ELAVIL(AMITRIPTYLINE HYDROCHLORIDE) - 美国FDA药品数据库

药品名称	ELAVIL
申请号	012703	产品号	003
活性成分	AMITRIPTYLINE HYDROCHLORIDE	市场状态	停止上市
剂型或给药途径	TABLET;ORAL	规格	25MG
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	ASTRAZENECA PHARMACEUTICALS LP
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
012703	093	AP	Letter	2003/08/06	下载
012703	092	AP	Letter	2001/03/27	下载
012703	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
012703	093	AP	2003/07/29	Labeling Revision
012703	092	AP	2001/03/27	Labeling Revision
012703	091	AP	2001/01/22	Control Supplement
012703	090	AP	2000/04/05	Labeling Revision
012703	089	AP	1998/12/24	Manufacturing Change or Addition
012703	088	AP	2000/04/05	Labeling Revision
012703	087	AP	1996/12/30	Package Change
012703	086	AP	2000/04/05	Labeling Revision
012703	085	AP	1995/07/13	Control Supplement
012703	084	AP	2000/04/05	Labeling Revision
012703	083	AP	1994/06/01	Formulation Revision
012703	082	AP	1994/06/01	Control Supplement
012703	081	AP	1991/06/24	Labeling Revision
012703	080	AP	1989/07/28	Manufacturing Change or Addition
012703	079	AP	1991/06/24	Labeling Revision
012703	078	AP	1988/04/08	Package Change
012703	077	AP	1988/12/12	Formulation Revision
012703	076	AP	1991/06/24	Labeling Revision
012703	075	AP	1988/02/26	Control Supplement
012703	074	AP	1986/04/02	Expiration Date Change
012703	073	AP	1986/07/10	Labeling Revision
012703	072	AP	1985/09/20	Labeling Revision
012703	071	AP	1984/09/13	Package Change
012703	070	AP	1984/08/15	Package Change
012703	069	AP	1984/03/07	Manufacturing Change or Addition
012703	068	AP	1983/03/15	Labeling Revision
012703	067	AP	1983/05/26	Manufacturing Change or Addition
012703	065	AP	1984/05/21	Labeling Revision
012703	064	AP	1983/05/03	Control Supplement
012703	062	AP	1981/06/25	Manufacturing Change or Addition
012703	061	AP	1981/03/23	Labeling Revision
012703	060	AP	1980/09/03	Labeling Revision
012703	059	AP	1980/06/23	Labeling Revision
012703	058	AP	1981/03/02	Formulation Revision
012703	057	AP	1981/09/04	Formulation Revision
012703	056	AP	1981/03/02	Manufacturing Change or Addition
012703	054	AP	1980/03/04	Labeling Revision
012703	053	AP	1980/01/29	Labeling Revision
012703	052	AP	1979/11/06	Labeling Revision
012703	050	AP	1981/03/02	Manufacturing Change or Addition
012703	049	AP	1980/01/29	Manufacturing Change or Addition
012703	046	AP	1978/01/25	Package Change
012703	044	AP	1977/03/01	Package Change
012703	043	AP	1976/08/02	Control Supplement
012703	042	AP	1976/09/17	Labeling Revision
012703	041	AP	1976/08/02	Control Supplement
012703	039	AP	1976/10/28	Labeling Revision
012703	038	AP	1975/09/18	Labeling Revision
012703	037	AP	1975/09/18	Labeling Revision
012703	036	AP	1975/09/17	Control Supplement
012703	035	AP	1975/09/17	Control Supplement
012703	032	AP	1981/03/09	Control Supplement
012703	000	AP	1961/04/07	Approval

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