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
KEFLEX	050405	002	NDA	CEPHALEXIN	CAPSULE;ORAL	EQ 250MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	Yes	No	1971/01/04	Approved Prior to Jan 1, 1982	PRAGMA	Discontinued
KEFLEX	050405	003	NDA	CEPHALEXIN	CAPSULE;ORAL	EQ 500MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	Yes	No	1971/01/04	Approved Prior to Jan 1, 1982	PRAGMA	Discontinued
KEFLEX	050405	004	NDA	CEPHALEXIN	CAPSULE;ORAL	EQ 333MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	Yes	No	1971/01/04	2006/05/12	PRAGMA	Discontinued
KEFLEX	050405	005	NDA	CEPHALEXIN	CAPSULE;ORAL	EQ 750MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	Yes	No	1971/01/04	2006/05/12	PRAGMA	Discontinued
KEFLEX	050406	001	NDA	CEPHALEXIN	FOR SUSPENSION;ORAL	EQ 125MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	Yes	No	1971/01/04	Approved Prior to Jan 1, 1982	PRAGMA	Discontinued
KEFLEX	050406	002	NDA	CEPHALEXIN	FOR SUSPENSION;ORAL	EQ 250MG BASE/5ML *Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	Yes	No	1971/01/04	Approved Prior to Jan 1, 1982	PRAGMA	Discontinued
KEFLEX	050406	003	NDA	CEPHALEXIN	FOR SUSPENSION;ORAL	EQ 100MG BASE/ML *Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	Yes	No	1971/01/04	Approved Prior to Jan 1, 1982	PRAGMA	Discontinued