197 Eberconazole 1% w/w + Mometasone Furate USP 0.1% w/w cream For the treatment of mild 1. For the treatment of 198 Lubiprostone Soft Gelatin Capsules 2. For the treatment of ..…8mcg /24mcg women > 18 years old. 199 Pazopanib (as Hydrochloride) film coated / 400mg For the treatment of Tablets…200mg for the treatment of (idiopathic) corticosteroids, 200 Eltrombopag (as Olamine) Tablets ...25mg / 50mg (It should be used only in and clinical condition attempt to normalize 201 Tolperisone HCL 150mg + Paracetamol IP 500mg tablet For the treatment of For anti inflammatory 202 Zaltoprofen film coated tablet low back pain, …80mg JP post trauma, and post 203 Hyoscine Butylbromide 20 mg tablet (Additional Strength) Same as Approved. Cerebroprotein Hydrolysate injection / 2100mg For amelioration of (Lyophilised) …..1050mg 204 (approx) equivalent to / 60mg respectively. aprosexia in dementia. nitrogen….30mg For the treatment of Clebopride (as Malate) (1)Tablets...0.5 mg Ph. Eur. motility like non-ulcer 205 (2.) Syrup...0.1 mg / ml Ph. Eur. gastroesophageal reflux (3.) Injection...1 mg / 2mlPh. Eur. functional origin. Tolperisone HCl Mouth Dissolving tablet 50/100 mg (Additional Dosage 206 Same as Approved. Form) For the treatment of 207 Oxybutynin Gel 100 mg incontinence, urgency 208 Dapoxetine ( as Hydrochloride) Tablets For the treatment of …30mg/60mg
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
207362327approval.docx