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
APOGEN	062289	001	ANDA	GENTAMICIN SULFATE	INJECTABLE;INJECTION	EQ 10MG BASE/ML	No	No	--	Approved Prior to Jan 1, 1982	KING PHARMS	Discontinued
APOGEN	062289	002	ANDA	GENTAMICIN SULFATE	INJECTABLE;INJECTION	EQ 40MG BASE/ML	No	No	--	Approved Prior to Jan 1, 1982	KING PHARMS	Discontinued
AMNESTROGEN	083266	001	ANDA	ESTROGENS, ESTERIFIED	TABLET;ORAL	0.3MG	No	No	--	Approved Prior to Jan 1, 1982	BRISTOL MYERS SQUIBB	Discontinued
AMNESTROGEN	083266	002	ANDA	ESTROGENS, ESTERIFIED	TABLET;ORAL	0.625MG	No	No	--	Approved Prior to Jan 1, 1982	BRISTOL MYERS SQUIBB	Discontinued
AMNESTROGEN	083266	003	ANDA	ESTROGENS, ESTERIFIED	TABLET;ORAL	1.25MG	No	No	--	Approved Prior to Jan 1, 1982	BRISTOL MYERS SQUIBB	Discontinued
AMNESTROGEN	083266	004	ANDA	ESTROGENS, ESTERIFIED	TABLET;ORAL	2.5MG	No	No	--	Approved Prior to Jan 1, 1982	BRISTOL MYERS SQUIBB	Discontinued
ESTERIFIED ESTROGENS	083414	001	ANDA	ESTROGENS, ESTERIFIED	TABLET;ORAL	0.625MG	No	No	--	Approved Prior to Jan 1, 1982	PVT FORM	Discontinued
ESTROGENIC SUBSTANCE	083488	001	ANDA	ESTRONE	INJECTABLE;INJECTION	2MG/ML	No	No	--	Approved Prior to Jan 1, 1982	WYETH AYERST	Discontinued
ESTERIFIED ESTROGENS	083765	001	ANDA	ESTROGENS, ESTERIFIED	TABLET;ORAL	1.25MG	No	No	--	Approved Prior to Jan 1, 1982	PVT FORM	Discontinued
FEMOGEN	085076	001	ANDA	ESTROGENS, ESTERIFIED	TABLET;ORAL	0.625MG	No	No	--	Approved Prior to Jan 1, 1982	PVT FORM	Discontinued
NATURAL ESTROGENIC SUBSTANCE-ESTRONE	085237	001	ANDA	ESTRONE	INJECTABLE;INJECTION	2MG/ML	No	No	--	1982/11/23	WATSON LABS	Discontinued
ESTERIFIED ESTROGENS	085302	001	ANDA	ESTROGENS, ESTERIFIED	TABLET;ORAL	1.25MG	No	No	--	Approved Prior to Jan 1, 1982	SANDOZ	Discontinued
ESTERIFIED ESTROGENS	085907	001	ANDA	ESTROGENS, ESTERIFIED	TABLET;ORAL	2.5MG	No	No	--	Approved Prior to Jan 1, 1982	PVT FORM	Discontinued
COGENTIN	009193	002	NDA	BENZTROPINE MESYLATE	TABLET;ORAL	2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	Yes	No	1954/03/05	Approved Prior to Jan 1, 1982	MERCK	Discontinued
COGENTIN	009193	003	NDA	BENZTROPINE MESYLATE	TABLET;ORAL	1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	Yes	No	1954/03/05	Approved Prior to Jan 1, 1982	MERCK	Discontinued
COGENTIN	009193	004	NDA	BENZTROPINE MESYLATE	TABLET;ORAL	0.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	Yes	No	1954/03/05	Approved Prior to Jan 1, 1982	MERCK	Discontinued
DELESTROGEN	009402	002	NDA	ESTRADIOL VALERATE	INJECTABLE;INJECTION	10MG/ML	Yes	Yes	1954/07/15	Approved Prior to Jan 1, 1982	ENDO OPERATIONS	Prescription
DELESTROGEN	009402	003	NDA	ESTRADIOL VALERATE	INJECTABLE;INJECTION	40MG/ML	Yes	No	1954/07/15	Approved Prior to Jan 1, 1982	ENDO OPERATIONS	Discontinued
DELESTROGEN	009402	004	NDA	ESTRADIOL VALERATE	INJECTABLE;INJECTION	20MG/ML	Yes	Yes	1954/07/15	Approved Prior to Jan 1, 1982	ENDO OPERATIONS	Prescription
COGENTIN	012015	001	NDA	BENZTROPINE MESYLATE	INJECTABLE;INJECTION	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	Yes	No	1959/12/21	Approved Prior to Jan 1, 1982	EPIC PHARMA LLC	Discontinued