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New Drugs Approved in India

Year 2011

S. No. Drug Name Indication Approval Date
707
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
708 Ropinirole ER Tablet 1 mg.                 
Same as approved
 04.01.11
709 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
710 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
711 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
712  S (+) Etodolac 300mg +Thiocolchicoside 8mg Tablet
For the treatment of patients with acute painful musculoskeletal conditions
 05.01.11
713 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
715 Metformin HCl IP 500mg + Alpha Lipoic Acid USP 200mg Tablet
For the treatment of patients with diabetic polyneuropathy
 05.01.11
716 Spironolactone IP 25mg  + Furosemide IP 40mg Tablet 
Additional strength
 05.01.11
717 Bicalutamide Tablet 150 mg.( 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
718 Paracetamol Chewable Tablet 500 mg. 
(Additional Dosage Form)
Same as approved
 05.01.11
719 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
720 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
721 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
722 Paracetamol Fast Release Tablet 500mg            
For treatment of hyper pigmentry disorders
10.02.11
723 Each bowel preparatory kit contains: One enteric coated tablet Biscodyl IP 5mg & One sachet of powder for reconstitution contains: Polyethyleneglycol 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
724 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
725 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
726 Ursodeoxycholic Acid Suspension 125mg/5ml and 250 mg /5ml.
For the treatment of patients with chronic cholestatic liver disease.
 11.02.11
727 Iloperidone Tablets 1mg/2mg/4mg/6mg/8mg /10mg/12mg
For the acute treatment of adults with schizophrenia.
 17.02.11
728 Calf lung surfactant Intratracheal Suspension containing Phospholipids.... 35mg (containing 26 mg  phosphatidylcholine
of which 16mg is disaturatedphosphatidylcholine)    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
729 Baclofen ER Capsule 10 mg/50 mg
Same as approved
 17.02.11
730 Dexketoprofen Trometamol ER Tablet 50 mg
Same as approved
 21.02.11
731 Gatifloxacin Eye drop 5 mg/ml
For the treatment of bacterial conjunctivitis caused by susceptible strains
 21.02.11
732 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
733 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
734 Ketoprofen Plaster   ( Size - 7cm x 10 cm)         
For the Relief of Musculoskeletal pain and Inflammation.
 09.03.11
735 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
736 Dasatinib 20mg/50mg/70mg  (Additional Indication)
Treatment of newly Diagnosed Adults with Chronic Myeloid Leukaemia (CML) in Chronic Phase.
 16.03.11
737 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
738 Tioconazole Vaginal Gel 65mg per gm
For the local treatment of vulvo vaginal candidiasis in adult patients.
 22.03.11
739 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
740 Ilaprazole Tablets 5mg/10mg
For the treatment of duodenal ulcer in adults only.
 05.04.11
741 Asenapine Maleate Sublingual Tablets 5mg/10mg
For acute treatment of schizophrenia in adults only.
 07.04.11
742 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
743 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
744 Cefixime Trihydrate IP Eq. to Anhydrous Cefixime 100mg/200mg + Ofloxacin IP 100mg/200mg Dispersible Tablet
Same as approved
 20.04.11
745 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
746 Dexketoprofen 50mg + Dicyclomine 20mg per 2ml Injection
For the treatment of acute colicky pain in adult patients
 28.04.11
747 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
748 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
749 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
750 Besifloxacin Ophthalmic Suspension 0.6% w/v
For the treatment of bacterial conjunctivitis.
 31.05.11
751 Diclofenac (as EC Tablets) 25mg + Paracetamol 325 mg Capsule
Same as approved
 31.05.11
752  
 
753 Amlodipine 10mg/10mg+ Telmisartan 40mg/80mg Tablets
Same as approved
 31.05.11
754

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
755 Paracetamol 325mg + Tramadol Hydrochloride 37.5 mg Tablets
Additional indication. (For Symptomatic Treatment of Moderate To Severe Pain.)
 21.06.11
756 Silodosin Capsules2mg/4mg/8mg
For the treatment of signs and symptoms of benign prostatic hyperplasia (BPH) in adults only.
 23.06.11
757 Tiapride Hydrochloride Tablets 25mg/50mg/100mg 
For the treatment of agitation and aggressiveness in adult patients with cognitive impairment.
 23.06.11
758 Eletriptan Hydrobromide Tablets 20mg/40mg
For the treatments of Migraine with or without aura in adults
 25.08.11
759 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
760 Udenafil Tablet 100mg/200mg
For the treatment of erectile dysfunction
  
761 Acrivastine Capsules 8mg
For the symptomatic relief of allergic rhinitis
 26.09.11
762 Tacalcitol ointment 4mcg For the treatment of psoriasis vulgaris in adults only. 26.09.11
763      
764 Fexofenadine 120mg + Montelukast 10mg Chewable tablet Additional dosage form  
765 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
766 Cefixime (SR) 400mg +Moxifloxacin (SR) 400 mg Tablets For the treatment of lower respiratory tract infections in adults only 08.08.11
767 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
768 Levosulpride (SR)  75mg + Rabeprazole sodium IP  (EC Pellets) 20mg Capsule For the treatment of Gastro-oesophageal Reflux Disease (GERD) 19.08.11
769 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
770 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
771 Rosuvastatin Calcium eq. to Rosuvastatin 20mg/20mg + Fenofibrate BP 67.5mg/145mg Tablets Additional Strength 24.08.11
772 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
773
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
774
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
775
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
776
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
777
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
778
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
779
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
780
Tafluprost Eye Drops 0.0015% w/v
For the reduction of elevated intraocular pressure in open angle glaucoma and ocular hypertension.
21.10.11
781
Arterolane Maleate 150mg + Piperaquine Phosphate 750mg Tablet
Treatment of acute uncomplicated malaria infection due to Plasmodium falciparum in adults.
19.10.11
782
Diazinon Flea Drops Spot on Dogs 30.0% w/w
For dogs infected with fleas.
11.11.11
782
Diazinon Flea Drops Spot on Dogs 30.0% w/w
For dogs infected with fleas.
11.11.11
783
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
Year 2010 Go To Top


484 Ferrous ascorbate 100mg + Folic acid 1.1 mg tablet and Omega-3-fatty acid 200mg capsules combikit  For iron, folic acid & omega-3-fatty acid deficiency   1/8/2010
485 Sphaeranthus Indicus Extract Tablets 700mg For the management of psoriasis. 1/8/2010
486 Febuxostat 40mg  Same As approved 1/16/2010
487 Dexamethasone Intravitreal Implant 0.7mg (in solid polymer drug delivery system) For the treatment of macular edema following branch retinal vein occlusion (CRVO) 1/16/2010
488 Buclizine Hcl 25mg Tablet (Additional Indication) For the Symptomatic treatment of various allergic conditions (rhinitis, conjunctivitis and urticaria) and for prevention and treatment of motion sickness 1/16/2010
489 Pemetrexed Disodium 500mg/100mg Powder for Injection (additional indication) Indicated as a monotherapy for the maintenance treatment of locally advanced or metastatic Non Small Cell Lung Cancer (NSCLC) other than predominantly squamous cell histology in patients whose disease has not progressed immediately following platinum-based chemotherapy.  First line treatment should be a platinum doublet with gemcitabine, paclitaxel or docetaxel. 1/16/2010
490 Levobetaxolol HCl Opthalmic Suspension 0.5% For lowering of intraoccular pressure in patients with chronic open-angle glaucoma or occular hypertension. 1/16/2010
491 Sarpogrelate Hydrochloride film coated Tablets 100mg For the improvement of ischemic symptoms including ulcer, associated with chronic arterial occlusion. 1/16/2010
492 Propanol 1-ol 18gm + Ethanol 100% 45gm/100ml solution For hygenic and surgical hand disinfection 1/18/2010
493 Aliskiren 150/160mg + Valsartan  300/320mg tablets For the treatment of hypertension  1/19/2010
494 Piroxicam 20mg tab& Paracetamol 500mg tab combikit   For treatment of fever and pain associated with acute upper respiratory tract inflammation, acute musculoskeletal disorders, pain after operative intervetion and following trauma, chronic condition like rheumatoid arthritis, osteoarthritis etc for short term management of acute painful episodes. 1/19/2010
495 Soybean oil 60gm + Triglycerides (medium chain) 50gm + olive oil  purified fish oil 30gm + dl-alpha-tocopherol 163-225mg + glycerol (anhydrous) 25gm + Egg lecithin 12gm + sodium hydroxide (to approx pH 8) + sodium pleate 0.3mg emulsion for infusion in 100ml. Total parenteral nutrition following major abdominal, major thoracic or major urological surgery  1/19/2010
496 Raltegravir (as Potassium) film coated Tablets 400mg  In combination with other anti retroviral agents for  the treatment of human immunodeficiency virus (HIV-1) infection in treatment experienced patients with evidence of HIV-1 replication despite ongoing retroviral therapy. 1/27/2010
497 Deflazacort Tablet 18mg  Same as approved 1/30/2010
498 Pregabalin SR Tablet 75mg  Same as approved 1/30/2010
499 Rivaroxaban film coated Tablets 10mg For the prevention of venous thromboembolism in patients (VTE) in adult patients undergoing hip or knee replacement surgery. 1/30/2010
500 Cinnarizine 20mg + Dimenhydrinate 40mg tablets   For the treatment of vertigo 2/3/2010
501 Lipid Based Amphotericin-B  Gel 0.1% Indicated in the treatment of cutaneous and mucocutaneous mycotic infections caused by candida (Monilia) species. 2/5/2010
502 Sodium Hyaluronate Injectable Gel 14mg/ml, 18mg/ml, 25.5mg/ml  Same as approved 2/6/2010
503 Milnacipran Hcl 12.5mg (Addl. Strength) Same as approved 2/6/2010
504 Ropinirole 6mg ER Tablets (Addl. Strength) Same as approved 2/6/2010
505 Coseal Surgical Sealent 2/4/8ml (Addl. Indication) (1)  Enforcement of suture and staple lines in lung resection procedures.     (2)Patients undergoing cardiac surgery to prevent or reduce the incidence, severity and extend of post surgical adhesion formation.         (3)Patients undergoing laparotomy or laproscopic abdomino-pelvic surgery as an adjunct to good surgical technique intended to reduce the incidence, severity and extent of post surgical adhesion formation.                              2/6/2010
506 Pregabalin SR 75/150/300mg + Methylcobalamin 1500mcg tablets   For the treatment of adult patients with peripheral neuropathy 2/9/2010
507 Ivabradine Hcl Tablets 5/7.5mg (Additional Indication)  For Symptomatic Treatment of chronic stable angina pectoris in coronary artery disease patients with normal sinus rhythm, indicated in combination with beta-blockers in patients inadequately controlled with an optimal beta-blocker dose and whose heart rate is >60bpm. 2/10/2010
508 Paracetamol Solution for Infusion (10mg/ml) in 50ml (Additional Packsize) Same as approved 2/10/2010
509 Ketorolac Tromethamine Ophthalmic Solution 0.45% Indicated for the treatment of pain and inflammation following cataract surgery. 2/10/2010
