PPB - eCTD

Public View of Retained Products - Shows all Approved products for the year 2019

Product Details

#	Evaluation	Paid	Retention No	Product Trade Name	Human Vet	Local Foreign	Inn Of Api	Api Strength Per Dosage	Packaging	Product Pack Size	Pharmacotherapeutic Group	Mah Company Name
1	Evaluated	Paid	10465	BORTIMORE 3.5		Foreign	BORTEZOMIB	each vial contains 3.5 mg Bortezomib		vial	Other antineoplastic agents	ATLANTA BIOLOGICALS PVT LTD
2	Evaluated	Paid	12751	CHEMOGEM 200	Human	Foreign	Gemcitabine Hydrochloride equivalent to…	200 mg/Vial	10 ml USP type I glass vial, 20 mm Bromobutyl…	10 ml vial	gemcitabine	ATLANTA BIOLOGICALS PVT LTD
3	Evaluated	Paid	12752	CHEMOGEM 1000	Human	Foreign	Gemcitabine Hydrochloride equivalent to…	1000 mg/ Vial	50 ml USP type I glass vial, 20 mm Bromobutyl…	50ml vial	ANTINEOPLASTIC AGENTS	ATLANTA BIOLOGICALS PVT LTD
4	Evaluated	Paid	13731	PEMITA 100	Human	Foreign	Pemetrexed Disodium	Each vial contains 100 mg Pemetrexed Disodium…	10 ml USP type I glass vial, 20 mm Bromobutyl…	10 ml vial	pemetrexed	ATLANTA BIOLOGICALS PVT LTD
5	Evaluated	Paid	13732	PEMITA 500	Human	Foreign	Pemetrexed Disodium	Each vial contains 500 mg Pemetrexed Disodium…	50 ml USP type I glass vial, 20 mm Bromobutyl…	50 ml vial	pemetrexed	ATLANTA BIOLOGICALS PVT LTD
6	Evaluated	Paid	12754	BEMUSTAR 100	Human	Foreign	Bendamustine Hydrochloride 100 mg	100mg/Vial	20 ml USP type I glass vial, 20 mm Bromobutyl…	20 ml vial	bendamustine	ATLANTA BIOLOGICALS PVT LTD
7	Evaluated	Paid	10467	RUBIDOX 50		Foreign	DOXORUBICIN HYDROCHLORIDE	each vial contains 50mg of Doxorubicin…		VIAL	Cytotoxic antibioticsand related substances:…	ATLANTA BIOLOGICALS PVT LTD
8	Evaluated	Paid	11907	CISPOLE 50	Human	Foreign	Cisplatin	Each vial contains 50 mg Cisplatin	1vial in a carton	1vial in a carton	Other antineoplastic agents: Platinumcompounds	ATLANTA BIOLOGICALS PVT LTD
9	Evaluated	Paid	10463	ZOLEONE INFUSION		Foreign	Zoledronic acid monohydrate	each vial contains 4mg of Zoledronic acid		VIAL	Drugs affecting bone structure and…	ATLANTA BIOLOGICALS PVT LTD
10	Evaluated	Paid	11694	AREST 120	Human	Foreign	Fexofenadine	Fexofenadine 120mg	1x10 Blister pack	1 x 10	Other antihistamines for systemic use	Ravenbhel Healthcare Pvt. Ltd