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Culture Documents
Drug Approvals by DCGI
Drug Approvals by DCGI
Drug Approvals by DCGI
No Name Of Drug 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 Ropinirole ER Tablet 1 mg. (Additional Strength) Indication Date of issue
1.
03.01.11
2.
Same as approved 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. For the reduction of post operative inflammatory conditions of the eye
04.01.11
3.
04.01.11
4.
Moxifloxacin HCl BP 0.5% w/v + Bromfenac Sodium 0.09% w/v Eye drop
05.01.11
5.
Ferrous Ascorbate 100mg + Folic Acid IP 1.5mg + Cyanocobalamin IP 15mcg + Zinc Sulphate Monohydrate Eq. to Elemental Zinc 22.5mg Tablet
05.01.11
6.
S (+) Etodolac 300mg +Thiocolchicoside 8mg Tablet Beclomethasone Dipropionate IP 100mcg + Formoterol Fumarate Dihydrate BP Eq. to Formoterol Fumarate 6 mcg Metered Dose Inhaler Amlodipine Besilate IP Eq. to Amlodipine 5mg + Indapamide USP SR 1.5mg Tablet Metformin HCl IP 500mg + Alpha Lipoic Acid USP 200mg Tablet
For the treatment of patients with acute painful musculoskeletal conditions For the treatment of bronchial asthma where use of inhaled corticosteroid therapy found appropriate
05.01.11
7.
05.01.11
8.
For the treatment of mild to moderate hypertension For the treatment of patients with diabetic polyneuropathy
05.01.11
9.
05.01.11
10.
Additional strength Indicated either alone or as adjuvant to radical Prostatetomy or radiotherapy in Patients with Locally advanced Prostate cancer at High risk for disease Progression. Same as approved
05.01.11
11.
05.01.11
12.
Paracetamol Chewable Tablet 500 mg. ( Additional Dosage Form) 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 Dextromethorphan Extended Release Oral Suspension 30 mg per 5 ml Hydroquinone USP 2% w/w + Tretinoin USP 0.025% w/w + Allantoin USP 1%w/w Gel Paracetamol Fast Release Tablet 500mg (Additional Dosage Form) Each bowel preparatory kit contains: One enteric coated tablet Biscodyl IP 5mg & One sachet of powder for reconstitution contains: Polyethylene glycol 3350NF: 210gm + Sodium Bicarbonate IP 2.86gm + Sodium Chloride IP 5.6gm + Potassium Chloride IP 0.74gm Ferric Carboxymaltose equivalent to elemental Iron50mg/ml Injection
05.01.11
13.
11.01.11
14.
For the Relief of Persistent Dry irritating cough in adult patients Only. For treatment of hyper pigmentry disorders
17.01.11
15.
31.01.11
16.
Same as approved
10.02.11
17.
11.02.11
18.
For the treatment of iron deficiency in adults when oral iron preparations are ineffective or cannot be used.
11.02.11
19.
Pidotimod Tablet 400 mg/800 mg & Oral Solution 400 mg/800 mg per 7ml
For infections of the respiratory system in secondary and primary immunodeficiency with alteration in maturation of T cells in adults only. For the treatment of patients with chronic cholestatic liver disease.
11.02.11
20.
11.02.11
21.
For the acute treatment of adults with schizophrenia. (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. Same as approved
17.02.11
22.
Calf lung surfactant Intratracheal Suspension containing Phospholipids.... 35mg (containing 26 mg phosphatidylcholine of which 16mg is disaturated phosphatidylcholine) Proteins....0.65mg (including 0.26mg of surfactant associated proteins B) per ml
17.02.11
23.
Baclofen ER Capsule 10 mg/50 mg. (Additional Strength) Dexketoprofen Trometamol ER Tablet 50 mg (Additional Strength)
17.02.11
24.
Same as approved For the treatment of bacterial conjunctivitis caused by susceptible strains Advanced squmous cell carcinoma of Head and Neck SCCHN: 1. Diagnosed but unrectable locally advanced SCCHN
21.02.11
25.
21.02.11
26.
24.02.11 2. Recurrent SCCHN, if surgery or radiation is not feasible. 3. Palliative treatment of metastatic SCCHN.
27.
As an adjunctive therapy in adults with partial-onset seizures with or without secondary generalisation.
07.03.11
28.
Ketoprofen Plaster ( Size - 7cm x 10 cm) Meropenem IP 1000mg + Sulbactam sodium USP 500mg injection Dasatinib 20mg/50mg/70mg (Additional Indication) Adenosylcobalamin 15mcg + Ferrous Ascorbate 100mg + Folic Acid IP 1.5mg + Zinc Sulphate USP Eq. to Elemental Zinc 22.5mg tablet Tioconazole Vaginal Gel 65mg per gm
For the Relief of Musculoskeletal pain and Inflammation. For the treatment of lower respiratory tract infection caused by gram negative bacteria in adults only Treatment of newly Diagnosed Adults with Chronic Myeloid Leukaemia (CML) in Chronic Phase. For the treatment of iron deficiency anaemia in adults only
09.03.11
29.
15.03.11
30.
16.03.11
31.
21.03.11
32.
For the local treatment of vulvo vaginal candidiasis in adult patients. For the treatment of dyslipidemia associated with arthersclerotic arterial disease with risk of Myocardial infarction, stroke or peripheral vascular disease. For the treatment of duodenal ulcer in adults only. For acute treatment of schizophrenia in adults only. For the Treatment of Lower and upper respiratory tract infection and Typhoid fever in adults only For relief of moderate to severe acute pain in adults 18 years of age or older.
22.03.11
33.
30.03.11
34. 35.
Ilaprazole Tablets 5mg/10mg Asenapine Maleate Sublingual Tablets 5mg/10mg Cefpodoxime IP 100mg/100mg/200mg/200mg +Ofloxacin IP 100mg/200mg/100mg/200mg Tablets Tapentadol Hydrochloride Tablets 50mg/75mg/100mg Cefixime Trihydrate IP Eq. to Anhydrous Cefixime 100mg/200mg + Ofloxacin IP 100mg/200mg Dispersible Tablet (Additional dosage form )
05.04.11 07.04.11
36.
16.04.11
37.
18.04.11
38.
Same as approved
20.04.11
39.
For surgical anaesthesia in adults for epidural (including caesarean section), intrathecal, peripheral nerve block.
28.04.11
40.
28.04.11
41.
Gatifloxacin 0.3% + Loteprednol Etabonate 0.5% + Benzalkonium Chloride 0.01% w/v Opthalmic suspension
For Post-Operative Steroid repulsive inflammatory Ocular conditions when Ocular bacterial infections or a risk of bacterial infection exists 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. For the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma. For the treatment of bacterial conjunctivitis.
19.05.11
42.
19.05.11
43.
26.05.11
44.
Besifloxacin Ophthalmic Suspension 0.6% w/v Diclofenac (as EC Tablets) 25mg + Paracetamol 325 mg Capsule
31.05.11
45. (Additional Strength) Amlodipine 10mg/10mg+ Telmisartan 40mg/80mg Tablets 46. (Additional Strength) 1. PROBIO : Each sachet (1g) contains: 47. Total Probiotic.... Not less than 1.25 Billion CFU (Lactobacillus acidophilus, Lactobacillus rhamnosus, Bifidobacterium longum, Saccharomyces boulardii)
Same as approved
31.05.11
Same as approved
31.05.11
09.06.11
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 Additional indication. (For Symptomatic Treatment of Moderate To Severe Pain.) For the treatment of signs and symptoms of benign prostatic hyperplasia (BPH) in adults only. For the treatment of agitation and aggressiveness in adult patients with cognitive impairment. Additional dosage form
48.
21.06.11
49.
Silodosin Capsules2mg/4mg/8mg
23.06.11
50.
Tiapride Hydrochloride Tablets 25mg/50mg/100mg Fexofenadine 120mg + Montelukast 10mg Chewable tablet 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
23.06.11
51.
07.07.11
52.
27.07.11
53.
Cefixime (SR) 400mg +Moxifloxacin (SR) 400 mg Tablets Alpha Lipoic acid 100mg + Folic acid 1.5mg + Methylcobalamin 1500mcg + Pyridoxine Hydrochloride 3mg + Vitamin D3 1000 IU Tablets Levosulpride (SR) 75mg + Rabeprazole sodium IP (EC Pellets) 20mg Capsule 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 Diclofenac sodium (SR) 100mg + Eperisone Hydrochloride (SR) 150mg Capsules Rosuvastatin Calcium eq. to Rosuvastatin 20mg/20mg + Fenofibrate BP 67.5mg/145mg Tablets Eletriptan Hydrobromide Tablets 20mg/40mg Acyclovir 50g + Hydrocortisone 10mg Cream Clindamycin Phosphate eq. to Clindamycin 1% w/w + Hydrous Benzoyl Peroxide eq. to Anhydrous Benzoyl peroxide 2.5% w/w topical gel Polyethylene glycol 0.4% w/v + Propylene Glycol 0.3% w/v Eye Drops
For the treatment of lower respiratory tract infections in adults only For the treatment of Diabetic neuropathy For the treatment of Gastrooesophageal Reflux Disease (GERD)
08.08.11
54.
10.08.11
55.
19.08.11
56.
23.08.11
57.
For the treatment of patient with acute musculoskeletal spasm associated with low back pain. Additional Strength For the treatments of Migraine with or without aura in adults 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 For topical treatment of inflammatory acne vulgaris (Additional lower strength) For temporary relief of burning and irritation due to dryness of the eye For the treatment of alcoholic liver diseases like alcoholic fatty liver, alcoholic liver fibrosis, alcoholic liver cirrhosis, and hepatitis For the treatment of erectile dysfunction
24.08.11
58.
24.08.11
59.
25.08.11
60.
30.08.11
61.
30.08.11
62.
13.09.11
63.
14.09.11
64.
15.09.11
65.
Metformin (ER )1000mg/500mg +Saxagliptin 2.5 mg/5mg Tablets Ceftriaxone Sodium eq. to Ceftriaxone Sodium 1000mg/2000mg + Sulbactam Sodium eq. Sulbactam 500mg/1000mg.injection Difluprednate 0.05% w/v + Moxifloxacin 0.5% w/v Eye Drops
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 Additional Indication - For the treatment of urinary tract infections and lower respiratory tract infections, various bacteria For steroid responsive inflammatory ocular conditions for which a corticosteroid is indicated and where bacterial infection or a risk of bacterial ocular infection exists 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 For the symptomatic relief of allergic rhinitis. For the treatment of psoriasis vulgaris in adults only.
19.09.11
66.
21.09.11
67.
22.09.11
68.
22.09.11
69.
26.09.11
70.
Tacalcitol ointment 4mcg 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 Akiskiren Hemifumarate eq. to Aliskiren 150mg/150mg/300mg/300mg +Amlodipine Besilate IP eq. to Amlodipine 5mg/10mg/5mg/10mg Tablets
26.09.11
58.
30.09.11
59.
For the treatment of hypertension: a) As initial therapy in the patient likely to need multiple drugs to achieve blood pressure control. B) In the patients whose blood pressure is not adequately controlled with the Aliskiren alone or Amlodipine (or another di-
12.10.11
hydropyridine calcium channel blocker) alone. C) As replacement therapy in patients already receiving Aliskiren and Amlodipine from separate tablets at the same dose level. Ferrous Ascorbate eq. to elemental iron 100mg + Folic acid IP 1.1mg + Methylcobalamin 1.5mg +Zinc Sulphate monohydrate IP eq to elemental Zinc 22.5mg Tablets. (Additional strength) Arterolane Maleate 74.
73.
19.10.11
Treatment of acute uncomplicated malaria infection due to Plasmodium 150mg + Piperaquine Phosphate 750mg Tablet falciparum in adults. Tafluprost Eye Drops For the reduction of elevated intraocular pressure in open angle glaucoma and ocular hypertension. For the treatment in the patients with inflammatory occular conditions where bacterial infection or a risk of bacterial occular infection exists
19.10.11
75. 0.0015% w/v Gatifloxacin IP eq. to Gatifloxacin (Anhydrous) 3.0mg + Difluprednate 0.5mg + Benzalkonium Chloride IP (As preservative) 0.01% w/v Eye Drops Diazinon Flea Drops 77. Spot on Dogs 30.0% w/w Diclofenac Sodium IP (as sustained release Pellets) 100mg + Thiocolchicoside (as sustained release pellets) 16mg Capsule. (New Dosage Form) Epalrestat 50mg + Methylcobalamin 500mcg Tablets
21.10.11
76.
24.10.11
11.11.11
78.
For the treatment of acute inflammation conditions associated with spasm in adults only. For the treatment of Diabetic Neuropathy In combination with prednisone for treatment of patients with hormonerefractory metastatic prostrate cancer previously treated with a docetaxelcontaining treatment regimen.
15.11.11
79.
16.11.11
16.11.11
81.
Ketorolac Tromethamine IP 4.00mg + Olopatadine Hcl eq. to Olopatadine 1.00mg + Benzalkonium Chloride IP 0.05mg Ophthalmic solution Tramadol Hcl IP (As Immediate Release Layer) 50mg + Diclofenac Sodium IP (As Sustained Release Layer) 75mg Tablets Budesonide IP 1mg/0.5mg + Formoterol Fumarate Dihydrate IP eq to Formoterol Fumarate 20mcg/20mcg Respirator suspension. (Additional Strength) Amlodipine Besilate IP eq.to Amlodipine 10mg/5mg/5mg/5mg/2.5mg + Olmesartan Medoxomil 40mg/40mg/20mg/5mg/5mg + Hydrochlorothiazide IP 25mg/12.5mg/12.5mg/12.5mg/12.5mg Tablet
21.11.11
82.
For the symptomatic treatment of moderate to severe pain in adult patients For the treatment of asthma where the use of corticosteroid and long acting beta agonist in combination is appropriate
21.11.11
83.
21.11.11
84.
23.11.11
85.
Each Combipack contains Part (A) One Strip of FDC of Ramipril + Amlodipine Tablets;Each uncoated tablet contains Ramipril IP 5mg, Amlodipine besylate IP eq to Amlodipine 5mg B) Each Film coated tablet contains ;- Atorvastatin Calcium IP eq to Atorvastatin 10mg/20mg.
For the treatment of hypertension and as an adjunct to diet in patients to reduce elevated total cholesterol and triglyceride levels hypertension and dyslipidemia. The polypack should be used in patients for whom treatment with all of the three i.e Ramipril, Amlodipine and Atorvastatin is appropriate. For the treatment of patients with primary hypercholesterolemia. For the treatment of Patients with acute muscle/musculoskeletal spasm in adult For the treatment of patient with premenstrual syndrome in adults only For the treatment of neuropathic pain.
28.11.11
86.
Rosuvastatin Calcium IP eq to Rosuvastatin 5mg + Ezetimibe 10mg. (Additional Strength) Tolperisone Hcl IP 150mg + Diclofenac IP 50mg Tablets Paracetamol IP 325mg + Pamabrom USP 25mg Tablets Dosulepine Hcl 50mg/75mg + Methylcobalamin 1500mcg/1500mcg Tablets
05.12.11
87.
07.12.11
88.
07.12.11
90.
08.12.11
For the treatment of primary keratoconjunctivitis and recurrent epithelial keratitis due to herpes simplex viruses type 1 and 2.
08.12.11
92.
Dabigatran Etexilate( as Mesilate) hard gelatin For prevention of stroke, systemic embolism and reduction of vascular Capsules 75mg/110mg/150mg mortality in adult patients with atrial fibrillation. Montelukast Sodium IP eq.to Montelukast 10mg +Olopatadine Hcl 5mg Tablets For the treatment of relief of symptoms of allergic rhinitis 1. Prevention of acute and delayed nausea and vomiting associated with highly emetogenic cisplatin based cancer chemotherapy in adults. 2. Prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy in adults. In combination with prednisone for the treatment of patients with metastatic castration-resistant prostrate cancer who have received prior chemotherapy containing docetaxel. For the treatment of patients with locally advanced or metastatic nonsmall cell lung cancer (NSCLC) that is anaplastic lymphoma kinase (ALK) positive as detected by an FDAapproved test. For the treatment of mild to moderate hypertension in adults only and or treatment of stable coronary artery disease in patients already controlled with Perindopril & Amlodipine given concurrently at same dose level
12.12.11
93.
16.12.11
94.
16.12.11
16.12.11
96.
16.12.11
97.
Amlodipine Besilate IP eq. to Amlodipine 5mg + Perindopril Erbumine BP 8mg Tablets. (Additional Strength).
20.12.11
98.
Iron Amino Acid Chelate as Ferrous Bisglycinate (75mg) eq. to Elemental Iron 15mg + Folic acid IP 0.25mg + Vitamin B 12 IP 3.75mcg +Zinc Picolinate (26mg) eq. to Elemental Zinc 5.5mg Syrup
22.12.11
LIST OF APPROVED DRUG FROM 01.01.2010 T S.NO 1 2 3 4 5 PRODUCT NAME Ferrous ascorbate 100mg + Folic acid 1.1 mg tablet and Omega-3-fatty acid 200mg capsules combikit Sphaeranthus Indicus Extract Tablets 700mg Febuxostat 40mg Additional Strength
Dexamethasone Intravitreal Implant 0.7mg (in solid polymer drug delivery For the treatment of macul system) (CRVO) Buclizine Hcl 25mg Tablet (Additional Indication)
Indicated as a monotherap metastatic Non Small Cell squamous cell histology in following platinum-based doublet with gemcitabine,
7 8 9 10
Levobetaxolol HCl Opthalmic Suspension 0.5% Sarpogrelate Hydrochloride film coated Tablets 100mg Propanol 1-ol 18gm + Ethanol 100% 45gm/100ml solution Aliskiren 150/160mg + Valsartan 300/320mg tablets
For lowering of intraoccul glaucoma or occular hyper For the improvement of isc chronic arterial occlusion.
11
For treatment of fever and inflammation, acute muscu following trauma, chronic short term management of
12
Soybean oil 60gm + Triglycerides (medium chain) 50gm + olive oil purified fish oil 30gm + dl-alpha-tocopherol 163-225mg + glycerol Total parenteral nutrition f (anhydrous) 25gm + Egg lecithin 12gm + sodium hydroxide (to approx pH urological surgery 8) + sodium pleate 0.3mg emulsion for infusion in 100ml.
13 14 15 16 17 18 19 20 21
Raltegravir (as Potassium) film coated Tablets 400mg Deflazacort Tablet 18mg (Additional Strength) Pregabalin SR Tablet 75mg (Additional Strength) Rivaroxaban film coated Tablets 10mg Cinnarizine 20mg + Dimenhydrinate 40mg tablets Lipid Based Amphotericin-B Gel 0.1% Sodium Hyaluronate Injectable Gel 14mg/ml, 18mg/ml, 25.5mg/ml (Additional Strength) Milnacipran Hcl 12.5mg (Addl. Strength) Ropinirole 6mg ER Tablets (Addl. Strength)
In combination with other immunodeficiency virus (H evidence of HIV-1 replica Same as approved Same as approved
Indicated in the treatment caused by candida (Monili Same as approved Same as approved Same as approved
22
(3)Patients undergoing la adjunct to good surgical te extent of post surgical adh 23 Pregabalin SR 75/150/300mg + Methylcobalamin 1500mcg tablets For the treatment of adult
24
For Symptomatic Treatme disease patients with norm blockers in patients inadeq whose heart rate is >60bpm Same as approved
25 26
Paracetamol Solution for Infusion (10mg/ml) in 50ml (Additional Packsize) Ketorolac Tromethamine Ophthalmic Solution 0.45%
27
In combination with other induction in acute non-lym been found useful in the tr phase of chronic myelocyt indicated in the prophylax
28
29
Sodium chloride 6.80gm + Potassium chloride 0.30 gm + Calcium chloride dihydrate 0.37gm + Magnesium chloride hexahydrate 0.20gm + Sodium Replacement of extracellu acetate trihydrate 3.27gm + L-malic acid 0.67gm in 1000ml solution for especially if acidosis is bei infusion Chemically Modified Sodium Hyaluronate and Caboxymethylcellulose Absorbable Adhesion Barrier. Lornoxicam 4mg/4mg + Thiocolchicoside 4mg/8mg tablets Cefixime 100mg/200mg + Cloxacillin 500mg/500mg tablets Celecoxib Mouth Dissolving Tablet 50/100/200 mg Propofol 2% w/v Injection (additionalStrength) Spironolactone 25mg + Furosemide 20mg tablets Olopatadine5mg + Ambroxol30mg tablets Methylcobalamin750mcg + Pregabalin75/150mg + Vitamin B61.5mg + Folic acid0.75mg + Benfothiamine7.5mg capsules Calcium acetate 435mg + Magnesium carbonate 235mg tablets
30
31 32 33 34 35 36 37
For the treatment of adult skin and soft tissue infecti Same as Approved
38
39
Dicyclomine2.5mg + Dried Aluminimum Hydroxide200mg + Light Magnesium Oxide100mg + Simethicone 20mg per 5ml suspension.
