KEFLEX(CEPHALEXIN) - 美国FDA药品数据库

药品名称	KEFLEX
申请号	050405	产品号	003
活性成分	CEPHALEXIN	市场状态	处方药
剂型或给药途径	CAPSULE;ORAL	规格	EQ 500MG BASE
治疗等效代码	AB	参比药物	否
批准日期	Approved Prior to Jan 1, 1982	申请机构	PRAGMA PHARMACEUTICALS LLC
化学类型		审评分类

与本品相关的专利信息（来自橙皮书Orange Book）
专利号	专利过期日	是否化合物专利	是否产品专利	专利用途代码	专利下载
无
历史专利信息
无

与本品相关的市场独占权保护信息
独占权代码	失效日期
无
历史市场独占权保护信息
无

与药品注册相关的信息
申请号	修订号	审批结论	公开文档类型	文档创建时间	获取文档
050405	106	AP	Letter	2015/11/04	下载
050405	106	AP	Label	2015/11/04	下载
050405	101	AP	Letter	2008/09/17	下载
050405	099	AP	Letter	2008/05/21	下载
050405	097	AP	Label	2006/05/16	下载
050405	097	AP	Letter	2006/05/16	下载
050405	095	AP	Letter	2004/07/01	下载
050405	094	AP	Letter	2004/01/22	下载
050405	094	AP	Label	2004/01/22	下载
050405	092	AP	Letter	2004/12/02	下载

药品注册审批历史信息
申请号	修订号	审批结论	审批日期	审批内容
050405	106	AP	2015/10/30	Labeling Revision
050405	104	AP	2013/12/30	Manufacturing Change or Addition
050405	101	AP	2008/09/16	Labeling Revision
050405	099	AP	2008/05/21	Labeling Revision
050405	097	AP	2006/05/12	Efficacy Supplement with Clinical Data to Support
050405	095	AP	2004/06/25	Labeling Revision
050405	094	AP	2004/01/15	Labeling Revision
050405	093	AP	2002/10/23	Control Supplement
050405	092	AP	2004/11/19	Labeling Revision
050405	091	AP	2001/07/27	Manufacturing Change or Addition
050405	090	AP	1996/05/15	Labeling Revision
050405	089	AP	1995/02/13	Labeling Revision
050405	088	AP	1988/11/04	Manufacturing Change or Addition
050405	087	AP	1977/05/25	Manufacturing Change or Addition
050405	086	AP	1977/04/28	Expiration Date Change
050405	085	AP	1977/04/22	Labeling Revision
050405	084	AP	1977/03/15	Control Supplement
050405	083	AP	1977/03/09	Control Supplement
050405	082	AP	1977/02/28	Labeling Revision
050405	081	AP	1976/12/17	Labeling Revision
050405	080	AP	1976/12/10	Control Supplement
050405	079	AP	1976/12/10	Control Supplement
050405	078	AP	1976/09/08	Labeling Revision
050405	077	AP	1976/09/08	Labeling Revision
050405	076	AP	1976/09/02	Labeling Revision
050405	075	AP	1976/08/10	Control Supplement
050405	074	AP	1976/06/08	Labeling Revision
050405	073	AP	1976/04/22	Labeling Revision
050405	072	AP	1976/04/09	Labeling Revision
050405	071	AP	1976/03/10	Control Supplement
050405	070	AP	1976/03/10	Control Supplement
050405	069	AP	1975/11/17	Labeling Revision
050405	068	AP	1975/10/24	Labeling Revision
050405	065	AP	1975/09/16	Labeling Revision
050405	064	AP	1975/09/08	Labeling Revision
050405	063	AP	1975/09/04	Labeling Revision
050405	062	AP	1975/08/12	Labeling Revision
050405	061	AP	1975/08/04	Labeling Revision
050405	060	AP	1975/07/31	Control Supplement
050405	059	AP	1975/07/08	Labeling Revision
050405	057	AP	1975/04/07	Expiration Date Change
050405	056	AP	1974/12/13	Labeling Revision
050405	055	AP	1974/10/02	Labeling Revision
050405	054	AP	1974/09/03	Labeling Revision
050405	053	AP	1974/10/04	New or Modified Indication
050405	052	AP	1974/08/28	Labeling Revision
050405	051	AP	1974/08/22	Labeling Revision
050405	050	AP	1974/08/16	Labeling Revision
050405	049	AP	1974/07/10	Formulation Revision
050405	048	AP	1974/05/24	Labeling Revision
050405	047	AP	1974/06/28	Labeling Revision
050405	046	AP	1974/03/06	Labeling Revision
050405	045	AP	1974/02/20	Expiration Date Change
050405	044	AP	1974/01/24	Control Supplement
050405	043	AP	1974/01/15	Control Supplement
050405	042	AP	1973/11/08	Expiration Date Change
050405	041	AP	1973/10/02	Labeling Revision
050405	040	AP	1973/07/31	Labeling Revision
050405	039	AP	1973/07/25	Control Supplement
050405	038	AP	1973/06/25	Labeling Revision
050405	037	AP	1973/06/19	Labeling Revision
050405	036	AP	1973/06/04	Labeling Revision
050405	035	AP	1973/04/27	Labeling Revision
050405	034	AP	1973/02/15	Control Supplement
050405	033	AP	1973/01/18	Control Supplement
050405	032	AP	1972/12/13	Labeling Revision
050405	031	AP	1972/07/19	Control Supplement
050405	030	AP	1972/12/13	Labeling Revision
050405	029	AP	1972/02/24	Labeling Revision
050405	028	AP	1972/01/12	Control Supplement
050405	027	AP	1971/12/13	Control Supplement
050405	025	AP	1971/11/30	Control Supplement
050405	024	AP	1971/10/06	Labeling Revision
050405	023	AP	1971/10/19	Expiration Date Change
050405	022	AP	1971/07/01	Labeling Revision
050405	021	AP	1971/05/19	Labeling Revision
050405	020	AP	1971/05/13	Labeling Revision
050405	019	AP	1971/04/14	Labeling Revision
050405	018	AP	1971/01/07	Manufacturing Change or Addition
050405	016	AP	1991/10/09	Control Supplement
050405	015	AP	1992/08/27	Labeling Revision
050405	014	AP	1990/04/10	Labeling Revision
050405	013	AP	1988/09/21	Labeling Revision
050405	012	AP	1987/02/17	New or Modified Indication
050405	011	AP	1987/03/04	Labeling Revision
050405	010	AP	1987/03/04	Manufacturing Change or Addition
050405	009	AP	1986/08/29	Labeling Revision
050405	008	AP	1971/08/06	Labeling Revision
050405	007	AP	1971/07/07	Labeling Revision
050405	005	AP	1986/08/21	New or Modified Indication
050405	004	AP	1985/11/22	Labeling Revision
050405	003	AP	1985/11/04	Control Supplement
050405	002	AP	1971/02/08	Control Supplement
050405	001	AP	1984/09/05	Control Supplement
050405	000	AP	1971/01/04	Approval

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