LIST OF APPROVED DRUG FROM 01-01-2011 to 31-12-2011
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. (Additional Strength)
|
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:
1. Diagnosed but unrectable locally advanced SCCHN
2. Recurrent SCCHN, if surgery or radiation is not feasible.
3. Palliative treatment of metastatic 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
( Size - 7cm x 10 cm)
|
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/100mg/200mg/200mg +Ofloxacin IP 100mg/200mg/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 :
Each sachet (1g) contains:
Total Probiotic.... Not less than 1.25 Billion CFU (Lactobacillus acidophilus, Lactobacillus rhamnosus, Bifidobacterium longum, Saccharomyces boulardii)
2. PROBIO & PREBIO (F)s
Each sachet (1g) contains:
Probio (CMP 5)
Total Probiotic...Not less than 1.25 Billion CFU (Lactobacillus acidophilus, Lactobacillus rhamnosus, Bifidobacterium longum, Saccharomyces boulardii) Fructo Oligo Saccharides …. 100mg
3. PROBIO & PREBIO (D)
Each sachet (1.3g) contains:
Probio (CMP 5)
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 :
A) FDC of Norgestrel & Ethinyl estradiol tablets IP Each sugar coated white tablet contains:
Norgestrel 0.30mg & Ethinyl estradiol 0.03mg
B) 7 tablets of Ferrous Fumarate:
Each sugar coated tablet contains : - Ferrous Fumarate 75mg eq. to 24.375mg of ferrous iron
|
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
Part A - One film coated tablet of Tenofovir Disoproxil Fumarate 300mg eq. to Tenofovir 245mg + Emtricitabine 200mg.
Part B - One film coated tablet of Atazanavir sulphate eq. to Atazanavir 300mg + Ritonavir 100mg
|
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: -
A) One tablet of Risedronate Sodium - Each film coated tablet contains:
Risedronate Sodium (as Risedronate Sodium Hemi-Pentahydrate) - 35 mg
B) Six Capsules of FDC of Calcitriol +Calcium carbonate + Zinc
Each soft gelatin capsule contains : -
Calcitriol IP - 0.25mcg
Calcium Carbonate IP - 500mg (eq. to elemental calcium 200mg)
Zinc (as Zinc Sulphate USP) 7.5 mg
|
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.
2. Prevention of nausea and vomiting associated with moderately emetogenic 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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