TAGAMET(CIMETIDINE) - 美国FDA药品数据库

药品名称	TAGAMET
申请号	017920	产品号	004
活性成分	CIMETIDINE	市场状态	停止上市
剂型或给药途径	TABLET;ORAL	规格	400MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons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	1983/12/14	申请机构	GLAXOSMITHKLINE
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
017920	095	AP	Letter	2006/07/21	下载
017920	094	AP	Letter	2005/12/16	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
017920	095	AP	2006/07/12	Labeling Revision
017920	094	AP	2005/12/14	Labeling Revision
017920	092	AP	1998/07/29	Control Supplement
017920	091	AP	1998/07/14	Package Change
017920	090	AP	1997/04/15	Control Supplement
017920	089	AP	1996/07/16	Manufacturing Change or Addition
017920	088	AP	1996/01/19	Control Supplement
017920	087	AP	1995/02/22	Labeling Revision
017920	086	AP	1993/11/10	Manufacturing Change or Addition
017920	085	AP	1993/09/29	Control Supplement
017920	084	AP	1993/06/08	Manufacturing Change or Addition
017920	082	AP	1992/07/16	Control Supplement
017920	081	AP	1992/01/07	Labeling Revision
017920	080	AP	1992/08/27	Control Supplement
017920	078	AP	1991/11/13	Labeling Revision
017920	077	AP	1989/11/13	Labeling Revision
017920	075	AP	1990/05/30	Control Supplement
017920	074	AP	1991/03/07	New or Modified Indication
017920	073	AP	1989/06/26	Labeling Revision
017920	072	AP	1989/06/26	Labeling Revision
017920	069	AP	1988/06/15	Labeling Revision
017920	068	AP	1988/05/20	Labeling Revision
017920	067	AP	1988/03/31	New Dosage Regimen
017920	066	AP	1986/04/29	New or Modified Indication
017920	065	AP	1986/04/23	Labeling Revision
017920	064	AP	1986/01/13	Labeling Revision
017920	063	AP	1985/12/18	Manufacturing Change or Addition
017920	062	AP	1986/04/30	Control Supplement
017920	061	AP	1985/04/18	Labeling Revision
017920	059	AP	1985/02/07	Labeling Revision
017920	057	AP	1986/04/29	New Dosage Regimen
017920	055	AP	1984/09/26	Package Change
017920	054	AP	1984/06/18	Labeling Revision
017920	053	AP	1984/07/19	Labeling Revision
017920	052	AP	1984/03/22	Labeling Revision
017920	051	AP	1984/03/05	Labeling Revision
017920	050	AP	1983/09/23	Manufacturing Change or Addition
017920	048	AP	1984/07/19	Labeling Revision
017920	047	AP	1983/12/14	General Efficacy (MarkIV)
017920	045	AP	1983/02/28	Labeling Revision
017920	044	AP	1983/01/31	General Efficacy (MarkIV)
017920	043	AP	1984/12/27	General Efficacy (MarkIV)
017920	042	AP	1983/01/04	Control Supplement
017920	041	AP	1982/08/25	General Efficacy (MarkIV)
017920	038	AP	1982/01/22	Labeling Revision
017920	037	AP	1981/11/02	Labeling Revision
017920	036	AP	1981/07/13	Labeling Revision
017920	035	AP	1982/12/30	Labeling Revision
017920	032	AP	1981/01/22	Labeling Revision
017920	031	AP	1981/01/22	Labeling Revision
017920	030	AP	1982/12/30	General Efficacy (MarkIV)
017920	029	AP	1981/06/02	Formulation Revision
017920	028	AP	1980/07/08	Labeling Revision
017920	027	AP	1980/07/08	Labeling Revision
017920	026	AP	1980/07/08	Labeling Revision
017920	024	AP	1980/04/23	Labeling Revision
017920	023	AP	1981/08/28	Expiration Date Change
017920	022	AP	1980/01/07	Package Change
017920	019	AP	1979/06/29	Labeling Revision
017920	018	AP	1980/01/08	Control Supplement
017920	017	AP	1980/04/23	General Efficacy (MarkIV)
017920	016	AP	1979/02/01	Labeling Revision
017920	015	AP	1979/02/28	Control Supplement
017920	014	AP	1978/11/30	Labeling Revision
017920	013	AP	1978/11/30	Labeling Revision
017920	011	AP	1978/09/28	Labeling Revision
017920	009	AP	1978/09/28	Manufacturing Change or Addition
017920	008	AP	1980/04/23	General Efficacy (MarkIV)
017920	005	AP	1978/03/16	Expiration Date Change
017920	004	AP	1977/11/30	Labeling Revision
017920	003	AP	1977/11/30	Labeling Revision
017920	001	AP	1978/03/17	Labeling Revision
017920	000	AP	1977/08/16	Approval

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