510 Cytarabine Injection 100mg Additional Packsize (20ml) In combination with other approved anticancer drugs is indicated for remission induction in acute non-lymphocytic leukemia of adults and children.  It has also been found useful in the treatment of acute lymphocytic leukemia and the blast phase of chronic myelocytic leukemia.  Intrathecal administration of cytarabine is indicated in the prophylaxis and treatment of meningal leukemia. 2/10/2010
511 Olopatadine Hcl Nasal Spray 0.6% w/w (Additional Indication) For the relief of the symptoms of seasonal allergic rhinitis in patients 6 years of age and older. 2/10/2010
512 Sodium chloride 6.80gm + Potassium chloride 0.30 gm + Calcium chloride dihydrate 0.37gm  + Magnesium chloride  hexahydrate 0.20gm + Sodium acetate trihydrate 3.27gm + L-malic acid 0.67gm in 1000ml solution for infusion   Replacement of extracellular fluid losses in case of isotonic dehydration, especially if acidosis is being imminent or present  2/11/2010
513  Chemically Modified Sodium Hyaluronate and          Caboxymethylcellulose Absorbable Adhesion Barrier. As an adjunct in abdominal or pelvic surgery for reducing the incidence, extent and severity of postoperative adhesions at the site of placement. 2/11/2010
514 Lornoxicam 4mg/4mg + Thiocolchicoside 4mg/8mg tablets  For the treatment of patients with acute painful musculoskeletal conditions 2/12/2010
515 Cefixime 100mg/200mg + Cloxacillin 500mg/500mg tablets  For the treatment of adult patients with upper & lower respiratory tract infections, skin and soft tissue infections 2/12/2010
516 Celecoxib Mouth Dissolving Tablet 50/100/200 mg For the Treatment of Osteoarthritis and Rheumatoid Arthritis 2/25/2010
517 Propofol 2% w/v Injection (additionalStrength) Same as Approved 2/27/2010
518 Spironolactone 25mg + Furosemide 20mg tablets For treatment of resistant oedema associated with secondary hyperaldosteronism; resistant hypertension, chronic cardic failure and hepatic cirrhosis 3/5/2010
519 Olopatadine5mg + Ambroxol30mg tablets  For the management of cough in adult patients only  3/5/2010
520 Methylcobalamin750mcg + Pregabalin75/150mg + Vitamin B61.5mg + Folic acid0.75mg + Benfothiamine7.5mg capsules For the treaetment of painful diabetic neuropathy in adults only  3/5/2010
521 Calcium acetate 435mg + Magnesium carbonate 235mg tablets For the management of hyperphosphatemia in adults patients with renal failure being treated with dialysis (hemodialysis or peritoneal dialysis 3/5/2010
522 Dicyclomine2.5mg + Dried Aluminimum Hydroxide200mg + Light Magnesium Oxide100mg + Simethicone 20mg per 5ml suspension. For the treatment of the symptoms of functional gastrointestinal disorders like irratible bowel syndrome, functional dyspepsia, peptic ulcers., GERD which includes smooth muscle spasm, flatulence, abdominal distension, hyperacdity, gastric distress, bloting etc. 3/5/2010
523 Sertaconazole 2% w/v+ Zinc Pyrithione 1% w/v Shampoo For the treatment in adults patients with dandruff/seborrheic dermatitis of the scalp 3/5/2010
524 Faropenam Sodium Extended Release Tablet 225/300/450 mg For the Treatment of respiratory tract infections, urinary tract infection, skin and skin structure infections and gynaecological infections 3/8/2010
525 Amlodipine5mg + Ramipril10mg/5mg Tablets  For the treatment of hypertension only 3/10/2010
526 Doxofylline MR Tablet 650 mg For the treatment of Bronchial Asthma and COPD in Adults 3/11/2010
527 Lidocaine7.5mg + Prilocaine2.5mg per acutation spray For the treatment of adult male patients with premature ejaculation 3/12/2010
528 Pramipexole Di HCl monohydrate ER Tablet 0.375/0.75/1.5/3/4.5 mg For the treatment of the sign and symptoms of idiopathic parkinsons disease 3/13/2010
529 Drosperinone 3mg + Ethinyl Estradiol0.02mg tablets  For the treatment of symptoms of premenstrual dysphoric disorders (PMDD) in women (additional indication) 3/16/2010
530 Miglitol 25 mg + Metformin 500mg tablets Additional Strength 3/16/2010
531 Propranolol 40mg (SR Pellets) + Fluarizine 5mg/10mg capsules  For the prophylaxis of migraine 3/16/2010
532 Citicholine 500mg + Piracetam 400mg Tablets  For the treatment of acute stroke  3/16/2010
533 Diclofenac 50mg + Chlorzoxazone500mg Tablets For the treatment of acute inflammation conditions associated with spasm in adults only 3/16/2010
534 Mecobalamin 750 mcg + Pyridoxine 1.5mg + Nicotinamide 45 mg + Benfotiamine 150mg Tablets For the treatment of diabetic neuropathy in adults 3/16/2010
535 Etoricoxib 1%+ Menthol 5% Spray  For the topical treatment of acute musculoskeletal pain 3/16/2010
536 Pantoprazole 40mg + Cinitapride (ER) 3mg Capsules For the treatment of patients suffering from non-ulcer dyspepsia (NUD) or gasteroesophageal reflux disease (GERD) 3/17/2010
537 Atorvastatin 20mg + Ramipril 2.5mg/5mg Capsules  Additional higher strength 3/17/2010
538 Lamotrigine Orodispersible Tablet 12.5 mg Same as Approved 3/20/2010
539 Trabectedin powder for Conc. solution for infusion (Additional Indication) In combination with pegylated liposomal doxorubicin, it is indicated for the treatment of patients with relapsed platinum- sensitive ovarian cancer 3/20/2010
540 Lornoxicam 8mg/8mg + Thiocolchicoside 4mg/8mg Tablets  Additional higher strength 3/23/2010
541 Diclofenac sodium SR Tablet 150 mg For the treatment of rheumatoid arthritis, osteoarthritis, ankylosing spondilytis,gout,painful post perative pain following dental surgery etc. 3/26/2010
542 Magnesium Valproate CR Tablet 200/ 300/400/ 500 mg (additonal strength) Same as Approved  3/26/2010
543 Lidocaine 2.5% w/w+Prilocaine 2.5% w/w Gel Additional higher Strength 3/26/2010
544 Nicotinic Acid and Laropiprant Modified Release Tablets: Nicotinic Acid.........1000 mg     Laropiprant...........20mg 1. For the treatment of dyslipidaemia, particularly in patients with combined mixed dyslipidaemia (characterised by elevated levels of LDL-cholesterol and triglycerides and low HDl-cholesterol) and in patients with primary hypercholesterolemia (heterozygous familial and non-familial).     2. In combination with HMG-CoA reductase inhibitors (statins), when cholesterol lowering effect of HMG-CoA reductase inhibitor monotherapy is inadequate. It can be used as monotherapy only in patients in whom HMG-CoA reductase inhibitors are considered inappropriate or not tolerated. Diet or other non-pharmacological treatments (e.g. exercise, weight reduction) should be continued during therapy. 3/26/2010
545 Pantoprazole Mouth Dissolving Tablet 20/40 mg For the treatment of gastric ulcer, duodenal ulcer & gastroesophageal reflux disease (GERD). 3/30/2010
546 Praziquntel 175mg + Pyrantel 504mg + Febental 525mg Tablets  For the treatment of mixed infections with roundworms and tapeworms in dogs  3/30/2010
547 Difluprednate Opthalmic Emulsion 0.05% w/v For the treatment of inflammation and pain  associated with ocular surgery.  3/30/2010
548 Tolperisone Hcl SR 450mg Tablets For the relief of painful muscle spasms of the skeletal muscualture. 3/30/2010
549 S(-)Metoprolol 25mg/50mg (ER) + Atorvastatin (IR)10mg tablets  For the treatment of patients with both essential hypertension and hypercholesterolemia 1/4/2010
550 Atorvastatin10mg + Ramipril 5mg + Aspirin (EC pellets) 75mg/150mg + Metoprolol (ER tablets) 25mg Capsules For secondary prophylaxis of ischemic heart disease in patients where use of such combinations in appropriate  4/5/2010
551 Lamotrigine 25mg Modified Release Tablet (Addl. Strength) Same as Approved 4/5/2010
552 Imatinib Mesylate 100/400mg Tablets (Addl. Indication) Adjuvant treatment of adult patients following resection of gastro-intestinal stromal tumours (GIST) 4/5/2010
553 Azithromycin SR Granules for Oral Suspension 1gm (Addl. Strength) Same as Approved 4/5/2010
554 Gemfibrozil Capsule USP & Gemfibrozil Tablet USP 200mg/600mg (Addl. Indication) For the treatment of other dyslipidemias: (a) Fredrickson Types III and V.(b) Associated with diabetes.(C) Associated with xanthomata. 4/5/2010
555 Ibuprofen 400mg + Chlorzoxazone 500mg Tablets For the short term treatment of musculoskeletal pain associated with inflammation and spasm in adults only 4/7/2010
556 Doxophylline (SR) 400mg/800mg + Montelukast 10mg/10mg Tablets  For the treatment of bronchial asthma in adults 4/7/2010
557 Dronedarone( as Hydrochloride) film coated tablet .... 400 mg.  To reduce the risk of cardiovascular hospitalization in patients with paroxysmal or persistent atrial fibrillation (AF) or atrial flutter (AFL), with a recent episode of AF/AFL and associated cardiovascular risk factors (i.e., age > 70, hypertension, diabetes, prior cerebrovascular accident, left atrial diameter > 50mm or left ventricular ejection fraction [LVEF] < 40%), who are in sinus rhythm or who will be cardioverted. 4/8/2010
558 Dosulepin Hcl Tablet 25mg/75mg (Additional Indication) For the treatment of chronic pain. 4/8/2010
559 Prasugrel (as Hydrochloride) film coated tablet ....5 mg / 10mg.  To reduce the rate of thrombotic cardiovascular (CV) events (including stent thrombosis) in patients with acute coronary syndrome (ACS) who are to be managed with percutaneous coronary intervention (PCI) as  follows:  • Patients with unstable angina (UA) or non-ST-elevation myocardial infarction (NSTEMI).     • Patients with ST-elevation myocardial infarction (STEMI) when managed with primary or delayed PCI.   4/13/2010
560 Tofisopam uncoated tablet JP... 50/100mg For the treatment of anxiety and depression. 4/13/2010
561 Zotepine tablet ....25/50/100mg For the treatment of schizophrenia 4/15/2010
562 Armodafinil uncoated tablet ..50/150/250mg To improve wakefulness in patients with excessive sleepiness associated with treated obstructive sleep apnea (OSA), shift work sleep disorder (SWD) or narcolepsy. 4/23/2010
563 Indacaterol ( as Maleate ) Inhalation Powder Hard Capsules ….. ...150/300mcg For maintenance bronchodilator treatment of airflow obstruction in adult patients with chronic obstructive pulmonary disease (COPD). 4/24/2010
564 Ranolazine ER Tablets 750mg  Same as Approved 4/24/2010
565 Tacrolimus Capsules 3mg  Same as approved 4/24/2010
566 Cefixime 100mg/200mg + Ofloxacin 100mg/200mg Tablets For the treatment of patients with typhoid fever and urinary tract infection in adults  4/26/2010
567 Liquid paraffin 6% + White soft paraffin 15%w/v Cream  For symptomatic relief of dermatological condition associated with dry skin including atopic dermatitis, eczema, pruritus, ichthyosis, xerosis, psoriasis 4/29/2010
568 Levosimendan Injection 2.5mg / ml For the short term treatment of acutely decompensated chronic heart failure (ADHF) in situations where conventional therapy is not sufficient and in cases where ionotropic support is considered appropriate. 4/30/2010
569 Thiocholchicoside SR Tablet 16 mg As an adjuvant treatment in painful spasms associated with degenerative vertebral disorders and vertebral static problems, torticollis dorsal pain, low back pain, traumatological and neurological disorders. 31/04/2010
570 Telmisartan 40/80 mg+ Indapamide SR 1.5/1.5 mg tablet  For the treatment essential hypertension  4/5/2010
571 one strip of 3 uncoated tablets of artesunate 150mg & one strip of 2 uncoated tablets of FDC of Sulphadoxine IP 500mg + Pyrimethamine IP 25mg  Additional strength  4/5/2010
572 Lapatinib Ditosylate Tablets 250mg (addl. Indication) In combination with letrozole for the treatment of postmenopausal women with hormone receptor positive metastatic breast cancer that overexpresses the HER2 receptor for whom hormonal therapy is indicated. 5/10/2010
573 Pentosan polysulfate Sodium Cpasules  100mg For the relief of bladder pain or discomfort associated with interstitial cystitis. 5/11/2010
574 Indapamide (SR) 1.5mg/1.5mg +Nebivolol 2.5mg/5mg tablet For the treatment of hypertension not controlled with monotherapy  5/12/2010
