美国FDA药品数据库-药物在线

商品名	申请号	产品号	申请类型	活性成分	剂型/给药途径	规格/剂量	RLD	RS	申请号原始批准/暂定批准日期	产品号批准日期	申请人	市场状态
CORTISPORIN	050168	002	NDA	BACITRACIN ZINC; HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE	OINTMENT;TOPICAL	400 UNITS/GM;1%;EQ 3.5MG BASE/GM;5,000 UNITS/GM Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	Yes	No	1957/03/26	1984/05/04	MONARCH PHARMS	Discontinued
CORTISPORIN	050218	001	NDA	HYDROCORTISONE ACETATE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE	CREAM;TOPICAL	0.5%;EQ 3.5MG BASE/GM;10,000 UNITS/GM Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	Yes	No	1963/04/16	1985/08/09	MONARCH PHARMS	Discontinued
CORTISPORIN	050169	001	NDA	HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE	SUSPENSION/DROPS;OPHTHALMIC	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	No	No	1964/12/18	Approved Prior to Jan 1, 1982	MONARCH PHARMS	Discontinued
CORTISPORIN	050416	002	NDA	BACITRACIN ZINC; HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE	OINTMENT;OPHTHALMIC	400 UNITS/GM;1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	Yes	No	1971/05/10	Approved Prior to Jan 1, 1982	CASPER PHARMA LLC	Discontinued
CORTISPORIN	050479	001	NDA	HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE	SOLUTION/DROPS;OTIC	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	Yes	No	1975/12/09	Approved Prior to Jan 1, 1982	MONARCH PHARMS	Discontinued