TOFRANIL-PM(IMIPRAMINE PAMOATE) - 美国FDA药品数据库

药品名称	TOFRANIL-PM
申请号	017090	产品号	004
活性成分	IMIPRAMINE PAMOATE	市场状态	停止上市
剂型或给药途径	CAPSULE;ORAL	规格	EQ 100MG HCL Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons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	Approved Prior to Jan 1, 1982	申请机构	MALLINCKRODT INC
化学类型	New active ingredient	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
017090	078	AP	Letter	2014/07/29	下载
017090	078	AP	Label	2014/07/29	下载
017090	077	AP	Label	2014/07/11	下载
017090	077	AP	Letter	2014/07/11	下载
017090	076	AP	Label	2012/10/26	下载
017090	076	AP	Letter	2012/10/29	下载
017090	074	AP	Label	2007/07/16	下载
017090	074	AP	Letter	2007/07/24	下载
017090	070	AP	Letter	2005/01/13	下载
017090	070	AP	Label	2005/01/13	下载
017090	069	AP	Letter	2004/03/28	下载
017090	000	AP	Other Important Information from FDA	2007/05/09	下载
017090	000	AP	Medication Guide	2012/10/29	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
017090	078	AP	2014/07/28	Labeling Revision
017090	077	AP	2014/07/10	Labeling Revision
017090	076	AP	2012/10/26	Labeling Revision
017090	074	AP	2007/07/13	Labeling Revision
017090	070	AP	2005/01/12	Labeling Revision
017090	069	AP	2004/03/26	Labeling Revision
017090	068	AP	2002/06/20	Manufacturing Change or Addition
017090	067	AP	2002/01/03	Labeling Revision
017090	066	AP	2000/06/21	Manufacturing Change or Addition
017090	065	AP	2000/04/26	Control Supplement
017090	064	AP	1999/04/15	Package Change
017090	063	AP	1997/07/31	Control Supplement
017090	062	AP	2000/03/27	Labeling Revision
017090	061	AP	2000/03/27	Labeling Revision
017090	060	AP	2000/03/27	Labeling Revision
017090	059	AP	1993/02/19	Control Supplement
017090	058	AP	1992/12/08	Labeling Revision
017090	057	AP	1991/08/02	Control Supplement
017090	056	AP	1990/04/05	Package Change
017090	055	AP	1989/10/25	Manufacturing Change or Addition
017090	054	AP	1989/10/25	Manufacturing Change or Addition
017090	053	AP	1989/08/08	Manufacturing Change or Addition
017090	052	AP	1989/04/07	Package Change
017090	051	AP	1987/08/12	New Dosage Regimen
017090	050	AP	1986/05/20	Control Supplement
017090	049	AP	1985/11/27	Labeling Revision
017090	048	AP	1985/05/05	Control Supplement
017090	047	AP	1985/04/26	Labeling Revision
017090	046	AP	1984/10/29	Control Supplement
017090	045	AP	1984/03/26	Labeling Revision
017090	044	AP	1984/11/05	Control Supplement
017090	042	AP	1983/05/04	Package Change
017090	041	AP	1986/07/18	Expiration Date Change
017090	040	AP	1981/02/04	Labeling Revision
017090	039	AP	1980/04/16	Manufacturing Change or Addition
017090	038	AP	1980/04/16	Package Change
017090	037	AP	1980/01/30	Package Change
017090	036	AP	1979/06/07	Package Change
017090	035	AP	1979/06/07	Manufacturing Change or Addition
017090	034	AP	1979/12/28	Control Supplement
017090	033	AP	1979/12/28	Control Supplement
017090	032	AP	1979/01/02	Labeling Revision
017090	025	AP	1977/06/07	Control Supplement
017090	023	AP	1975/12/03	Control Supplement
017090	019	AP	1974/06/03	Control Supplement
017090	017	AP	1974/05/28	Control Supplement
017090	016	AP	1974/05/28	Control Supplement
017090	015	AP	1974/05/28	Control Supplement
017090	014	AP	1974/05/28	Control Supplement
017090	013	AP	1974/05/28	Control Supplement
017090	012	AP	1974/05/28	Control Supplement
017090	010	AP	1974/05/22	Other Amendment
017090	009	AP	1974/05/22	Other Amendment
017090	008	AP	1974/05/22	Other Amendment
017090	007	AP	1974/05/22	Other Amendment
017090	006	AP	1974/05/22	Other Amendment
017090	000	AP	1973/03/11	Approval

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