575 Cinitapride (ER) 3mg + Omeprazole (EC) 20mg Capsules  For the treatment of gastirc ulcer,gastroesophageal reflux disease(GERD) & Dyspepsia not responding to omeprazole alone 5/12/2010
576 Timolol Maleate Long Acting Ophthalamic Solution 5mg/ml For the treatment of elevated intraocular pressure in patient with ocular hypertension or open angle glaucoma. 5/14/2010
577 Telmisartan tablet 20/40/80 mg(Additional indication) For the prevention of cardiovascular morbidity and mortality in patient 55 years older at high risk of cardiovascular disease 5/14/2010
578 Dexketoprofen Trometamol 25mg + Thiocolchicoside 4mg tablets For the treatment of acute low back pain and other musculoskeletal painful & inflammatory conditions in adult patients 5/20/2010
579 Troxipide  film coated Tablets 50mg /100mg For the treatment of Gastric ulcers and for amelioration of gastric mucosal lesions (erosion, hemorrhage, redness and edema) in the diseases such as acute gastritis, acute exacerbation stage of chronic gastritis.  5/20/2010
580 Ambrisentan film coated Tablets 5 mg / 10mg For the treatment of pulmonary arterial hypertension (WHO Group I) in patients with WHO class II or III symptoms to improve exercise capacity and delay clinical worsening. 5/24/2010
581 Rosuvastatin Calcium Tablet(Additional Indication) Risk reduction of MI stroke and arterial evascularisation procedure in patients without clinically evident CHD but with multiple risk factor 5/24/2010
582 Paracetamol SR 1000mg Bilayered tablet  For symptomatic treatment of pain and fever 5/24/2010
583 Tacrolimus PR Caps 0.5/1/5 mg For Prophylaxis of transplant rejection in adult kidney or liver allograft rejection 5/24/2010
584 Rizatriptan Benzoate orally disintegrating tablet 10 mg Same as Already approved 5/24/2010
585 Ramipril 1.25/ 2.5/5/10 mg(Additional Indication) For the treatment ofnon-diabetic overt glomerular or incipient nephropathy 5/24/2010
586 Exenatide Inj. (Additional Indication) Use in patients with type-2 diabetes mellitus who are using a thiazolidinedione alone or in combination with metformibn but have not achieved adequate glycemic control 5/24/2010
587 Temozolomide lyophilised powder 100mg / vial For the treatment of  "Adult patients with newly-diagnosed glioblastoma multiforme concomitantly with radiotherapy (RT) and subsequently as monotherapy treatment."     Children from the age of three years, adolescents and Adult patients with malignant giloma, such as glioblastoma multiforme or anaplastic astrocytoma, showing recurrence or progression after standard therapy.  5/24/2010
588 Fluticasone Propionate 50mcg/125mcg/250mcg + Salmeterol xinafoate 25mcg/25mcg/25mcg Powder for inhalation  For the maintenance treatment of asthma and for the treatment of COPD associated with chronic bronchitis 5/25/2010
589 Cross linked Hyaluronic Acid 24mg + Lidocaine 3mg Pre-filled syrings  For filling any medium sized depression of the skin via mid dermis injection as well as for lip definition. The presence of lidocaine is meant to reduce the patients pain during the treatment 5/28/2010
590 Aceclofenac 1% w/w + Menthol 5% Spray  For the treatment of acute painful inflammatory conditions in adults only 5/28/2010
591 Metformin SR 500mg/500mg + GliclazideSR 60mg/30mg + Pioglitazone 15mg/15mg tablets As 3rd line treatment of type II diabetes mellitus when diet, exercise and the single agents and the second line therapy with two drugs do not result in adequate glycemic control 5/28/2010
592 3 tablets of artesunate 100mg + 3 tablets of Artesuante 50mg & 2 tablets of FDC of Pyrimethamine 25mg + Sulphadoxine 500mg combipack Additional strength  5/28/2010
593 Calcium carbonate 600mg +Simethicone 80mg Chewable tablet To relive the uncomfortable symptoms of acid indigestion, heart burn, gas or sour stomach 5/28/2010
594 Activated Dimethicone 50mg + Magnesium Hydroxide 250mg+ Dried Aluminium Hydroxide250 mg + Sorbitol (70%)1.25 gm /5ml Solution  For treatment of symptoms of hyperacidity (e.g. heartburn, epigastric discomfort, or their equivalents) that are often associated with dyspepsia, peptic ulcers, gastritis, peptic esophagitis and indicated for relief of flatulence  5/28/2010
595 Aspirin 75mg + Simvastatin 10mg/20mg + Lisinopril 5mg/10mg + Atenolol 25mg/50mg Tablets For secondary prevention of coronory heart disease/stroke in patients where use of such combination is appropriate  6/1/2010
596 Irsogladine Maleate Tablet  2mg /4mg For gastric ulcers, improvement of gastric mucosal lesion (erosion, hemorrhage, redness and edema) caused by acute gastritis and acute exacerbation stage of chronic gastritis. 6/5/2010
597 Lacosamide film coated tablet 50mg /100mg /150mg /200mg As an adjunctive treatment of partial onset seizures in patients > 17 years of age. 6/10/2010
598 Carmustine for inj. 100 mg Indicated as palliative therapy as a single agent or in established combination therapy with other approved chemotherapeutic agents in the following: 1.Brain tumors—glioblastoma, brainstem glioma, medulloblastoma, astrocytoma, ependymoma, and metastatic brain tumors.  2.Multiple myeloma—in combination with prednisone. 3.Hodgkin’s Disease—as secondary therapy in combination with other approved drugs in patients who relapse while being treated with primary therapy, or who fail to respond to primary therapy. 4.Non-Hodgkin’s lymphomas—as secondary therapy in combination with other approved drugs for patients who relapse while being treated with primary therapy, or who fail to respond to primary therapy.      6/10/2010
599 Monteleukast Sodium Tablet 10mg; Monteleukast Sodium 4/5mg Chewable Tablet; Monteleukast Sodium Oral granule(Additional Indication) For the relief of symptoms of seasonal allergic rhinitis in adults and pediatric patients 2 years of age and older. 6/12/2010
600 Ramosetron Dispersible Tablet 0.1 mg For the prevention and treatment of gastrointestinal symptoms(nausea and vomitting) associated with ematogenic cancer chemotherapy 6/12/2010
601 Amitraz 2%w/v pour on solution  For the control of ticks on cattle and ostriches 6/12/2010
602 Flupirtine Maleate Capsules 100mg For treatment  of acute and chronic pain  ,i.e, for painful increased muscle tone of the posture and motor muscles, primary headache,                                    tumor pain, dysmenorrhea and pain after traumatologic / orthopaedic operations and injuries. 6/12/2010
603 Lidocaine Patch 350mg (Additional Pack Size) For the relief of pain associated with post-herpetic neuralgia. It should be applied only to intact skin. 6/17/2010
604 Oseltamivir Phosphate (Additional indication) In the treatment of children 6 to 12 months of age during a pandemic influenza outbreak. 6/19/2010
605 Methylcobalamin 1500mcg +Folic acid 0.7mg +Niacinamide 12mg injection   For the treatment of diabetic neuropathy in adults 6/23/2010
606 Methylcobalamin 1500mcg +Pyridoxine 100mg +Nicotinamide 100mg injection  For the treatment of diabetic neuropathy in adults 6/23/2010
607 1 tablet of Tenofovir disoproxil 300mg + Lamivudine 300mg  & 2 tablet of Nevirapine 200mg combipack    For the treatment of HIV infection in adults 6/23/2010
608 Vitamin A (oily form) as palmiate 2000IU + Vitamin B1 1mg + Vitamin B2 1mg + Vitamin B6 1.34mg + Vitamin B12 1mcg + Ascorbic acid 33.3mg  + Vitamin D3 200IU + Folic acid 0.3mg + Calcium pantothenate 1mg + Niacinamide 15mg + Dibasic calcium phosphate 100mg + Phosphorus 77mg+ Ferrous fumarate 50mg + Copper 0.01mg+ Potassium iodide 0.0015mg + Heavy magnesium oxide 1mg + Manganse sulphate 0.01mg + Potassium sulphate 1mg + Zinc sulphate 0.15mg Capsule For the treatment of vitamin deficiency states in adults 6/23/2010
609 Ramipril MR Capsules 2.5/5 mg  Same As Approved 7/3/2010
610 Sitagliptin Phosphate 25/50/100 mg Tablet (Additional Indication) (i) Use of Sitagliptin Phosphate in combination with Metformin and a PPARγ agonist as an adjunct to diet & exercise in adult patients with type-2 Diabetes mellitus who are inadequately controlled on combination therapy with Metformin and a PPARγ agonist. (ii) Use of Sitagliptin Phosphate in combination with insulin, alone or in combination with Metformin. 7/3/2010
611 Erlotinib HCl 25/100 mg Tablet (Additional Indication) As monotherapy for maintenance treatment in patients with locally advanced or metastatic non-small cell lung cancer with stable disease after 4 cycles of standard platinum based first line chemotherapy. 7/3/2010
612 Gemcitabine HCl injection 2gm/vial  Same as Approved 7/3/2010
613 Etizolam 0.25 mg tablet  Same As Approved 7/3/2010
614 Dexketoprofen1.25% w/w +Linseed Oil 3.0%w/w +Menthol 5%w/w +Methyl Salicylate 10%w/w (12.5mg) For the topical treatment of acute musculoskeletal pain 7/6/2010
615 Cefuroxime Sodium 750/1500mg +Sulbactam Sodium 375/750mg For the treatment of mild to moderate lower respiratory tract infection  7/6/2010
616 HPMC 0.3% +Dextran 0.1% + Glycerin 0.2% For the temporary relief of burning and irritation due to dryness of the eye and for use as a protection against further irritation. For the temporary relief of discomfort due to minorirritations of the eyes or to exposure to wind or sun  7/6/2010
617 Cyanocobalamin 15mcg+Chromium Picolinate USP 250mcg+Folic Acid USP 1500 mcg+Nicotinamlide IP100 mg+Pyridoxine 3mg +Selenius Acid USP 100mcg+Zinc Sulfate Monohydrate USP 61.8 mg eq. to 22.5 mg For Mineral & Vitamins deficiency states in adult patients 7/6/2010
618 Methylparaben 0.15%w/w +Propyl paraben 0.05%w/w+Glycerin 20%w/w +CMC 1.74%w/w +Allantoin 0.5%w/w +Benzyl alcohol 0.5%w/w. For short term treatment of chronic wounds including stage III & IV pressure sores, leg ulcers  7/6/2010
619 Clonazepam IR 0.5mg/0.5mg+ Paroxetine CR 12.5/25mg  For the treatment of patients with co-morbid depression and axiety  7/8/2010
620 Nilotinib Capsules 200mg For the treatment of chronic and accelerated phase Philadelphia chromosome positive chronic myelogenous leukemia (CML) in adult patients resistant to or intolerant to prior therapy that included imatinib. 7/10/2010
621 Imipenem 50mg + Clistatin 50mg Treatment of infection caused by susceptible bacteria for the following indication as in neonates and infants (below 3 months of age) 1. Lower respiratory tract infections 2. Urinary tract infections 3. Intra-abdominal infections 4. Bacterial septicemia 5. bone and joint infections 6. Skin and Skin structure infections 7. Bacterial endocarditis  7/14/2010
622 Lidocaine Lozenges 100mg  Same as Approved 7/15/2010
623 Metoprolol succinate ER 25/50 mg+Telmisartan 20/40mg For the treatment of essential hypertension  7/16/2010
624 Etodolac 300/300mg +Thiocolchicoside 4/8mg  For the treatment of patients with acute painful musculoskeletal conditions 7/19/2010
625 Celecoxib 100/200mg +Diacerein 50/50mg For the treatment of adult patients with osteoarthritis of knee and/or hip joints  7/19/2010
626 Metoprolol succinate ER 25mg+50mg + Olmesartan 20/20mg For the treatment of essential hypertension  7/19/2010
627 1 tablet of Atazanavir 300mg & 1 tablet of ritonavir Ritonavir 100mg & FDC of Tenofovir Disoproxil fumarate 300mg + Lamivudine 300mg  (Each Co-pack contains :- 1 capsule of Atazanavir 300mg & 1 Tablet of Ritonavir 100mg & 1 Tablet of FDC of Tenofovir Disoproxil Fumarate 300mg + Lamivudine 300mg) For the treatment of HIV infections in adults  7/19/2010
628 Gliclazide 40/80mg+Metformin 500mg+Pioglitazone15mg Additional strength  7/19/2010
629 Lidocaine HCl Ophthalmic Sterile Gel 35 mg/ml Indicated for ocular surface anaesthesia during ophthalmologic procedures. 7/30/2010
630 Naftopidil Tablets 25/50/75mg For the treatment of dysuria associated with benign prostratic hyperplasia. 7/30/2010