For the treatment of the sy irratible bowel syndrome, includes smooth muscle sp gastric distress, bloting etc
40 41 42 43 44 45 46 47 48
Sertaconazole 2% w/v+ Zinc Pyrithione 1% w/v Shampoo Faropenam Sodium Extended Release Tablet 225/300/450 mg Amlodipine5mg + Ramipril10mg/5mg Tablets (additional strength) Doxofylline MR Tablet 650 mg Lidocaine7.5mg + Prilocaine2.5mg per acutation spray Pramipexole Di HCl monohydrate ER Tablet 0.375/0.75/1.5/3/4.5 mg Drosperinone 3mg + Ethinyl Estradiol0.02mg tablets Miglitol 25 mg + Metformin 500mg tablets Propranolol 40mg (SR Pellets) + Fluarizine 5mg/10mg capsules
49 50 51 52 53 54 55 56 57 58 59 60
Citicholine 500mg + Piracetam 400mg Tablets Diclofenac 50mg + Chlorzoxazone500mg Tablets Mecobalamin 750 mcg + Pyridoxine 1.5mg + Nicotinamide 45 mg + Benfotiamine 150mg Tablets Etoricoxib 1%+ Menthol 5% Spray Pantoprazole 40mg + Cinitapride (ER) 3mg Capsules Atorvastatin 20mg + Ramipril 2.5mg/5mg Capsules Lamotrigine Orodispersible Tablet 12.5 mg(additional strength) Trabectedin powder for Conc. solution for infusion (Additional Indication) Lornoxicam 8mg/8mg + Thiocolchicoside 4mg/8mg Tablets Diclofenac sodium SR Tablet 150 mg Magnesium Valproate CR Tablet 200/ 300/400/ 500 mg (additonal strength) Lidocaine 2.5% w/w+Prilocaine 2.5% w/w Gel
61
62 63 64 65 66 67
1. For the treatment of dys mixed dyslipidaemia (char triglycerides and low HDlhypercholesterolemia (hete Nicotinic Acid and Laropiprant Modified Release Tablets: Nicotinic familial). Acid.........1000 In combination with HMG mg Laropiprant...........20mg lowering effect of HMG-C can be used as monotherap inhibitors are considered in pharmacological treatment during therapy. For the treatment of gastric Pantoprazole Mouth Dissolving Tablet 20/40 mg disease (GERD). Praziquntel 175mg + Pyrantel 504mg + Febental 525mg Tablets Difluprednate Opthalmic Emulsion 0.05% w/v Tolperisone Hcl SR 450mg Tablets S(-)Metoprolol 25mg/50mg (ER) + Atorvastatin (IR)10mg tablets Atorvastatin10mg + Ramipril 5mg + Aspirin (EC pellets) 75mg/150mg + Metoprolol (ER tablets) 25mg Capsules
68 69 70 71 72 73
Lamotrigine 25mg Modified Release Tablet (Addl. Strength) Imatinib Mesylate 100/400mg Tablets (Addl. Indication) Azithromycin SR Granules for Oral Suspension 1gm (Addl. Strength) Gemfibrozil Capsule USP & Gemfibrozil Tablet USP 200mg/600mg (Addl. Indication) Ibuprofen 400mg + Chlorzoxazone 500mg Tablets Doxophylline (SR) 400mg/800mg + Montelukast 10mg/10mg Tablets
Same as Approved
74
To reduce the risk of cardi persistent atrial fibrillation AF/AFL and associated ca diabetes, prior cerebrovasc ventricular ejection fractio be cardioverted.
75
To reduce the rate of throm thrombosis) in patients wit managed with percutaneou 76 Prasugrel (as Hydrochloride) film coated tablet ....5 mg / 10mg.
Patients with ST-elevati primary or delayed PCI. 77 78 79 80 81 82 83 84 Tofisopam uncoated tablet JP... 50/100mg Zotepine tablet ....25/50/100mg Armodafinil uncoated tablet ..50/150/250mg Indacaterol ( as Maleate ) Inhalation Powder Hard Capsules .. ...150/300mcg Ranolazine ER Tablets 750mg (Additional Strength) Tacrolimus Capsules 3mg (Additional Strength) Cefixime 100mg/200mg + Ofloxacin 100mg/200mg Tablets Liquid paraffin 6% + White soft paraffin 15%w/v Cream
For the treatment of schizo To improve wakefulness in treated obstructive sleep ap narcolepsy.
For maintenance bronchod with chronic obstructive p Same as Approved Same as approved
85
For the short term treatmen (ADHF) in situations wher where ionotropic support i
86
Thiocholchicoside SR Tablet 16 mg
87
Telmisartan 40/80 mg+ Indapamide SR 1.5/1.5 mg tablet one strip of 3 uncoated tablets of artesunate 150mg & one strip of 2 uncoated tablets of FDC of Sulphadoxine IP 500mg + Pyrimethamine IP 25mg
88
Additional strength
89 90 91 92 93 94 95
Lapatinib Ditosylate Tablets 250mg (addl. Indication) Pentosan polysulfate Sodium Cpasules 100mg Indapamide (SR) 1.5mg/1.5mg +Nebivolol 2.5mg/5mg tablet Cinitapride (ER) 3mg + Omeprazole (EC) 20mg Capsules Timolol Maleate Long Acting Ophthalamic Solution 5mg/ml Telmisartan tablet 20/40/80 mg(Additional indication) Dexketoprofen Trometamol 25mg + Thiocolchicoside 4mg tablets
In combination with letroz hormone receptor positive receptor for whom hormon
96
For the treatment of Gastri (erosion, hemorrhage, redn acute exacerbation stage o
97
For the treatment of pulmo with WHO class II or III s clinical worsening.
Rosuvastatin Calcium Tablet(Additional Indication) Paracetamol SR 1000mg Bilayered tablet Tacrolimus PR Caps 0.5/1/5 mg
Rizatriptan Benzoate orally disintegrating tablet 10 mg(Additional Dosage Same as Already approved Form) Ramipril 1.25/ 2.5/5/10 mg(Additional Indication)
103
Use in patients with type-2 alone or in combination w glycemic control For the treatment of
104
Children from the age of malignant giloma, such as showing recurrence or pro 105 Fluticasone Propionate 50mcg/125mcg/250mcg + Salmeterol xinafoate 25mcg/25mcg/25mcg Powder for inhalation
Cross linked Hyaluronic Acid 24mg + Lidocaine 3mg Pre-filled syrings Aceclofenac 1% w/w + Menthol 5% Spray Metformin SR 500mg/500mg + GliclazideSR 60mg/30mg + Pioglitazone 15mg/15mg tablets
For filling any medium siz well as for lip definition. T pain during the treatment For the treatment of acute
As 3rd line treatment of ty agents and the second line glycemic control
109
3 tablets of artesunate 100mg + 3 tablets of Artesuante 50mg & 2 tablets of Additional strength FDC of Pyrimethamine 25mg + Sulphadoxine 500mg combipack Calcium carbonate 600mg +Simethicone 80mg Chewable tablet
110
111
Activated Dimethicone 50mg + Magnesium Hydroxide 250mg+ Dried Aluminium Hydroxide250 mg + Sorbitol (70%)1.25 gm /5ml Solution Aspirin 75mg + Simvastatin 10mg/20mg + Lisinopril 5mg/10mg + Atenolol 25mg/50mg Tablets Irsogladine Maleate Tablet 2mg /4mg
112
113
For gastric ulcers, improve redness and edema) caused chronic gastritis.
114
As an adjunctive treatmen
115
Indicated as palliative ther therapy with other approve following: 1.Brain tumorsglioblast ependymoma, and metasta tumors. combination with predniso 3.Hodgkins Diseaseas s drugs in patients who relap to respond to primary thera 4.Non-Hodgkins lymphom approved drugs for patient or who fail to respond to p
116
Monteleukast Sodium Tablet 10mg; Monteleukast Sodium 4/5mg Chewable Tablet; Monteleukast Sodium Oral granule(Additional Indication) Ramosetron Dispersible Tablet 0.1 mg Amitraz 2%w/v pour on solution
117 118
For the prevention and trea vomitting) associated with For the control of ticks on
119
For treatment of acute and the posture and motor mus pain, dysmenorrhea and pa injuries.
Lidocaine Patch 350mg (Additional Pack Size) Oseltamivir Phosphate (Additional indication) Methylcobalamin 1500mcg +Folic acid 0.7mg +Niacinamide 12mg injection Methylcobalamin 1500mcg +Pyridoxine 100mg +Nicotinamide 100mg injection
1 tablet of Tenofovir disoproxil 300mg + Lamivudine 300mg & 2 tablet of For the treatment of HIV i Nevirapine 200mg combipack
125
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 + For the treatment of vitam 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 Ramipril MR Capsules 2.5/5 mg (Additional Strength) Same As Approved
126
127
(i) Use of Sitagliptin Phos agonist as an adjunct to die mellitus who are inadequa and a PPAR agonist. (ii) U insulin, alone or in combin
Erlotinib HCl 25/100 mg Tablet (Additional Indication) Gemcitabine HCl injection 2gm/vial (Additional Strength) Etizolam 0.25 mg tablet (Additional Strength) Dexketoprofen1.25% w/w +Linseed Oil 3.0%w/w +Menthol 5%w/w +Methyl Salicylate 10%w/w (12.5mg) Cefuroxime Sodium 750/1500mg +Sulbactam Sodium 375/750mg HPMC 0.3% +Dextran 0.1% + Glycerin 0.2%
As monotherapy for maint metastatic non-small cell l platinum based first line ch Same as Approved Same As Approved
134
Cyanocobalamin 15mcg+Chromium Picolinate USP 250mcg+Folic Acid USP 1500 mcg+Nicotinamlide IP100 mg+Pyridoxine 3mg +Selenius Acid For Mineral & Vitamins d USP 100mcg+Zinc Sulfate Monohydrate USP 61.8 mg eq. to 22.5 mg
Methylparaben 0.15%w/w +Propyl paraben 0.05%w/w+Glycerin 20%w/w For short term treatment o +CMC 1.74%w/w +Allantoin 0.5%w/w +Benzyl alcohol 0.5%w/w. sores, leg ulcers Clonazepam IR 0.5mg/0.5mg+ Paroxetine CR 12.5/25mg Nilotinib Capsules 200mg
138
Lidocaine Lozenges 100mg (Additional Strength) Metoprolol succinate ER 25/50 mg+Telmisartan 20/40mg Etodolac 300/300mg +Thiocolchicoside 4/8mg Celecoxib 100/200mg +Diacerein 50/50mg Metoprolol succinate ER 25mg+50mg + Olmesartan 20/20mg
For the treatment of chron positive chronic myelogen intolerant to prior therapy Treatment of infection cau as in neonates and infants infections 2. Urinary tract septicemia 5. bone and joi Bacterial endocarditis Same as Approved
144
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) Gliclazide 40/80mg+Metformin 500mg+Pioglitazone15mg Lidocaine HCl Ophthalmic Sterile Gel 35 mg/ml Naftopidil Tablets 25/50/75mg
Additional strength
148
A) FDC is indicated as trip thiazolidinedione) as an ad controlled on their maxima FDC is also indicated as ad adjucnjt to diet and exercis dosage of insulin and metf
Bimatoprost Eye Drps 0.1mg/ml S(+) Etodolac 5/10%w/w + Camphor 4%w/w + Menthol 10%w/w + Methyl salicylate 5%w/w + Linseed oil 3%w/w Cefpodoxime 100/200mg+Dicloxacillin ER 500/500mg Voglibose0.3 + Metformin (SR) 500mg Amoxycillin Oral Suspension 200/400 mg per 5ml
For the treatment of lower ENT infections in adult pa Additional higher strength
in the treatment of infectio organisms in the condition lower respiratory tract infe uncomplicated (anogenital
154
Doripenem 500 mg powder for injection (Additional Indication) Nadolol tablet USP 20/40/80 mg Fluconazole For Oral suspension 50/200 mg per 5ml (Pack Size : 35ml)
158
159
Additional indication: 1. F antihypertensive agents 2. need multiple antihyperten Complicated intra-abdomi including complicated and concurrent bacteremia in the treatment of anginafor the treatment of system fungal infections in patien Indicated as an adjunct to with type 2 diabetes mellit metformin or who have ina metformin For management of pruritu and atopic contact dermato
Rosuvastatin 5/10/20mg+Fenofibrate 67/145/160mg Fexofenadine 120mg + Montelukast 10mg Irinotecan HCl Trihydrate Injection 20 mg/ml (Pack Size 25ml)
163
Additional strength
164
165
166 167
Buserelin Acetate injection 1mg/ml (Additional Indication) Etodolac 400mg/400mg + Thiocolchicoside 4mg/8mg tablet
168
Montelukast Sodium 10 mg Tablet, Montelukast Sodium 4/5 mg Chewable For The relief of perennial Tablet and Montelukast Sodium Oral Granules (Additional Indication). of age and older.
169
170
171
172
Beclomethasone Dipropionate IP 0.025% w/w + Neomycin sulphate IP 0.5% w/w cream Amlodipine 5mg/2.5mg + Valsartan 320mg/80mg + HCTZ 12.5mg/12.5mg tablet Paracetamol 500mg/500mg +Thioclchicoside 4mg/8mg tablet
173 174
175
Ketorolac Tromethamine 0.4% w/v +Moxifloxacin 0.5% w/v Opthalmic solution Nilotinib Capsules 150 mg. Levocloperastine ( as Fendizoate) Suspension eq. to Levocloperastine Hcl 20mg / 5ml. Zileuton uncoated bilayered extended release tablet ...600mg
176
177
178
179
180
Dried Aluminium Hydroxide Gel IP 600mg +Magnesium Hydroxide IP 300mg +Simethicone IP 25mg +Oxetacaine BP 10mg per 5ml syrup
For the treatment of sympt bowel syndrome, function disease which include smo hyperacidity, gastric distre
181
S(-) Metoprolol Succinate ER Eq. to S (-) Metoprolol tartarate 25mg/50mg + Clopidogrel (IR) 75mg/75mg tablet
182 183
Exenatide Injection (Additional indication) Bimatoprost Ophthalmic Solution 0.01% w/v (Additional Strength)
Exenatide is a glucagon lik adjunct to diet and exercis diabetes mellitus. Same as approved.
184
For the treatment of moder contraindications to oral co should be used for the trea contraceptive for birth con For the treatment of acute only Additional dosage form
185
186
187
Thiocolchicoside 0.25% +Methyl salicylate IP 100mg +Menthol IP 50mg +Absolute alchol IP 50mg per gm gel
188
Amlodipine Besylate IP Eq. to Amlodipine 10mg/5mg/2.5mg +Telmisartan 80mg/40mg/20mg + HCTZ 25mg/12.5mg/12.5mg tablet
189
Pregabalin 150mg/75mg +Methylcobalamin 750mcg +Alpha lipoic acid 100mg +Pyridoxine 3mg +Folic acid 1.5mg capsule
190
Ferrous bisglycinate 60mg + Zinc sulphate monohydrate Eq. to Zinc 14mg + Copper as copper sulphate 1 mg + Selenium as selenomethionine 70mcg For Vitamin and mineral d + Vitamin B6 IP 10mg + Methylcobalamin 1500mcg + Folic acid 5mg + Fish oil 10/40 (DHA 200mg) 500mg capsule.
191
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. As contraceptive pill for w to 24.375 mg of Ferrous iron)
192
Amitriptyline Hydrochloride IP 4%w/w + Ketamine HCL eq. to Ketamine For the treatment of patien 2% w/w per gm cream. Paracetamol IP 500mg + Phenylephrine HCL IP 5mg +Caffeine (anhydrous) IP 30mg + Diphenhydramine HCL IP 25mg tablet. Levocetirizine dihydrochloride 2.5mg +Montelukast 5mg dispersible tablet Calcium citrate maleate Eq. to elemental calcium 250mg +Vitamin D3 IP 200 IU tablet
193
194
Additional strength
195
196
197
198
1. For the treatment of chr 2. For the treatment of irrit women > 18 years old.
199
200
for the treatment of throm (idiopathic) thrombocytop corticosteroids, immunogl (It should be used only in and clinical condition incr attempt to normalize plate
201
202
For anti inflammatory and low back pain, periarthriti post trauma, and post dent Same as Approved.
203
204
Cerebroprotein Hydrolysate injection (Lyophilised) ..1050mg / 2100mg For amelioration of crania (approx) equivalent to nitrogen.30mg / 60mg respectively. aprosexia in dementia.
205
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 variou motility like non-ulcer dys gastroesophageal reflux di functional origin.
Tolperisone HCl Mouth Dissolving tablet 50/100 mg (Additional Dosage Form) Oxybutynin Gel 100 mg Dapoxetine ( as Hydrochloride) Tablets 30mg/60mg
Same as Approved.
Opipramol dihydrochloride Tablet 50mg/100mg. Ondansetron Rapid Film Oral Strip 4/8 mg Acebrophylline SR Tablet 200 mg
212
Rabeprazole Sodium Powder oral suspension ( sachet of 20 mg) (Additional dasage form) Temsirolimus Concentrate for Infusion for Injection 25mg/ml Acetyl Cysteine Eye Drops 5% w/v
Same as approved
216
217
Same as approved
218
219
(Additional Strength)
Same as approved
220
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 )
221
Pyridoxine HCL IP 3mg + Nicotinamide IP 100mg + Cyanocobalamin IP 15mcg + Folic acid IP 500mcg + Chromium Picolinate USP 250mcg Tablet Rosuvastatin Calcium IP 5mg/10mg + Fenofibrate BP 160mg/160mg tablet
222
Additional strength
223
224
For the treatement of osteoporosis in post-menopausal wom and in men who are at increased risk offracture,including t with a recent low-trauma hip fracture.
Addl. Strength
For the treatement of adult patients with chronic obstructiv pulmonarydisease(COPD) and bronchial asthma.
(I) For the treatement and lasting prevention of flea infestations,treatmentand control of flea allergy derma prevention of heartwormdisease,treatement and prevention amectin Tropical solution (for verterinaryuse.) 60mg/120mg per ear mites in dogs and cats; (II) For the treatement and prevention of sarcoptic mange,roundworms and for control of tick infestations in dogs.
ethylcobalamin1500mcg + Calcium 200mg + Calcitriol 0.25mcg For the treatment of vitamin deficiency states in adults Folic Acid1.5mg + Pyridoxine3mg Capsules
For the treatment of secondary hyperparathyroidism in pat with chronic kidney diseases (CKD) on dialysis and for hypercalcemia in patients with parathyroid carcinoma
ycophenolate mofetil Capsules 250mg, Tablets 500mg, Oral pension 200mg/ml (addl. Indication)
For the prophylaxis of acute organ rejection in patients recieving allogenic hepatic transplantation.
quid Paraffin1.25ml + Milk of Magnesia 3.75ml + dium Picosulphate 3.33mg per 5ml
Same as approved
For use in following: (I) Empirical therapy for presumed f infections in febrile neutropenic patients.
(II) Treatment of Candidemia and the following Candida infections: Intra-abdominal abscesses, Peritonitis and Pleu space infections. (III) Treatment of EsophagealCandidiasis.
(IV) Treatment of invasive Aspergillosis in patients who a refractory to or intolerant of other therapies (i.e, amphoter B, lipid formulations of amphotericin B, and/oritraconazol
For the treatment of patients withcandidemia, acute disseminated candidiasis, candida peritonitis, abscess and esophageal candidiasis. For the prophylaxis of Candid infection in patients undergoing hematopoietic stem cell transplantation (HSCT)
For prophylaxis and treatment of the nasal symptoms of seasonal allergic rhinitis.
For the tratment of signs and symptoms of idiopathic Parkinson's disease as intial monotherapy and as an additio levodopa.
To reduce the withdrawal symptoms, including nicotine craving, associated with quitting the smoking and quitting chewed tobacco and guthka containing tobacco.
For the infestation of trematodes, nematodes, cestodes and arthropods of domestic animals, including milch and other producing animals.
For the short term use in acute painful & inflammatory conditions in adults
trimide15% w/v + Chlorhexidine Gluconate 7.5% v/v + propyl Alcohol 7.5% v/v Concentrate Solution
To reduce the withdrawal symptoms, including nicotine craving, associated with quitting the smoking and quitting chewed tobacco and guthka containing tobacco.
For the treatment of dizziness and feeling of dizziness resu from Meniere's disease, Meniere's syndrome and vertigo.
In moderately to severly active rheumatoid arithritis in adu and may be used as monotherapy or concomitantly with DMARD's other than TNF antagonists
For the treatment of invasive candidiasis including candidemia andesophageal candidiasis in adult patients.
