For the Treatment of 209 Opipramol dihydrochloride Tablet 50mg/100mg. disturbances. 210 Ondansetron Rapid Film Oral Strip 4/8 mg For chemotherapeutic For the treatment of adult 211 Acebrophylline SR Tablet 200 mg (COPD) and bronchial Indicated For the 212 Ammonium Lactate Cream 12% w/w for temporary relief of Rabeprazole Sodium Powder oral suspension ( sachet of 20 mg) 213 Same as approved (Additional dasage form) 214 Temsirolimus Concentrate for Infusion for Injection 25mg/ml For the treatment of Indicated the relief of Dry 215 Acetyl Cysteine Eye Drops 5% w/v impaired or abnormal Indicated for the 216 Clindamycin Palmitate Hcl For Oral Solution 75mg/5ml. 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 Solution for haemofiltration and haemodialysis (Each unit contains two compartments A & B. Before reconstitution: 1000ml of electrolyte solution in Compartment A contains: For treatment of acute • Calcium Chloride. 2H2O .....5.145gm 220 continuous Magnesium Chloride. 2H2O.... 2.033gm Lactic Acid....5.4gm continuous 1000ml of buffer solution in Compartment B contains: • Sodium Chloride....6.45gm Sodium Bicarbonate....3.090gm ) Pyridoxine HCL IP 3mg + Nicotinamide IP 100mg + Cyanocobalamin IP 221 15mcg + Folic acid IP 500mcg + Chromium Picolinate USP 250mcg For Mineral & Vitamins Tablet 222 Rosuvastatin Calcium IP 5mg/10mg + Fenofibrate BP 160mg/160mg tablet Additional strength
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
207362327approval.docx