631 Metformin 500/850/1000mg+Sitagliptin Phosphate 50/50/50mg (Additional Indication) A) FDC is indicated as triple combination therapy with a PPARy agonist (i.e a thiazolidinedione) as an adjunct to diet and exercise in patients inadequtely controlled on their maximal tolerated dose of metfomin and a PPARy agonist. B) FDC is also indicated as add-on to insulin(i.e triple combination therapy) as an adjucnjt to diet and exercise to improve glycemic contrl in patients when stable dosage of insulin and metformin alone do not provide adequte control.  8/2/2010
632 Bimatoprost Eye Drps 0.1mg/ml for the treatment of hypotrichosis of the eye-lashes by increasing their growth including length, thickness & darkness. 8/5/2010
633 S(+) Etodolac 5/10%w/w + Camphor 4%w/w  + Menthol 10%w/w + Methyl salicylate 5%w/w + Linseed oil 3%w/w  For the painful & inflammatory conditions associated with joint, tendons, ligaments and muscles   8/5/2010
634 Cefpodoxime 100/200mg+Dicloxacillin ER 500/500mg For the treatment of lower RI, Skin and soft tissue, bone and joint infections and ENT infections in adult patients prone to antibiotic induced diarrhoea 8/6/2010
635 Voglibose0.3 + Metformin (SR) 500mg Additional higher strength 8/6/2010
636 Amoxycillin Oral Suspension 200/400 mg per 5ml in the treatment of infections due to susceptible strains of the designated micro-organisms in the condition of E.N.T infection, skin & skin structure infection, lower respiratory tract infection, genito-urinary tract infection, gonorrhea, acute uncomplicated (anogenital & urethral) infections. 8/9/2010
637 Olmesartan 40mg + Amlodipine 5mg  Additional indication: 1. For the treatmenmt of hypertension alone or with other antihypertensive agents 2. To use as initial therapy in patients who are likely to need multiple antihypertensive agents to achieve their blood pressure goals  8/9/2010
638 Doripenem 500 mg powder for injection (Additional Indication) Complicated intra-abdominal infections and complicated urinary tract infections, including complicated and uncomplicated pyelonephritis and cases with concurrent bacteremia 8/10/2010
639 Nadolol tablet USP 20/40/80 mg in the treatment of angina-pectoris, cardiac arrythmias & essential hypertension. 8/20/2010
640 Fluconazole For Oral suspension 50/200 mg per 5ml (Pack Size : 35ml) for the treatment of systemic candidiasis, mucosal candidiasis, prevention of fungal infections in patients with malignancy. 8/20/2010
641 Metformin 500/500mg + Repaglinide 1/2mg  Indicated as an adjunct to diet and excersice to improve glycemic control in adults with type 2 diabetes mellitus who are already treated with a meglitinide & metformin or who have inadequte glycemic control on a meglotinide alone or metformin  8/20/2010
642 Hydroxyzine Hydrochloride SR Tablets 25/50/75mg For management of pruritus due to allergic conditions such as chronic urticaria and atopic contact dermatoses, and in histamine - mediated pruritus. 8/20/2010
643 Rosuvastatin 5/10/20mg+Fenofibrate 67/145/160mg For the treatment of combined hyperlipidemia in patients with normal hepatic and renal function 8/23/2010
644 Fexofenadine 120mg + Montelukast 10mg For treatment of allergic rhinitis in adults only 8/31/2010
645 Irinotecan HCl Trihydrate Injection 20 mg/ml (Pack Size 25ml) for the treatment of metastatic colorectal cancer . 31.08.10
646 Cefixime SR 200mg/400mg + Ofloxacin SR 200mg/400mg Tablet  Additional strength  31.08.10
647 Ademetionine enteric coated Tablets ..200mg/400mg For the management of intrahepatic cholestasis and liver disease. 01.09.10
648 Memantine HCl ER Tablet 28mg in the treatment of moderate to severe Alzheimer's disease. 06.09.10
649 Buserelin Acetate injection 1mg/ml (Additional Indication) indicated for the palliative (initial & maintenance treatment) of patients with hormone-dependent advanced carcinoma of the Prostate gland (Stage D). 08.09.10
650 Etodolac 400mg/400mg + Thiocolchicoside 4mg/8mg tablet  Additional higher strength 09.09.10
651 Montelukast Sodium 10 mg Tablet, Montelukast Sodium 4/5 mg Chewable Tablet and Montelukast Sodium Oral Granules (Additional Indication). For The relief of perennial allergic rhinitis in adults & pediatrics patients 6 months of age and older. 11.09.10
652 Acyclovir SR Tablet 1200 mg For the treatment of uncomplicated Herbis Zoster in immunocompetent patients. 11.09.10
653 Lornoxicam 4mg + Eperisone 50mg tablet For the improvement of myotonic conditions caused by neck shoulder arm syndrome, scapulumeral periarthiritis and low back pain in adult patients only  13.09.10
654 Pirfenidone film coated tablet ...200mg For the treatment of idiopathic pulmonary fibrosis. 14.09.10
655 Beclomethasone Dipropionate IP  0.025% w/w + Neomycin sulphate IP 0.5% w/w  cream Additional lower strenth  15.09.10
656 Amlodipine 5mg/2.5mg + Valsartan 320mg/80mg + HCTZ 12.5mg/12.5mg tablet Additional strength 21.09.10
657 Paracetamol 500mg/500mg +Thioclchicoside 4mg/8mg tablet  For the treatment of acute inflammation conditions associated with spasm in adults only 21.09.10
658 Ketorolac Tromethamine 0.4% w/v +Moxifloxacin 0.5% w/v Opthalmic solution Additional lower strenth  21.09.10
659 Nilotinib Capsules 150 mg. Treatment of newly diagnosed adult patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+CML) in chronic phase. 9/29/2010
660 Levocloperastine ( as Fendizoate) Suspension eq. to Levocloperastine Hcl  20mg / 5ml. For the treatment of non productive cough in adult patients 29.09.10
661 Zileuton uncoated bilayered extended release tablet ...600mg For the prophylaxis and chronic treatment of asthma in adults. 30.09.10
662 Etodolac 400mg + Paracetamol IP 500mg tablet Additional higher strength 01.10.10
663 Dried Aluminium Hydroxide Gel IP 600mg +Magnesium Hydroxide IP 300mg +Simethicone IP 25mg +Oxetacaine BP 10mg per 5ml syrup For the treatment of symptoms of functional gastrointestinal disorders like irritable bowel syndrome, functional dyspepsia, peptic ulcer, gasteroesophagal reflux disease which include smooth muscle spasms, flatulence, abdominal distension, hyperacidity, gastric distress, bloting etc. 05.10.10
664 S(-) Metoprolol Succinate ER Eq. to      S (-) Metoprolol tartarate 25mg/50mg + Clopidogrel (IR) 75mg/75mg tablet  For the treatment of essential hypertension who need antiplatelet therapy especially for prophylaxis of atherombotic event. 07.10.10
665 Exenatide Injection (Additional indication) Exenatide is a glucagon like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus. 09.10.10
666 Bimatoprost Ophthalmic Solution 0.01% w/v  Same as approved. 09.10.10
667 Drosperinone + Ethinylestradiol tablets Same as approved For the treatment of moderate acne vulgaris in adult females, who have no known contraindications to oral contraceptive therapy, and have achieved menarche. It should be used for the treatment of acne only if the patient desires an oral contraceptive for birth control. 09.10.10
668 Etodolac USP 400mg +Tolperisone HCL  150mg tablet For the treatment of acute inflammation conditions associated with spasm in adults only 11.10.10
669 Citicoline 500mg +Piracetam 400mg per 5 ml syrup Additional dosage form  11.10.10
670 Thiocolchicoside 0.25% +Methyl salicylate IP 100mg +Menthol IP 50mg +Absolute alchol IP 50mg per gm gel For the topical treatment of painful muscles spasms of skeletal musculature 11.10.10
671 Amlodipine Besylate IP Eq. to Amlodipine 10mg/5mg/2.5mg +Telmisartan 80mg/40mg/20mg + HCTZ 25mg/12.5mg/12.5mg tablet  For the treatment of essential hypertension  12.10.10
672 Pregabalin 150mg/75mg +Methylcobalamin 750mcg +Alpha lipoic acid 100mg +Pyridoxine 3mg +Folic acid 1.5mg capsule For the treatment of painful diabetic neuropathy in adults only 12.10.10
673 Ferrous bisglycinate 60mg + Zinc sulphate monohydrate Eq. to Zinc 14mg + Copper as copper sulphate 1 mg + Selenium as selenomethionine 70mcg + Vitamin B6 IP 10mg  + Methylcobalamin 1500mcg + Folic acid 5mg + Fish oil 10/40 (DHA 200mg) 500mg capsule. For Vitamin and mineral deficiency  13.10.10
674 Combipack of 21 tablets of FDC of  Ethinylestradiol IP 0.03 mg + Levonorgestrel IP 0.15 mg and 7 tablets of Ferrous Fumarate IP 75mg (Eq. to 24.375 mg of Ferrous iron)   As contraceptive pill for women  13.10.10
675 Amitriptyline Hydrochloride IP 4%w/w + Ketamine HCL eq. to Ketamine 2% w/w per gm cream. For the treatment of patients suffering from neuralgia 13.10.10
676 Paracetamol IP 500mg + Phenylephrine HCL IP 5mg +Caffeine (anhydrous) IP 30mg + Diphenhydramine HCL IP 25mg tablet. For the treatment of fever associated with cold, nasal congestion in adults 13.10.10
677 Levocetirizine dihydrochloride 2.5mg +Montelukast 5mg dispersible tablet  Additional strength 13.10.10
678 Calcium citrate maleate Eq. to elemental calcium 250mg +Vitamin D3 IP 200 IU tablet For the treatment of calcium and Vitamin D deficiency states  13.10.10
679 Levonorgesterel 100mcg +Ethniyl estradiol IP 20mcg tablet (Additional indication) For the treatment of moderate acne vulgaris in women more than 18 years of age who have no therapy contraindications to oral contraceptive therapy, desire contraceptiopn, and have achieved menarche  13.10.10
680 Eberconazole 1% w/w + Mometasone Furate USP 0.1% w/w cream For the treatment of mild to moderate inflammed cutaneous mycoses 13.10.10
681 Lubiprostone Soft Gelatin Capsules ..…8mcg /24mcg 1. For the treatment of chronic constipation in adults. 2. For the treatment of irritable bowel syndrome with constipation (IBS-C) in women > 18 years old. 16.10.10
682 Pazopanib (as Hydrochloride) film coated Tablets…200mg / 400mg For the treatment of patients with advanced renal cell carcinoma. 16.10.10
683 Eltrombopag (as Olamine) Tablets ...25mg / 50mg for the treatment of thrombocytopenia in patients with chronic immune (idiopathic) thrombocytopenic purpura who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. (It should be used only in patients with ITP whose degree of thrombocytopenia and clinical condition increase the risk for bleeding. It should not be used in an attempt to normalize platelet counts). 16.10.10
684 Tolperisone HCL 150mg + Paracetamol IP 500mg tablet For the treatment of patients with acute painful musculoskeletal conditions 21.10.10
685 Zaltoprofen film coated tablet …80mg JP For anti inflammatory and analgesic activity in rheumatoid arthritis, osteoarthritis, low back pain, periarthritis of shoulder, cervicobrachial syndrome, postoperative, post trauma, and post dental extraction. 31.10.10
686 Hyoscine Butylbromide 20 mg tablet  Same as Approved. 04.11.10
687 Cerebroprotein Hydrolysate  injection (Lyophilised) …..1050mg / 2100mg (approx)   equivalent to nitrogen….30mg / 60mg respectively.  For amelioration of cranial injury, cerebrovascular pathological sequelae and aprosexia in dementia. 04.11.10
688 Clebopride (as Malate) (1)Tablets...0.5 mg Ph. Eur. (2.) Syrup...0.1 mg / ml Ph. Eur.  (3.) Injection...1 mg / 2mlPh. Eur. For the treatment of various disorders associated with altered gastrointestinal motility like non-ulcer dyspepsia (NUD) and / or chronic gastritis, gastroesophageal reflux disease (GERD), nausea and vomiting of organic or functional origin. 04.11.10
689 Tolperisone HCl Mouth Dissolving tablet 50/100 mg  Same as Approved. 04.11.10
690 Oxybutynin Gel 100 mg For the treatment of overactive bladder with the symptoms of urge urinary incontinence, urgency and urinary frequency. 04.11.10
691 Dapoxetine ( as  Hydrochloride) Tablets …30mg/60mg For the treatment of premature ejaculation  (PE) in men 18 to 64 years of age. 13.11.10
692 Opipramol dihydrochloride Tablet 50mg/100mg. For the Treatment of generalised anxiety disorder(GAD) and somatic disturbances. 13.11.10.