For the treatment of asthma and chronic obstructive pulmo disease in adult patients only
droquinone 20mg + Tretinoin 0.25mg + Fluocinolone Acetonide For the treatment of melasma of face in adults mg per gm Cream
mivudine 30mg + Zidovudine 60mg +Nevirapine 50mg Oral spension (Tablets for oral Suspension)
As 3rd line treatment of type II diabetes mellitus when die exercise and the single agents and the second line therapy two drugs do not result in adequate glycemic control
tinoxate 7.5% + Avobenzone 3% + Oxybenzone 3% + Titanium As sunscreen lotion for prevention of sunburn skin xide 2% lotion
For the symptomatic relief of productive cough associated allergic rhinitis, when both anti-histamine and mucolytic a are desired
For the treatment of mild to moderate hypertension in adul patients (in whom combination therapy is appropriate) wh have been stabilized on the individual components given i same proportion
Addl. Strength
For the treatment of human immunodeficiency virus (HIV infection in antiretroviral treatment experienced adult patie such as those patients with HIV-1 strains resistant to more one protease inhibitor when co-administered with 100mg ritonavir, and with other antiretroviral agents.
For the production of local or regionalanasthesia for surge and for acute pain management.
taphosphan 100g + Methyl Hydroxybenzoate 1gm + anocobalamin50 gm Oral powder (Veterinary Drug)
Additional Strength
For the symptomatic relief of bronchospasm in bronchial asthma & chronic bronchitis
rgical Sealant
To be indicated for use in sealing suture lines along arteria venous reconstructions.
For the relief of pain associated with post-herpetic neuralg should be applied only to intact skin.
For the treatment of hypotrichosis of the eyelashes by increasing their growth including length, thickness and darkness.
For the treatment of patients with advanced soft tissue sarc after failure of anthracyclines and ifosfamide, or who are unsuited to recieve these agents.
For the treatment of children (age 6to 12years) with chron obstructive pulmonary disease(COPD) and bronchial asthm
For the induction of remission in patients with active, mild moderate ulcerative colitis.
Same as approved
aluronic Acid Sodium Salt 0.2 gm + Silver Sulfadiazine 1.0 /25 gm tube Hyaluronic Acid Sodium Salt 50 mg + Silver lfadiazine 1.0 gm/ 100 gm gauze pads impregneted with cream.
Sterile Gauze Pads impregnated with cream: Each gauze pad ntains HyaluronicAcid Sodium Salt 50/100mg
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 respon one or more DMARD's such as MTX
For symptomatic relief of productive cough associated wit allergic rhinitis, when both anti-histamine and mucolytic a are desired
Indicated as third line treatment of severe cases of COPD whenmonotherapy and second line therapy with two drugs not respond adequately.
For the symptomatic treatment of pain and inflammation i patients of osteoarthritis & rheumatoid arthritis
Same as approved
ch film coated bilayred tablet contains: Metoprolol 25mg/50mg Chlorthalidone 6.25 mg /12.5mg
Additional strength
For the treatment of intestinalhelminthes and suppression ofmicrofilaraemia especially with bancrofti infections
For treatment of patients with myelodysplastic syndromes (MDS) including previously treated and untreated, de novo 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 Sco System groups.
tapamulin Ointment 1%
For the topical treatment of bacterial skin and skin structur infections:-Primary impetigo, secondarily infected traumat lesions, secondarily infected dermatoses.
ch ml contains Calamine 15% w/v + Zinc oxide 5% w/v + ntonite 3% w/v+Glycerin 5%w/v + Sodium citrate 0.05 % w/v ion
ch 1000 ml of emulsion contains: Medium chain triglycerides 0 gm + Soya oil 80 gm + Omega-3 acid triglycerides 20 gm + g lecithin 12 gm + Glycerl 25 gm + Sodium oleate 0.30 gm + pha -tocopherol 0.20 gm + Ascorbypalmitate0.30 gm + Sodium droxide max. 0.06 gm + water for injection 784 gm emulsion for usion
For the supply of fats, including essential omega-6 fatty ac and omega-3 fatty acids, as part of a parenteral nutrition regimen in adults iforal or enteral nutrition is impossible,inadequte or contraindicated.
For the topical treatment of the superficial fungal infection the skin.
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 coron revascularization procedures and the need for hospitalizati due to angina in patients with coronary artery disease.
ndamycin Phosphate Inj. 150mg/ml & ndamycin HCl Capsules 150mg/300mg (additional indication)
cralose
To reduce cardiovascular mortality in clinically stable pati who have survived the acute phase of a myocardial infarct and have a left ventricular ejection fraction of 40% (with without symptomatic heart failure)
mesulide ER 200mg
dditional Indication)
ndamustine Hydrochloride Lyophilized powder Injection 100mg/ For the treatment of patients with chronic l lymphocytic leukemia.
ffeine(as Citrate)
10mg / ml Injection
For the short term treatment of apnoea of prematurity of in between 28 and < 33 weeks gestational age.
For the treatment of arterial hypertension, congestive heart failure and coronary artery disease.
ch gm contains: Halobetasol 0.05% w/w + Mupirocin 2.0 % w/w For the topical treatment of inflammatory dermatitis with secondrybacterial infection
Additional strength
For the treatment of overactive bladder with the symptoms urge urinary incontinence, urgency, and urinary frequency
For the long term, twice daily (morning and evening) maintainence treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COP including chronic bronchitis and emphysema.
For sedation of initially and mechanically ventilated patien during treatment in an intensive care setting.
same as approved
For the reduction of the frequency of relapses in patients w Relapsing-Remitting Multiple Sclerosis.
For the treatment of unresectablemetastatic liver tumors fr primary colorectal cancer with intra-hepatic artery rium-90 Microspheres Injection (Yttrium-90...3GBq (at the time chemotherapy (IHAC) of FUDR (Floxuridine) calibration) per vial)
liconazole Cream 1%
For the treatment of cutaneous mycosis viz. Tinea pedis, T corporis, Tinea cruris.
1) For the treatment of generelized or partial seizures as monothreapy or adjunctive threapy. 2) For prophylaxis migraine headache in adults. 3) For the treatment of manic episodes associated with bi polar disorders
For the treatment of pulmonary arterial hypertension (WH Group I) in patients with WHO Class III or IV symptoms, improve excercise ability and decrease the rate of clinical worsening.
same as approved
for the treatment for mild to moderate susceptible infection including RTI, uncomplicated skin/ skin structure, non gonococcal urethritis, cervicitis
As 2nd line treatment of patients with both essential hypertension and hypercholesterolemia who are not adequ controlled by combination of an anti-hypertensive with lip lowering agent.
same as approved
As 2nd line treatment of type II Diabetes mellitus when di exercise and the single agent do not result in adequate glycemic control.
mbipack of artesunate tablet and FDC Tablet sulphadoxine + pyrimethamine mposition: A. combipack of 1 stip of ablets ofartesunate 25 mg and 1 strip of 1 tablet sulphadoxine 125mg+ pyrimethamine 6.25
combipack of 1 stip of 3 tablets ofartesunate 50 mg and 1 strip 1 tablet of sulphadoxine 500mg+ pyrimethamine 25
combipack of 1 stip of 3 tablets ofartesunate 100 mg and 1 strip 2 tablet of sulphadoxine 500mg+ pyrimethamine 25 D.combipack of 1 stip of ablets ofartesunate 200 mg and 1 strip of 3 tablet sulphadoxine 500mg+ pyrimethamine 25 mg. same as approved
For the treatment of HIV infection in combination with oth anti retro viral agents
For the treatment of oropharyngeal candidiasis, including oropharyngeal candidiasis refractory to itraconazoleand/orfluconazole. prophylaxis of invasive Aspergillus and Candida infection 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-h disease (GVHD) or those with hematologic malignancies w prolonged neutropenia from chemotherapy.
ffeine Citrate 20mg / ml (equivalent to 10mg of Caffeine base) al Solution (Addl. Dosage form)
same as approved
listimethate Sodium powder for solution for injection/infusion 0000IU and 2000000IU (additional Strength)
same as approved
mvastatin 20 mg + Ramipril 5mg + Atenolol 50 mg + HCTZ 5 mg + Aspirin 100 mg (EC Pellets) Capsules
For secondary prevention of coronoryheart disease/stroke patients where use of such combination is appropriate
Treatment by inhalation of Pseudomonas aeruginosa lung infection in patients with cystic fibrosis
For the treatment of acute inflammation conditions associa with spasm in adults only
For the treatment of acute inflammation conditions associa with spasm in adults only
Treatment of generalized tonic-clonic seizures in adults an children for the treatment of diarrhoea of mixed infection in adult patients Indicated in the management of Schizophrenic patients
Is indicated for the relief of stuffy,running nose associated colds and influenza, also post nasal drip, sinusitis.
Treatment of acute ST-segment elevation myocardial infar including patients to be managed medically or with subseq percuaneous coronary intervention (PCI)
For single agent anesthesia in procedure involving the introduction of instrument & tubes into respiratory tract.
Indicated as monotherapy or as adjunctive therapy in lithium or valproate for the maintenance treatment of Bipo 1 disorder.
Indicated for adjuvant treatment of Post Menopausal Wom with estrogen receptor positive early breast cancer who ha received two-three year of tamoxifen and are switched to exemestane for completion of total of five years of adjuvan hormonal therapy.
01.09.2009 For the treatment of uncomplicated malaria due to plasmodium falciparum strain in various age groups For the treatment of combined hyperlipidemia in patients with normal hepatic and renal function
01.09.2009
Buprenorphine Transdermal Patch Each For the treatment of severe opioid responsive Transdermal Patch having an area of 6.25cm, painconditions which are not adequately responding to 12.5cm, and 25cmcontains: non-opioid analgesics.For Hospital supply only. Buprenorphine5mg/10mg/20mg having 143 release rate of 5mcg, 10mcg, 20mcg Buprenorphine per hour respectively(over a period of 7 days).
03.09.09
For the treatment of overactive bladder with the symptoms 04.09.2009 of urge urinary incontinence, urgency and urinary frequency. 09.09.09
145 Metoclopramide (as HCl) 200mg / 400mg per ml Intranasal Solution For the treatment of nausea and vomiting.
18.09.2009 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.
22.09.2009 For the treatment of adult patients with Upper and Lower respiratory tract infections, skin and soft tissue infections 03.10.09 For the treatment of mild to moderate hypetension.
148
03.10.09 For the treatment of skin bacterial infections in dogs and cats. 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
Imidacloprid 10% + Moxidectin 1.0% & 2.5% Topical solution (Veterinary) Each pippette contains: (a) 0.4ml, 1.0ml, 150 2.5ml, 4ml of 10% Imidacloprid and 1.0% moxidectin (b) 0.4ml, 0.8ml of 10% Imidacloprid and 2.5% moxidectin
Isoflupredone AcetateSuspension for Injection For the glucocorticoid, anti-inflammatory or supportive therapy to cattle suffering from conditions such as: (2mg per ml) ( For Veterinary) (1) Overwhelming infections with severe toxicity. (2) Bovine ketosis. (3) Musculoskeletal conditions. 151 (4) Shock. (5) Parturient paresis (supportive stress therapy for milk fever).
03.10.09
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
152
3.10.2009 (additional dosage form) For the treatment of moderate plaque psoriasis in adults same as approved 3.10.2009
3.10.2009
156
9.10.2009 For the treatment of cytomegalovirus (CMV) retinitis in AIDS patients and for prevention of CMV disease in solid organ transplant patients at high risk
Dexketoprofen Trometamol Gel 12.5mg/gm For the painful and inflammatory conditions associated with joints, tendons, ligaments and muscle For the treatment of mild to moderate severe Alzheimer's Dementia 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.
13.10.2009
157
Donepezil Hydrochloride Orodispersible 158 Tablet 5mg/10mg Dexketoprofen Trometamol Injection 50mg/2ml
15.10.2009
22.10.2009
159
22.10.2009 Indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. For the treatment of depression and schizophrenia in adults Additional strength
161
27.10.2009
Ambroxol 30 mg+ Terbutaline 2.5 mg + 162 Guaiphenesin 100mg + Menthol 2.5 mg per 5 ml syrup
27.10.2009
Additional strength
27.10.2009
Mecobalamin 750 mg + Pyridoxine 164 Hydrochloride1.5 mg + Nicotinamide 45 mg tablets Olmesartan (20/40mg )+ Atorvastatin 5/10/20mg film coated tablets Deltamethrin (0.50% m/v) and Piperonyl Butoxide (2.0% m/v) per ml PourOn Solution
27.10.2009
165
For the treatment of co-existing essential hypertension and 27.10.2009 hyperlipidemia in adult patients
166
Ready to use pour-on for cattle, sheep and goats. 29.10.2009 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
Glucosamine sulphate potassium chloride 500 For the treatment of adult patients with osteoarthritis of 167 mg + Ibuprofen IP 200mg film coated Tablets knee and/or hip joints
03.11.2009
Methylcobalamin 1500 mcg + Gabapentin SR Additional strength 168 600 mg film coated tablets 1. For conscious sedation for surgical and diagnostic procedures 2. for sedation of ventilated patients receiving intensive care For the management of seasonal allergic rhinitis (SAR)
4.11.2009
169
5.11.2009
10.11.2009
For improvement of mytonic conditions caused by neck shoulder arm syndrome , scapulhumeral periarthritis and low back pain in adult patients only
10.11.2009
172
For the treatment of: 11.11.2009 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. 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. For the treatment of pulmonary arterial hypertension
Ramosetron Hydrochloride Tablets 2.5mcg, 5mcg, 0.1mg & Injecton 0.3mg /2ml
11.11.2009
173
14.11.2009
174
Sedation of non-intubated patients prior to and/or during surgical and other procedure Same as approved
14.11.2009
14.11.2009
1) Triticum Vulgare Topical Cream Each 100gm of cream contains: Aqueous extract of Triticum Vulgare (dry 178 residue 200mg / 100ml) ..... 15gm 2-phenoxyethanol Eur. Ph.....1gm 2) Triticum Vulgare Vaginal Pessary Each
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
3.5gm of vaginal pessary contains: Aqueous extract of Triticum Vulgare (dry residue 200mg/ 100ml) .....0.60gm 2-phenoxyethanol Eur. Ph.....0.04gm 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
179
Euphorbia Prostrata Dry Extract :100mg tablet For the treatment of 3 and 4 haemorrhoids (Addl. 180 (addl. Indication) Indication). For the treatment of 1 and 2 internal haemorrhoids.
14.11.2009
14.11.2009
Lactobacillus Rhammnosus 1 billion cells + 182 Saccharomyces Boulardi 125 mg + Zinc Enriched yeast 20 mg sachets & capsules
4.11.2009
Nimesulide 1.0% w/w + Ethanol 31% w/w 183 topical solution Diacerein Modified Release Capsule 100mg
For the local application in relieving pain in acute low backache, tendonitis, tenosinovitis and sprains Symptomatic treatment of osteoarthritis of knee & hip
17.11.2009
20.11.2009
Amlodipine 5mg/10mg/5mg/10mg/10mg + Valsartan 185 160mg/160mg/160mg/160mg/320mg + Hydrochlorothizide 12.5mg/12.5mg/25mg/25mg/25mg Tablets Maraviroc Tablets 150mg/300mg.
24.11.2009
186
25.11.2009
S (+) Etodolac 150/200/300mg + Paracetamol For the symptomatic treatment of acute pain and 187 500/500/500mg Tablets inflammation in patients with osteoarthritis, rheumatoid arthritis and ankylosing spondylitis
25.11.2009
Tacrolimus Granules for oral suspension 0.2/1 Prophylaxis of transplant rejection in kidney, liver or heart 26.11.2009 188 mg per sachet allograft recipient Rifaximin Dispersible Tablet 200mg For infections diarrhoea in adults
26.11.2009
189 Indicating for condition required Glucocorticoids activity including collagen disease, allergic disease and hypersensitive reaction
26.11.2009
Cinitapride Hydrogen Tartrate ER Tablet 3mg For the treatment of gastroesophageal reflux disease 191 (GERD) and functional inconveniences of the gastrointestinal motility Sevelamer Carbonate (Additional Indication)
26.11.2009
192
for control of serum phosphorus in patients with chronic 26.11.2009 kidney disease on haemodialysis or peritoneal dialysis and patients with CKD not on dialysis with serum phosphate > 5.5 mg/dl Monotherapy in the treatment of partial seizures in children ages 4-16 for the relief of musculoskeletal pain & inflammation
26.11.2009
11.12.2009
194 Acipimox Capsules 250mg. As adjunctive therapy to diet and weight loss in the treatment of type IIa, IIb and IV lipid disorders. Same as approved
26.11.2009
27.11.2009
29.10.2009
Loteprednol etabonate 0.5% w/v + For the treatement of post operative steriod responsive 198 Moxifloxacin 0.5% w/v opthalmic Suspension inflammatory ocular infections or risk of bacterial ocular infections exists Ropinirole ER tablet 2/4/8mg for the treatment of signs & symptoms of idiopathic Parkinson's disease same as approved
1.12.2009
3.12.2009
199
Diclofenac Diethyl amine transdermal patch 200 100 mg/37.5 sq cm (Additional Strength)
4.12.2009
same as approved
11.12.2009
202
for the relief of pain & inflammation due to rheumatoid arthritis , osteoarthritis and allied disorder 1. Mild to severe chronic heart failure. 2. Left ventricular dysfunction following myocardial infarction in clinically stable patients 3. hypertension For the treatment of acute and chronic infected eczematous dermatitis
11.12.2009
11.12.2009
Halometasone monohydrate 0.05% w/w + 204 Fusidic acid 2.00% w/w cream
15.12.2009
For the treatment of type II diabetes mellitus associated with dyslipidemia indicated in the treatment of Menier's syndrome, characterized by unilateral or bilateral tinnitus, vertigo, sensorineural hearing loss 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".
17.12.2009
Betahistine Di hydrochloride CR capsule 206 24/32/48mg Gefitinib tab 250mg (Additional Indication)
17.12.2009
18.12.2009
For selection,anxiolysis and amnesia prior to diagnostic, 18.12.2009 therapeutic or endoscopic procedure or before induction of anesthesia. For the treatment of productive cough accompanied by phlegm for the treatment of uncomplicated urinary tract infectins (such as cystitis and urethritis) For symptomatic treatment of nasal congestion with running nose (rhinorrhea) For the treatment of patients with bronchial asthma and COPD, when use of both the drug is appropriate
18.12.2009
22.12.2009
210
23.12.2009
Doxofylline 400 mg + Ambroxol 30 mg 212 Tablets Ribavirin Capsules 200mg (Addl. Strength)
23.12.2009
213
Indicated in combination with peg interferon alpha-2b for 24.12.2009 the treatment of nave adult patients with chronic hepatitis C with clinically stable HIV co-infection.
Formoterol 6 mcg + Mometasone furoate For the treatment of patients with bronchial asthma and 30.12.2009 214 100/200/400mcg Metered dose Inhaler & Dry COPD, where the use of combination is found appropriate Powder Inhalation Chlorohexidine Gluconate Gel 0.2% For the prevention of Plaque and treatment of gengivitis.
30.12.2009
215 Chlorohexidine Gluconate Mouth wash 0.1% For the prevention of Plaque and treatment of gengivitis.
30.12.2009
216
Levodropropizine Eur. Ph. 30mg + Chlorpheniramine maleate IP 2mg per 5 ml Syrup For the treatment of non-productive cough 06.07.09
217
For temporary relief from pain, swelling & 29.11.07 inflammation due to musculoskeletal disorder For improvement of parantial hyperphemia in diabetis mellitus only. When diet and/or exercise or oral, hypoglyceamic drug or 28.12.07 insulin preparation in addition to diet and or exercise do not result in adequate glycemic control. Same as Approved 31.01.08
ISMN 30mg SR + Metoprolol Succinate equivalent to metoprolol tartrate 25mg/50mg tablets Same as Approved (Additional Strength) For the treatment of steroid responsive fungal infections including eczema and psoriasis
02.01.08
04.01.08
For the treatment of disturbance of consciousness resulting from head injuries, brain 04.01.08 operation and acute stage of cerebral infarction in adults only For Parkinson's Disease 08.01.08 For the treatment of burns and wound infections
04.01.08
inconveniences of the gastrointestinal motility 10 Tenofovir disoproxil fumarate 300mg + Lamivudine 300mg tablet For the treatment of adult patients with HIV 07.01.08 infection For the treatment of Urinary tract infections, respiratory tract infections, biliary tract 07.01.08 infections in adult patients prone to antibiotic associated diarrhoea Same as Approved 07.01.08
11
Cefixime 200mg/100mg + Lactic acid bacillus 2.5 billion spores tablet & dispersible tablet
12
For the treatment of lower respiratory tract 08.01.08 infection caused by pseudomonas aeruginosa Same as approved For the prophylaxis of surgical site infections following elective colorectal surgery 08.01.08
15.01.08
As an adjunct to diet and exercise to improve glycemic control in 18.01.08 patients with type-II diabetes mellitus For the treatment of dyslipidemia associated with atherosclerotic arterial disease with risk 18.01.08 of myocardial infarction, stroke or peripheral vascular disease For the treatment of acute migraine 22.01.08
18
Sodium Valproate 666mg + valproic acid 290mg 19 equivalent as sodium valproate 1000mg C.R. tablet Same as Approved (Additional Strength)
24.01.08
For serious CRTI, uncomplicated and complicated UTI, Cefepime (as hydrochloride) 2000/1000/500mg + Uncomplicated skin & 20 Sulbactam (as sodium) 1000/500/250mg per vial of skin structure, infection 24.01.08 injection acute exacerbation of chronic bronchitis & intraabdominal infection. 21 Paclitaxel Nanoparticle Solution for Injection 20mg/ml (Additional indication) Ovarian cancer, nonsmall cell lung cancer and AIDS related Kaposis Sarcoma For hepatocellular Carcenoma 22.01.08
22.01.08
23
For prophylaxes and treatment of both influenza A & B in 22.01.08 adults and children (greater than or equal to 5 years) For the prophylaxis of acute organ rejection in patients receiving 23.01.08 allogeneic hepatic transplantation
24
Mycophenolate Mofetil Capsule 250mg, 500mg & Oral suspension 200mg/ml (Additional Indication)
Combikit 4 tablets of Alendronate sodium trihydrate equivalent to Alendronic acid 70mg each For the treatment of 25 + 24 tablets of Calcium carbonate 1250mg osteoporosis in post(equivalent to 500mg Calcium) + cholecalciferol- menopausal women 250IU
23.01.08
For short term treatment of pain due to post 23.01.08 operative and post traumatic cases For the treatment of combined hyperlipidemia in patients with normal hepatic and renal functions.
