TEGRETOL(CARBAMAZEPINE) - 美国FDA药品数据库

药品名称	TEGRETOL
申请号	016608	产品号	001
活性成分	CARBAMAZEPINE	市场状态	处方药
剂型或给药途径	TABLET;ORAL	规格	200MG
治疗等效代码	AB	参比药物	是
批准日期	Approved Prior to Jan 1, 1982	申请机构	NOVARTIS PHARMACEUTICALS CORP
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
016608	107	AP	Label	2012/12/13	下载
016608	107	AP	Letter	2012/12/13	下载
016608	106	AP	Letter	2011/11/10	下载
016608	105	AP	Letter	2013/03/08	下载
016608	105	AP	Label	2013/03/08	下载
016608	103	AP	Letter	2014/01/17	下载
016608	103	AP	Label	2014/01/17	下载
016608	102	AP	Medication Guide	2011/03/07	下载
016608	102	AP	Letter	2011/03/07	下载
016608	102	AP	Label	2011/03/07	下载
016608	101	AP	Letter	2009/05/01	下载
016608	101	AP	Label	2009/05/12	下载
016608	100	AP	Letter	2011/03/07	下载
016608	100	AP	Medication Guide	2011/03/07	下载
016608	100	AP	Label	2011/03/07	下载
016608	099	AP	Letter	2014/09/17	下载
016608	099	AP	Label	2014/09/19	下载
016608	098	AP	Label	2007/12/12	下载
016608	098	AP	Other	2007/12/31	下载
016608	098	AP	Letter	2008/01/09	下载
016608	097	AP	Letter	2015/09/01	下载
016608	097	AP	Label	2015/09/03	下载
016608	096	AP	Label	2007/08/17	下载
016608	096	AP	Letter	2007/08/17	下载
016608	090	AP	Letter	2001/03/07	下载
016608	090	AP	Label	2001/03/07	下载
016608	090	AP	Review	2007/03/08	下载
016608	000	AP	Medication Guide	2012/12/18	下载
016608	000	AP	Review	2004/12/08	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
016608	111	AP	2015/10/30	Manufacturing Change or Addition
016608	108	AP	2013/11/08	Manufacturing Change or Addition
016608	107	AP	2012/12/11	Labeling Revision
016608	106	AP	2011/10/30	Labeling Revision
016608	105	AP	2013/03/06	Labeling Revision
016608	103	AP	2014/01/16	Labeling Revision
016608	102	AP	2011/03/03	Labeling Revision
016608	101	AP	2009/04/23	Labeling Revision
016608	100	AP	2011/03/03	Labeling Revision
016608	099	AP	2014/09/16	Labeling Revision
016608	098	AP	2007/12/11	Labeling Revision
016608	097	AP	2015/08/28	Labeling Revision
016608	096	AP	2007/08/16	Labeling Revision
016608	094	AP	2002/01/28	Control Supplement
016608	093	AP	2001/11/15	Manufacturing Change or Addition
016608	092	AP	2001/11/19	Manufacturing Change or Addition
016608	091	AP	2000/05/18	Manufacturing Change or Addition
016608	090	AP	2001/03/07	Labeling Revision
016608	089	AP	2000/04/11	Manufacturing Change or Addition
016608	088	AP	2000/04/10	Labeling Revision
016608	087	AP	1999/06/07	Manufacturing Change or Addition
016608	086	AP	1999/04/21	Package Change
016608	085	AP	1998/07/15	Labeling Revision
016608	084	AP	2000/04/10	Labeling Revision
016608	083	AP	1998/07/15	Labeling Revision
016608	082	AP	1997/03/06	Expiration Date Change
016608	081	AP	1998/07/15	Labeling Revision
016608	080	AP	1998/07/15	Labeling Revision
016608	079	AP	1995/10/05	Package Change
016608	077	AP	1993/10/06	Control Supplement
016608	071	AP	1991/03/14	Control Supplement
016608	070	AP	1990/06/01	Control Supplement
016608	068	AP	1990/03/26	Labeling Revision
016608	066	AP	1990/03/28	Manufacturing Change or Addition
016608	065	AP	1990/03/28	Manufacturing Change or Addition
016608	064	AP	1990/03/27	Manufacturing Change or Addition
016608	063	AP	1989/07/21	Labeling Revision
016608	062	AP	1989/04/07	Package Change
016608	061	AP	1988/08/01	Labeling Revision
016608	060	AP	1988/08/08	Control Supplement
016608	059	AP	1995/10/11	Patient Population Altered
016608	058	AP	1987/07/31	Labeling Revision
016608	056	AP	1986/02/03	Labeling Revision
016608	055	AP	1986/01/10	Labeling Revision
016608	054	AP	1986/06/02	General Efficacy (MarkIV)
016608	053	AP	1986/01/10	Labeling Revision
016608	052	AP	1985/05/06	Control Supplement
016608	051	AP	1985/03/08	Manufacturing Change or Addition
016608	050	AP	1984/07/31	Manufacturing Change or Addition
016608	049	AP	1983/09/14	Control Supplement
016608	048	AP	1987/07/31	Patient Population Altered
016608	047	AP	1982/07/08	Package Change
016608	046	AP	1982/02/09	Package Change
016608	045	AP	1981/12/08	Labeling Revision
016608	043	AP	1980/02/01	Manufacturing Change or Addition
016608	042	AP	1980/03/25	Labeling Revision
016608	041	AP	1979/04/09	Manufacturing Change or Addition
016608	039	AP	1978/11/22	Control Supplement
016608	038	AP	1978/11/22	Control Supplement
016608	037	AP	1978/08/09	Labeling Revision
016608	036	AP	1978/08/09	Labeling Revision
016608	035	AP	1977/04/04	Control Supplement
016608	034	AP	1977/04/04	Control Supplement
016608	033	AP	1977/04/04	Package Change
016608	032	AP	1975/12/12	Control Supplement
016608	029	AP	1975/12/09	Control Supplement
016608	028	AP	1976/11/08	Labeling Revision
016608	027	AP	1975/07/02	Control Supplement
016608	026	AP	1975/03/31	Control Supplement
016608	025	AP	1974/12/12	Control Supplement
016608	024	AP	1974/11/15	Control Supplement
016608	023	AP	1975/03/28	Distributor
016608	022	AP	1974/08/20	Control Supplement
016608	021	AP	1974/11/08	Control Supplement
016608	020	AP	1974/08/29	Control Supplement
016608	019	AP	1974/08/29	Control Supplement
016608	018	AP	1974/08/29	Control Supplement
016608	017	AP	1974/08/29	Control Supplement
016608	016	AP	1974/08/29	Control Supplement
016608	015	AP	1974/08/29	Control Supplement
016608	014	AP	1974/08/29	Control Supplement
016608	012	AP	1974/07/15	Labeling Revision
016608	000	AP	1968/03/11	Approval

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