18 Lipid Based Amphotericin-B Gel 0.1% Indicated in the treatment caused by candida 19 Sodium Hyaluronate Injectable Gel 14mg/ml, 18mg/ml, 25.5mg/ml (Additional Strength) Same as approved 20 Milnacipran Hcl 12.5mg (Addl. Strength) Same as approved 21 Ropinirole 6mg ER Tablets (Addl. Strength) Same as approved 22 Coseal Surgical Sealent 2/4/8ml (Addl. Indication) (1) Enforcement of (2)Patients undergoing and extend of post (3)Patients undergoing adjunct to good surgical extent of post surgical 23 Pregabalin SR 75/150/300mg + Methylcobalamin 1500mcg tablets For the treatment of adult 24 Ivabradine Hcl Tablets 5/7.5mg (Additional Indication) For Symptomatic disease patients with in patients whose heart rate 25 Paracetamol Solution for Infusion (10mg/ml) in 50ml (Additional Packsize) Same as approved 26 Ketorolac Tromethamine Ophthalmic Solution 0.45% Indicated for the 27 Cytarabine Injection 100mg Additional Packsize (20ml) In combination with other induction in acute been found useful in the phase of chronic indicated in the 28 Olopatadine Hcl Nasal Spray 0.6% w/w (Additional Indication) For the relief of the age and older. 29 Sodium chloride 6.80gm + Potassium chloride 0.30 gm + Calcium chloride dihydrate 0.37gm + Magnesium chloride hexahydrate 0.20gm + Sodium acetate trihydrate 3.27gm + L-malic acid 0.67gm in 1000ml solution for infusion Replacement of especially if acidosis is 30 Chemically Modified Sodium Hyaluronate and Caboxymethylcellulose Absorbable Adhesion Barrier. As an adjunct in and severity of 31 Lornoxicam 4mg/4mg + Thiocolchicoside 4mg/8mg tablets For the treatment of 32 Cefixime 100mg/200mg + Cloxacillin 500mg/500mg tablets For the treatment of adult skin and soft tissue
the 115 Carmustine for inj. 100 mg Indicated as palliative therapy with other following: 1.Brain ependymoma, and tumors. combination with 3.Hodgkin’s Disease—as drugs in patients who to respond to primary 4.Non-Hodgkin’s approved drugs for or who fail to respond to 116 Monteleukast Sodium Tablet 10mg; Monteleukast Sodium 4/5mg Chewable Tablet; Monteleukast Sodium Oral granule(Additional Indication) For the relief of patients 2 years of age 117 Ramosetron Dispersible Tablet 0.1 mg For the prevention and vomitting) associated 118 Amitraz 2%w/v pour on solution For the control of ticks on 119 Flupirtine Maleate Capsules 100mg For treatment of acute the posture and motor pain, dysmenorrhea and injuries. 120 Lidocaine Patch 350mg (Additional Pack Size) For the relief of pain only to intact skin. 121 Oseltamivir Phosphate (Additional indication) In the treatment of outbreak. 122 Methylcobalamin 1500mcg +Folic acid 0.7mg +Niacinamide 12mg injection For the treatment of 123 Methylcobalamin 1500mcg +Pyridoxine 100mg +Nicotinamide 100mg injection For the treatment of 124 1 tablet of Tenofovir disoproxil 300mg + Lamivudine 300mg & 2 tablet of Nevirapine 200mg combipack For the treatment of HIV 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 + Phosphorus 77mg+ Ferrous fumarate 50mg + Copper 0.01mg+ Potassium iodide 0.0015mg + Heavy magnesium oxide 1mg + Manganse sulphate 0.01mg + Potassium sulphate 1mg + Zinc sulphate 0.15mg Capsule For the treatment of 126 Ramipril MR Capsules 2.5/5 mg (Additional Strength) Same As Approved
197 Eberconazole 1% w/w + Mometasone Furate USP 0.1% w/w cream For the treatment of mild 198 Lubiprostone Soft Gelatin Capsules ..…8mcg /24mcg 1. For the treatment of 2. For the treatment of women > 18 years old. 199 Pazopanib (as Hydrochloride) film coated Tablets…200mg / 400mg For the treatment of 200 Eltrombopag (as Olamine) Tablets ...25mg / 50mg for the treatment of (idiopathic) corticosteroids, (It should be used only in and clinical condition attempt to normalize 201 Tolperisone HCL 150mg + Paracetamol IP 500mg tablet For the treatment of 202 Zaltoprofen film coated tablet …80mg JP For anti inflammatory low back pain, post trauma, and post 203 Hyoscine Butylbromide 20 mg tablet (Additional Strength) Same as Approved. 204 Cerebroprotein Hydrolysate injection (Lyophilised) …..1050mg / 2100mg (approx) equivalent to nitrogen….30mg / 60mg respectively. For amelioration of 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 motility like non-ulcer gastroesophageal reflux functional origin. 206 Tolperisone HCl Mouth Dissolving tablet 50/100 mg (Additional Dosage Form) Same as Approved. 207 Oxybutynin Gel 100 mg For the treatment of incontinence, urgency 208 Dapoxetine ( as Hydrochloride) Tablets …30mg/60mg For the treatment of
209 Opipramol dihydrochloride Tablet 50mg/100mg. For the Treatment of disturbances. 210 Ondansetron Rapid Film Oral Strip 4/8 mg For chemotherapeutic 211 Acebrophylline SR Tablet 200 mg For the treatment of adult (COPD) and bronchial 212 Ammonium Lactate Cream 12% w/w Indicated For the for temporary relief of 213 Rabeprazole Sodium Powder oral suspension ( sachet of 20 mg) (Additional dasage form) Same as approved 214 Temsirolimus Concentrate for Infusion for Injection 25mg/ml For the treatment of 215 Acetyl Cysteine Eye Drops 5% w/v Indicated the relief of Dry impaired or abnormal 216 Clindamycin Palmitate Hcl For Oral Solution 75mg/5ml. Indicated for the before dental, oral and 217 Deferasirox Tablet for Oral Suspension (Additional Sosage Form) Same as approved 218 Ramelteon film coated tablets 8mg For the treatment of 219 Memantine ER Tablet 7mg/14mg/21mg. (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 ) For treatment of acute continuous continuous 221 Pyridoxine HCL IP 3mg + Nicotinamide IP 100mg + Cyanocobalamin IP 15mcg + Folic acid IP 500mcg + Chromium Picolinate USP 250mcg Tablet For Mineral & Vitamins 222 Rosuvastatin Calcium IP 5mg/10mg + Fenofibrate BP 160mg/160mg tablet Additional strength