693 Ondansetron Rapid Film Oral Strip 4/8 mg For chemotherapeutic induced nausea and vomiting. 16.11.10
694 Acebrophylline SR Tablet 200 mg For the treatment of adult patients with chronic obstructive pulmonary disease (COPD) and bronchial asthma. 23.11.10
695 Ammonium Lactate Cream 12% w/w Indicated For the treatment of Dry,scaly skin(xerosis) and ichthyosis vulgaris and for temporary relief of itching associated with these condition.  03.12.2010
696 Rabeprazole Sodium Powder oral suspension   ( sachet of 20 mg) (Additional dasage form) Same as approved 03.12.2010
697 Temsirolimus Concentrate for Infusion for Injection 25mg/ml  For the treatment of advanced renal cell carcinoma 11.12.2010
698 Acetyl Cysteine Eye Drops 5% w/v Indicated the relief of Dry eye symptoms associated with defecient tear secretion, impaired or abnormal mucus Production. 14.12.2010
699 Clindamycin Palmitate Hcl For Oral Solution 75mg/5ml. Indicated for the Prophylaxis against alpha-hemolytic(viridans group) sreptococci before dental, oral and upper respiratory tract surgery. 14.12.2010
700 Deferasirox Tablet for Oral Suspension  (Additional Sosage Form) Same as approved 14.12.2010
701 Ramelteon film coated tablets 8mg For the treatment of insomnia characterized by difficulty with sleep onset. 15.12.2010
702 Memantine ER Tablet 7mg/14mg/21mg.     Same as approved 17.12.2010
703 Solution for haemofiltration and haemodialysis (Each unit contains two compartments A & B. Before   reconstitution: •  1000ml of electrolyte solution in Compartment A contains:Calcium Chloride. 2H2O .....5.145gm Magnesium Chloride. 2H2O.... 2.033gm   Lactic Acid....5.4gm • 1000ml of buffer solution in Compartment B      contains: Sodium Chloride....6.45gm Sodium Bicarbonate....3.090gm ) For treatment of acute kidney disease (renal failure),  as substitution solution in continuous haemofiltration and haemodiafiltration and as a dialysis solution in continuous haemodialysis. 23.12.2010
704 Pyridoxine HCL IP 3mg + Nicotinamide IP 100mg + Cyanocobalamin IP 15mcg + Folic acid IP 500mcg + Chromium Picolinate USP 250mcg Tablet   For Mineral & Vitamins deficiency states in adult patients 23.12.2010
705 Rosuvastatin Calcium IP 5mg/10mg + Fenofibrate BP 160mg/160mg tablet  Additional strength  29.12.2010
706 Chlorhexidine gluconate IP 1%w/v  + Ethyl Alcohol IP 61%w/v Solution  Surgical hand scrub & healthcare personnel hand wash 29.12.2010
Year 2009 Go To Top

269 Zoledronic Acid Injection 5mg/100ml (Addl. Indication) For the treatement of osteoporosis in post-menopausal women and in men who are at increased risk offracture,including those with a recent low-trauma hip fracture. 07.01.09
270 Misoprostol Tablet 600mcg Addl. Strength 09.01.09
271 Acebrophylline Syrup 10mg/ ml For the treatement of adult patients with chronic obstructive pulmonarydisease(COPD) and bronchial asthma. 09.01.09
272 Selamectin Tropical solution (for verterinaryuse.) 60mg/120mg per ml (I) For the treatement and lasting prevention of flea infestations,treatmentand control of flea allergy dermatitis, prevention of heartwormdisease,treatement and prevention of ear mites in dogs and cats; (II) For the treatement and prevention of sarcoptic mange,roundworms and for control of tick infestations in dogs. 09.01.09
273 Methylcobalamin1500mcg + Calcium 200mg + Calcitriol 0.25mcg + Folic Acid1.5mg + Pyridoxine3mg Capsules For the treatment of vitamin deficiency states in adults 14.01.09
274 Metoprolol tartrate tablets 50 mg (Addl. Indication) Adjunct to the treatement of Hyperthyroidism 14.01.09
275 Cinacalet (as HCl) Tablet 30/60/90mg For the treatment of secondary hyperparathyroidism in patients with chronic kidney diseases (CKD) on dialysis and for hypercalcemia in patients with parathyroid carcinoma 14.01.09
276 Mycophenolate mofetil Capsules 250mg, Tablets 500mg, Oral suspension 200mg/ml (addl. Indication) For the prophylaxis of acute organ rejection in patients recieving allogenic hepatic transplantation. 23.01.09
277 Liquid Paraffin1.25ml + Milk of Magnesia 3.75ml + Sodium Picosulphate 3.33mg per 5ml For symptomatic treatment of constipation in adults 29.01.09
278 Ranolazine 1000mg ER Tabs  Same as approved 31.01.09
279 Hyaluronic acid (cross linked) Pre-filled syringe 18mg/0.6ml and 24mg/0.8ml For intradermal implantation and facial soft tissue augmentation 31.01.09
280 Caspofungin acetate Injection (Addl. Indication) For use in following: (I) Empirical therapy for presumed fungal infections in febrile neutropenic patients. (II) Treatment of Candidemia and the following Candida infections: Intra-abdominal abscesses, Peritonitis and Pleural space infections. (III) Treatment  of  Esophageal Candidiasis. (IV) Treatment of invasive Aspergillosis in patients who are refractory to or intolerant of other therapies (i.e, amphotericin B, lipid formulations of amphotericin B, and/oritraconazole) 31.01.09
281 Micafungin ( as sodium) Powder for solution for infusion 50mg / vial For the treatment of patients withcandidemia, acute disseminated candidiasis, candida peritonitis, abscess and esophageal candidiasis. For the prophylaxis of Candida infection in patients undergoing hematopoietic stem cell transplantation (HSCT) 31.01.09
282 Loteprednol Etabonate Nasal spray 0.1% w/v For prophylaxis and treatment of the nasal symptoms of seasonal allergic rhinitis. 31.01.09
283 Rasagiline (as mesylate ) Tablet 0.5mg/1mg For the tratment of signs and symptoms of idiopathic Parkinson's disease as intial monotherapy and as an addition to levodopa. 31.01.09
284 Nicotine Polacrilex Gum 2mg & 4mg (Addl. Indication) To reduce the withdrawal symptoms, including nicotine craving, associated with quitting the smoking and quitting chewed tobacco and guthka containing tobacco. 03.02.09
285 Closantel Injection100mg/ ml (forverterinary use.) For the infestation of trematodes, nematodes, cestodes and arthropods of domestic animals, including milch and other food producing animals. 05.02.09
286 Lornoxicam 4mg + Paracetamol 500mg film coated tablets For the short term use in acute painful & inflammatory conditions in adults 05.02.09
287 Cetrimide15% w/v + Chlorhexidine Gluconate 7.5% v/v + Isopropyl Alcohol 7.5% v/v Concentrate Solution For cleansing of physically contaminated wounds and for pre-operative disinfection 09.02.09
288 Ketoconazole 2% w/v + Prepared Coal Tar 2% w/v (I.P. 1966) Solution For the treatment of dandruff 09.02.09
289 Doripenem (as monohydrate) Injection 250mg/500mg For the treatment of nosocomial pneumonia in adults. 16.02.09
290 Halobetasol Scalp Approved 0.05% w/v For the relief of inflammatory andpuritic manifestation of corticosteroidrespensive dermatosis 18.02.09
291 Nicotine (as Polacrilex) Lozenges 2mg & 4mg To reduce the withdrawal symptoms, including nicotine craving, associated with quitting the smoking and quitting chewed tobacco and guthka containing tobacco. 18.02.09
292 Tranexamic Acid Tab SR 750mg For the treatment of menorrhagia 20.02.09
293 Betahistine Mesilate Tablet 6mg/12mg For the treatment of dizziness and feeling of dizziness resulting from Meniere's disease, Meniere's syndrome and vertigo. 20.02.09
294 Abatacept Injection 250mg/vial (Addl. Indication) In moderately to severly active rheumatoid arithritis in adults and may be used as monotherapy or concomitantly with DMARD's other than TNF antagonists 20.02.09
295 Anidulafungin Injection (Lyophilized powder) 50mg/100mg per vial For the treatment of invasive candidiasis including candidemia andesophageal candidiasis in adult patients. 23.02.09
296 Hydroquinone 2%+ Tretinoin 0.05% + Hydrocortisone1%Cream For the treatment of patients with skin hyperpigmentation 23.02.09
297 Doxyphylline 400 mg + Terbutaline 5mg tablets For the treatment of asthma and chronic obstructive pulmonary disease in adult patients only 23.02.09
298 Hydroquinone 20mg + Tretinoin 0.25mg + Fluocinolone Acetonide 0.1mg per gm Cream For the treatment of melasma of face in adults 23.02.09
299 Ketoconazole 2% + Zinc Pyrithone 1% Lotion For the treatment of pityriasis and dandruff of the scalp 23.02.09
300 Lamivudine 30mg + Zidovudine 60mg +Nevirapine 50mg Oral Suspension (Tablets for oral Suspension) For the treatment of HIV patients 23.02.09
301 Glibenclamide 5mg + Pioglitazone 15mg + Metformin500mg film coated tablets As 3rd line treatment of type II diabetes mellitus when diet, exercise and the single agents and the second line therapy with two drugs do not result in adequate glycemic control 23.02.09
302 Aceclofenac 100mg + Tizanidine 2mg film coated tablets For the treatment of acute low back pain in adult patients only 23.02.09
303 Octinoxate 7.5% + Avobenzone 3% + Oxybenzone 3% + Titanium dioxide 2% lotion As sunscreen lotion for prevention of sunburn skin 23.02.09
304 Cetrizine 5/10mg + Ambroxol 30mg per 5ml syrup For the symptomatic relief of productive cough associated with allergic rhinitis, when both anti-histamine and mucolytic agents are desired 23.02.09
305 Lidocaine Lozenges 200/300mg For single agent anesthesia in upper gastro intestinal endoscopy. 26.02.09
306 Calamine 8% + Liquid Paraffin10% lotion As antipruritic and smoothening agent 26.02.09
307 Nifedipine 0.3% + Lidocaine1.5% cream For the treatment of anal fissures 26.02.09
308 Quinapril 20mg + HCTZ 25mg film coated tablet For the treatment of mild to moderate hypertension in adult patients (in whom combination therapy is appropriate) who have been stabilized on the individual components given in the same proportion 26.02.09
309 Levodopa 100/100/250 + Carbidopa10/25/25mg mouth dissolving tablet For the symptomatic symptoms of idiopathic Parkinson's Disease 04.03.09
310 Paliperidone ER Tablets 1.5mg Addl. Strength 04.03.09
311 Losartan 100mg+ HCTZ 25 mg tablet Additional higher strength 16.03.09
312 Darunavir(as ethanolate) Tablet 300mg For the treatment of human immunodeficiency virus (HIV) infection in antiretroviral treatment experienced adult patients, such as those patients with HIV-1 strains resistant to more than one protease inhibitor when co-administered with 100mg ritonavir, and with other antiretroviral agents. 19.03.09
313 Ropivacaine HCl Inj.2/5/7.5/10mg For the production of local or regionalanasthesia for surgery and for acute pain management. 19.03.09
314 Butaphosphan 100g + Methyl Hydroxybenzoate 1gm + Cyanocobalamin50 gm Oral powder (Veterinary Drug) As vitamin and phosphorous supplement for livestock, shirmp and fish. 19.03.09
