TOLECTIN(TOLMETIN SODIUM) - 美国FDA药品数据库

药品名称	TOLECTIN
申请号	017628	产品号	001
活性成分	TOLMETIN SODIUM	市场状态	停止上市
剂型或给药途径	TABLET;ORAL	规格	EQ 200MG BASE
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	ORTHO MCNEIL JANSSEN PHARMACEUTICALS INC
化学类型	New molecular entity (NME)	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
017628	068	AP	Letter	2008/01/24	下载
017628	068	AP	Label	2008/01/24	下载
017628	067	AP	Label	2006/02/22	下载
017628	067	AP	Letter	2006/02/22	下载
017628	000	AP	Medication Guide	2009/12/04	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
017628	068	AP	2008/01/22	Labeling Revision
017628	067	AP	2006/02/09	Labeling Revision
017628	065	AP	2001/03/21	Manufacturing Change or Addition
017628	064	AP	2001/02/26	Manufacturing Change or Addition
017628	062	AP	1996/03/04	Manufacturing Change or Addition
017628	060	AP	1993/06/11	Manufacturing Change or Addition
017628	059	AP	1993/01/21	Control Supplement
017628	058	AP	1992/10/02	Package Change
017628	057	AP	1991/03/25	Labeling Revision
017628	056	AP	1991/07/11	Control Supplement
017628	055	AP	1992/01/21	Control Supplement
017628	054	AP	1989/12/18	Manufacturing Change or Addition
017628	053	AP	1990/08/17	Control Supplement
017628	051	AP	1989/10/17	Control Supplement
017628	048	AP	1989/05/30	Control Supplement
017628	045	AP	1989/05/30	Control Supplement
017628	044	AP	1987/12/02	Package Change
017628	043	AP	1986/07/31	Package Change
017628	042	AP	1986/07/31	Package Change
017628	041	AP	1989/07/28	Package Change
017628	040	AP	1985/12/11	Labeling Revision
017628	039	AP	1985/12/11	Labeling Revision
017628	038	AP	1985/12/11	Labeling Revision
017628	037	AP	1988/10/19	Formulation Revision
017628	036	AP	1985/02/07	Labeling Revision
017628	035	AP	1984/10/05	Control Supplement
017628	034	AP	1984/05/03	Control Supplement
017628	033	AP	1985/01/18	Labeling Revision
017628	031	AP	1989/03/08	New Dosage Regimen
017628	030	AP	1983/05/25	Manufacturing Change or Addition
017628	029	AP	1983/01/31	Labeling Revision
017628	028	AP	1983/01/31	Labeling Revision
017628	027	AP	1985/01/18	Labeling Revision
017628	024	AP	1988/04/29	New Dosage Regimen
017628	020	AP	1984/12/11	Manufacturing Change or Addition
017628	019	AP	1985/01/18	Labeling Revision
017628	018	AP	1983/06/16	Manufacturing Change or Addition
017628	017	AP	1982/07/27	Control Supplement
017628	016	AP	1982/07/12	Manufacturing Change or Addition
017628	015	AP	1981/03/30	Manufacturing Change or Addition
017628	014	AP	1980/09/19	Manufacturing Change or Addition
017628	013	AP	1982/07/22	Manufacturing Change or Addition
017628	012	AP	1985/01/18	Labeling Revision
017628	011	AP	1981/11/22	Labeling Revision
017628	009	AP	1979/03/13	Package Change
017628	008	AP	1979/04/06	General Efficacy (MarkIV)
017628	005	AP	1978/02/21	General Efficacy (MarkIV)
017628	004	AP	1979/05/15	Expiration Date Change
017628	003	AP	1976/07/23	Labeling Revision
017628	002	AP	1976/06/28	Manufacturing Change or Addition
017628	001	AP	1976/07/23	Manufacturing Change or Addition
017628	000	AP	1976/03/24	Approval

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