PAMELOR(NORTRIPTYLINE HYDROCHLORIDE) - 美国FDA药品数据库

药品名称	PAMELOR
申请号	018013	产品号	004
活性成分	NORTRIPTYLINE HYDROCHLORIDE	市场状态	处方药
剂型或给药途径	CAPSULE;ORAL	规格	EQ 50MG BASE
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	MALLINCKRODT LLC
化学类型	New formulation or new manufacturer	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
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
018013	063	AP	Letter	2014/07/29	下载
018013	063	AP	Label	2014/07/29	下载
018013	062	AP	Label	2014/07/11	下载
018013	062	AP	Letter	2014/07/11	下载
018013	061	AP	Label	2012/10/26	下载
018013	061	AP	Letter	2012/10/29	下载
018013	058	AP	Label	2007/07/16	下载
018013	058	AP	Letter	2007/07/24	下载
018013	056	AP	Letter	2005/01/13	下载
018013	056	AP	Label	2005/01/13	下载
018013	053	AP	Review	2009/09/14	下载
018013	000	AP	Medication Guide	2009/11/20	下载
018013	000	AP	Other Important Information from FDA	2007/05/09	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
018013	063	AP	2014/07/28	Labeling Revision
018013	062	AP	2014/07/10	Labeling Revision
018013	061	AP	2012/10/26	Labeling Revision
018013	058	AP	2007/07/13	Labeling Revision
018013	056	AP	2005/01/12	Labeling Revision
018013	055	AP	2004/12/06	Manufacturing Change or Addition
018013	054	AP	2001/06/07	Manufacturing Change or Addition
018013	053	AP	2001/07/31	Labeling Revision
018013	052	AP	2000/04/27	Manufacturing Change or Addition
018013	051	AP	1999/04/15	Package Change
018013	050	AP	1999/04/28	Manufacturing Change or Addition
018013	048	AP	1995/12/07	Manufacturing Change or Addition
018013	047	AP	1995/09/18	Control Supplement
018013	044	AP	1994/07/07	Control Supplement
018013	043	AP	1994/04/15	Manufacturing Change or Addition
018013	042	AP	1994/04/01	Package Change
018013	041	AP	1993/10/06	Labeling Revision
018013	039	AP	1993/07/23	Package Change
018013	038	AP	1993/08/17	Formulation Revision
018013	037	AP	1993/06/16	Control Supplement
018013	036	AP	1993/06/16	Control Supplement
018013	035	AP	1993/06/10	Control Supplement
018013	034	AP	1993/07/23	Control Supplement
018013	033	AP	1992/01/21	Manufacturing Change or Addition
018013	032	AP	1992/03/12	Package Change
018013	031	AP	1991/08/02	Control Supplement
018013	030	AP	1993/08/26	Labeling Revision
018013	029	AP	1991/03/13	Labeling Revision
018013	026	AP	1990/03/26	Manufacturing Change or Addition
018013	023	AP	1989/11/07	Package Change
018013	021	AP	1988/11/07	Package Change
018013	020	AP	1990/01/16	Package Change
018013	019	AP	1986/08/25	Control Supplement
018013	016	AP	1985/06/11	Labeling Revision
018013	015	AP	1985/06/27	Formulation Revision
018013	014	AP	1984/12/11	Package Change
018013	012	AP	1984/05/01	Labeling Revision
018013	010	AP	1982/06/02	Control Supplement
018013	009	AP	1982/03/25	Package Change
018013	008	AP	1981/06/26	Manufacturing Change or Addition
018013	007	AP	1981/07/24	Package Change
018013	005	AP	1979/11/20	Labeling Revision
018013	004	AP	1979/09/17	Package Change
018013	003	AP	1979/06/14	Manufacturing Change or Addition
018013	002	AP	1982/02/18	General Efficacy (MarkIV)
018013	001	AP	1978/06/29	General Efficacy (MarkIV)
018013	000	AP	1977/08/01	Approval

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