PARLODEL(BROMOCRIPTINE MESYLATE) - 美国FDA药品数据库

药品名称	PARLODEL
申请号	017962	产品号	002
活性成分	BROMOCRIPTINE MESYLATE	市场状态	停止上市
剂型或给药途径	CAPSULE;ORAL	规格	EQ 5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons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	1982/03/01	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
017962	068	AP	Letter	2012/01/06	下载
017962	068	AP	Label	2012/01/06	下载
017962	065	AP	Letter	2012/01/06	下载
017962	065	AP	Label	2012/01/06	下载
017962	064	AP	Review	2006/05/08	下载
017962	064	AP	Label	2005/11/17	下载
017962	064	AP	Letter	2005/11/17	下载
017962	063	AP	Review	2006/05/08	下载
017962	063	AP	Letter	2005/11/17	下载
017962	063	AP	Label	2005/11/17	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
017962	076	AP	2016/09/27	Manufacturing Change or Addition
017962	075	AP	2014/11/26	Manufacturing Change or Addition
017962	074	AP	2016/06/13	Manufacturing Change or Addition
017962	072	AP	2014/02/27	Manufacturing Change or Addition
017962	071	AP	2013/07/31	Manufacturing Change or Addition
017962	068	AP	2012/01/05	Labeling Revision
017962	065	AP	2012/01/05	Labeling Revision
017962	064	AP	2005/11/09	Labeling Revision
017962	063	AP	2005/11/09	Labeling Revision
017962	062	AP	2002/02/21	Manufacturing Change or Addition
017962	061	AP	2001/11/20	Manufacturing Change or Addition
017962	060	AP	2001/05/22	Control Supplement
017962	059	AP	2000/05/01	Manufacturing Change or Addition
017962	058	AP	1999/10/01	Manufacturing Change or Addition
017962	057	AP	1999/09/10	Manufacturing Change or Addition
017962	056	AP	1999/04/22	Package Change
017962	055	AP	1998/09/03	Manufacturing Change or Addition
017962	054	AP	1998/08/13	Manufacturing Change or Addition
017962	053	AP	1999/11/09	Labeling Revision
017962	052	AP	1998/04/02	Labeling Revision
017962	051	AP	1996/07/03	Labeling Revision
017962	050	AP	1995/11/28	Manufacturing Change or Addition
017962	049	AP	1995/10/10	Control Supplement
017962	048	AP	1995/03/24	Labeling Revision
017962	047	AP	1995/02/08	Labeling Revision
017962	046	AP	1995/06/09	Control Supplement
017962	045	AP	1994/07/29	Package Change
017962	044	AP	1995/03/13	Control Supplement
017962	042	AP	1994/05/25	Labeling Revision
017962	040	AP	1993/04/01	Manufacturing Change or Addition
017962	039	AP	1993/04/01	Package Change
017962	038	AP	1992/05/29	Labeling Revision
017962	037	AP	1991/12/11	Labeling Revision
017962	036	AP	1992/05/29	Labeling Revision
017962	035	AP	1992/06/09	Control Supplement
017962	034	AP	1990/10/22	Control Supplement
017962	033	AP	1990/10/22	Control Supplement
017962	032	AP	1990/10/22	Control Supplement
017962	030	AP	1989/03/02	Control Supplement
017962	029	AP	1989/12/19	Package Change
017962	028	AP	1990/06/04	Package Change
017962	027	AP	1991/12/31	Labeling Revision
017962	025	AP	1987/07/01	Labeling Revision
017962	022	AP	1987/01/28	Labeling Revision
017962	021	AP	1987/01/21	Control Supplement
017962	020	AP	1985/09/17	Control Supplement
017962	019	AP	1984/12/14	Labeling Revision
017962	018	AP	1985/06/28	General Efficacy (MarkIV)
017962	017	AP	1983/11/30	Control Supplement
017962	016	AP	1982/07/29	Control Supplement
017962	015	AP	1982/07/29	Control Supplement
017962	014	AP	1982/08/26	Control Supplement
017962	013	AP	1984/02/16	Control Supplement
017962	012	AP	1981/06/11	Manufacturing Change or Addition
017962	011	AP	1982/03/01	Control Supplement
017962	010	AP	1984/12/14	Labeling Revision
017962	009	AP	1981/02/06	Package Change
017962	008	AP	1981/02/04	Package Change
017962	007	AP	1982/07/29	Control Supplement
017962	006	AP	1981/09/23	Other Amendment
017962	004	AP	1979/05/17	Package Change
017962	003	AP	1979/02/27	Manufacturing Change or Addition
017962	002	AP	1979/02/16	Control Supplement
017962	001	AP	1980/02/07	Manufacturing Change or Addition
017962	000	AP	1978/06/28	Approval

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