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
GARAMYCIN	060462	001	ANDA	GENTAMICIN SULFATE	CREAM;TOPICAL	EQ 0.1% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	No	No	1966/03/15	Approved Prior to Jan 1, 1982	SCHERING	Discontinued
GARAMYCIN	060463	001	ANDA	GENTAMICIN SULFATE	OINTMENT;TOPICAL	EQ 0.1% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	No	No	1966/03/15	Approved Prior to Jan 1, 1982	SCHERING	Discontinued
GARAMYCIN	050039	002	NDA	GENTAMICIN SULFATE	SOLUTION/DROPS;OPHTHALMIC	EQ 0.3% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	Yes	No	1970/06/19	Approved Prior to Jan 1, 1982	SCHERING	Discontinued
GARAMYCIN	050425	001	NDA	GENTAMICIN SULFATE	OINTMENT;OPHTHALMIC	EQ 0.3% BASE	No	No	1970/11/25	Approved Prior to Jan 1, 1982	SCHERING	Discontinued
GARAMYCIN	061739	001	ANDA	GENTAMICIN SULFATE	INJECTABLE;INJECTION	EQ 10MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	No	No	1973/05/03	Approved Prior to Jan 1, 1982	SCHERING	Discontinued
GARAMYCIN	050505	001	NDA	GENTAMICIN SULFATE	INJECTABLE;INTRATHECAL	EQ 2MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	Yes	No	1979/10/01	Approved Prior to Jan 1, 1982	SCHERING	Discontinued
GARAMYCIN	061716	001	ANDA	GENTAMICIN SULFATE	INJECTABLE;INJECTION	EQ 40MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	No	No	1981/03/03	Approved Prior to Jan 1, 1982	SCHERING	Discontinued
GARAMYCIN	061716	002	ANDA	GENTAMICIN SULFATE	INJECTABLE;INJECTION	EQ 1MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	No	No	1981/03/03	Approved Prior to Jan 1, 1982	SCHERING	Discontinued