27
25.01.08
Sodium Valproate 499.5mg + Valproic acid 28 217.5mg equivalent as sodium valproate- 750mg CR tablet (Additional Strength)
Same as Approved
24.01.08
29
Diclofenac 50mg + Serratiopeptidase 10mg enteric For the treatment of coated tablet acute pain in adults Gabapentin 100mg + methylcobalamin 500mcg tablets (Additional Strength)
24.01.08
30
Same as Approved
24.01.08
Cefpirome (as sulphate) 500/1000mg/2000mg + 31 Sulbactam (as sodium ) 250mg/500mg/1000mg powder for injection
For the treatment of infection caused by sensitive organisms viz. 24.01.08 lower RTI, complicated UTI, Septicemia, bacteremia For the treatment of Type-II diabetes associated with mixed dyslipidemia For the treatment of acne vulgaris For the treatment of bronchial asthma 25.01.08
Metformin HCl ER 500mg + Fenofibrate 32 80mg/160mg tablet Salicylic acid 10mg/20mg (Foaming facewash solution)
33
28.01.08 28.01.08
For the treatment of patients with mild to 2 Rivastigmine transdermal patch (each patch of 5m , moderately severe 35 10m2,15m2 & 20m2 contain Rivastigmine base dementia of the 28.01.08 9/18/27/36mg respectively Alzheimer type and dementia associated with Parkinsons disease For the treatment of complicated skin and Daptomycin powder for concentrate for solution for skin structure infections 36 28.01.08 infusion (350mg/500mg per vial) and for staphylococus aureus bloodstream infections (bacteremia) Dextromethorphan Orodispersible strip 37 5.5mg/11mg For the relief of persistent dry irritating cough in adult patients only 28.01.08
For the treatment of Diclofenac sodium 50mg + Dicyclomine HCl 20mg 38 acute colicky pain in per ml of injection adults
28.01.08
For decrease of intraocular pressure in patients with open angle glaucoma or ocular Travoprost 40mcg + Timolol (as Maleate) 5mg per 39 hypertension, who are 28.01.08 ml of eye drops insufficiently responsive to topical beta blockers or prostaglandin analogues Amoxicillin 250mg/125mg + Cloxacillin 40 250mg/125mg + Lactic Acid Bacillus 1.7 Billion spores For RTI, SRS of tissue infection, bons & joint infection, ENT infection 30.01.08 in adults prone to antibiotic associated diarrhoea For RTI, SRS of tissue infection, bons & joint infection, ENT infection 31.01.08 in adults prone to antibiotic associated diarrhoea
41
Mecobalamin1500mcg +Alpha Lipoic Acid100mg+Benfothiamine15mg+B63mg+Calcium For Vitamins and Pantothenate25mg+Folic Acid 1.5mg+Zinc 42 Minerals deficiency oxide22.5mg+Chromium states in adult patients picolinate65mcg+Inositol10mcg+Lutein5mg capsule
30.01.08
Methylcobalamine 750mcg + Alphalipoic acid For Vitamins and 100mg + Benfothiamine 7.5mg + B6 1.5mg + 43 Minerals deficiency Calcium pantothenate25mg + Nicotinamide 50mg + states in adult patients Folic acid0.75mg capsule
30.01.08
Mecobalamin500mcg + Alpha Lipoic Acid200mg + For Vitamins deficiency 44 Benfotiamin 10mg + Pyridoxine3mg + Biotin5mg + 30.01.08 states in adult patients Folic acid 1.5mg capsule For the treatment of lower RTI, skin & soft tissue bone & joint
45
30.01.08
infections, ENT infections in adult patients prone to antibiotic associated diarrhoea As 3rd line treatment of sever cases of COPD Tiotropium (as Tiotropium Bromide Monohydrate) when monotherapy and 46 18mcg + Formoterol Fumarate Dihydro. 12mcg + 31.01.08 second line therapy with Ciclesomide 400mcg per capsules two drugs do not respond adequately For the treatment of Metoprolol Succinate Equivalent to Metoprolol patient with both 47 Tartrate [ER 25/50mg] + Atorvastatin (As calcium ) essential hypertension 10mg tablets and hypercholesterolemia 48 Levocetrizine Di HCl Dispersible tablet 5mg/10mg For allergic rhinitis & (New Dosage form) chronic urticaria Oseltamivir 30mg & 45mg Capsules (Additional Strength) Same as Approved
28.01.08
28.01.08
49
28.01.08
Treatment of acute coronary syndrome 28.01.08 (ACS) with and without ST-segment elevation For remission of acute symptoms of chronic pancreatitis and postoperative reflux esophagitis
29.01.08
52
Hyaluronic Acid Salt 25mg + Cross-Linked Hyaluronic acid 25mg per ml in prefilledsyringe
For intradermal implantation and facial 30.01.08 soft tissue agumentation For the treatment of patients with chronic 30.01.08 cholestatic liver disease
For the extended treatment of symptomatic venous thromboembolism 54 Dalteparin Sodium Injection(Additional Indication) (VTE) proximal deep 30.01.08 thrombosis (DVT) and/or pulmonary embolism (PE), to reduce the recurrence of
55
For the topical treatment Beclomethasone Dipropionate 0.25mg + Econazole of bacterial and fungal 30.01.08 10mg + Neomycin 5mg per gm of Cream infections For adjunctive therapy to improve glycemic control in patients with type-II diabetes mellitus, who have not achieved adequate glycemic 30.01.08 control with metformin, a sulfonylurea or a combination of metformin and a sulfonylureas For the symptomatic treatment of acute pain and inflammation in patients with 30.01.08 osteoarthritis, rheumatoid arthritis and ankylosing spondylitis As adjunctive therapy in the treatment of partial 30.01.08 seizures of epilepsy For moderate to severe Alzheimer's disease 31.01.08
Exenatide injection (Each 2ml vial contains56 Exenatide 5mcg/10mcg per 0.2ml ) (Additional Strength)
57
For carcinoma of the stomach, colon, rectum, 31.01.08 breast, uterine, cervix and bladder For use for patients being treated by hemodialysis 1:- In newly diagnosed high-grade malignant glioma patients as an adjunct to surgery and radiation. 2:- In recurrent glioblastoma multiforme patients as an adjunct to surgery 31.01.08
61
62
31.01.08
31.01.08
As adjunct to rest and physical therapy for relief of muscle spasm 31.01.08 associated with acute painful musculoskeletal conditions For the topical treatment of the superficial 31.01.08 mycosis like dermatophytosis 31.01.08
66
Cefpodoxime 50mg + Clavulanic acid 31.25mg Same as Approved dispersible tablet & dry syrup (Additional strength)
67
For the treatment of overactive bladder with symptoms of urge 31.01.08 urinary incontinence, urgency and frequency
For the treatment of respiratory tract infection, skin and soft Amoxycillin 125mg/250mg/500mg + Lactobacillus 68 tissue infections & 1.66 billion Spores (Capsules) antibiotics associated diarrhoea in adult patients Halobetasol 0.5mg + Miconazole 20mg per gram 69 Cream For steroid responsive dermatoses associated with superficial fungal infection of skin
31.01.08
31.01.08
70
For the treatment of allergic rhinitis in adults 31.01.08 only For short term intermittent treatment of moderate to severe melasma of the face in 31.01.08 the presence of measures for sun avoidance including use of sun screen
71
Phenylephrine 5mg + Chlorpheniramine maleate For the treatment of 72 0.5mg + Paracetamol 125mg + sodium citrate 60mg common cold and cough 31.01.08 + Menthol 1mg (per 5ml) Syrup associated with fever For treatment of painful inflammatory conditions 31.01.08 associated with gastroduodenal ulcers As third line treatment of severe cases of COPD, when monotherapy and second 31.01.08 line therapy with two drugs do not respond adequately 31.01.08
Diclofenac Sodium 100mg (SR Pellets) + 73 Rabeprazole Sodium 20mg (E.C Pellets) Capsules
74
For the treatment of VSL # (Combination of lactic acid bacteria (VSL # 75 irritable bowel 3) syndrome
For the treatment of serious infection caused Gram-Ve bacteria including LRTI, UTI, 31.01.08 where commonly used anti bacterial agent may be infective because of bacterial resistance Same as Approved For the treatment of amoebiasis, urogenital trichomoniasis & giardiasis 20.02.08
77
21.02.08
for the additional indication "acute manic 21.02.08 episode associated with bipolar disorder additional Strength (it should not be used routinely because of increased risk of adverse events. It should be 25.02.08 reserved for patients who are considered to be at higher risk after careful risk assessment
80
81
Euphorbia Prostrata Dry Extract (ethanolic 80% (v/v) (35-70) :100mg tablet
For the treatment of haemorrhoid For the treatment of osteoarthritis & rheumatoid arthritis
29.02.08
07.03.08
Brimonidine Tartrate Opthalmic solution 0.1% 83 (with purite as preservation 0.0005%) (additional strength)
For lowering of IOP in patients with open angle 07.03.08 glaucoma occular hypertension 1:- For repigmentation of idiopathic vitiligo alongwith phototherapy. 2:- For symptomatic 07.03.08 control of severe, recalcitrant, disabling psoriasis in conjunction with phototherapy Same as Approved For the treatment of bronchial asthma & COPD in adults For the treatment of steroid responsive dermatoses associated with superficial fungal infections of the skin Same as Approved For gastric ulcer, duodenal ulcer, and GERD 11.03.08
85
12.03.08
12.03.08
88
Premetrxed disodium injection 100mg/vial (Additional Strength) Omeprazole 20mg/40mg + Sodium bicarbonate 1680mg per sachet powder for oral suspension
12.03.08
89
12.03.08
Mecobalamin 1000mcg+ Alpha Lipoic Acid 90 200mg+ vitamin B6 3mg + Folic Acid 1.5mg+ Inositol 100mg + Benfotiamine 100mg capsule
19.03.08
91
Same as Approved
19.03.08
92
For symptomatic relief Ambroxol HCl. 15mg + Guiphenesin 50mg + of bronchospasm in 95 Terbutalin sulphate 1.25mg + Menthol 2.5mg per 5 bronchial asthma and ml of syrup chronic bronchitis Ambroxol HCl 30mg + Guaiphenesin 100mg + 96 Terbutaline sulphate 2.5mg per 10ml Syrup For the symptomatic relief of bronchospasm in bronchial asthma & chronic bronchitis For the treatment of mild to moderate psoriasis For short term use in acute painful condition in adults only Oral contraceptive in women For symptomatic treatment of acute rhinosinusitis For the treatment of mild to moderate pain, such as dental pain, dysmenorrhoea & musculoskeletal pain
26.03.08
26.03.08
28.03.08
28.03.08
99
Drospirenone 3mg + Ethinyl estradiol 0.02mg tablets (Additional Strength) Nimesulide 100mg ER + Levocetirizine HCl 5mg Tablets
28.03.08
100
28.03.08
101
28.03.08
For the treatment of pain and inflammation 31.03.08 associated with cataract surgery For pain management in patients suffering with osteoarthritis of the 31.03.08 knee, hip, shoulder and ankle
103
For additional indication "advanced gastric adenocarcinoma, locally advanced squamous cell carcinoma of head & 31.03.08 neck, Harmone refraetory metastatic prostrate cancer, locally advanced or metastatic breast cancer
Methylcobalamin 1000mcg + Pyridoxine Hcl IP For peripheral 105 100mg + Nicotinamide IP 100mg + D-Panthenol IP neuropathy 50mg per 2 ml of injection
31.03.08
106
Same as Approved
01.04.08
For short-term treatment of hypertension when 07.04.08 oral therapy is not feasible or not desirable
Diclofenac Potassium 50mg + Serratiopeptidase (as For the treatment of 108 enteric coated pellets) 15mg capsules (Additional acute pain in adults Strength) For the treatment of adult patients with osteoarthritis of knee and or hip joints Same as Approved For the treatment of irritable bowel syndrome
08.04.08
11.04.08
110
Rabeprazole sodium Enteric coated pellets 15.4% w/w (20mg/129.83mg) Live freeze-dried lactic acid bacteria and bifidobacteria capsules Miltefosin Capsule 10mg/50mg (Additional Indication)
16.04.08
111
10.04.08
112
Treatment of cutaneous 16.04.08 leishmaniasis As an antimicrobial barrier for management of partial thickness 16.04.08 burns, incisions, skin grafts, donor sites, lacerations, abrasions
and Stage I-IV dermal ulcers (vascular, venous, pressure and diabetic) Diacerin 50mg + Glucosamine sulphate 500mg tablets. For the treatment of adult patients with osteoarthritis of knee and hip joints
114
21.04.08
115
For focal spasticity, including the treatment of arm symptoms 22.04.08 associated with focal spasticity in conjunction with physiotherapy For the treatment of systemic candidiasis, mucosal candidiasis, prevention of fungal infections in patients with malignancy In combination with dexamethasone for the treatment of multiple myeloma patients who have received at least one prior therapy
22.04.08
117
22.04.08
As an adjunct to diet & exercise to improve Sitagliptin ( As Phosphate) 50mg + Metformin Hcl. 118 glycemic control in 500mg/1000mg Film coated tablets patients with type-two diabetes mellitus
28.04.08
For short term treatment of errosive esophagitis when patients are unable 28.04.08 to take the oral formulation For the treatment of RA in children 5 years of 28.04.08 age and above For control of serum phosphorus in patients with chronic kidney disease on dialysis For the treatment of gastric ulcer, duodenal ulcer, Zollinger Ellison Syndrome and GERD 28.04.08
28.04.08
For the treatment of Pantoprazole Sodium (With Sodium bicarbonate as gastric ulcer, duodenal 123 buffer) 20mg/40mg tablets ulcer, Zollinger Ellison Syndrome and GERD
28.04.08
124
For the treatment of community acquired pneumonia, acute exacerabation of chronic 29.04.08 bronchitis, uncomplicated skin and skin structure infection, Pharyngitis/tonsillitis management of fibromyalgia syndrome Same as Approved 29.04.08
125 Pregabalin capsules (Addl. Indication) Pregabalin 75mg/150mg + Methylcobalamin 750mcg capsules (Additional Strength)
126
08.05.08
127
For the treatment of essential hypertension in adult patients whose 08.05.08 blood pressure is not adequately controlled on monotherapy . For diabetes insipidus and noctural emuresis 08.05.08
128
Desmoprission lyophilisate Oral tablets 60mcg/120mcg/240mcg per tablets Losartan Potassium 25mcg + Amlodipine (as besylate) 5mg tablets. (Additional Strength)
129
Same as Approved
14.05.08
For alcoholic liver Lecithin Liquid (each 5 ml contains lecithin 500mg 130 disease, drug induced equivalent to essential phospholipids 250mg hepatitis Halobetasol 0.05% + Salicylic acid 6% Ointment (additional Strength) For the treatment of plaque psoriasis
14.05.08
131
14.05.08
132
Benzoyl Peroxide Medicated Solution (each textured pad contains 4.5%/6.5%/8.5% of solution
Same as Approved
14.05.08
Sodium Chondroitin sulfate 40mg + sodium 134 Hyaluronate 30mg per ml Intraocular Injection (additional strength)
For use as a surgical aid in anterior segments procedure including 14.05.08 catract extraction & intra-ocular lens implantation
For the treatment of GERD, gastric and Esomeprazole (with Sodium bicarbonate as buffer) 135 duodenal ulcer, 20mg/40mg tablets Zollinger-Ellison syndrome Telmisartan 40 mg + Atorvastatin (as calcium) 10 136 mg Tablets Milnacipran Hcl. 25mg/50mg equivalent to Milnacipran free base 21.77 or 43.55 mg. tablet.
14.05.08
For coexisting essential hypertension & 22.05.08 hyperlipidemia For the treatment of adult patients with major 22.05.08 depressive disorder For hypertension in patients whose blood pressure is not 28.05.08 adequately controlled in monotherapy For essential hypertension in adult patients whose blood 28.05.08 pressure is not adequately controlled on monotherapy For the treatment of secondary hyperthyroidism in patients with chronic kidney disease on dialysis For the treatment of adult patients with chronic obstructive pulmonary disease and bronchial asthma For the treatment of gastric ulcer and management of gastric mucosal lesions (erosion, hemorrhage, redness or edema) associated with acute gastritis or acute
137
138
140
29.05.08
29.05.08
02.06.08
exacerbation of chronic gastritis For the relief of pain and inflammation in patients 02.06.08 with rheumatoid arthritis and osteoarthritis For the treatment of adult patients with signs 02.06.08 & symptoms of acute painful conditions
Sodium Hyaluronate injectable gel (each 0.6ml. 1ml For intradermal 145 pre filled syringe contains, sodium Hyaluronate implantation and facial 03.06.08 20mg/ml, 22.5mg/ml soft tissue augmentation For invasive fungal infection in patients who are refractory to or 03.06.08 intolerant of conventional amphotericin B therapy For the treatment of Gastroeasophageal Reflux Disease (GERD) 09.06.08 in patients not responding to dexrabeprazole alone For acute low back pain & other musculoskeletal painful and 11.06.08 inflammatory condition in adults For the treatment of lower respiratory tract infection in children Same as Approved 24.06.08
146
147
148
149
Cefotaxime sodium + Sulbactam sodium for injection (Additional Indication) Artemether 40mg/80mg + Lumefantrine 240mg/480mg tablets (additional Strength)
150
24.06.08
151
Mecobalamin 0.5mg+ Alpha Lipoic Acid 100mg+ Benfotiamin100mg + Pyridoxine 50mg tablets
03.07.08
For the treatment of chronic stable anginapectoris in patients with normal 03.07.08 sinus rhythm who have a contraindication or intolerance for Betablockers
Methylcobalamin 1500mcg + Alpha Lipoic Acid 153 200mg + Benfotiamine 50mg + Vit B6 3mg + Biotin 5mg + Folic Acid 1.5mg capsule
04.07.08
154
Indicated to meet daily requirement of nitrogen (amino acids), energy 08.07.08 (glucose) for patients needing parentral Nutrition 08.07.08
155 Temoporfin 1mg/ml Injection (Additional Strength) Same as Approved Pazufloxacin Mesylate i.v. infusion 300mg/100ml 156 & 500mg/100ml Metoprolol ER + Amlodipine tablets (Additional 157 Indication) Fenofovir Disoproxil fumarate 300mg + Lamivudine 300mg + Efavirenz 600mg tablets
For the treatment of RTI, UTI and abdominal 09.07.08 infections in adults For coronary artery disease/ischaemic lheartt 16.07.08 disease 18.07.08 For the treatment of type_II diabetes mellitus when single drug therapy alongwith diet, 21.07.08 exercise do not result in adequate glycemic control For Testosterone replacement therapy of male hypogonadism when testosterone dificiency has been confirmed by clinical feature or biochemical tests
158
159
22.07.08
For adult patients with severe active rheumatoid arthritis who had an inadequate response to 22.07.08 one more DMARDs such as methotixate or TNF antagonists For the treatment of rheumatoid arthritis patients 22.07.08
163
Tenofovir Fumarate 300mg + Lamivudine 300mg + For the treatment of HIV 23.07.08 Efavirenz 600mg Tablets infection in adults Bacillus Clausii Spores (2 Billion) Capsules (additional dosage form) Gatifloxacin 0.3% + Ketorolac Tramthamine 0.4% eye Drop
164
Same as Approved
23.07.08
165
For reduction of part operative inflammatory 24.07.08 condition of eyes For the reduction of post operative inflammatory 24.07.08 conditions of the eye
Ketorolac Tromethamine 4mg + Gatifloxacin 3mg 166 Eye Drops Cefadroxyl (as monohydrate) 125mg + Clavulanic 167 acid (as potassium) 31.25 per 5ml Syrup (Additional strength)
Same as Approved
25.07.08
For the treatment of secondary Doxercalciferol (0.5/ 2.5mcg) Soft Gelatin Capsule hyperparathyroidism in 168 (Additional Indication) patients with stage 3 or stage 4 chronic kidney disease Artemether + Lumefantrine Dispersible tablet (40/80mg + 240/480mg ) (Additional Strength)
05.08.08
169
Same as approved
05.08.08
170
Same as approved
05.08.08
For the relief of the symptoms of seasonal allergic rhinitis in 05.08.08 patients 12 years of age and older
For the symptomatic treatment of pain and inflammation condition 14.08.08 in patients with osteoarthritis For the treatment of mild to moderate pain, reduction of fever 14.08.08
For the treatment of postoperative inflammation & reduction of 14.08.08 postoperative ocular pain in patients who have undergone cataract extraction for the treatment of acute bacterial otitis media, skin & soft structure infections, UTI, uncomplicated gonorrhoea, pelvic inflammatory disease, bacterial septicemia, bone and joint infections, intra abdominal infections, meningitis, surgical prophylaxis
175
18.08.08
For the treatment of disturbance of consciousness as resulting from head 18.08.08 injuries , brain operation and acute stage of cerebral infraction in adult only 18.08.08
177
Ambroxol + loratadine + Guaifenesin Syrup (30mg For the treatment of + 5mg + 50mg per 5ml) productive cough Ferrous Ascorbate + Folic Acid + Zinc FC Tablets (100mg + 1.5 mg + 22.5 mg) Cyclobenzaprine 7.5mg tablets (Additional Strength)
178
For the treatment of iron 18.08.08 deficiency anaemia Same as approved 18.08.08
179
For the treatment of haemo-dynamically stably patients with S-Metoprolol Succinate Oral Solution (Each Ml definite or suspected 180 contains: S-Metoprolol Succinate 9.5mg equal to Sacute Myocardial Metoprolol Tartrate 10mg) Infarction to reduce cardio-vascular mortality.
