MONOPRIL(FOSINOPRIL SODIUM) - 美国FDA药品数据库

药品名称	MONOPRIL
申请号	019915	产品号	003
活性成分	FOSINOPRIL SODIUM	市场状态	停止上市
剂型或给药途径	TABLET;ORAL	规格	20MG
治疗等效代码		参比药物	否
批准日期	1991/05/16	申请机构	BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE
化学类型	New molecular entity (NME)	审评分类	Standard 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
5006344	2009/07/10				PDF格式
5006344*PED	2010/01/10				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
PED	2006/11/27

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
019915	042	AP	Letter	2009/02/13	下载
019915	038	AP	Letter	2003/11/05	下载
019915	037	AP	Letter	2003/06/08	下载
019915	037	AP	Label	2003/06/08	下载
019915	032	AP	Review	2003/07/08	下载
019915	032	AP	Letter	2002/08/29	下载
019915	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
019915	042	AP	2009/02/09	Labeling Revision
019915	038	AP	2003/10/29	Labeling Revision
019915	037	AP	2003/05/27	Patient Population Altered
019915	034	AP	2000/09/21	Control Supplement
019915	033	AP	2000/06/26	Control Supplement
019915	032	AP	2002/08/29	Labeling Revision
019915	031	AP	1999/11/16	Manufacturing Change or Addition
019915	030	AP	1999/05/24	Manufacturing Change or Addition
019915	029	AP	1999/05/21	Control Supplement
019915	028	AP	1999/03/11	Manufacturing Change or Addition
019915	027	AP	1998/08/11	Manufacturing Change or Addition
019915	026	AP	1998/01/28	Manufacturing Change or Addition
019915	025	AP	1997/10/01	Manufacturing Change or Addition
019915	024	AP	1997/09/12	Manufacturing Change or Addition
019915	023	AP	1997/02/21	Manufacturing Change or Addition
019915	022	AP	1997/01/14	Manufacturing Change or Addition
019915	021	AP	1997/01/08	Labeling Revision
019915	020	AP	1996/08/02	Manufacturing Change or Addition
019915	019	AP	1996/03/20	Manufacturing Change or Addition
019915	018	AP	1995/09/29	Control Supplement
019915	017	AP	1996/07/24	Labeling Revision
019915	016	AP	1995/03/27	Manufacturing Change or Addition
019915	015	AP	1994/12/30	Manufacturing Change or Addition
019915	014	AP	1995/02/08	Manufacturing Change or Addition
019915	013	AP	1995/03/28	Manufacturing Change or Addition
019915	012	AP	1994/12/30	Manufacturing Change or Addition
019915	011	AP	1994/06/14	Manufacturing Change or Addition
019915	010	AP	1994/05/19	Labeling Revision
019915	009	AP	1995/05/02	New or Modified Indication
019915	008	AP	1993/04/05	Manufacturing Change or Addition
019915	007	AP	1992/10/07	Labeling Revision
019915	006	AP	1992/07/10	Manufacturing Change or Addition
019915	005	AP	1992/09/22	Formulation Revision
019915	004	AP	1992/06/25	Labeling Revision
019915	003	AP	1991/09/09	Manufacturing Change or Addition
019915	002	AP	1991/06/27	Control Supplement
019915	001	AP	1991/06/27	Control Supplement
019915	000	AP	1991/05/16	Approval

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