315 Fluticasone furoate Nasal spray 27.5mcg per spray For the treatment of symptoms of allergic rhinitis. 19.03.09
316 Octinoxate 7.5% + Avobenzone 2% + Oxybenzone 3% + Octocrylene 3%+ Zinc Oxide 2% lotion A sunscreen lotion for prevention of sunburn skin 19.03.09
317 Omeprazole 20/40mg + Sodium Bicarbonate 600mg+ Magnesium Hydroxide 700mg sachet Additional Strength 19.03.09
318 Ambroxol 30mg + Levo salbutamol 1mg+Guiphenesin 50mg /5ml syrup For the symptomatic relief of bronchospasm in bronchial asthma & chronic bronchitis 19.03.09
319 Montelucast 4 mg+ Levocetrizine 2.5 mg tablet Additional lower paedriatric dose 19.03.09
320 Surgical Sealant To be indicated for use in sealing suture lines along arterial and venous reconstructions. 26.03.09
321 Lidocaine Patch 700mg in aqueous base. (50 mg per gram adhesive) For the relief of pain associated with post-herpetic neuralgia. It should be applied only to intact skin. 26.03.09
322 Bimatoprost Opthalmic solution 0.03% For the treatment of hypotrichosis of the eyelashes by increasing their growth including length, thickness and darkness. 30.03.09
323 Trabectedin powder for concentrate for solution for infusion 1 mg/ vial For the treatment of patients with advanced soft tissue sarcoma, after failure of anthracyclines and ifosfamide, or who are unsuited to recieve these agents. 30.03.09
324 Acebrophylline Syrup 10mg/ml (Additional Indication) For the treatment of children (age 6to 12years) with chronic obstructive pulmonary disease(COPD) and bronchial asthma. 30.03.09
325 Mesalamine PR Tablets 1.2gm For the induction of remission in patients with active, mild to moderate ulcerative colitis. 30.03.09
326 Mycophenolate Mofetil Tablets 750mg  Same as approved 31.03.09
327 Ketorolac Tromethamine Gel 2%w/w For the treatment of muscle, joint and post-traumatic stress. 31.03.09
328 Theophylline 400mg SR + Montelukast10mg Tablet For the treatment of patients with bronchial asthma 31.03.09
329 Hyaluronic Acid Sodium Salt 0.2 gm + Silver Sulfadiazine 1.0 gm/25 gm tube Hyaluronic Acid Sodium Salt 50 mg + Silver Sulfadiazine 1.0 gm/ 100 gm gauze pads impregneted with cream. For the treatment of wound of differentetiology 31.03.09
330 Telmisartan 80mg + Amlodipine 5mg tablet Additional higher strength 31.03.09
331 Hyaluronic Acid Sodium Salt (i) Each 15gm tube contains: HyaluronicAcid Sodium Salt 0.2gm/100gm (ii) Sterile Gauze Pads impregnated with cream: Each gauze pad contains HyaluronicAcid Sodium Salt 50/100mg For the treatment of wound of differentetiology 31.03.09
332 Abatacept Injection 250mg/vial  (additional indication) For reducing signs and symptoms of moderately to severly active polyarticular juvenile idiopathic arthritis/juvenile rheumatoid arthritis inpediatric patients 6 years of age and older who have had an inadequate response to one or more DMARD's such as MTX 10.04.09
333 Cetrizine 10 mg + Ambroxol 75 mg SR Tablet For symptomatic relief of productive cough associated with allergic rhinitis, when both anti-histamine and mucolytic agents are desired 13.04.2009
334 Ciclesonide 200mcg + Formoterol 6mcg +Tiotropium 9mcg MDI Indicated as third line treatment of severe cases of  COPD, whenmonotherapy and second line therapy with two drugs do not respond adequately. 13.04.2009
335 Each film coated bilayred tablet contains: Metoprolol 25mg/50mg + Chlorthalidone 12.5mg For the tretament of patients with mild to modrate essential hypertension 13.04.2009
336 Milnacipran 25/50mg Caps      (Addl. Indication) For the management of fibromylagia. 15.04.2009
337 Lornoxicam SR 16mg Tabs For the symptomatic treatment of pain and inflammation in patients of osteoarthritis & rheumatoid arthritis 25.04.2009
338 Palonosetron Hcl 0.075mg IV Inj (Addl. Strength) Same as approved 25.04.2009
339 Each film coated bilayred tablet contains: Metoprolol 25mg/50mg + Chlorthalidone 6.25 mg /12.5mg Additional strength 25.04.2009
340 Albendazole 400 mg + Ivermectin 6 mg tablet   For the treatment of intestinalhelminthes and suppression ofmicrofilaraemia especially with bancrofti infections 25.04.2009
341 Decitabine Lyophilized powder for injection 50mg/20ml vial For treatment of patients with myelodysplastic syndromes (MDS) including previously treated and untreated, de novo and secondary MDS of all French-American-British subtypes(refractory anemia, refractoryanemia with ringed sideroblasts, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, and chronic myelomonocytic leukemia) and intermediate-1, intermediate-2, and high-risk international Prognostic Scoring System groups. 25.04.2009
342 Retapamulin Ointment 1% For the topical treatment of bacterial skin and skin structure infections:-Primary impetigo, secondarily infected traumatic lesions, secondarily infected dermatoses. 25.04.2009
343 Each ml contains Calamine 15% w/v + Zinc oxide 5% w/v + Bentonite 3% w/v+Glycerin 5%w/v + Sodium citrate 0.05 % w/v lotion For the tretament of pruritis and prickly heat 08.05.2009
344 Each 1000 ml of emulsion contains: Medium chain triglycerides 100 gm + Soya oil 80 gm + Omega-3  acid triglycerides 20 gm + egg lecithin 12 gm + Glycerl 25 gm + Sodium oleate 0.30 gm + Alpha -tocopherol 0.20 gm + Ascorbypalmitate0.30 gm + Sodium hydroxide max. 0.06 gm + water for injection 784 gm emulsion for infusion For the supply of fats, including essential omega-6 fatty acids and omega-3 fatty acids, as part of a parenteral nutrition regimen in adults  iforal or enteral nutrition is impossible,inadequte or contraindicated. 14.05.2009
345 Sertaconazole Nitrate Powder 2% w/w & Lotion 2% w/v For the topical treatment of the superficial fungal infections of the skin. 02.05.2009
346 Amlodipine Tablets 5mg/10mg  (additional indication) 1. To reduce of fatal coronary heart disease and non-fatal myocardial infarction, and to reduce the risk of stroke.                                   2. To reduce the risk of coronary revascularization procedures and the need for hospitalization due to angina in patients with coronary artery disease. 02.05.2009
347 Clindamycin Phosphate Inj. 150mg/ml & Clindamycin HCl Capsules 150mg/300mg (additional indication) Prophylaxis of infection in neck and head surgery 02.05.2009
348 Each 15 gm sachet contains: Lactulose 10 gm + Ispaghula husk 3.50 gm granules For the treatment of chronic idiopathic constipation in adult patients only 16.05.2009
349 Sucralose for use as sweetner in drug formulations 09.05.2009
350 CarvedilolTablets 3.125/6.25/12.5/25mg (additional indication) To reduce cardiovascular mortality in clinically stable patients who have survived the acute phase of a myocardial infarction and have a left ventricular ejection fraction of ≤ 40% (with or without symptomatic heart failure) 09.05.2009
351 Dexketoprofen 12.5 mg/25 mg + Paracetamol 500 mg film coated tablets For the treatment of Acute musculoskeletal pain 18.05.2009
352 Pregabalin SR Tablet 150/300mg For the treatment of peripheral neuropathic pain in adults 16.05.2009
353 Guaiphenesin ER Tablet 1200mg For the treatment of productive cough accompanied by Phlegm 16.05.2009
354 Everolimus 5/10mg Tablets (Addl. Indication) Treatment of advance renal cell carcinoma 16.05.2009
355 Nimesulide ER 200mg Acute pain in Orthopaedic, ENT, Dental and Post Operative condition 16.05.2009
356 Palonesetron Injection 0.25mg/5ml (Additional Indication) For treatment of Post Operative Nausea & vomiting 16.05.2009
357 Bendamustine Hydrochloride Lyophilized powder Injection 100mg/ vial For the treatment of patients with chronic lymphocytic leukemia. 16.05.09
358 Caffeine(as  Citrate)       10mg / ml Injection For the short term treatment of apnoea of prematurity of infants between 28 and < 33 weeks gestational age. 16.05.09
359 Perindopril arginine 2.5mg/5mg/10mg  film coated tablet For the treatment of arterial hypertension, congestive heart failure and coronary artery disease. 16.05.09
360 Each gm contains: Halobetasol 0.05% w/w + Mupirocin 2.0 % w/w gel For the topical treatment of inflammatory dermatitis with secondrybacterial infection 16.05.09
361 Mometasone 0.1 % + Fusidic acid 2% cream/ointment For the treatment of dermatoses wheresecondry bacterial and/or candidialinfection is present 25.04.09
362 Thiocolchicoside 8 mg + Etoricoxib 60 mg tablets Additional strength 25.04.09
363 Methadone Hydrochloride 5mg/10mg per ml syrup;  5mg/ 10mg/ 20mg / 40mg  tablet For the treatment of opioddependence and in maintainencetreatment for opioid dependence. 28.05.09
364 Trospium Chloride  film coated tablet 20mg For the treatment of overactive bladder with the symptoms of urge urinary incontinence, urgency, and urinary frequency. 28.05.09
365 Arformoterol (as Tartrate ) 15mcg / 2ml Inhalation Solution For the long term, twice daily (morning and evening) maintainence treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. 29.05.09
366 Zolmitriptan...5.0% w/v   Benzalkonium Chloride NF ... 0.01% w/v        Nasal spray For the acute treatment of migraine with or without aura in adults. 29.05.09
367 Dexmedetomidine ( as HCl) 100mcg /ml Injection    
368 Levetiracetam SR Tablet 500/750/1000mg same as approved 2.05.2009
369 Glatiramer Acetate Injection (20mg/ ml) & Pre-filled syringe (20mg/ml) For the reduction of the frequency of relapses in patients with Relapsing-Remitting Multiple Sclerosis. 3.06.2009
370 Yttrium-90 Microspheres Injection  (Yttrium-90...3GBq (at the time of calibration) per vial) For the treatment of unresectablemetastatic liver tumors from primary colorectal cancer with intra-hepatic artery chemotherapy (IHAC) of FUDR (Floxuridine) 3.06.2009
371 Luliconazole Cream 1% For the treatment of cutaneous mycosis viz. Tinea pedis, Tinea corporis, Tinea cruris. 3.06.2009
372 Magnesium Valporate Prolonged release tablet 600mg 1) For the treatment of generelized or partial seizures as monothreapy or adjunctive threapy. 2) For prophylaxis of migraine headache in adults. 3) For the treatment of manic episodes associated with bi polar disorders 3.06.2009
373 Tenofovir Disoproxil Fumerate 300mg For the treatment of chronic Hepatitis B in adults 19.6.2009
374 Bosentan (as monohydrate) Tablets 62.5/125mg For the treatment of pulmonary arterial hypertension (WHO Group I) in patients with WHO Class III or IV symptoms, to improve excercise ability and decrease the rate of clinical worsening. 23.6.2009