19.08.08
181
In combination with bortezumab for the treatment of progressive multiple myeloma in patients who have 23.08.08 received at least one prior therapy and who have already undergone or are unsuitable for bone marrow transplant As mouthwash for oral hygeine in various oropharyngeal conditions, surgery, dental infections, and halitosis
Povidone Iodine Sachet (containing Effervescent 182 Granules) Each 2gm Sachet contains: 175mg (available iodine 17.5mg)
25.08.08
Sodium Chondroitin Sulphate + Sodium 183 Hyaluronate injection (40mg + not more than 17mg Same as approved per ml)
25.08.08
For the treatment of oedema associated with Metolazone + Spironolactone FC Tablets (2.5/5mg 184 congestive heart failure, 25.08.08 + 50mg) cirrhosis and nephritic syndrome 185 Tretinoin Microsphere Gel (0.1% W/V) 186 Misoprostol 50Mcg tablet (Additional Strength) For topical treatment of 26.08.08 acne vulgaris Same as approved 26.08.08
Ferrous Ascorbate + Folic Acid Suspension (Equiv. 187 to elemental iron 30mg + 550mcg per 5ml) (New Same as approved Dosage Form)
27.08.08
As approved
02.09.08
For the treatment of 190 Capecitabine 150/500mg Tablets (addl. Indication) patients with metastatic 02.09.08 colorectal cancer Lopinavir + Ritonavir (100 + 25mg) Tablets 191 (additional strength) For the treatment of patients with HIV infection 08.09.08
in combination with capecitabine for the treatment of patients with metastatic or locally advanced breast cancer resistant to Ixabepilone lyophilized powder inj. 15mg/45mg per 192 treatment with an 13.09.08 vial anthracycline and a taxane, or whose cancer is taxane resistant and for whom further anthracycline therapy is contraindicated. For the relief of inflammatory and pruritic manifestation of 13.09.08 non-infected corticosteroid responsive dermatoses like eczema For the treatment of milk fever, hypocalcaemia tetanies 13.09.08 and disorders of calcium metabolism in dairy cattle. for the treatment of essential hypertension 15.09.08
194
195
196
For the treatment of adult patients with 15.09.08 muscular pain associated with spasm For the treatment of mild to moderate hypertension in adult 15.09.08 patients whose blood pressure is not adequately controlled by
197
monotherapy
198
Olmesartan + Ramipril (40mg + 5mg) tablets (Additional Strength) Fluconazole + Zinc Pyrethrone (Each 30/60ml bottle contains: 2% + 1%) Lotion
for the treatment of essential hypertension For the treatment of seborrhoeic dermatitis
15.09.08
199
15.09.08
For the treatment of patients with serious cerebral injuries of vascular traumatic nature with or without loss of consciousness & 16.09.08 for treatment of degenerative damages & chronic cerebral vascular injuries in senile dementia. 1. For the treatment of Prophylaxis & chronic treatment of Asthma in Pediatrics patients 12 months of age & older. 2. For relieving symptoms of seasonal 16.09.08 allergic rhinitis in Pediatric patients 2 years of age & older & perennial allergic rhinitis in Pediatric Patients 6 months of age & older. For the treatment of pain, swelling & 16.09.08 inflammatory conditions due to arthritis. As already approved 16.09.08
203
For the treatment of depression and schizophrenia in adults 26.09.08 when oral therapy is not possible
26.09.08
206
Ceftiofur Crystalline free acid Suspension equi to Ceftiofur ---- 200 mg(veterinary)
For treatment of bovine respiratory disease (BRD, Shipping fever, pneumonia) associated with Mannhenia haemolytica, Pasteurella 26.09.08 multocida, andHistophilus somni in beef, non-lactating dairy, and lactating dairy cattle For treatment of sub clinical mastitis in dairy cattle at the time of dry off asssociated with 26.09.08 staphylococcus aureus, Streptococcus dysgalactiae, and Streptococcus uberis. For treatment of clinical mastitis in lactating dairy cattle asssociated with coagulase- negative 26.09.08 staphylococci, Streptococcus dysgalactiae, and Escherichia coli. For the treatment of acute uncomplicated urinary tract infections (acute cystitis) caused 26.09.08 by susceptible strains of Escherichia coli or Staphylococcus saprophyticus For the relief of painful muscle spasms of the skeletal musculature 26.09.08
207
208
For the short term use in acute painful and 30.09.08 inflammatory condition For the treatment of disturbance of 30.09.08 consciousness resulting
from head injuries, brain operation & acute stage of cerebral infraction in adult. Indicated for the treatment of mastitis, metritis, pneumonia, pleuritis, fever and 30.09.08 relieving of acute pain in musculoskeletal disorders in animals For the treatment of calcium and Vitamin D deficiency states (pregnancy, lactation, growing Children) for the treatment of chloroquine resistant/multidrug resitant on complicated malaria
Calcium (as Calcium Citrate Malate) + 214 Colecalciferol (as Colecalciferol Concentrate) + Folic Acid (250mg + 100IU + 50mcg) Tablets
30.09.08
215
30.09.08
For the treatment of hyperprolactinemia and 01.10.08 inhibition of lactation. In combination with cisplatin is indicated for the first line treatment of patients with locally advanced or metastatic 08.10.08 non-small cell lung cancer other than predominantly squamous cell histology For the prevention and treatment of mycoplasma induced chronic respiratory disease in broilers and breeders, the prevention and treatment of 08.10.08 diseases due to clostridium perfringens (necrotic enteritis, wet litter, cholangiohepatitis), the prevention and treatment of ornithobacterium
217
218
rhinotacheale (ORT)
Treatment of patients with multiple myeloma For the treatment of vulvo-vaginal candidiasis in women
09.10.08
09.10.08
For the treatment of uncomplicated urinary tract infections (acute cystitis) in women due 09.10.08 to susceptible strains of E.Coli and Entreococcus faecalis As monotherapy for the treatment of metastatic or locally advanced breast cancer in patients whose tumors are resistant or refractory to 09.10.08 cytotoxic chemotherapy. Previous therapy should have included as anthracycline, a taxane, and capecitabine For the treatment of essential hypertension 11.10.08
222
223 Eprosartan Mesylate 400 mg / 600mg Tablets 224 Tretinoine Gel as Micro Sphere 0.04% % 0.1% Hydroxychloroquine Sulphate (Additional indication )
For topical treatment of 14.10.08 Acne vulgaris. For the treatment of systemic lupus erythematosus 17.10.08
225
226
Indicated in the regular treatment of patients with moderate to severe 17.10.08 COPD with frequent symptoms and a history of exacerbations
For post operative Azithromycin + Dexamethasone (10mg + 1mg) Eye steroid responsive 227 21.10.08 Drops inflammatory ocular condition when bacterial
ocular infections or a risk of bacterial ocular infections exists. For the treatment of acute inflammation Diclofenac + Thiocolchicoside (50mg (EC) + 8mg) 228 conditions associated Capsules with spasm in adults only 229 Adapalene 0.1% + Benzoyl Peroxide 2.5% gel For the treatment of acne vulgaris For the treatment of acute musculoskeletal pain in patients For the treatment of patients with serious cerebral injuries of vascular traumatic nature with or without loss of consciousness and for treatment of degenerative damages and chronic cerebral vascular injuries in senile dementia.
21.10.08
24.10.08
24.10.08
31.10.08
For acute and chronic schizophrenic disorders, in which positive symptoms and or negative symptoms are 03.11.08 prominent, including patients characterised by predominant negative symptoms. For the treatment of hypocalcaemia and/or osteoporosis For the treatment of patients with HIV infection 04.11.08
233
04.11.08
For the treatment of elevated intraocular pressure in patients with 08.11.08 ocular hypertension or open angle glaucoma.
1) As an adjunctive therapy to diet for the treatment of adult patients with hypertriglyceridemia. 2)As an adjunctive Rosuvastatin Calcium tablets 5/10/20/40mg (Addl. 236 therapy to diet to slow 08.11.08 Indication) the progression of atherosclerosis in adult patients as part of a treatment strategy to lower Total-C and LDLC to target levels. For the treatment of 237 Paclitaxel inj.30/100/300mg vial (Addl. Indication) advanced gastric carcinoma 238 Montelucast + Desloratidine(10mg + 5mg) FC Tablets Amlodipine + Metoprolol (2.5/5 mg + 25/50mg (ER))Tablets 08.11.08
For the treatment of allergic rhinitis in adults 10.11.08 only Additional Lower Strength Additional Strength For the treatment of lumbago, integumental pain, musculoskeletal pain 10.11.08 10.11.08
239
14.11.08
For scaling of seborrhea, seborrheic dermatitis, 17.11.08 psoriasis of scalp For the treatment of psoriasis and fungal skin 17.11.08 infection For the acute treatment of inflammatory musculoskeletal disorders associated with painful muscle spasm in adults. Additional Lower Strength
Salicylic Acid + Coal Tar + Precipitated Sulphur 243 (3% + 1% + 3%) Ointment
244
17.11.08
245
17.11.08
Calcium Hypochlorite 4gm Sachet (Calcium 246 Hypochlorite 0.542% Other Ingredients: 99.458%)
23.11.08
24.11.08
For the treatment and management of patients with community Amoxycillin + Clavulanic acid(1gm + 62.5mg ) FC 248 acquired pneumonia or 25.11.08 Tablets acute bacterial sinusitis due to beta lactamase producing pathogens 249 Buprenorphine + Naloxone (2 mg/0.4mg + 0.5/0.1 mg) Tablets Additional Lower Strength 02.12.08
As adjunctive therapy to diet and exercise in 04.12.08 patients with diabetic dyslipidemia As monotherapy for the second-line treatment of patients with locally advanced or metastatic 04.12.08 non-small cell lung cancer other than predominantly squamous cell histology For the treatment of generalized or partial seizures as monotherapy or adjunctive therapy. For the treatment of 04.12.08 maniac episodes associated with bipolar disorders. For prophylaxis of migraine headache in adults. For the dissolution of Radiolucent collestral goll stone, chronic cholestatic liver disease 08.12.08 in particular primary biliary cirrhosis, primary sclerosing cholangitis & cholestasis associated
251
253
254
For the treatment of adult patients with 11.12.08 pulmonary tuberculosis For the treatment of adult patients with 11.12.08 pulmonary tuberculosis 12.12.08
256
Amphotericin B Lipid suspension 50mg/ vial (Addl. Additional Strength Strength) For the treatment of cranial diabetes insipidus , primary noctumal enuresis in patients.
12.12.08
Mifepristone + Misoprostol (1 tab of mifepristone 258 200mg and 4 tab of misoprostol 200mcg) Combipack
For the medical termination of intrauterine pregnancy (MTP) of up to 63 days 16.12.08 gestation based on the first day of the last menstrual period For the treatment of bipolar I disorder. (addl. 17.12.08 Indication) For the treatment of different Gastro intestinal problems like functional dyspepsia, nausea, vomiting & diabetic gastroparesis. For the treatment of schizophrenia and depression in adults.
260
17.12.08
As an adjunct to rest and physical therapy for relief of muscle spasm 17.12.08 associated with acute, painful, musculoskeletal conditions.
262
In combination with cisplatin and 5fluorouracil is indicated for the induction treatment of patients 17.12.08 with locally advanced squamous cell carcinoma of the head and neck. For the treatment of scaly dermatoses Additional Strength 18.12.08 19.12.08
263
Salicylic Acid + Cetyl Alcohol + Stearyl Alcohol (2% + 2.65% + 0.26%) Lotion
For short term treatment of moderate pain, especially following surgery and for the short 23.12.08 term treatment of fever, when administration by i.v route is clinically justified
Indicated for the treatment of lower Gemifloxacin + Ambroxol (320mg + 75mg SR) FC 266 respiratory tract Tablets infections in adult patients
24.12.08
267
1. For LRTI infections, 2. for UTI - Complicated and uncomplicated, 3. for bacterial septicemia, 4. for bone and joint infections, 5. for gynaecologic infections 24.12.08 including endometritis, pelvic cellutitis, and other infections of female genital tract, 6. for CNS infections including meningitis
For the treatment of Paracetamol + Phenylephrine Hydrochloride (Each fever associated with 268 24.12.08 6gm Sachet contains: 500mg + 10mg) Sachet cold, nasal congestion in adults
Carboinoxamine Maleate + Ammonium Chloride + For symptomatic 269 Sodium Citrate (Each 5 ml contains: 2 mg + 120 mg treatment of cough + 120 mg) syrup Diclofenac + Thiocolchicoside (50 mg + 4 mg) Capsules Additional Lower Strength
24.12.08
270
24.12.08
6 7 8 9 10 11 12 13
FluvAstatin Tablet (As calcium) 10mg/20mg/40mg (additional As approved strength) Halobetazol Propionate Cream (0.05%) Eszopiclone tablet (1mg/2mg/3mg) Diltiazem Hcl. 2% gel Nalbuphine injection 10mg/20mg per ml. Levonorgestrel 1.5mg tablets Pantaprazole sodium 20mg/40mg Tablet (with sodium bicarbonate As buffer) Corticosteroid responsive dermatomes For insomnia For anal fissure For moderate to severe pain For emergency contraceptive For gAstric ulcer, duodenal ulcer, Z. E Syndrome, GERD
levofloxacin (250mg/500mg) + For lower respiratory tract ambroxol SR 75mg tablet infection in adult
14
For testosterone deficiency (i) Testosterone cypionate primary hypogonadism (ii) (100mg/200mg) + Cotton seed 08.02.07 Hypogonadotropine oil 736/566mg per ml injection hypogonadism Rosiglitazone 1mg + Metofmin Hcl 500mg tablet (additional As approved strength) Loteprednol Etabonate 5mg + Tobramycine 3mg per ml ophthalmic solution 08.02.07
15
16
17
Amlodipine (As besylate) 5mg + Metoprolol (As succinate) ER As approved 25mg (additional strength) Glibeneclamide 5mg + MetFormin SR 850mg tablet (additional strength) Aceclofenac injection (150mg/3ml) As approved
18
15.02.07
19
For short term treatment of pain due to post operative and 19.02.07 post traumatic cAses 20.02.07
20
Metoprolol (As succinate) 50mg/25mg ER) + Amlodipine Angina pectoris in adults 5mg/2.5mg tablet (For additional indication) Ramipril 10mg + HCTZ 12.5mg tablet (additional strength) Amlodipine (As besylate) 5mg/5mg/10mg + valsartan 80mg/160mg/160mg tablet Glatiramer Acetate injection (20mg/ml) Baclofen ER (GRS) Capsule 45mg/60mg (additional strength) Amlodipine (As besylate )5mg/10mg + Perindopril 4mg tablet Olopatadine Hcl. Tablet 2.5mg/5mg Metoprolol (As succinate) ER 25mg/50mg + Ramipril 2.5mg/5mg Rabeprazole Sodium 20mg/10mg with sodium As approved
21
20.02.07
22 23 24
25
For hypertension Allergic nAsal inflammation hives, itching with skin diseAses Essential hypertension For Duodenal ulcer, G.U, Z.E.S. & GERD
23.02.07
26
26.02.07
27 28
26.02.07 26.02.07
bicarbonate As buffer Ciclesonide 160mcg/320mcg + Formoterol Fumarate (12mcg) As approved (Dry powder inhaler additional strength) Moxonidine tablet 0.2mg/0.3mg/0.4mg For hypertension
29
27.02.07
30
27.02.07
31
Ceftriaxone (As sodium) 125mg/250mg + Sulbactam (As As approved sodium) 62.5mg/125mg For injection (additional strength) Quetiapine (As fumarate) SR 400mg tablet (additional strength) Cabergoline 1mg tablet (additional strength) Levofloxacin Oral Solution (each 240ml bottle contains Levofloxacin 125mg/5ml.) As approved For Hyperprolactinemia
01.03.07
32 33 34 35 36
05.03.07 06.03.07
Clindamycin 1% + Isotretinoin For acne 0.05% gel Estradiol topical emulsion 2.5mg/gm Vasomotor symptoms Associated with menopause
37
Levosalbutamol MDI (50mcg/actuation) & Dry Powder inhaler As approved (100mcg/capsule) (New Dosage Form) Polonosetron (As Hcl.) For Injection 0.25mg/5ml Cifixime 200mg + Erdosteine 300mg Capsules Etoricoxib 10mg + Methyl salicylate 20mg per gm. of cream Eberconazole cream (1%) ISMN 60mg Sr + Atenolol 50mg/100mg Levonorgestrel 0.03mg tablet
16.03.07
38 39 40 41
Chemotherapy induced nausea 20.03.07 & Vomiting Acute Exacerbation of chronic 21.03.07 bronchitis 21.03.07 21.03.07
42 43 44
Dermatophyte infection of skin such As T-corporis, T-c, T22.03.07 Pedis For angina pectoris For control of fertility 23.03.07 23.03.07
45 46
Bortezomib 2mg/vial (additional pack size) Comb kit of two capsule of Azaranari 150mg each + 1 tablet of Ritonavir 100mg)
28.03.07 02.04.07
47 48 49 50
Mecobalamine 500mcg + Alpha Lipoic acid 100mg soft gelatin For diabetic neuropathy capsule Propofol 10mg + Lignocaem 1mg per ml injection Ezetimibe 10mg + Fenofibrate 160mg tablet For induction of anesthesia For combined hypertipidemia
Atopic dermatitis (eczema) Methylprednisolone Acrponate inflammatory and allergic skin 04.04.07 topical solution 0.1% reaction Citicoline (750mg) tablet (additional strength), syrup As approved 500mg/5ml (new dosage Form) (not For children) Ertapenem For injection (1gm/vial) Letrozole 2.5mg tablet (for additional indication) Quetiapine SR Tablets 50mg ( additional strength) Metoprolol (As succinate) 25mg + Amlodipine (As besylate) 5mg (additional strength) Sunitinib Maleate Capsules 12.5mg/25mg/50mg Comb pack of 1 bottle of ciprofloxacin Injection (200mg/100ml) & 1 bottle of Ornidazole injection 500mg/100ml) Aprepitant 40mg capsules (additional strength) Olopatadime Ophthalmic solution (0.2%) (additional Strength) Antibiotic For induction of ovulation in anovulatory infertility ( additional indication) As approved 10.04.07
51
52 53 54
55
As approved
10.04.07
56
57
Antibiotic
20.04.07
58
Prevention of post-operative nausea & vomiting (additional 24.04.07 indication) As approved 24.04.07
59
60
Combi pack of 1 tablet of Residronate sodium (35mg) + 6 For osteoporosis in tablet of calcium carbonate postmenopausal women equivalent to 500mg calcium each Levocetirizem 2Hcl. Dispersible tablet (2.5mg)
01.05.07
61 62 63 64
Amlodipine (As besylate) 10mg + Perindopril 8mg tablets As approved (additional strength) Etodolac ER tablets 400mg/500mg Levosulpiride tablet (25mg) For osteoarthritis & rheumatoid arthritis
For G.I. problem like fanatical dyspepsia, nausea, vomiting 10.05.07 and diabetic gAstroperisis For Obese Patients BMI 30kg/m2 or overweight patients BMI 27kg/m2 with 11.05.07 Associated risk factors such As type-I diabetes or dyslipidemia For constipation For essential hypertension For apthous ulcers in people with normal immune system 14.05.07 16.05.07 16.05.07
65
66 67 68
Lactitol monohydrate Syrup 66.67/100ml S(-) Metoprolol (As succinate) 25mg + S(-) Amlodipine (As besylate 2.5/5mg Amlexanox Oral PAste (5%)
69
Lenalidomide capsule (5mg/10mg/15mg/25mg) Cefotaxim (As sodium) 0.5mg/1gm + Sulbactam (As sodium) 250mg/500mg injection (for additional indication) Lornoxicam tablet 4mg/ 8mg Atenolol 25mg/50mg + Indapamide SR 1.5mg
For transfusion dependent anemia due to myalodysplastic syndrom Associated with 16.05.07 deletion 5q cytogenic abnormality For surgical prophylaxis (additional indication)
70
18.05.07
71 72
73
As adjunctive therapy in Livetiracetam conc. for partial onset seizures in adults infusion 100mg/ml (new dosage 21.05.07 with epilepsy when oral form) administration is temporarily
not feasible
74
Eplerstat tablet 50mg Citicoline tablet 200mg (additional strength) Varenicline (As tartrate) 0.5mg/1mg tablets Azithromycin eye drops 1% Ciclesonide Nasal Spray 50mcg/spray Ceftazidime 500mg/1000mg + Sulbactam (As Sodium) 250mg/500mg For injection Isotretinoin 0.05% + Erythromycin 2% gel Glimepiride 1mg/2mg. + Metformin SR 1000mg tablet (additional strength)
For abnormality of vibration sense and abnormal change in 25.05.07 heart rate associated with diabetic peripheral neuropathy As approved 25.05.07
75 76 77 78
As an aid to smoking cessation 29.05.07 treatment in adults Conjunctivitis For seasonal & perennial allergic rhinitis in adults, adolescents aged 12 years Antibiotic For acne 06.06.07 08.06.07
79 80 81 82
83 84 85
Cefditorene pivoxil dispersible tablet (30mg/50mg) (New As approved Dosage form for children) Dexrabeprazole sodium Enteric For Duodenal ulcer, Gastric Coated tablet 5mg/10mg ulcer & GERD Renolazine Extend ReleAse tablet (500mg) For Chronic Angina
86
For control of generalized toniclonic and treatment & Phenytoin sodium ER capsules prevention of seizures 14.06.07 (300mg) (New dosage form) occurring during or following neurosurgery Alfuzocin Hcl. ER (10mg) + Dutasteride 0.5mg tablet Cefepime injection 500mg/1gm/2gm (For additional indication) Tranexamic acid mouthwash (50mg/ml) For BPH in men with enlarged 14.06.07 prostate For bacterial meningitis in children For prevention of oral hemorrhage in anticoagulant treated patients undergoing 14.06.07
87 88
89
15.06.07
oral surgery
90 91
Deflazocort oral suspension As approved (6mg/5ml) (new Dosage Form) Tolterodine tartrate ER 4mg + Tamsulocin Hcl. ER 0.4mg tablet Omeprazole 20mg/40mg + Sodium Bicarbonate 1100mg capsules Dexrabeprazole Sodium E. coated tablet 5mg/10mg. Cefepime Injection (New indication) For BPH with overactive bladder For duodenal ulcer, gastric ulcer & GERD For duodenal ulcer, gastric ulcer and GERD. For bacterial meningitis in children.
