AZULFIDINE EN-TABS(SULFASALAZINE) - 美国FDA药品数据库

药品名称	AZULFIDINE EN-TABS
申请号	007073	产品号	002
活性成分	SULFASALAZINE	市场状态	处方药
剂型或给药途径	TABLET, DELAYED RELEASE;ORAL	规格	500MG
治疗等效代码	AB	参比药物	是
批准日期	1983/04/06	申请机构	PHARMACIA AND UPJOHN CO
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
007073	128	AP	Label	2014/03/05	下载
007073	128	AP	Letter	2014/03/06	下载
007073	126	AP	Letter	2013/07/22	下载
007073	126	AP	Label	2013/07/23	下载
007073	125	AP	Label	2012/12/13	下载
007073	125	AP	Letter	2012/12/18	下载
007073	124	AP	Label	2009/10/21	下载
007073	120	AP	Letter	2004/05/27	下载
007073	115	AP	Letter	2004/05/27	下载
007073	115	AP	Label	2003/05/07	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
007073	128	AP	2014/03/04	Labeling Revision
007073	127	AP	2015/11/20	Manufacturing Change or Addition
007073	126	AP	2013/07/18	Labeling Revision
007073	125	AP	2012/12/12	Labeling Revision
007073	124	AP	2009/10/19	Labeling Revision
007073	121	AP	2002/11/12	Manufacturing Change or Addition
007073	120	AP	2002/07/30	Labeling Revision
007073	118	AP	2000/09/26	Labeling Revision
007073	117	AP	2001/02/05	Package Change
007073	116	AP	2000/08/18	Labeling Revision
007073	115	AP	2001/08/17	Labeling Revision
007073	113	AP	2000/04/18	Labeling Revision
007073	112	AP	2000/04/25	Labeling Revision
007073	110	AP	1999/08/13	Labeling Revision
007073	109	AP	2000/04/24	Labeling Revision
007073	107	AP	1997/12/23	Manufacturing Change or Addition
007073	106	AP	1995/05/18	Manufacturing Change or Addition
007073	105	AP	1996/07/25	Manufacturing Change or Addition
007073	104	AP	1996/03/05	Control Supplement
007073	103	AP	1996/06/14	Package Change
007073	102	AP	1996/10/17	Labeling Revision
007073	101	AP	1996/06/14	Package Change
007073	100	AP	1995/03/29	Manufacturing Change or Addition
007073	099	AP	1996/02/21	Formulation Revision
007073	098	AP	1994/12/19	Control Supplement
007073	097	AP	1995/09/28	Manufacturing Change or Addition
007073	096	AP	1993/11/03	Labeling Revision
007073	095	AP	1993/11/02	Labeling Revision
007073	094	AP	1993/10/20	Manufacturing Change or Addition
007073	093	AP	1994/06/08	Manufacturing Change or Addition
007073	092	AP	1994/06/08	Formulation Revision
007073	091	AP	1993/04/05	Labeling Revision
007073	090	AP	1993/04/05	Labeling Revision
007073	089	AP	1993/08/09	Control Supplement
007073	088	AP	1993/08/09	Control Supplement
007073	087	AP	1994/01/26	Control Supplement
007073	086	AP	1993/06/09	Control Supplement
007073	085	AP	1994/06/07	Control Supplement
007073	084	AP	1993/10/20	Manufacturing Change or Addition
007073	083	AP	1992/09/22	Control Supplement
007073	082	AP	1990/11/07	Labeling Revision
007073	081	AP	1990/11/07	Labeling Revision
007073	080	AP	1991/07/10	Formulation Revision
007073	079	AP	1991/07/10	Formulation Revision
007073	077	AP	1984/05/11	Labeling Revision
007073	076	AP	1983/12/12	Labeling Revision
007073	075	AP	1983/01/18	Package Change
007073	074	AP	1985/07/19	Manufacturing Change or Addition
007073	073	AP	1982/07/02	Manufacturing Change or Addition
007073	072	AP	1982/07/15	Manufacturing Change or Addition
007073	071	AP	1985/02/05	Practioner Draft Labeling
007073	070	AP	1985/02/05	Practioner Draft Labeling
007073	065	AP	1981/06/30	Labeling Revision
007073	064	AP	1981/03/25	Labeling Revision
007073	061	AP	1981/03/25	Labeling Revision
007073	060	AP	1981/03/25	Labeling Revision
007073	054	AP	1981/03/05	Control Supplement
007073	020	AP	1983/04/06	Labeling Revision
007073	018	AP	1983/04/06	Control Supplement
007073	017	AP	1983/04/06	Control Supplement
007073	000	AP	1950/06/20	Approval

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