375 Lornoxicam 12 mg SR  same as approved 26.6.2009
376 Azithromycin SR Granules for oral suspension  2000mg for the treatment for mild to moderate susceptible infection including RTI, uncomplicated skin/ skin structure, non gonococcal urethritis, cervicitis 26.6.2009
377 Metoprolol 50/50/25 mg  + Atorvastatin20/10/10 mg  + Ramipril 10/5/2.5 mg capsules As 2nd line treatment of patients with both essential hypertension and hypercholesterolemia who are not adequately controlled by combination of an anti-hypertensive with lipid lowering agent. 1.07.2009
378 Methyl Phenidate ER Tablet 10/20/30mg For the treatment of Attention Deficit Hyperactivity Disorder (ADHD) 10.07.2009
379 Dasatinib Tablets 100mg (addl. Strength) same as approved 10.07.2009
380 Voglibose 0.2 mg  + Metformin 500mg Tablets As 2nd line treatment of type II Diabetes mellitus when diet, exercise and the single agent do not result in adequate glycemic control. 13.7.2009
381 Combipack of artesunate tablet and FDC Tablet of sulphadoxine + pyrimethamine  Composition:    A. combipack of  1 stip of 3 tablets ofartesunate 25 mg and 1 strip of 1 tablet  of  sulphadoxine  125mg  +  pyrimethamine 6.25 mg   B. combipack of  1 stip of 3 tablets ofartesunate 50 mg and 1 strip of 1 tablet of sulphadoxine 500mg+ pyrimethamine 25 mg  C. combipack of  1 stip of 3 tablets ofartesunate 100 mg and 1 strip of 2 tablet of sulphadoxine 500mg+ pyrimethamine 25 mg D.combipack of  1 stip of 3 tablets ofartesunate 200 mg and 1 strip of 3 tablet of sulphadoxine 500mg+ pyrimethamine 25 mg.                                        For the treatment of P. falciparum resistant malaria patients 15.7.2009
382 Milnacipran 100mg  same as approved 16.7.2009
383 Rifaximin 400mg (additional Indication) For the treatment of hepatic encephalopathy 18.7.2009
384 Nevirapine tablet 50 mg for oral suspension mg For the treatment of HIV infection in combination with other anti retro viral agents 18.7.2009
385 Desvenlafaxine (as Succinate) ER Tablets 50mg/100mg For the treatment of major depressive disorder (MDD) 18.7.2009
386 Posaconazole Oral Suspension 40mg/ml For the treatment of oropharyngeal candidiasis, including oropharyngeal candidiasis refractory to itraconazoleand/orfluconazole.  For prophylaxis of invasive Aspergillus and Candida infections in patients, 13 years of age and older, who are at high risk of developing these infections due to being severlyimmunocompromised, such as hematopoietic stem cell transplant (HSCT) recipients with graft-versus-host disease (GVHD) or those with hematologic malignancies with prolonged neutropenia from chemotherapy.  18.7.2009
387 Caffeine Citrate 20mg / ml (equivalent to 10mg of Caffeine base) Oral Solution (Addl. Dosage form) same as approved 18.7.2009
388 Amphotericin B Emulsion 5mg/ml (Addl. Indication) Febrile Neutropenia in cancer patients 18.7.2009
389 Hydroxy ethyl starch 10% Solution for infusion For the treatment of imminent or manifest hypovolemia and shock. 18.7.2009
390 Naratriptan (as HCl)  Tablets 1/ 2.5mg For the acute treatment of migraine with or without aura in adults. 18.7.2009
391 Colistimethate Sodium powder for solution for injection/infusion 500000IU and 2000000IU  same as approved 20.7.2009
392 Simvastatin 20 mg + Ramipril 5mg  + Atenolol 50 mg + HCTZ 12.5 mg + Aspirin 100 mg (EC Pellets) Capsules For secondary prevention of coronoryheart disease/stroke in patients where use of such combination is appropriate 21.7.2009
393 Colistimethate Sodium powder for solution for inhalation 500000IU/1000000IU/2000000IU Treatment by inhalation of Pseudomonas aeruginosa lung infection in patients with cystic fibrosis 28.7.2009
394 Ramipril MR capsule 10mg For the treatment of hypertension/ cardiac failure and myocardial infarction 30.7.2009
395 Abacavir Sulfate Tablet 60mg For the treatment of HIV-1 infection in combination with other antiretroviral agents 1.08.2009
396 Zoledronic Acid Solution for Infusion Addl. Indication Prevention of clinical fractures after hip fracture in men and women 1.08.2009
397 Sumatriptan 85 mg + Naproxen 500 mg Tablets Additional Strength  for the treatment of migraine 3.08.2009
398 Aceclofenac(100mg) + Thiocolchicoside ( 8 mg) tablets For the treatment of acute inflammation conditions associated with spasm in adults only 3.08.2009
399 Oxcarbazepine 150/300/600mg Tablet (Addl. Indication Treatment of generalized tonic-clonic seizures in adults and children 13.08.2009
400 Ofloxacin 2mg + Ornidazole 5 mg  per ml Infusion for the treatment of diarrhoea of mixed infection in adult patients 17.08.2009
401 Clozapine Tablet200mg (Addl. Strength) Indicated in the management of Schizophrenic patients 19.08.2009
402 Oxymetazoline Hydrochloride Nasal Spray50mcg/0.05%w/w Is indicated for the relief of stuffy,running nose associated with colds and influenza, also post nasal drip, sinusitis. 19.08.2009
403 Enoxaparin Sodium Injection (Addl.Indication) Treatment of acute ST-segment elevation myocardial infarction including patients to be managed medically or with subsequent percuaneous coronary intervention (PCI) 19.08.2009
404 Fluvoxamine Maleate100/150mg ER Tablets For the treatment of obsessive compulsive disorder (OCD)and depression 19.08.2009
405 Lidocaine Lozenges 200/300mg (Addl. Indication) For single agent anesthesia in procedure involving the introduction of instrument & tubes into respiratory tract. 19.08.2009
406 Risperidone long acting injection (Addl. Indication) Indicated as monotherapy or as adjunctive therapy in lithium  or valproate for the maintenance treatment of Bipolar-1 disorder. 29.08.2009
407 Exemestane 25mg Tablet (Addl. Indication) Indicated for adjuvant treatment of Post Menopausal Women with estrogen receptor positive early breast cancer who have received two-three year of tamoxifen and are switched to exemestane for completion of total of five years of adjuvant hormonal therapy. 29.08.2009
408 Artesunate (25/50/100mg) + Amodiaquine (67.5 mg/135/270mg) bilayerd Tablets For the treatment of uncomplicated malaria due to plasmodium falciparum strain in various age groups 01.09.2009
409 Ezetimibe 10 mg + Fenofibrate 145 mg Film coated tablets For the treatment of combined hyperlipidemia in patients with normal hepatic and renal function 01.09.2009
410 Buprenorphine Transdermal Patch Each Transdermal Patch having an area of  6.25cm², 12.5cm², and 25cm²contains: Buprenorphine…5mg/10mg/20mg having release rate of 5mcg, 10mcg, 20mcg Buprenorphine per hour respectively(over a period of 7 days). For the treatment of severe opioid responsive painconditions which are not adequately responding to non-opioid analgesics.For Hospital supply only. 03.09.09
411  Trospium Chloride ER Capsules 60 mg  For the treatment of overactive bladder with the symptoms of urge urinary incontinence, urgency and urinary frequency.  04.09.2009
412 Metoclopramide (as HCl) 200mg / 400mg per ml Intranasal Solution For the treatment of nausea and vomiting. 09.09.09
413 Isosorbibe 20 mg  + Hydralazine 37.5 mg tablets For the treatment of heart failure as an adjunct to standard therapy in patients to improve survival, to prolong time to hospitalization for heart failure and to improve patients reported functional status. 18.09.2009
414 Cefixime 200 mg + Dicloxacillin ER 500 mg Tablets For the treatment of adult patients with Upper and Lower respiratory tract infections, skin and soft tissue infections 22.09.2009
415 Chlorthalidone Tablet 6.25mg               For the treatment of mild to moderate hypetension. 03.10.09
416 Cefovecin( as sodium) 80mg/ ml Lyophilised powder for injection (Veterinary)              For the treatment of skin bacterial infections in dogs and cats. 03.10.09
417 Imidacloprid 10% + Moxidectin 1.0% & 2.5%   Topical solution (Veterinary)           Each pippette contains:                             (a) 0.4ml, 1.0ml, 2.5ml, 4ml of 10% Imidacloprid and 1.0% moxidectin             (b) 0.4ml, 0.8ml of 10% Imidacloprid and 2.5% moxidectin   For the treatment and prevention of flea infestations, prevention of heartworm disease and treatment of infections with gastrointestinal nematodes in dogs and cats. 03.10.09
418 Isoflupredone AcetateSuspension for Injection (2mg per ml) ( For Veterinary) For the glucocorticoid, anti-inflammatory or supportive therapy to cattle suffering from conditions such as: (1) Overwhelming infections with severe toxicity.  (2)   Bovine ketosis. (3)  Musculoskeletal conditions. (4)  Shock. (5) Parturient paresis (supportive stress  therapy for milk fever). 03.10.09
419 Saxagliptin (as HCl) 2.5mg/ 5mg Tablets As an adjunct to diet and exercise to improve glycemic control in adults with type-2 diabetes mellitus. (It should not be used for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis, as it would not be effective in these settings. 24.10.09
420 Calcipotriol Gel 0.005%                        For the treatment of moderate plaque psoriasis in adults 3.10.2009
421 Lamotrigine MR Tablets 150mg (Addl. Strength) same as approved 3.10.2009
422 Metoprolol Tartrate ER Tablet 75mg                                                  same as approved 3.10.2009
423 Valganciclovir Powder for Oral Solution 50mg/ml For the treatment of cytomegalovirus (CMV) retinitis in AIDS patients and for prevention of CMV disease in solid organ transplant patients at high risk 9.10.2009
424 Dexketoprofen Trometamol Gel 12.5mg/gm For the painful and inflammatory conditions associated with joints, tendons, ligaments and muscle 13.10.2009
425 Donepezil Hydrochloride Orodispersible Tablet 5mg/10mg For the treatment of mild to moderate severe Alzheimer's Dementia 15.10.2009
426 Dexketoprofen Trometamol Injection 50mg/2ml Symptomatic treatment of acute pain of moderate to severe intensity, when oral administration is not appropriate such as post-operative pain, renal colic and low back pain. 22.10.2009
427 Bromocriptine Mesylate Tablet IP 0.8mg, (additional Indication) Indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. 22.10.2009
428 Levosulpride ER Tablet 100/150/200mg For the treatment of depression and schizophrenia in adults 27.10.2009
429 Ambroxol 30 mg+ Terbutaline 2.5 mg + Guaiphenesin 100mg + Menthol 2.5 mg per 5 ml syrup Additional strength 27.10.2009