15.06.07 15.06.07
92 93 94
95
For control of generalised tonic-clonic (grand-mal) and Phenytoin Sodium E.R (300mg) prevention and treatment of seizures occuring during or following neurosurgery. Tranexamic acid Mouth Wash (50mg/ml) For prevention of oral hemorrhage in anticoagulant treated patients undergoing oral surgery. For asthma, rheumatoid arthritis when glucocorticosteriod therapy is warranted. For BPH with overaction bladder in Adults only.
14-6-2007.
96
15.6.2007.
97
Deflazacort Oral Suspension (6mg/5ml) (New dosage form) Tolterodine Tartrate 4mg (ER) + Tamsulosin HCL 0.4mg Capsule.
15-06-2007.
98
15-06-2007.
Omeprazole (E.coated) 40mg + For gastric ulcer, duodenal Sodium Bicarbonate 1100mg ulcer and GERD. capsule. Mebeverine HCl prolonged release capsule (200mg). Cilnidipine Tabs. 5mg, 10mg Azithromycin 500mg + Ambroxol S.R (75mg) Tablet. For irritable bowel syndrome For the treatment of mild to moderate hypertension
103
For symptomatic relief of dry ticklish and unproductive coughs in children above 1 years.
06-07-2007.
104
For adjunctive therapy to improve glycemic control in patients with Type-II diabetes mellitus, who have not 06-07-2007. achieved adequate glycemic control with Metformin, a sulfonyl urea or a combination of metformin and sulfonylurea.
105
Moxifloxacin HCL (0.5%) + For reduction of post-operative Ketorolac Tromethamine 0.5% inflammatory conditions of the 11-07-2007. Ophthalmic Solution. eyes. For post-operative steriod Levofloxacin (15mg) + responsive inflammatory Prednisolone Acetate 10mg per ocular conditions when ocular 11-07-2007. ml eye drops. bacterial infections or a risk of bacterial infection exists. Mecobalamine 500/1500mcg + Alpha Lipoic Acid 100mg + Inositol 100mg + Folic Acid For Vitamins and Mineral 0.5/1.5mg + Chromium deficiency states in adult Polynicotinate 65mcg/200mcg+ patients Selenium Dioxide18/55mcg + Benfotiamine 50/150mg capsule
106
107
39275
108
For post-operative steriod responsive inflammatory Loteprednol Etabonate (0.5%) + ocular conditions when ocular 12-07-2007. Levofloxacin (1.5%) Eye drops. bacterial infections or a risk of bacterial infection exists.
109
Clotrimazole (10mg) + MethylFor fungal infection of skin prednisolone aceponate 12-7-2007. associated with inflammation. 1mg/gm of cream.
110
(i). First line treatment of advanced gastric cancer in combination with platinum Capecitabin Tablet based regimen.(ii). Treatment (150mg/500mg). (for additional of patients with locally indication). advanced or metastatic breast cancer in combination with docetaxel following failure of cytotoxic chemotherapy.
16-07-2007.
111
For treatment of pulmonary T.B only in patients coinfected with HIV. (It should 16-07-2007. never be used as a substitute to Rifampicin in T.B patients without HIV co-infection). In combination with capecitabine it is indicated in patients with advanced or metastatic breast cancer whose 24-07-2007. tumour overexpress HER2 and who have received prior therapy including trastuzumab. For the treatment of allergic rhinitis and chronic urticaria.
112
113
25-07-2007.
114
For improvement of neurologic symptoms, disorders of activitis of daily Idaravone Injection (1.5mg/ml). 26-07-2007. living and functional disorder associated with acute ischemic stroke. Diclofenac Sodium (75mg/ml) Injection (addl. Strength). Cefpodoxime (as Proxetil) (100mg/200mg) + Clavulanic acid (62.5/125mg) tablet. For management of painful conditions in post-operative 30-07-2007. cases, rheumatoid arthritis and osteoarthritis. For LRTI, URTI and UTI. 30-07-2007.
115
116
117
Atorvastatin (40mg) + Ezetimibe (10mg) Tablet (addl. As approved. Strength). Cefepime (250mg) + Tazobactam (31.25mg) Injection (addl. Strength). As approved.
30-07-2007.
118
30-07-2007.
119
VSL # 3 (Probiotic Blend) sachet Sorafenib (as Tosylate) (200mg) Tablet. Methylcobalamin (500mcg) + Alpha Lipoic Acid (100mg) + Pyridoxine (3mg) + Folic acid (1.5mg) Soft Gelatin Capsule.
31-07-2007.
120
31-07-2007.
121
31-07-2007.
122
Halobetasol Propionate (0.5mg) + Salicylic Acid 30mg per gm For plaque psoriasis. of ointment. Combipack of 12 tablet of Artesunate (50mg) each + 3 tablet of each containing Sulfadoxine (500mg) + Pyrmethamine (25mg) Tablet. (Addl. Strength) Omeprazole (20mg/40mg)+Sod. Bicarbonate-600mg+ Mg.Hydroxide-700mg .chew tab. Deferasirox dispersible tablet (400mg) (addl. Strength). Tegafur (100mg) + Uracil (224mg) capsule.
01-08-2007.
123
As Approved
01-08-2007.
124
1/8/2007
125
As approved
17-08-2007.
126
For first line treatment of metastatic colorectal cancer in 22-08-2007. combination with calcium folinate. For the treatment of patients with mantle cell lymphoma 05-09-2007. who have received at least one prior therapy. 06-09-2007.
127
128
Amlodipine (5mg) + Nebivolol As approved. (5mg) tablet (addl. Strength). Ceftazidine (2gm) + Sulbactam For serious abdominal (1gm) Injection ( addl. strength infection. for additional indication). Polyethylin Glycol 400 (0.4%) + Propylene Glycol (0.3%).
129
06-09-2007.
130
For temprory relief of dryness, irritation burning, stinging, 18-9-2007. grittiness or foreign body
sensation caused due to environmental factors. Resperidone E.R. (long-acting) injection (12.5mg/vial) (addl. As approved. strength). Levocetirizine Di-HCl syrup (2.5mg/5ml) (for use in children As approved. 2 years and above).
131
25-09-2007.
132
26-09-2007.
133
As an adjunctive therapy for the management of obesity including weight loss and 26-09-2007. maintenance of weight loss in pateints whose BMI is 30Kg/m2 or higher. For adult patients with infection caused susceptible micro-organisms including S.aureus viz UTI, upper and lower RTI and gonoccoccal urethritis. For diagnostic use in echocardiography doppler of macrovasculature an doppler of microvasculature.
134
27-09-2007.
135
Sulphur Hexafluoride Powder and solvent for dispersion for injection (45mcg/ml).
28-09-2007.
136
Ondansetron orally For chemotherapy induced disintegrating tablet (4mg/8mg) nausea and vomiting (additional dosage form)
28-09-2007.
137
Cefuroxime Axetil (250mg) + For UTI, URTI and LRTI and 05-10-2007. Clavulanic acid (125mg) tablet. gonococcal urethritis. For adult patients with infection caused by susceptible microbs,including 5/10/2007 s.aureus.(e.gUTI,Upper&lower RTI & gonococcal urethrities) For cardiopulmonary resuscitation in the event of cardiac arrest related to 05-10-2007. ventricular fibrilation resistant to external electric shock.
138
Cefuroxime-125/250/500mg +Clav.Acid-31.25/62.5/125mg
139
140
08-10-2007.
141
Sucralfate (70mg ) + Metronidazole (10mg) + Povidone Iodine (50mg) per gram of Ointment.
09-10-2007.
142
(i) (i) As monotherapy in partial onset seizures with or without secondary generalisation in patients with 16 years of age with newly diagnosed epilepsy. (ii) As adjunctive therapy in myoclonic seizures in adults 09-10-2007. and adolescents from 12 years of age with Juvenile myoclonic epilepsy. In primary generalised tonic-clonic seizures in adults and adolescents from 12 years of age with idiopathic generalised epilepsy. 10-10-2007.
143
Combipack of two tablet of chloroquine phosphate (250mg) For drug resistant malaria. each + 14 tablet of Proguanil HCl (100mg) each Paclitaxel (protein bound particle) for injectable suspension (paclitaxel (100mg) + Albumin Human 900mg per 20ml.
144
For breast cancer after failure of combination chemotherapy for metastatic disease or 11-10-2007. relapse within 6 months of adjuvant chemotherapy. 15-10-2007.
145
Olmesartan Medoxomil (20mg) For mild to moderate + Amlodipine Besylate (5mg) hypertension. Tablet. For treatment of patients with Atorvastatin Calcium (10mg ) + both hypertension and Ramipril (2.5mg/5mg) tablet hypercholesterolemia.
146
15-10-2007.
147
As approved.
15-10-2007.
148
For inflammation after ocular Moxifloxacin HCl (5mg) + surgery and where a risk of Prednisolone Acetate (10mg)per bacterial ocular infection ml. (eye drops) exists. Methylcobalamine (500mcg) + Alpha Lipoic acid (100mg) + Pyridoxine HCl (1.5mg) + For diabetic neuropathy. Thiamine (2mg) + Calcium Picolinate (200mg) tablet. Satranidazole (300mg) + Ofloxacin (200mg) Tablet. For diarrhoea of mixed infection in adults.
16-10-2007.
149
16-10-2007.
150
18-10-2007.
151
Methylcobalamin 500mcg+beta carotine-10.33mg+alpha lipoic For adult patients with diabetic 18-10-2007. acid 100mg+B6 1.5mg+B1 2mg neuropathy. & Cr.polynicotinate. Calcium Pidolate equivalent to Calcium 500mg + Vit-D3 250 IU Etizolam Tablet (0.5mg/1mg). For osteoporosis and calcium deficiency state. 23-10-2007.
152 153
For anxiety disorder associated 29-10-2007. with depression. For relief of signs and symptoms of osteoarthritis, rheumatoid arthritis.
154
30-10-2007.
155
For acute uncomplicated lower urinary tract infection (simple cystitis), complicated lower 30-10-2007. UTI, acute exacerbation of chronic bronchitis. For management intermittent claudication. 30-10-2007. 30-10-2007.
156 157
Atorvastatin Calcium (10mg) + Fenofibrate (145mg) (addl. As Approved strength) Sitagliptin Tablet (25mg/50mg/100mg). Miglitol (50mg) + Metformin HCl SR (500mg) tablet.
158
As adjunct to diet and exercise to improve glycemic control in 30-10-2007. patients with type-II diabetes. For adult with Type-II diabetes mellitus where simple drug 31-10-2007. therapy, diet and exercise do
159
not result in adequate glycemic control. Mupirocin (2%) + Methylprednisolone Aceponate For atopic dermatitis. (0.1%) Cream. Methyl cobalamine 500mcg+folic acid1.5mg+B55mg,+Zn.sulphate For Vitamins and mineral 25mg+Cr.Polynicotinate deficiency states. 200mcg+selenium65mcg+inositol-1.5mg + alpha lipoic acid 100mg capsule Methylcobalamine 500mcg+folic acid1.5mg+ For diabetic neuropathy alpha lipoic acid 300mg +Benfothiamine-50mg. capsule Methyl prednisolone aceponate1mg + salicylic acid-50mg For treatment of psoriasis ointment Propanol 50gm+povidone iodine-1gm in 100ml solution Propanol-18 gm+Ethenol(100%)-45gm in 100ml solution Voglibose disp.tab.0.2mg/0.3mg Ceftriaxone 2gm+ Tazobactum 250mg for injection For surgical & hygenic hand disinfection. -doAs Approved As Approved
160
31-10-2007.
161
31.10.07
162
13.11.07
168
Methylprednisolone aceponate- For the treatment of atopic 1mg + Mupirocin-20mg. cream dermatitis Citicholine(as Sod.)200mg/500mg/750mg granules As Approved per sachet. Butarphenol tartrate 10mg/ml nasal spray For management of pain in patients using opioid analgesics.
21.11.07
169
26.11.07
170
26.11.07
171
As Approved
28.11.07
172
Methyl cobalamine 500mcg+folic acid1.5mg+B63mg,+Zn.sulphate 61.8mg+Ca.Pantothenate 10mg+ Niacinamide-50mg +chrimium-50mcg capsule Mecobalamin0.5mg + Pyridoxine 50mg + Benfotiamine100mg capsule
29.11.07
173
29.11.07
174
Methylcobalamine 500mcg+folic acid 1.5mg+ For diabetic neuropathy alpha lipoic acid 100mg +B63mg+Thiamine 10mg capsule Doxophylline400mg+Salbutamol(as sulphate)-2mg/4mg Tablets For treatment of Bronchial asthma in adults
29.11.07
175
29.11.07
176
For reduction of post-operative Gatifloxacin (as sequihydrate)inflammatory conditions of 3mg + Flurbiprofen sod.29.11.07 eye ,when bacterial infection 0.3mg/ml eye drops. exists. Sertanidazole-300mg+ Ofloxacin-200mg tablet Zoledronic acid 5mg/100ml solution for infusion (addl. indication). For treatment of diarrhoea of mixed infection in adults patients. 29.11.07
177
Olmesartan medoximil-20mg + For treatment of essential Ramipril-5mg. tablet hypertention. Levosulpiride Tablet (50mg/100mg) (addl. strength for addl. indication). Combipack of 12 Artesunate 50mg tablets & 6 Mefloquin250mg tablets Pregabalin-75mg/150mg +Methylcobalamine 500mcg cap Doxycycline-100mg +L.bacillus spores-5 billion For depression and schizophrenia in adults.
181
For drug resistant P.falciparum 12.6.07 malaria infection. For the treatment of adult patients with peripheral neuropathy. For adult patients prone to intrabdominal bacterial infection & Antibiotic associated diarrhoea 12.10.07
182
183
12.11.07
184
For the treatment of adult Cefprozil 250mg/500mg+Clav. patients with upper&lower Acid-62.5mg /125mg. tab RTI, Skin & Skin structure infection
12.11.07
185
For the temporary relief of cough due to throat irritation, sneezing & ruunning nose. For Short-term treatment of mild to moderate pain, when oral administration is inappropriate(i.e after dental surgery) For erectile dysfunction in adult men.
12.11.07
186
12.11.07
187
12.11.07
188
Escitlopram (as oxalate)10mg + For comobid depression and Clonazepam-0.5mg tablet (addl. anxiety disorder. Strength). Doxophylline injection-10mg /ml
12.12.07
189
For bronchial asthama & COPD in adult patients, when 31.12.07 oral therapy is in approriate.
