VASOTEC(ENALAPRIL MALEATE) - 美国FDA药品数据库

药品名称	VASOTEC
申请号	018998	产品号	005
活性成分	ENALAPRIL MALEATE	市场状态	处方药
剂型或给药途径	TABLET;ORAL	规格	2.5MG
治疗等效代码	AB	参比药物	否
批准日期	1988/07/26	申请机构	VALEANT PHARMACEUTICALS NORTH AMERICA LLC
化学类型	New molecular entity (NME)	审评分类	Priority review drug

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
018998	080	AP	Label	2015/08/26	下载
018998	080	AP	Letter	2015/08/27	下载
018998	079	AP	Letter	2014/12/30	下载
018998	079	AP	Label	2015/01/09	下载
018998	077	AP	Label	2012/09/14	下载
018998	077	AP	Letter	2012/09/17	下载
018998	076	AP	Label	2012/02/22	下载
018998	076	AP	Letter	2012/02/23	下载
018998	071	AP	Letter	2008/09/29	下载
018998	071	AP	Label	2010/05/18	下载
018998	070	AP	Letter	2007/11/08	下载
018998	064	AP	Review	2006/10/26	下载
018998	063	AP	Letter	2002/08/30	下载
018998	062	AP	Review	2006/10/25	下载
018998	061	AP	Review	2006/10/25	下载
018998	059	AP	Review	2001/02/13	下载
018998	059	AP	Letter	2001/02/13	下载
018998	059	AP	Label	2001/02/13	下载
018998	058	AP	Review	2001/11/27	下载
018998	058	AP	Letter	2001/11/27	下载
018998	058	AP	Label	2001/11/27	下载
018998	057	AP	Review	2001/06/22	下载
018998	053	AP	Review	1997/06/11	下载
018998	052	AP	Review	2007/04/09	下载
018998	051	AP	Review	2007/04/09	下载
018998	050	AP	Review	2007/07/06	下载
018998	046	AP	Review	2007/07/06	下载
018998	045	AP	Review	2007/06/12	下载
018998	044	AP	Review	2011/02/15	下载
018998	043	AP	Review	2011/02/15	下载
018998	042	AP	Review	2007/06/12	下载
018998	041	AP	Review	2007/06/12	下载
018998	040	AP	Review	2011/01/04	下载
018998	039	AP	Review	2011/01/04	下载
018998	038	AP	Review	2011/01/04	下载
018998	034	AP	Review	2007/07/06	下载
018998	025	AP	Review	2007/09/14	下载
018998	024	AP	Review	2007/09/14	下载
018998	023	AP	Review	2007/07/20	下载
018998	022	AP	Review	2007/07/20	下载
018998	021	AP	Review	2007/07/20	下载
018998	020	AP	Review	2007/07/06	下载
018998	018	AP	Review	2007/07/06	下载
018998	017	AP	Review	2007/09/14	下载
018998	016	AP	Review	2007/11/19	下载
018998	015	AP	Review	2007/07/06	下载
018998	013	AP	Review	2007/11/19	下载
018998	011	AP	Review	2007/11/19	下载
018998	009	AP	Review	2006/10/26	下载
018998	006	AP	Review	2006/10/26	下载
018998	005	AP	Review	2006/10/26	下载
018998	000	AP	Review	2005/04/27	下载
018998	000	AP	Other Important Information from FDA	2006/06/09	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
018998	080	AP	2015/08/25	Labeling Revision
018998	079	AP	2014/12/24	Labeling Revision
018998	077	AP	2012/09/13	Labeling Revision
018998	076	AP	2012/02/17	Labeling Revision
018998	071	AP	2008/09/25	Labeling Revision
018998	070	AP	2007/10/31	Labeling Revision
018998	064	AP	2002/10/10	Manufacturing Change or Addition
018998	063	AP	2002/08/30	Manufacturing Change or Addition
018998	062	AP	2002/04/03	Control Supplement
018998	061	AP	2002/02/04	Manufacturing Change or Addition
018998	059	AP	2001/02/13	Efficacy Supplement with Clinical Data to Support
018998	058	AP	2001/11/27	Labeling Revision
018998	057	AP	1999/02/17	Labeling Revision
018998	056	AP	1997/12/10	Control Supplement
018998	055	AP	1997/07/21	Manufacturing Change or Addition
018998	054	AP	1997/07/23	Package Change
018998	053	AP	1997/06/11	Labeling Revision
018998	052	AP	1997/02/03	Manufacturing Change or Addition
018998	051	AP	1997/01/09	Manufacturing Change or Addition
018998	050	AP	1996/03/22	Manufacturing Change or Addition
018998	049	AP	1995/09/19	Control Supplement
018998	048	AP	1995/09/19	Control Supplement
018998	047	AP	1995/09/19	Control Supplement
018998	046	AP	1995/09/28	Labeling Revision
018998	045	AP	1994/07/25	Labeling Revision
018998	044	AP	1994/05/16	Labeling Revision
018998	043	AP	1994/02/18	Labeling Revision
018998	042	AP	1994/07/15	Control Supplement
018998	041	AP	1994/12/12	Manufacturing Change or Addition
018998	040	AP	1993/10/21	Labeling Revision
018998	039	AP	1994/01/14	Labeling Revision
018998	038	AP	1994/05/11	Labeling Revision
018998	037	AP	1993/07/01	Labeling Revision
018998	036	AP	1993/02/24	Labeling Revision
018998	035	AP	1993/07/26	Manufacturing Change or Addition
018998	034	AP	1996/07/31	Labeling Revision
018998	033	AP	1992/09/30	Labeling Revision
018998	032	AP	1993/11/04	New or Modified Indication
018998	031	AP	1992/05/07	Labeling Revision
018998	030	AP	1992/05/13	Labeling Revision
018998	029	AP	1992/09/30	Package Change
018998	027	AP	1992/04/08	Patient Population Altered
018998	026	AP	1991/08/02	Package Change
018998	025	AP	1991/02/06	Labeling Revision
018998	024	AP	1990/11/28	Labeling Revision
018998	023	AP	1990/07/19	Package Change
018998	022	AP	1990/06/12	New or Modified Indication
018998	021	AP	1990/03/09	Labeling Revision
018998	020	AP	1989/11/30	Labeling Revision
018998	018	AP	1989/04/18	Labeling Revision
018998	017	AP	1991/02/20	Manufacturing Change or Addition
018998	016	AP	1989/01/10	Labeling Revision
018998	015	AP	1989/03/29	Labeling Revision
018998	013	AP	1988/08/03	Manufacturing Change or Addition
018998	012	AP	1988/07/26	Formulation Revision
018998	011	AP	1988/04/25	Labeling Revision
018998	009	AP	1987/07/10	Package Change
018998	007	AP	1988/06/24	New or Modified Indication
018998	006	AP	1987/01/28	Labeling Revision
018998	005	AP	1987/05/14	Labeling Revision
018998	004	AP	1986/10/03	Labeling Revision
018998	003	AP	1986/11/07	Control Supplement
018998	002	AP	1986/10/27	Control Supplement
018998	000	AP	1985/12/24	Approval

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