430 Propofol 10 mg+ Lignocaine 2.5 mg per ml injection Additional strength 27.10.2009
431 Mecobalamin 750 mg + Pyridoxine Hydrochloride1.5 mg + Nicotinamide 45 mg tablets For the treatment of diabetic neuropathy 27.10.2009
432 Olmesartan (20/40mg )+  Atorvastatin 5/10/20mg film coated tablets For the treatment of co-existing essential hypertension and hyperlipidemia in adult patients 27.10.2009
433 Deltamethrin (0.50% m/v) and Piperonyl Butoxide  (2.0% m/v) per ml Pour–On Solution Ready to use pour-on for cattle, sheep and goats.  1. For use in Cattle to control ticks, stable flies, horn flies, cattle louse flies and nuisance flies e.g. house flies, to kill lice and protection against blackflies. 2. For use in sheep and goats for controlling Karoo paralysis, bont- legged and red-legged ticks  29.10.2009
434 Glucosamine sulphate potassium chloride 500 mg + Ibuprofen IP 200mg film coated Tablets For the treatment of adult patients with osteoarthritis of knee and/or hip joints 03.11.2009
435 Methylcobalamin 1500 mcg + Gabapentin SR 600 mg film coated tablets Additional strength  4.11.2009
436 Propofol 1% for injection (Additional Indication) 1. For conscious sedation for surgical and diagnostic procedures 2. for sedation of ventilated patients receiving intensive care 5.11.2009
437 Rupatadine 10 mg + Montelukast 10 mg Tablets For the management of seasonal allergic rhinitis (SAR) 10.11.2009
438 Eperisone 50 mg + Paracetamol 500 mg Tablets For improvement of mytonic conditions caused by neck shoulder arm syndrome , scapulhumeral periarthritis and low back pain in adult patients only  10.11.2009
439 Lafutidine Tablets ....5mg/10mg.  For the treatment of:• gastric ulcers, duodenal ulcers and stromal ulcers • gastric mucosal lesions (erosion, hemorrhage, redness or edema) associated with acute gastritis and acute exacerbation of chronic gastritis. 11.11.2009
440 Ramosetron Hydrochloride Tablets 2.5mcg, 5mcg, 0.1mg & Injecton 0.3mg /2ml  1. Tablets 0.1mg & Injection 0.3-- for the prevention and treatment of gastrointestinal symptoms (nausea and vomiting) associated with emetogenic cancer chemotherapy. 2. Tablets 2.5mcg & 5mcg--- for the treatment of diarrhoea predominant irritable bowel syndrome. 11.11.2009
441 Tadalafil tablet 20 mg (Additional Indication) For the treatment of pulmonary arterial hypertension 14.11.2009
442 Flurbiprofen Sodium 0.03% Ophthalmic solution USP for the reduction of post-operative inflammatory condition 14.11.2009
443 Dexmedetomidine HCl Injection (Additional Indication) Sedation of non-intubated patients prior to and/or during surgical and other procedure 14.11.2009
444 Paliperidone ER tablet 12 mg  Same as approved 14.11.2009
445 1) Triticum Vulgare Topical Cream      Each 100gm of cream contains: Aqueous extract of Triticum Vulgare (dry residue 200mg / 100ml) ..... 15gm   2-phenoxyethanol Eur. Ph.....1gm    2) Triticum Vulgare Vaginal Pessary Each 3.5gm of vaginal pessary contains: Aqueous extract of Triticum Vulgare (dry residue 200mg/ 100ml) .....0.60gm   2-phenoxyethanol Eur. Ph.....0.04gm 1) Triticum Vulgare Cream is indicated for the treatment of ulcers and bed sores. 2) Triticum Vulgare Vaginal Pessary is indicated for the treatment of phlogistic and dystrophic disorders of the female genital tract.  14.11.2009
446 Febuxostat Tablets 80mg / 120mg For treatment of chronic hyperuricemia in conditions where urate depression has already occured (including a history, or presence of tophus and /or gouty arthritis). 14.11.2009
447 Euphorbia Prostrata Dry Extract :100mg tablet (addl. Indication) For the treatment of 3° and 4° haemorrhoids (Addl. Indication). 14.11.2009
448 Euphorbia Prostrata dry extract ethanolic 80%v/v[(35-70):1] cream 1% w/w For the treatment of 1° and 2° internal haemorrhoids. 14.11.2009
449 Lactobacillus Rhammnosus 1 billion cells + Saccharomyces Boulardi 125 mg + Zinc Enriched yeast 20 mg sachets & capsules  For the treatment of acute diarrhoea in children  4.11.2009
450 Nimesulide 1.0% w/w + Ethanol 31% w/w topical solution For the local application in relieving pain in acute low backache, tendonitis, tenosinovitis and sprains 17.11.2009
451 Diacerein Modified Release Capsule 100mg Symptomatic treatment of osteoarthritis of knee & hip 20.11.2009
452 Amlodipine 5mg/10mg/5mg/10mg/10mg + Valsartan 160mg/160mg/160mg/160mg/320mg + Hydrochlorothizide 12.5mg/12.5mg/25mg/25mg/25mg Tablets  For the treatment of essential hypertension  24.11.2009
453 Maraviroc Tablets 150mg/300mg. For the treatment of patients infected with CCR5- trophic HIV-1. 25.11.2009
454 S (+) Etodolac 150/200/300mg + Paracetamol 500/500/500mg Tablets For the symptomatic treatment of acute pain and inflammation in patients with osteoarthritis, rheumatoid arthritis and ankylosing spondylitis 25.11.2009
455 Tacrolimus Granules for oral suspension 0.2/1 mg per sachet Prophylaxis of transplant rejection in kidney, liver or heart allograft recipient 26.11.2009
456 Rifaximin Dispersible Tablet 200mg For infections diarrhoea in adults 26.11.2009
457 Prednisolone Sodium Phosphate Orally Disintegrating Tablet 10/15/30mg Indicating for condition required Glucocorticoids activity including collagen disease, allergic disease and hypersensitive reaction 26.11.2009
458 Cinitapride Hydrogen Tartrate ER Tablet 3mg For the treatment of gastroesophageal reflux disease (GERD) and functional inconveniences of the gastrointestinal motility 26.11.2009
459 Sevelamer Carbonate (Additional Indication) for control of serum phosphorus in patients with chronic kidney disease on haemodialysis or peritoneal dialysis and patients with CKD not on dialysis with serum phosphate > 5.5 mg/dl 26.11.2009
460 Oxcarbazepine Tablets (Additional Indication)150/300/600 mg Monotherapy in the treatment of partial seizures in children ages 4-16  26.11.2009
461 Ketoprofen plaster 30 mg (7cm X 10 cm) for the relief of musculoskeletal pain & inflammation 11.12.2009
462 Acipimox Capsules 250mg. As adjunctive therapy to diet and weight loss in the treatment of type IIa, IIb and IV lipid disorders. 26.11.2009
463 Amisulpiride SR Tablet 100 mg Same as approved 27.11.2009
464 Mycophenolate Sodium Enteric coated tablet 540 mg  Same as approved 29.10.2009
465 Loteprednol etabonate 0.5% w/v + Moxifloxacin 0.5% w/v opthalmic Suspension For the treatement of post operative steriod responsive inflammatory ocular infections or risk of bacterial ocular infections exists  1.12.2009
466 Ropinirole ER tablet 2/4/8mg for the treatment of signs & symptoms of idiopathic Parkinson's disease 3.12.2009
467 Diclofenac Diethyl amine transdermal patch 100 mg/37.5 sq cm  same as approved 4.12.2009
468 Lornoxicam ER Tablet 8 mg  same as approved 11.12.2009
469 Flurbiprofen plaster 20 mg (7cm X 10cm) for the relief of pain & inflammation due to rheumatoid arthritis , osteoarthritis and allied disorder 11.12.2009
470 Carvedilol Phosphate ER tablet 10/20/40/80mg 1. Mild to severe chronic heart failure. 2. Left ventricular dysfunction following myocardial infarction in clinically stable patients 3. hypertension 11.12.2009
471 Halometasone monohydrate  0.05% w/w + Fusidic acid 2.00% w/w cream For the treatment of acute and chronic infected eczematous dermatitis 15.12.2009
472 Glimepiride 1/2 mg + Metformin 500 mg + Atorvastatin 10 mg tablets For the treatment of type II diabetes mellitus associated with dyslipidemia  17.12.2009
473 Betahistine Di hydrochloride CR capsule 24/32/48mg indicated in the treatment of Menier's syndrome, characterized by unilateral or bilateral tinnitus, vertigo, sensorineural hearing loss 17.12.2009
474 Gefitinib tab 250mg (Additional Indication) Indicated for the first line treatment of patients with locally advanced or metastatic non small cell lung cancer (NSLC) who have activating mutationof the EGFRTK". 18.12.2009
475 Midazolam Hcl Syrup 2mg/ml For selection,anxiolysis and amnesia prior to diagnostic, therapeutic or endoscopic procedure or before induction of anesthesia. 18.12.2009
476 Guaiphenasin Syrup 133mg/5ml For the treatment of productive cough accompanied by phlegm 18.12.2009
477 Balofloxacin Tablet 100mg for the treatment of uncomplicated urinary tract infectins (such as cystitis and urethritis) 22.12.2009
478 Xylometazoline 0.5 mg + Ipratropium 0.6 mg Nasal spray For symptomatic treatment of nasal congestion with running nose (rhinorrhea) 23.12.2009
479 Doxofylline 400 mg + Ambroxol 30 mg Tablets For the treatment of patients with bronchial asthma and COPD, when use of both the drug is appropriate  23.12.2009
480 Ribavirin Capsules 200mg (Addl. Strength) Indicated in combination with peg interferon alpha-2b for the treatment of naïve adult patients with chronic hepatitis C with clinically stable HIV co-infection. 24.12.2009
481 Formoterol 6 mcg + Mometasone furoate 100/200/400mcg Metered dose Inhaler & Dry Powder Inhalation For the treatment of patients with bronchial asthma and COPD, where the use of combination is found appropriate  30.12.2009
482 Chlorohexidine Gluconate Gel 0.2% For the prevention of Plaque and treatment of gengivitis. 30.12.2009
483 Chlorohexidine Gluconate Mouth wash 0.1% For the prevention of Plaque and treatment of gengivitis. 30.12.2009
Year 2008 Go To Top
1 Hydroxychloroquine 400mg tablets  Same as Approved 31.01.08
2 ISMN 30mg SR + Metoprolol Succinate equivalent to metoprolol tartrate 25mg/50mg tablets  Same as Approved 02.01.08
3 Halobetasol 0.05% + Clotrimazole 1.0% cream For the treatment of steroid responsive fungal infections including eczema and psoriasis 04.01.08
4 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
5 Levodopa 200mg + Carbidopa 50mg C.R. tablet For Parkinson's Disease 08.01.08
6 Nanocrystalline Silver Gel 0.002% For the treatment of burns and wound infections 04.01.08
7 Cinitapride (as hydrogen tartrate) 1mg tablet For the treatment of gastroesophageal reflux disease and functional inconveniences of the gastrointestinal motility 04.01.08
8 Tenofovir disoproxil fumarate 300mg + Lamivudine 300mg tablet For the treatment of adult patients with HIV infection 07.01.08
9 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
10 D-Trans Fentanyl Metrix system (12mcg/hr.)  Same as Approved 07.01.08
11 Ceftazidime 500mg + Tobramycin 60mg per vial (Injection) For the treatment of lower respiratory tract infection caused by pseudomonas aeruginosa 08.01.08
12 Atazanavir 300mg capsules <