For neovascular (wet) age related mac degeneration. For persistent Asthma For hypertension For bronchial asthma & COPD. For influenzae
20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60
Tenofovir Disoproxil Fumarate (300mg) + Emtricitabine (200mg) tablet Levetiracetam Oral Solution (100mg/ml). Atomoxetine 60mg capsule (Addl. Strength) Diclofenac Sodium (75/50mg) as (E.C) + Misoprostol 200mcg. Fluorescein Sodium Solution for Injection (100mg/ml) Cefditeron (as pivoxil) 200mg tablet Sodium Hyaluronate Cream 0.2% Saquinavir (500mg) tablet (addl. Strength) Eflornithine HCl Cream (139mg/gm) Propionyl-L-Carnitine HCl Tablet (500mg) & injection 300mg/vial Tobramycin Inhalation solution (300mg/5ml) Lactulose Enema (20%) Haloperidol Tablet (0.5mg) (addl. Lower strength) Cholestyramine Powder for oral suspension (4gm/sachet) Doxofylline Syrup (20mg/ml) Resperidone Tablet & Syrup (addl. Ind ) D-trans Fentantyl Transdermal patches Pantoprazole (as Sodium) (E.C) 40mg + Itopride (150mg) S.R Oseltamivir formulation (additional indication) Atazanavir (100/150/200mg) Nicorandil E.R Tablet (10mg/20mg) Amlodipine (as besylate) 5mg + HCTZ 12.5mg Tablet Nadifloxacin Gel 1% Formoterol Fumarate (6mcg) + Fluticasone Propionate (100/250/500mcg) dry powder inhaler Midazolam (as maleate) 7.5mg/15mg tablet Olmesartan (as Medoxomil) 10mg (addl. Strength) Pregabalin Capsule 25/50/100/200mg (addl. Strength) Oxcarbazepine S.R 450mg/900mg (addl. Strength). Ciclesonide rotacaps (200/400mcg) Itopride 150mg capsule (S.R) Nevibolol (as HCl) 5mg + Amlodipine (as besylate) 5mg/10mg Levocetrizine 5mg + Ambroxol Hydrochloride SR (75mg) tablet Ibandronic Acid Tablet (150mg) addl. Strength Zonisamide capsule 25/50mg (addl. Strength) Perflutren liquid microsphere injectable suspension Cyclosporin Eye drops (0.1%) (addl. Strength) Gatifloxacin (0.3%) + Prednisolone Acetate (1%) eye drops Amlodipine (as besylate) 5mg + Metoprolol Succinate equivalent to Metoprolol Tartrate 50mg. Nadifloxacin (1%) + Miconazole Nitrate (2%) + Mometasone Furoate (0.1%) Cream Bemiparin Sodium Solution for injection(5000/7500/10,000 I.U). Icodextrin 7.5% peritoneal dialysis solution
For HIV-1 infection Anti-epileptic For ADHD For OA & RA Ophthalmological diagnostic agent Anti-biotic For leg ulcer, diabetic ulcer etc. Anti-AIDS Chronic congestive heart failure
For chronic pulmonary infection cystic fib As approved earlier. For hypercholesterolaemia For bronchial asthma & COPD. For pain For GERD
For Prophylaxis of influenzae in adult an years of age Anti-HIV in adults. Angina Pectoris For hypertension Acne vulgaris For Asthma & COPD For insomnia Anti-hypertensive Same as approved. Anti-epileptic For Asthma For GERD For hypertension For production cough Same as approved. Same as approved. For diagnostic use For Ophthalmic use For Ophthalmic use For hypertension For dermatoses For deep vein thrombosis For peritoneal dialysis
61 62 63 64 65 66 67 68 69 70 71 72 73 74 75 76 77 78 79 80 81 82 83 84 85 86 87 88 89 90 91 92 93 94 95 96 97 98
Lamotrigin 200mg tablet (addl. Strength) dispersible tablet (5mg/50mg/100mg/200mg Amoxycillin 1000mg + Clavulanate Potassium 62.5mg E.R tablet Lopinavir 200mg + Ritonavir 50mg Tablet (addl. Strength) Olopatadine Ophthalmic solution( 0.1%) Ferrous ascorbate (equivalent to 50mg Iron) + Folic acid 1.5mg. Methyl Prednisolone Aceponate Cream (0.1%) Aspirin 150mg + Clopidogrel (as bisulphate) 300mg tablet (addl. Strength) Levofloxacin 0.5% Ear drops Olmesartan 40mg + HCTZ 25mg tablet (addl. Strength) Buclizine HCl tablet (25mg) & Syrup 6mg/5ml Ceftriaxone (as sodium) 250mg + Tazobactam 31.25 mg for injection (addl. Strength) Bimatoprost 300mg + Timolol (as maleate) 5mg/ml eye drops Mebeverine HCl 135mg + Isabgula husk 3.5gm sachet. Solifenacin Succinate Tablet (5mg/10mg). Zolpidem Tartrate E.R tablet (6.25mg/12.5mg). Deferasirox dispersible tablet 125/250/500mg. Lamivudine 40mg + Stavudine 10mg dispersible tablet. Levocetrizine 2.5/5mg + Ambroxol 30mg/5ml of syrup Cefixime 200mg + Pot. Clavulanate (125mg) tablet ISMN SR 30mg + Aspirin75/150mg tablet (addl. Strength). Clobestasol Propionate (0.05%) + Calcipotriol Ointment (0.005%) Ointment. Sodium Hyaluronate Injection (1%). Forskolin Eye drop (1%). Baclofen E.R capsule (30mg) Amisulpiride Tablet (50/100/200mg) Quetiapine S.R tablet 200/300mg. Lumiracoxib Tablet (100/200/400mg). Tenofovir Disoproxil Fumarate300mg + Emtricitabin 200mg + Efavirenz 600mg tablet
Anti-epileptic Anti-biotic Anti-HIV For allergic conjunctivitis For iron deficiency anemia For atopic dermatitis
As loading dose for prevention of in-sten PCI For otitis media Anti-hypertensive As appetite stimulant Anti-biotic For reduction of IOP
Irritable bowel syndrome For overactive bladder with urge urinary urgency & urinary frequency For insomnia
For chronic iron overload due to blood tr For HIV infection For productive cough Anti-biotic Same as approved For plaque psoriasis For OA For open angle glaucoma For spasticity For schizophrenic disorder For psychotic disorder
Vitamin C 500mcg + Zinc Citrate 2.2mg + Selenium 60mcg tablet. For vitamin C deficiency
For OA, RA acute pain & primary dysme For HIV-1 infection
Oxandrolone Tablet (2.5/10mg) To promote weight gain Erdosteine 150mg + Guaiphenesin 50mg + Terbutaline 1.25mg per 5ml syrup Mucolytic Rosiglitazone (as maleate)2mg + Glibenclamide 5mg + MetFormin 500mg tablet Anti Diabetic L- Lysine Hcl Ointment (150mg/gm) Levocitirizine 2 Hcl 5mg+ Ambroxol Hcl SR 75mg + Pseudoephedrine Hcl 120mg SR Capsules Alprazolam SR 0.25mg + Sertraline (As Hcl) 25mg/50mg tablet Dexibuprofen 200mg/300mg +Paracetamol 500mg tablet ISMN SR 60mg + Metoprolol Succinate ER 25/50mg Aspirin 75mg / 150mg + Glycine 37.5mg/75mg tablet For wounds of various etiology
For SAR, PAR & Chronic idiopathic urtic For RA, OA & ankolysing spondylosis
For angina & Hypertension For prevention of acute coronary syndro with CAD prophylaxis against stroke
99 100 101 102 103 104 105 106 107 108 109 110 111 112 113 114 115 116 117 118 119 120 121 122 123 124 125
Combipack of 21 tablet of Quinin sulphate 600mg each & 8 capsule of Doxycycline (as Hcl) 100mg each) Pravastatin 40mg tablet (Additional strength) Olanzapine powder For oral suspensian (10mg/5ml) Cefepem (as Hcl) 0.5/1gm + Amikacin (as sulphate) 0.125/0.250gm Inj. Lamivudine 20mg + Nevirapine 35mg + Stavudine 5mg tablet Nadifloxacin (10mg/gm) + Mometasone Furoate (1mg/gm) cream Premetrexed(Disodium) powder For solution For Inj. 500mg/vial Gliclazide 40mg/80mg + MetFormin Hcl 500mg + Rosiglitazone 2mg tablet Tiropramide Hcl (100mg) tablet Eperisone Hcl (50mg ) tablet Caroverine cap. 20mg & Inj. 40mg/2ml Paclitaxel nanoparticle Inj. (20mg/ml) Amoxycillin 250mg + Dicloxacillin 250mg cap. Rifaximine 200mg tab. Tigecycline powder For Inj. 50mg/vial Stavudine SR 100mg tablet Cefixime (50mg/100mg) + Clavulanic acid 31.125mg/62.5mg per ml dry syrup & tablet
For P. Falciparam malaria As Approved For schizophrenia in adults Antibiotic Anti HIV For mixed infection of skin Anti Cancer
Ant- diabetic For abdominal spasmodic pain, colics of track, abdominal colics For neck-shoulder orm syndrome scapu arthritis and low back pain For abdominal pain & tinnitus in adult For metastatic breast cancer Anti biotic
For infections diarrhea in adults For skin & skin structure infection & intra infection Anti HIV Antibiotic
Ciclsonide 80mcg/160mcg + Formotorol 4.5mg inhaler Anti asthratic Ciclsonide 100mcg/ 200mcg/400mcg + Formotorol Fumarate 6mg rotacaps Anti asthmatic Abacavir Sulphate syrup 20mg/ml S(-) pantoprazole (as sodium) 20mg (E.C.) + Domperidome SR 30mg tablet Cefadroxil 500mg + Clavulanic acid 125mg tablet Cefadroxil 250mg + Clavulanic acid 62.5mg dispersible tablet Cefadroxil 250mg + Clavulanic acid 62.5mg per 5ml syrup Human Insulin (r-DNA) Powder inhaler Fulvestrant Inj. 250mg/5ml prefilled syringe S(-) Pantoprazole (as Sodium) Inj. 20mg/vial For HIV Infection FOR GERD Antibiotic Antibiotic Antibiotic For type-I & Type-2 Diabetes Anti Cancer
Dasatinib tablet 20mg/50mg/70mg tablet Telbivudine 600mg tablet Aprepitant cap (80mg/125mg) Telmisartan 40mg + Amlodipine (as Besylate) 5mg tablet Gemifloxacin (as msylate) 320mg tablet Ceftazidime 500mg /1000mg + Tazobactum (as sodium) 62.5mg/125mg per vial for injection Cefepime (As Hcl) 500mg/1000mg + Tazobactum (as Sodium) 62.5mg/125mg Paromomycin Inj. 375mg/ml
For the treatment of adults with chronic myeloid or lymphoid blast phase chronic leukemai (CML) For chronic hepatitis B infection For essential hypertension Antibiotic Antibiotic Antibiotic For visceral leishmaniasis (Kalaazar)
134 135 136 137 138 139 140 141 142 143 144 145 146 147 148 149 150 151 152 153
Cefixime 100mg + Cloxacillin (as Sodium) 500mg + Lactobacillus (45 million spore)tab. Alprazolam Dispersible Tab. 0.125mg/0.25mg/0.50mg Epinastine Hcl (0.05%) Opthlamic solution Levofloxacin tablet (250mg /500mg) & Infusion 5mg/ml (For additional indication) Feracrylum 1% mouth gargle 10mg/ml Aceclofenac Inj. (150mg/ml) combipack of one cap. Of aprepitant .125mg & two cap. Of aprepitant 80mg each (combipack) Formoterol fumarate 6mcg + Fluficasone propinate 50mcg/125mcg/250mcg MDI Amlodipine 25mg + Metoprolol 25mg (additional lower strength) Estrogen vaginal tablet 25mcg Esomeprazole 40mg (E.C.) + Itopride 150mg SR Capsules Cefixime 200mg + Cloxacillin 500mg (ER) + Lactobacillus 90 million Spore tab. (additional strength) Cefixime dispersible tablet 400mg (new dosage Form) Trandalopril 1mg/2mg/4mg/2mg + Verapamil (ER) 240mg/240mg/240mg/180mg Ciclesonide 160mcg/320mcg cap. for inhalation Rabeprazole 20mg (EC) + Itopride SR 150mg Metoprolol succinate 25mg /50mg ER + HCTZ 12.5mg Atorvastatin 5mg + Fenofibrate 160mg (additional strength) Aceclofenac Inj. 50mg/ml (additional strength) Amisulpride 400mg tablet (additional strength) Misoprostol tablet 25mcg/100mcg/200mcg (additional strength indication Atazanavir 150mg + Ritonavir 50mg capsules Mebeverine Hcl 135mg + Chlordiazepoxide 5mg tablet Ampicillin 250mg + Dicloxacillin 250mg tablet Etoricoxib 10mg + Methyl Salicylate 100mg + Mentol 50mg + Linseedoril 30mg per gm. of Gel Racecadotril dispersible tablet (10mg/30mg) (new dosage Form) Gabapentin ER 450/600/900mg tablet Aceclofenac dispersible tablet 100mg (new dosage form)
Antibiotic For anxiety For allergic conjunctivitis For prostatitis As hacmostatic agent in dental surgery
For pain in post operative & post trauma As Approved For Asthma & COPD For atropic viginitis For GERD Antibiotic Antibiotic Anti hypertensive Anti asthmatic For GERD Anti hypertensive As Approved As Approved As Approved
For cervical ripening, prevention of post haemorrhage & First trimester of aborati mifepristone Anti HIV For IBS Antibiotic For acute Musculoskeletal pain For diarrhea As Approved
270 271
Lipid Lowering agent For diarrhea of mixed infection For alteration of intestinal bacterial flora
Bacillus calusii spores suspension (2billion/5ml vial) 272 Lamivudine (40mg) +Nevirapine (70mg 273 +Stavudine (10mg) (in 5ml) powder for suspension 274 275 Diflorasone Diacetate Cream (0.5mg/gm) Etonogestrel (11.7mg) + Ethinylestradiol (2.7mg) Contraceptive rings Metaxalone (400mg) + Diclofenac Potassium (50mg) tablet Tranexamic Acid (500mg) + Mefenamic acid (250mg) tablet Fluconazole (2%) + Zinc Pyrethione (1%) suspension Azelaic acid Cream (15%)
Anti-HIV.
28-012005 08-022005 15-022005 22-022005 22-022005 22-022005 23-022005 25-022005 28-022005 02-032005 04-032005 04-032005 09-032005
For acute painful musculoskeletal condition in adult For primary dysmenorrhoea and pain associated with menorrhagia in women For seborrhoic dermatitis For the treatment of inflammatory papules and pustules of mild to moderate rosacea For non-productive cough in adults
Levodropropizine oral suspension (30mg/5ml) Duloxetine HCl (60mg) tablet (additional strength) Desloratadine (2.5mg) + Ambroxol (30mg) +Guiphenasine (50mg) + Menthol 1mg/5ml Syrup Levofloxacin Ophthalmic Solution (0.5%) Metformin Oral Solution (100mg/ml) Tirofiban (0.25mg/ml injection)
282
283 284
For susceptible bacterial conjunctivitis For type-II diabetes mellitus For acute coronary syndrome including patients undergoing PTCA or atherectomy For GERD not responding to Omeprazole.
285
10-032005
286
Enteric coated + Domperidone (30mg) (S.R.) capsule Stavudine powder for suspension Erdosteine (150mg/300mg) Capsules For HIV-1 infusion For chronic obstructive bronchitis 11-032005 01-042005 11-032005
287
288 Tazarotene (1mg) +Mometasone Furoate (1mg) per gram cream For plaque psoriasis
289
Levetiracetam (250mg,500mg, 290 750mg) Tablets Esomeprazole Sodium For injection 291
As adjunctive therapy in treatment of partial onset seizures in adults with epilepsy. For GERD in patients with esophagitis and/or severe symptoms of reflux as an alternative to oral therapy when oral intake is not appropriate For perinial allergic rhinitis As sweetener in pharmaceutical preparation For opioid dependence For HIV infection For Hypertension
04-042005 04-042005
Rupatadine (10mg) tablet Acesulfame Potassium Buprenorphine (0.4mg) + Naloxone (0.1mg) sublingual tablet Lamivudine (40mg) +Stavudine (10mg/5ml) reconstituted solution S(-) Metoprolol Succinate S.R. tablets (equivalent to S(-) Metoprolol Tartrate 12.5mg/25mg/50mg) R(-) Ondansetron (2mg/4mg) tablet Balanced salt intra ocular irrigating solution enriched with glutathione Dextrose, bicarbonate Gliclazide M.R. (30mg/60mg)+
296
297
298
For chemotherapeutic induced nausea and vomiting For intraocular irrigating during intraocular surgical procedures For type-II diabetes
299
Metformin HCl (500mg) ER Tablet Drosperinone (3mg) + Ethinylestradiol (0.035mg tablet) Simvastatin (10/20mg) + Ezetimibe (10mg) Tab Oral Contraceptive For primary Hypercholesterolemia 11-052005 11-052005 11-052005 12-052005 17-052005 18-052005 20-052005
300 301
Ramipril (5mg) + Telmisartan (40mg) tablet 302 303 Intralipid 30% Montelukast Granules (4mg/pack) 304 Bortezomib for injection (3.5mg/vial) Nelfinavir 625mg tablet (addl.strength) 306 Sevelamer (400mg/800mg) tablet 307 308 S(-)Pantoprazole (10mg/20mg) tablet
For Hypertension
For patients with essential fatty acid deficiencies For Prophylaxis and chronic treatment of asthma in adult and pediatric patients of 12 months age and older For the treatment of myeloma patients For HIV patients
305
For control of serum phosphorus in patients with chronic kidney disease and hemodialysis. For gastric ulcer, duodenal ulcer & GERD
20-052005 20-052005
Tazarotene (0.05%) + Mometasone Furoate (0.1%) Cream (addl.strength) R (-) Ondansetron oral Solution (1mg/5ml) Gatifloxacin (200mg) +Ornidazole (500mg) tablet Combikit of 2 tablet of Stavudine (40mg) + Lamivudine (150mg) each & 1 tablet of Efavirenz (600mg) Combikit of 2 tablet of Lamivudine (150mg) + Zidovudine (300mg) each and 1 tablet of Egavirenz (600mg) Aceclofenac gel 1.5% alongwith linseed oil, menthol, Salicylate, Capsaicin Emtricitabine (200mg) capsule Eplerenone Tablet (25mg/50mg) Strontium Ranelate Granules (2gm/Sachet) Lamivudine 30/60mg + Stavudine 6mg/12mg + Nevirapine 50mg/100mg dispersible tablet Nitazoxanide (500mg) + Ofloxacin (200mg) Tablet Midazolam Maleate Bulk Calcium Polycarbophil (500mg) Tablet FDC of Papain + Urea Ointment Testosterone Gel 1%.
For Plaque psoriasis For Chemotherapy induced nausea and vomiting For diarrhoea of mixed infection in adults For HIV infection in adults
24-052005 24-052005 06-062005 07-062005 07-062005 08-062005 09-062005 10-062005 14-062005 14-062005 30-062005 05-072005 06-072005 11-072005 12-072005
313
For pain, swelling etc For HIV infection in adults For hypertension For post-menopausal women with Osteoporosis For pediatric patients with HIV infection For urogenital infection in adults. Anesthetic IBS For debriment of necrotic tissues. For replacement therapy in male with Testosterone deficiencies and hypogonadotropic hypogonadism For metastatic non-small cell lung cancer. For dry eye syndrome For neuropathic pain Anti-hypertension Addl. Strength Anti-hypertension Anti-bacterial Anti-bacterial For Parkinsons disease
323 Erlotinib Hydrochloride (25mg/100mg/150mg Tablet Chloroquine Phosphate eye drops (0.3mg/ml) Mecobalamine E.R. tablet (1500mcg) Olmesartan Medoxomil (5mg/20mg/40mg) Tablet Ursodeoxycholic Acid (500mg) S.R Tablet FDC of Amlodipine (5mg) + Bisoprolol (2.5mg) FDC of Ceftriaxone (500mg/100mg) + Tazobactum (12.5mg/62.5mg) Injection Feropenem Sodium (150mg/200mg) Tablet Levodopa (50mg/100mg/150mg) + Carbidopa (12.5mg/25mg/37.5mg + Entacapone (200mg) tablet
Saquinavir (as mesylate) 500mg Tablet 333 Pramipexole Di-hydrochloride Tablet (0.125mg/0.25mg/0.5mg/1mg/1.5mg). FDC of Atorvastatin (10mg) + Niacin (375mg/500mg E.R) Capsule FDC of Levocetirizine (5mg) + Ambroxol (75mg S.R) Capsule FDC of Gabapentin (300mg) + Methylcobalamin (500mcg) Tablet Phenytoin Sodium (300mg) tablet FDC of Calciptriol (50mcg) + Betamethasone Dipro (0.5mg/gm) Ointment FDC of Glimepiride (1mg/2mg) + Pioglitazone (15mg)+ Metformin (500mg E.R) Tablet Tenofovir Disoproxil Fumarate Tablet (300mg) Sucralfate (7%) + Povidone Iodine (5%) Ointment Bivalirudin Injection (250mg/vial) Efavirenz Oral Solution (30mg/ml) Didanosine Powder for oral solution (2gm/4gm per bottles) Sodium Valproate (750mg/1000mg) C.R. Tablet Oxcarbazepine S.R. (150mg/300mg/600mg) Tablet Acitretin Dried IVY Leaf Extract (0.7gm/100ml) Nimesulide 1% + Methyl Salicylate 5%. Feracrylum (1%) + Metronidazole 1%) FDC of Methylcobalamin (1500mcg E.R) + Pyridoxine (20mg) + Folic Acid (5mg) Tablet Ketorolac Tromethamine 0.4% Eye drops (addl. Strength) Levetiracetam Oral Solution (100mg/ml) Zinc (Gluconate) oral solution (20mg/5ml) Trimebutine Maleate Enalapril (2.5mg/5mg) + HCTZ (12.5) Tablet (Addl. Strength) Oseltamivir (as phosphate) Capsule (75mg) & oral suspension (12mg/ml)
Addl. Strength. For Parkinsons disease For Hypercholesterolemia Anti-histaminic & mucolytic For neuropathic pain in adults. Addl. Strength For psoriasis vulgaris. Anti-diabetic Anti-HIV Anti-infective Anti-coagulant in PTCA Anti-AIDS Anti-AIDS Addl. Strength Anti-epileptic For sever psoriasis in adults. Cough Syrup Aerosol For local application in acute pain. Antiseptic gel. For hyper-homocysteinemia Ophthalmic Anti-epileptic For acute diarrhoea For irritable bowel syndrome For Hypertension For influenzae
25-072005 25-072005 26-072005 29-072005 05-082005 05-082005 12-082005 12-082005 17-082005 18-082005 25-082005 25-082005 26-082005 26-082005 08-092005 09-092005 15-092005 16-092005 16-092005 16-092005 20-092005 22-092005 05-102005 10-102005 17-102005 25-102005
340 341 342 343 344 345 346 347 348 349 350 351 352 353 354 355 356 357 358
Cetirizine HCl drops (10mg/ml) Lanthanum Carbonate Chewable tablet (250mg/500mg) Ambroxol HCl 75mg (S.R) + Desloratadine 5mg Capsule. Sodium Hyaluronate 0.1% eye drops (addl. Strength) FDC of S-Metoprolol Succinate Tartrate equivalent to Metoprolol Tartrate (E.R) 25/50mg + HCTZ (12.5mg) Tablet. Stavudine 10mg+Lamivudine 40mg+ Nevirapine 70mg dispersible tablet Voglibose (0.2mg/0.3mg) Tablet Lactitol Sachet (10gm/20gm). Aspirin Bolus (Vet.) 6gm/bolus) Domperidone (10mg) + Activaed dimethicone (125mg) chewable tablet Moxifloxacin (0.5%) + Dexamethasone Phosphate (0.1%) Eye drops Pregabalin capsule (75/150/300mg) Methotrexate Topical gel (1%) Addl. Strength Brimonidine Tartrate (2mg/1.5mg) + Timolol (as HCl) 5mg/ml. Testosterone Spray (25mg) Omeprazole Powder for suspension (20mg/Sachet) Doxazosin (as Mesylate) 4mg/8mg E.R. Tablet Amlodipine (as besylate) 5mg + Bisoprolol 5mg Tablet (Addl. Strength) FDC of Olmesartan Medoxomil (20mg/40mg/40mg) + HCTZ(12.5mg/12.5mg/25mg) Phenylephrine 2.5% Eye drops Entecavir Tablet (0.5mg/1.0mg) & oral solution (0.05mg/ml). Ketorolac Tromethamine 5mg + Ofloxacin 3mg/ml Eye drops Hyoscine-N-Butylbromide (10mg) + Paracetamol 500mg Tablet Amlodipine (as besylate ) 5mg + Losartan Pot. 50mg Travoprost Eye drops (40mcg/ml)
Anti-histaminic For the treatment of hyperphosphatemia. For relief of productive cough. Ophthalmic use. For essential hypertension
362
For HIV infection Anti-diabetic For the treatment of constipation. For Veterinary use. For dyspepsia, colicy pain & GERD. For Ophthalmic use. For neuropathic pain. Psoriasis. Ophthalmic
11-112005 17-112005 21-112005 21-112005 22-112005 24-112005 25-112005 25-112005 25-112005 29-112005 30-112005 30-112005 30-112005 02-122005 02-122005 05-122005 07-122005 08-122005 08-122005 08-122005
370
For replacement therapy in males with testosterone deficiency. Anti-ulcer For hypertension For hypertension For essential hypertension Ophthalmic For chronic Hepatitis-B infection. Ophthalmic For spasmodic pain For hypertension For glaucoma & ocular hypertension.
