 |
Amlodipine 10mg/10mg+ Telmisartan 40mg/80mg Tablets (Additional Strength) |
Same as approved | 31.05.11 |
47 |
1. PROBIO : Total probiotic... not less than 1.25 billion CFU (Lactobacillus acidophilus, Lactobacillus rhamnosus, Bifidobacterium longum, Saccharomyces boulardii) Fructo Oligo Saccharides...1000mg |
For the treatment of rotavirus diarrhoea. | 09.06.11 |
48 |
Paracetamol 325mg + Tramadol Hydrochloride 37.5 mg Tablets | Additional indication. (For Symptomatic Treatment of Moderate To Severe Pain.) | 21.06.11 |
49 |
Silodosin Capsules2mg/4mg/8mg | For the treatment of signs and symptoms of benign prostatic hyperplasia (BPH) in adults only. | 23.06.11 |
50 |
Tiapride Hydrochloride Tablets 25mg/50mg/100mg | For the treatment of agitation and aggressiveness in adult patients with cognitive impairment. | 23.06.11 |
| 51 | Eletriptan Hydrobromide Tablets 20mg/40mg | For the treatments of Migraine with or without aura in adults | 25.08.11 |
| 52 | Glutathione for Injection 600mg | For the treatment of alcoholic liver diseases like alcoholic fatty liver, alcoholic liver fibrosis, alcoholic liver cirrhosis, and hepatitis | 14.09.11 |
| 53 | Udenafil Tablet 100mg/200mg | For the treatment of erectile dysfunction | 15.09.11 |
| 54 | Acrivastine Capsules 8mg | For the symptomatic relief of allergic rhinitis. | 26.09.11 |
| 55 | Tacalcitol ointment 4mcg | For the treatment of psoriasis vulgaris in adults only. | 26.09.11 |
| 56 | Fexofenadine 120mg + Montelukast 10mg Chewable tablet | Additional dosage form | 07.07.11 |
| 57 | Each Combipack of 21 tablets contains : |
As contraceptive pill for women | 27.07.11 |
| 58 | Cefixime (SR) 400mg +Moxifloxacin (SR) 400 mg Tablets | For the treatment of lower respiratory tract infections in adults only | 08.08.11 |
| 59 | Alpha Lipoic acid 100mg + Folic acid 1.5mg + Methylcobalamin 1500mcg + Pyridoxine Hydrochloride 3mg + Vitamin D3 1000 IU Tablets | For the treatment of Diabetic neuropathy | 10.08.11 |
| 60 | Levosulpride (SR) 75mg + Rabeprazole sodium IP (EC Pellets) 20mg Capsule | For the treatment of Gastro-oesophageal Reflux Disease (GERD) | 19.08.11 |
| 61 | Each Combikit contains |
For the treatment of HIV infection in adults. | 23.08.11 |
| 62 | Diclofenac sodium (SR) 100mg + Eperisone Hydrochloride (SR) 150mg Capsules | For the treatment of patient with acute musculoskeletal spasm associated with low back pain. | 24.08.11 |
| 63 | Rosuvastatin Calcium eq. to Rosuvastatin 20mg/20mg + Fenofibrate BP 67.5mg/145mg Tablets | Additional Strength | 24.08.11 |
| 64 | Acyclovir 50g + Hydrocortisone 10mg Cream | For the early treatment of recurrent cold sores in adult patients to reduce likelihood of ulcerative cold sores and to shorten the lesion healing time | 30.08.11 |
| 65 | Clindamycin Phosphate eq. to Clindamycin 1% w/w + Hydrous Benzoyl Peroxide eq. to Anhydrous Benzoyl peroxide 2.5% w/w topical gel | For topical treatment of inflammatory acne vulgaris (Additional lower strength) | 30.08.11 |
| 66 | Polyethylene glycol 0.4% w/v + Propylene Glycol 0.3% w/v Eye Drops | For temporary relief of burning and irritation due to dryness of the eye | 13.09.11 |
| 67 | Metformin (ER )1000mg/500mg +Saxagliptin 2.5 mg/5mg | As an Adjunct to diet and exercise to improve glycemic control in adults patients with type 2 diabetes mellitus when treatment with both Saxagliptin and Metformin is appropriate | 19.09.11 |
| 68 | Ceftriaxone Sodium eq. to Ceftriaxone Sodium 1000mg/2000mg + Sulbactam Sodium eq. Sulbactam 500mg/500mg. | Additional Indication - For the treatment of urinary tract infections and lower respiratory tract infections, various bacteria | 21.09.11 |
| 69 | Difluprednate 0.05% w/v + Moxifloxacin 0.5% w/v Eye Drops | For steroid responsive inflammatory ocular conditions for which a corticosteroid is indicated and where bacterial infection or a risk of bacterial ocular infection exists | 22.09.11 |
| 70 | S(-) Amlodipine 2.5mg/5mg + Clopidogrel 75mg/75mg Tablets |
For the treatment of high risk hypertensives who need anti-platelet therapy especially for prophylaxis of artherothrombotic events in patients with a history of recent stroke or established peripheral arterial disease | 22.09.11 |
| 71 | Each Combipack contains: - |
For the treatment of Osteoporosis in post menopausal women |
30.09.11 |
| 72 | Tafluprost Eye Drops 0.0015% w/v |
For the reduction of elevated intraocular pressure in open angle glaucoma and ocular hypertension. | 21.10.11 |
| 73 | Arterolane Maleate 150mg + Piperaquine Phosphate 750mg Tablet |
Treatment of acute uncomplicated malaria infection due to Plasmodium falciparum in adults. | 19.10.11 |
| 74 | Diazinon Flea Drops Spot on Dogs 30.0% w/w |
For dogs infected with fleas. | 11.11.11 |
| 75 | Cabazitaxel Injection 60mg / 1.5ml |
In combination with prednisone for treatment of patients with hormone-refractory metastatic prostrate cancer previously treated with a docetaxel-containing treatment regimen. | 16.11.11 |
| 76 | Trifluridine Eye Drops 1% w/v |
For the treatment of primary keratoconjunctivitis and recurrent epithelial keratitis due to herpes simplex viruses type 1 and 2. |
08.12.11 |
| 77 | Fosaprepitant (as Dimeglumine) for Injection 150mg. |
1. Prevention of acute and delayed nausea and vomiting associated with highly emetogenic cisplatin based cancer chemotherapy in adults. |
16.12.11 |
| 78 | Abiraterone Acetate Tablets 250mg |
In combination with prednisone for the treatment of patients with metastatic castration-resistant prostrate cancer who have received prior chemotherapy containing docetaxel. |
16.12.11 |
| 79 | Dabigatran Etexilate( as Mesilate) hard gelatin Capsules 75mg/110mg/150mg |
For prevention of stroke, systemic embolism and reduction of vascular mortality in adult patients with atrial fibrillation. |
12.12.11 |
| 80 | Crizotinib hard gelatin Capsules 200mg/250mg |
For the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) that is anaplastic lymphoma kinase (ALK) – positive as detected by an FDA-approved test. |
16.12.11 |
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