LOPRESSOR(METOPROLOL TARTRATE) - 美国FDA药品数据库

药品名称	LOPRESSOR
申请号	017963	产品号	001
活性成分	METOPROLOL TARTRATE	市场状态	处方药
剂型或给药途径	TABLET;ORAL	规格	50MG
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	US PHARMACEUTICALS HOLDINGS I 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
017963	068	AP	Letter	2013/03/15	下载
017963	068	AP	Label	2013/03/15	下载
017963	067	AP	Letter	2012/12/26	下载
017963	067	AP	Label	2013/01/11	下载
017963	064	AP	Label	2011/03/21	下载
017963	063	AP	Label	2009/11/23	下载
017963	063	AP	Letter	2010/01/06	下载
017963	062	AP	Label	2008/07/29	下载
017963	062	AP	Letter	2008/07/30	下载
017963	061	AP	Letter	2008/01/09	下载
017963	059	AP	Letter	2006/09/18	下载
017963	058	AP	Letter	2003/09/25	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
017963	071	AP	2016/03/21	Manufacturing Change or Addition
017963	070	AP	2014/10/30	Manufacturing Change or Addition
017963	069	AP	2014/10/30	Manufacturing Change or Addition
017963	068	AP	2013/03/14	Labeling Revision
017963	067	AP	2012/12/21	Labeling Revision
017963	064	AP	2011/03/15	Labeling Revision
017963	063	AP	2009/11/20	Labeling Revision
017963	062	AP	2008/07/24	Labeling Revision
017963	061	AP	2008/01/08	Labeling Revision
017963	059	AP	2006/09/05	Labeling Revision
017963	058	AP	2003/09/12	Labeling Revision
017963	057	AP	2002/06/14	Control Supplement
017963	056	AP	2002/04/29	Manufacturing Change or Addition
017963	055	AP	2001/07/30	Manufacturing Change or Addition
017963	054	AP	2000/05/10	Manufacturing Change or Addition
017963	053	AP	1999/04/28	Package Change
017963	052	AP	1999/02/18	Manufacturing Change or Addition
017963	051	AP	1999/03/16	Labeling Revision
017963	050	AP	1995/11/02	Manufacturing Change or Addition
017963	049	AP	1995/02/03	Control Supplement
017963	047	AP	1991/01/30	Manufacturing Change or Addition
017963	046	AP	1990/06/14	Labeling Revision
017963	044	AP	1989/10/26	Formulation Revision
017963	043	AP	1989/01/03	Formulation Revision
017963	042	AP	1988/05/31	Package Change
017963	041	AP	1988/02/04	Control Supplement
017963	039	AP	1985/11/20	Formulation Revision
017963	038	AP	1985/10/16	Control Supplement
017963	037	AP	1985/07/30	Control Supplement
017963	036	AP	1985/01/03	Control Supplement
017963	034	AP	1986/06/27	New or Modified Indication
017963	033	AP	1984/06/28	Formulation Revision
017963	031	AP	1984/02/28	Control Supplement
017963	030	AP	1984/12/14	Formulation Revision
017963	028	AP	1983/04/12	General Efficacy (MarkIV)
017963	027	AP	1983/05/17	Package Change
017963	025	AP	1982/10/14	Package Change
017963	024	AP	1984/03/30	General Efficacy (MarkIV)
017963	023	AP	1982/03/26	Expiration Date Change
017963	022	AP	1981/09/03	Control Supplement
017963	021	AP	1981/04/20	Labeling Revision
017963	020	AP	1981/01/15	Package Change
017963	019	AP	1981/01/30	Labeling Revision
017963	017	AP	1980/09/03	Package Change
017963	016	AP	1980/01/17	Package Change
017963	015	AP	1980/02/05	Manufacturing Change or Addition
017963	014	AP	1980/05/12	Control Supplement
017963	013	AP	1981/03/27	Control Supplement
017963	012	AP	1980/01/17	Labeling Revision
017963	011	AP	1979/10/24	Manufacturing Change or Addition
017963	010	AP	1979/10/10	Manufacturing Change or Addition
017963	008	AP	1979/04/27	Package Change
017963	007	AP	1979/10/24	Package Change
017963	006	AP	1979/04/27	Package Change
017963	005	AP	1979/08/07	Package Change
017963	004	AP	1979/03/26	Manufacturing Change or Addition
017963	003	AP	1979/04/09	Manufacturing Change or Addition
017963	002	AP	1979/04/09	Package Change
017963	001	AP	1979/11/05	Package Change
017963	000	AP	1978/08/07	Approval

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