383
Ceftriaxone (as sodium) (500mg/1000mg) + Sulbactam (as sodium) (250mg/500mg) powder for injection. Atomoxetine (as HCl) Sachet (10/18/25/40mg) Levofloxacin Oph. Solu. (1.5%) 15mg/ml. (Addl. Strength). Zonisamide (100mg) capsule Methimazole Tablet ( 5mg/10mg) Caspofungin Acetate injection (50mg/70mg per vial).
For LRTI
08-122005
For ADHD Ophthalmic Anti-epileptic For hyperthyroidism. For invasive candidiasis fungal infection.
NSAID 05-03-2004 193 Diacerein For Osteoarthritis 12-03-2004 194 Nitazoxanide Anti-Diarrhoeal 17-03-2004 195 Trolamine Cream (0.67%) For Topical use 20-03-2004 196 Neotame Sweetening Agent 22-04-2004 197 Oxybutynine E.R. tablets For Neurogenic bladder disorder 05-05-2004 198 Cabergoline 1 mg/2 mg/4 mg tablets For Parkinsons disease 07-05-2004 199
Rabeprazole Sodium Injection 20 For organ rejection 21-05-2004 205 Cefdinir Dispersible tablet (125mg) Anti-biotic 27-05-2004 206 Linezolid (600 mg) Tablet For Osteomyelitis in adults 30-05-2004 207 FDC of Gatifloxacin 0.3% + Dexamethasone Phos. 0.1% w/w Eye drops For post-operative inflammatory and bacterial infection of eyes. 15-06-2004 208 Cefprozil Dispersible Tablet (125 mg/ 250 mg) Anti-biotic 22-06-2004 209 Divalproex Sodium E.R. Tablets (750mg/1000 mg) Anti-Epileptic 24-06-2004 210 Lithium Carbonate ER (450mg) tablet Anti-Depression 28-06-2004
211 Nimesulide Injection 75mg/ml. For short-term treatment of post-operative pain. 28-06-2004 212 FDC of Esomeprazole 20 mg/40 mg + Domperidone 30 mg SR Capsule For GERD 29-06-2004. 213 Aceclofenac (100 mg) + Paracetamol(500 mg) For acute painful condition in adults 29-06-2004 214. FDC of Lamivudine 300 mg (E.R) + Zidovudine 600 mg (E.R) + Nevirapine 400 mg tablets Anti-AIDS 15-07-2004 215. Levosalbutamol Tablet 1 mg/2mg & Syrup 1 mg/5 ml. For Obstructive airway disease 16-07-2004 216. Memantine HCl tablet 5 mg/10 mg. For dementia of Alzheimers type 19-07-2004 217. Pimcrolimus 10 mg/gm cream For atopic dermatitis
23-07-2004 218. FDC of Rabeprazole (20 mg) + Mosapride S.R. (15 mg) Tablet For GERD 27-07-2004 219. Rebamipide 100 mg tablet For gastric ulcer 28-07-2004 220. Cefetamet Pivoxil Suspension 250 mg/5ml Anti-biotic 09-08-2004 221. Diclofenac Transdermal patch 100 mg/50 Cm2 For Osteoarthritis & soft tissue injury 10-08-2004 222 . Fluconazole Gel (0.5%) Anti-fungal 12-08-2004 223. FDC of Atorvastatin (10 mg/20 mg) + Ezetimibe (10 mg) Table For Hypercholesterolemia 13-08-2004 224 . Miglitol Tablet 25 mg/50 mg/100 mg
Anti-Diabetic 18-08-2004 225. FDC of Buprenorphin 2 mg + Naloxone (0.5 mg) For Opiod Dependency 19-08-2004 226. FDC of Sucralfate 0.07 + metronidazole 0.01 gm + Lignocain 0.04 gm per gram of cream For bedsore, haemorrhoid fistula and anal fussure 19-08-2004 227. Citicholine Tablet 500 mg & Injection 250 mg/ml Membrane permeability enhancer 20-08-2004 228. FDC of Glibenclamide 2.5 mg/ 5 mg + Metformin SR 500 mg tablet Anti-diabetic 20-08-2004 229. Lamotrigine S.R. tablet 50 mg/100 mg/200 mg Anti-Epileptic 26-08-2004 230 Moxifloxacin Eye drops (0.5%) For bacterial conjunctivitis 26-08-2004231 Risperidone long-acting suspension for injection 25 mg/37.5 mg/50 mg per vial
For Schizophrenia 26-08-2004232 Escitalopram (10mg) + Clonazepam (0.5mg) For co-morbid depression & anxiety disorder. 27-08-2004234 Everolimus Tablets Immunosuppressant 30-08-2004235 Dorzolamide (20 mg) + Timolol (5 mg) per ml For reduction of elevated IOP. 01-09-2004236 Gemcitabine (1.4 gm/vial) Anti-cancer 01-09-2004237 b -arteether Injection (150 mg/2 ml) Anti-malaria 01-09-2004238 Ziprasidone powder for injection(after reconstitution 20 mg/ml) Anti-psychotic 03-09-2004239 Voriconazole Tablet Anti-fungal 09-09-2004240 FDC of Nebivolol Anti-hypertensive 14-09-2004241 (5 mg) + S(-) Amlodipine (2.5 mg ) tablet (50 mg/200 mg) Infusion (200 mg/vial) Eye drops (0.25 mg/ 0.5 mg/0.75 mg/1.0 mg)
Amlodipine (5 mg) + Ramipril (2.5 mg) tablet Anti-hypertensive 24-09-2004242 FDC of Rabeprazole Sodium (20 mg) + Domperidone(30 mg) S.R Capsule For GERD 04-10-2004243 Cefuroxime Axetil ER tablets Anti-biotic 06-10-2004244 Diclofenac Transdermal Patch (200 mg/75 cm2) For pain relief. 06-10-2004245 Gatifloxacin Eye Ointment (1%) Ophthalmic use 06-10-2004246 Nimesulide Injection (100 mg/ml) Veterinary use 08-10-2004247 Isotretinoin Gel (0.05%) For acne 11-10-2004248 FDC of Epi-Growth Factor (1 gm) + Silversulphadiazine Cream For Burns 19-10-2004249 FDC of Amlodipine (5mg/10 mg) + Atorvastatin (10/20/40 mg) For co-existing hypertension & hyperlipidemia 20-10-2004250 (Veterinary) (500 mg/1000mg)
Levosalbutamol rotacaps (100 mcg/capsule) & inhaler (50 mcg /actuation) For obstructive airway disease. 20-10-2004251 Celecoxib Injection (100 mg/ml) For acute pain 28-10-2004252 Orlistat (120 mg) Capsule Anti-obesity 27-10-2004253 Duloxetine HCl (20,30,40mg) Tablet Anti-depressant 02-11-2004254 Deflazacort (1,6,30mg) tablet Anti-asthma, anti-arthritis. 02-11-2004255 Atomoxetine HCl (10,18, 25 & 40mg ) capsule For ADHD 09-11-2004256 Ursodeoxycholic acid S.R. Capsule (450mg) For dissolution of gall stones 01-12-2004257 Methylphenidate HCl (18, 36, 54 mg) E.R. tablet For ADHD 08-12-2004258 FDC of Lovastatin (20mg) + Nicacin ER (500mg) tablet For Lipid-lowering 20-12-2004259
FDC of Gatifloxacin (400mg) + Ambroxol HCl (75mg) tablet RTI in adults. 21-12-2004260 FDC of Nebivolol HCl (5mg) + Hydrochlorothiazide (12.5mg) tablet Anti-hypertensive 22-12-2004261 FDC of Atorvastatin Calcium (10mg) + Finofibrate (160mg) tablet For hyperlipidemia 22-12-2004262 Calcium Polycarbophil (500mg) tablet For constipation 23-12-2004263 Pantoprazole (40mg) + Domperidone (20mg) ( 10mg IR + 10mg SR) GERD 23-12-2004264 Imiquimod Cream 5% w/w For warts in adults 28-12-2004265 Entacapone (200mg) tablet For Parkinsons disease 30-12-2004
Name of Drug Cefprozil Cilostazol Escitalopram Oxalate. Anastrazole Rizatriptan Gadobenate(Dimeglumine IV Injection) Tacrolimus Ointment
Pharmacological Classification Antibiotic For intermittent claudication. Anti depressant Anti cancer Anti migrain MRI Contrast Medium Immuno-modulator
156 157 158 159 160 161 162 163 164 165 166 167 168 169 170 171 172 173 174 175 176 177 178 179 180 181 182 183 184 185 186 187
Metolazone Tiotropium Bromide Gadoversetamide Injection Torsamide Cyproterone Tablet Aripiprazole Azelaic Acid Bendrofluazide Imipenem +Cilastatin Vinpocetin Tirofiban HCl I.V Teriparatide Cladribine Tadalafil S-Atenolol Rosuvastatin Tazarotene Aceclofenac Ibopamine HCl Trandolapril Dorzolamide Fenoverine Risedronate Sodium Fondaparinax Sodium Metadoxine Valgancyclovir Isopropyl Unoprostone Amorolfine Fluvastatin Sodium Modafinil Sufentanil Citrate Ezetimibe
Diuretic Anti asthematic MRI Contrast Medium Diuretic For Prostatic Cancer Anti schizophrenia Anti-Acne Diuretic Anti-Bacterial Anti-pychotic Anti-Platelet For Osteoporosis Anti-Cancer For Erectile Dysfunction Anti-hypertensive Lipid lowering Agent Anti-Acne NSAID Opthalmic Anti-Hypertensive Opthalmic Anti-spasmodic For Osteoporosis LMWH For Hepatic Disorder For CMV Ophthalmic Anti-Fungal Lipid Lowering Agent For sleeping disorder Anesthetic Agent Lipid Lowering Agent
23.04.2003 16.04.2003 04.06.2003 09.06.2003 10-06-2003 11.06.2003 08-07-2003 24.07.2003 25-07-2003 01.08.2003 12.08.2003 04-09-2003 09-09-2003 11-09-2003 11-09-2003 12-09-2003 12.09.2003 15-09-2003 03-10-2003 03-10-2003 03-10-2003 08-10-2003 17-10-2003 22-10-2003 24-10-2003 20-11-2003 25-11-2003 25-11-2003 25-11-2003 15-12-2003 17-12-2003 18-12-2003
Name of Drug Bimatoprost (Ophthalmic Sol.) Meropenem Inj. Fosinopril Sodium Divalproax Sodium Zaleplon Tizanidine SR Thymogen Inj. Montelukast Sodium Methyl Cobalamin Mifepristone Dexarazoxane Injection Tranexamic Acid
Pharmacological Classification Anti-Glaucoma Beta-lactum Antibiotic Antihypertensive Antiepileptic Sedative-Hypnotic Multiple Sclerosis Anticancer Antiasthmatic (Leukotriene Receptor Antagonist) Peripheral Neuropathy Progesterone Antagonist Cardio Protective Agent Antifibrinolytic
Date of Approval 08.01.2002 08.01.2002 10.01.2002 17.01.2002 17.01.2002 06.02.2002 12.02.2002 13.02.2002 13-02.2002 13.02.2002 26.02.2002 06.03.2002
104 105 106 107 108 109 110 110 111 112 113 114 115 116 117 118 119 120 121 122 123 124 125 126 127 128 129 130 131 132 133 134 135 136 137 138 139 140 141 142 143 144 145 146 147 148
Bicalutamide Loteprednol Etabonate Ophtalmic Sol. Apraclonidine Ophthalmic Sol. Mizolastine Miltefosine Ziprasidone HCl ABACAVIR Nadifloxacin Cream Meloxicam Inj. (Vet) Mesalazine SR Tamsulosin HCl Famciclovir Nateglinide Lercanidine HCl Itopiride Capsules Alprostadil Injection Vimpocetine Quetiapine Fumerate Isotretinoin Soft Gel Cap. Nebivolol HCl Sirolimus Drotrecogin alpha Pygenum Africum Valdecoxib Thalidomide S (-) Amlodipine Besylate Cabergoline Butarphenol Tartarate Gemtuzumab Quinapril Valacyclovir Fosphenytoin Sod. Ceftiofur Sodium & CeftiofurHCl Metaxalone Meglumine gadoteric Cefepine HCl Acamprosate Calcium Aztreonam Tegaserod Maleate Parecoxib Inj. Balsalezide Disodium Cefetemet-piroxil Telmisartan Levocetrizine Poractant a Reboxetine
Anticancer Corticosteroid, ophthalmic anti-inflammatory Alpha 2-adrenoreceptor agonist Antiallergic For Kalazar For Schizophrenia Anti HIV Antibacterial; antiacne NSAID Bowel disease (inflammatory) For BPH Antiviral Antidiabetic Antihypertensive Gastro Prokinetic Agent For Erectile Dysfunction Vasodilator Antipsychotic For Acne vulgaris Antihypertensive Immunosuppressant For severe sepsis For BPH NSAID For Leprosy Anti-hypertensive For hyperprolactemia Opoid Analgesic For Myeloid Leukemia Anti Hypertensive Anti-viral Anti-Epileptic Antibiotic (For Veterinary Use) Muscle Relaxant Contrast media Anti-Biotic For Alcohol dependency Anti-Bacterial For irritable bowel syndrome NSAID For ulcerative colitis Antibacterial Antihypertensive Anti-Histaminic For respiratory distress in preterm babies Anti-depressant
07.03.2002 15.03.2002 15.03.2002 15.03.2002 15.03.2002 18.03.2002 22.03.2002 28.03.2002 02.04.2002 04.04.2002 04.04.2002 11.04.2002 01.05.2002 07.05.2002 09.05.2002 09.05.2002 13.05.2002 31.05.2002 21.06.2002 12.07.2002 15.07.2002 23.07.2002 30.07.2002 01.08.2002 12.08.2002 16.08.2002 05.09.2002 11.09.2002 12.09.2002 19.09.2002 25.09.2002 01.10.2002 08.10.2002 08.10.2002 16.10.2002 30.10.2002 30.10.2002 01.11.2002 01.11.2002 01.11.2002 12.11.2002 14.11.2002 25.11.2002 12.12.2002 24.12.2002 31.12.2002
Name of Drug Sildenafil Citrate Triflusal Thymosin Alfa-1 Inj. Vinorelbin Tartrate Inj. Broncho-Vaxom Indinavir Sulphate Butenafine HCl cream Mirtazapine Clopidogrel Mosapride Donepezil HCl Bupropion SR Raloxifene HCl Efavirenz Moxifloxacin Misoprostol Human Recombinant Granulocyte Colony Stimulating Factor Inj. Nelfinavir Mesylate Ciprofloxacin 1g SR Tolterodine-L-Tartrate Ebastine Leflunomide Citalopram Hydrobromide Gatifloxacin Linezolid Genirelix Racecadotril Cefdinir Iobitridol Estemestane Decapeptide Oxcarbazepine Desloratidine Zolendronic Acid Zafirlukast Ropinirole Esomeprazole Mag. Etanercept-Recomb.
Pharmacological Classification Male Erectile Dysfunction Platelet Aggregation Inhibitor Immunomodulator (for chronic Hepatitis-B) Antineoplastic aggregation inhibitor Antiasthamatic, immune boosting drug Antiviral (Anti-HIV) Antifungal Antidepressant Antithrombotic; platelet aggregation inhibitor Prokinetic agent, GERD For Alzheimer's Dementia Smoking cessation adjunct Menopausal osteoporosis Anti-HIV Antibacterial Antiulcer agent Haemopoietic stimulant, antineutropenic Anti-HIV Antibacterial Overactive Bladder Antiallergic Anti-rheumatoid Arthritis Antidepressant Antibacterial Antibacterial Antigonadotropin releasing hormone (fertility drug) Antidiarrhoel Antibacterial Contrast Medium Antineoplastic For Vitiligo Antiepileptic Antiallergic For Hypercalcaemia Antiasthmatic (Leukotriene Receptor Antagonist) Dopamine Agonist (for Parkinson's Disease) Antiulcer Antirheumatic, Tumor Necrosis Factor Receptor
Date of Approval 08.01.2001 17.01.2001 17.01.2001 17.01.2001 Feb, 2001 01.02.2001 14.02.2001 14.02.2001 22.02.2001 12.03.2001 20.03.2001 10.04.2001 04.05.2001 06.06.2001 26.06.2001 21.06.2001 29.06.2001
52 53 54 55 56 57 58 59 60 61 62 63 64 65 66 67 68
69 70 71 72 73 74 75 76 77 78 79 80 81 82 83 84 85 86 87 88 89
02.07.2001 Aug, 2001 13.09.2001 28.09.2001 01.10.2001 03.10.2001 03.10.2001 04.10.2001 08.10.2001 10.10.2001 10.10.2001 17.10.2001 18.10.2001 22.10.2001 30.10.2001 30.10.2001 05.11.2001 03.12.2001 03.12.2001 04.12.2001 07.12.2001
90 91 92
Name of Drug Oxiconazole Temozolomide Olanzapine Fluvoxamine Maleate Celecoxib Nevirapine Repaglinide Ganciclovir Trapidil Cerivastatin Rofecoxib Irbesartan Rosiglitazone Maleate Granisetron Rituximab Trastuzumab Rosiglitazone Moclobemide Candesartan Venlafaxine Hdrochloride Paroxetine Hydrochloride Iomeprol Capecitabine Daclizumab Pioglitazone Hydrochloride Didanosine Octy.lonium Bromide Pravastatin
Pharmacological Classification Antifungal Antineoplastic Antipsychotic Antidepressant NSAID Anti HIV Antidiabetic Antiviral Adjunct in angioplasty Lipid lowering agent NSAID Antihypertensive Antidiabetic Antiemetic Antineoplastic Antineoplastic Antidiabetic Antidepressant Antihypertensive Antidepressant Antidepressant Contrast medium Antineoplastic Immunosuppressive agent Antidiabetic AntiHIV Irritable bowel syndrome Lipid lowering agent
Date of Approval 17.01.2000 17.01.2000 27.01.2000 21.02.2000 22.02.2000 06.03.2000 23.03.2000 05.04.2000 11.05.2000 11.05.2000 26.06.2000 26.06.2000 28.06.2000 05.07.2000 10.07.2000 10.07.2000 14.07.2000 28.07.2000 31.08.2000 18.09.2000 04.10.2000 05.10.2000 12.10.2000 12.10.2000 17.10.2000 15.11.2000 12.12.2000 20.12.2000
24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51
Pharmacological Classification Antidiabetic agent Immunosuppressant NSAID Pre-Synaptic monoamine depleting agent Antihypertensive agent
1 2 3 4 5
6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23
Nafarelin Acetate Milrinone Lactate Inj. Brimonidine Tartrate Nabumetone Zolpidem Basiliximab Inj. Topotecan Hydrochloride Fludarabine Phosphate IV Inj. Zuclopenthixol Acetate Piperacillin - Tazobactam Inj. Topiramate Eptifibatide Atorvastatin Sulpiride Bambuterol Bulaquine Fenofibrate Sibutramine Hydrochloride
Antiendometriotic agent; gonadotropin inhibitor Cardiotonic Alpha2-adrenoreceptor agonist, adjunct in glaucoma NSAID Sedative-Hypnotic Immunosuppressant Antineoplastic Antineoplastic Antimaniac & antischizoprenic Antibiotic Antiepileptic Platlet Aggregation Inhibitor Antihyperlipidemic; HMGCoA reductase inhibitor Antipsychotic Bronchodilator Antimalarial Lipid lowering agent Appetite suppressant
17.03.99 17.05.99 18.05.99 18.05.99 28.05.99 28.05.99 15.06.99 26.06.99 29.07.99 13.08.99 23.08.99 25.08.99 17.09.99 26.10.99 13.12.99 21.12.99 22.12.99 23.12.99