CAPOTEN(CAPTOPRIL) - 美国FDA药品数据库

药品名称	CAPOTEN
申请号	018343	产品号	003
活性成分	CAPTOPRIL	市场状态	停止上市
剂型或给药途径	TABLET;ORAL	规格	100MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons
治疗等效代码		参比药物	否
批准日期	Approved Prior to Jan 1, 1982	申请机构	PAR PHARMACEUTICAL INC
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
5238924	2010/08/24			U-92	PDF格式

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
018343	086	AP	Letter	2015/06/22	下载
018343	086	AP	Label	2015/06/22	下载
018343	085	AP	Letter	2014/12/30	下载
018343	085	AP	Label	2015/01/09	下载
018343	084	AP	Label	2012/08/28	下载
018343	084	AP	Letter	2012/08/29	下载
018343	083	AP	Label	2011/12/14	下载
018343	083	AP	Letter	2011/12/15	下载
018343	082	AP	Label	2011/05/23	下载
018343	082	AP	Letter	2011/05/24	下载
018343	081	AP	Letter	2008/09/29	下载
018343	075	AP	Letter	2004/05/07	下载
018343	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
018343	086	AP	2015/06/19	Labeling Revision
018343	085	AP	2014/12/24	Labeling Revision
018343	084	AP	2012/08/27	Labeling Revision
018343	083	AP	2011/12/14	Labeling Revision
018343	082	AP	2011/05/19	Labeling Revision
018343	081	AP	2008/09/25	Labeling Revision
018343	075	AP	2004/05/07	Labeling Revision
018343	073	AP	1999/04/20	Labeling Revision
018343	072	AP	1998/01/09	Control Supplement
018343	071	AP	1997/08/21	Control Supplement
018343	070	AP	1996/06/25	Manufacturing Change or Addition
018343	069	AP	1996/03/01	Control Supplement
018343	068	AP	1996/07/31	Labeling Revision
018343	067	AP	1995/03/06	Control Supplement
018343	066	AP	1995/06/13	Formulation Revision
018343	065	AP	1993/11/04	Labeling Revision
018343	064	AP	1994/01/28	New or Modified Indication
018343	063	AP	1994/03/31	Labeling Revision
018343	062	AP	1993/05/12	Package Change
018343	061	AP	1992/06/25	Labeling Revision
018343	060	AP	1992/09/03	Labeling Revision
018343	059	AP	1992/12/21	Control Supplement
018343	058	AP	1992/01/14	Control Supplement
018343	057	AP	1995/06/19	Control Supplement
018343	056	AP	1992/05/07	Formulation Revision
018343	055	AP	1991/10/07	Manufacturing Change or Addition
018343	054	AP	1991/01/31	Package Change
018343	053	AP	1991/04/12	Manufacturing Change or Addition
018343	052	AP	1990/11/05	Package Change
018343	051	AP	1991/03/21	Labeling Revision
018343	050	AP	1990/09/27	Labeling Revision
018343	049	AP	1990/05/10	Manufacturing Change or Addition
018343	048	AP	1993/09/23	New or Modified Indication
018343	047	AP	1989/05/03	Labeling Revision
018343	046	AP	1989/10/19	Labeling Revision
018343	045	AP	1988/05/13	Control Supplement
018343	044	AP	1988/02/19	Labeling Revision
018343	041	AP	1987/06/26	Expiration Date Change
018343	040	AP	1988/05/13	New or Modified Indication
018343	039	AP	1987/01/06	Package Change
018343	038	AP	1987/01/21	Control Supplement
018343	037	AP	1987/02/13	Control Supplement
018343	036	AP	1987/04/02	Manufacturing Change or Addition
018343	035	AP	1986/08/14	Manufacturing Change or Addition
018343	033	AP	1986/07/24	Control Supplement
018343	032	AP	1990/03/23	Control Supplement
018343	031	AP	1986/03/04	Control Supplement
018343	030	AP	1986/09/17	Control Supplement
018343	029	AP	1986/05/27	Control Supplement
018343	028	AP	1986/02/27	Expiration Date Change
018343	027	AP	1986/01/17	Labeling Revision
018343	026	AP	1985/12/18	Package Change
018343	025	AP	1985/04/16	Control Supplement
018343	024	AP	1985/06/12	Manufacturing Change or Addition
018343	023	AP	1985/04/16	Control Supplement
018343	022	AP	1984/11/19	Control Supplement
018343	021	AP	1984/10/12	Labeling Revision
018343	020	AP	1984/07/12	Package Change
018343	018	AP	1985/01/17	General Efficacy (MarkIV)
018343	017	AP	1984/09/18	Control Supplement
018343	016	AP	1984/06/08	Package Change
018343	015	AP	1984/06/08	Package Change
018343	014	AP	1984/08/28	General Efficacy (MarkIV)
018343	013	AP	1983/10/14	Package Change
018343	012	AP	1984/02/07	Expiration Date Change
018343	011	AP	1983/10/14	Formulation Revision
018343	010	AP	1983/05/18	Control Supplement
018343	009	AP	1985/07/10	Labeling Revision
018343	008	AP	1984/02/07	Manufacturing Change or Addition
018343	007	AP	1982/03/09	Control Supplement
018343	006	AP	1982/02/25	Control Supplement
018343	005	AP	1982/10/25	General Efficacy (MarkIV)
018343	004	AP	1981/11/30	Formulation Revision
018343	003	AP	1981/10/27	Control Supplement
018343	002	AP	1982/10/07	Control Supplement
018343	001	AP	1981/06/12	Package Change
018343	000	AP	1981/04/06	Approval

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