EFUDEX(FLUOROURACIL) - 美国FDA药品数据库

药品名称	EFUDEX
申请号	016831	产品号	003
活性成分	FLUOROURACIL	市场状态	处方药
剂型或给药途径	CREAM;TOPICAL	规格	5%
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	VALEANT PHARMACEUTICALS INTERNATIONAL
化学类型	New dosage form	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
016831	051	AP	Letter	2006/05/16	下载
016831	049	AP	Letter	2005/10/19	下载
016831	049	AP	Label	2005/10/19	下载
016831	047	AP	Letter	2004/06/25	下载
016831	047	AP	Label	2004/06/25	下载
016831	046	AP	Letter	2004/04/29	下载
016831	035	AP	Review	2011/06/23	下载
016831	031	AP	Review	2011/06/23	下载
016831	030	AP	Review	2011/06/23	下载
016831	028	AP	Review	2011/06/23	下载
016831	011	AP	Review	2011/06/23	下载
016831	008	AP	Review	2011/06/23	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
016831	059	AP	2015/11/04	Manufacturing Change or Addition
016831	058	AP	2015/08/18	Manufacturing Change or Addition
016831	057	AP	2015/05/06	Manufacturing Change or Addition
016831	056	AP	2013/07/02	Manufacturing Change or Addition
016831	055	AP	2013/12/12	Manufacturing Change or Addition
016831	051	AP	2006/05/10	Package Change
016831	049	AP	2005/10/13	Labeling Revision
016831	047	AP	2004/06/24	Labeling Revision
016831	046	AP	2004/04/27	Manufacturing Change or Addition
016831	043	AP	2002/11/27	Manufacturing Change or Addition
016831	042	AP	2001/08/30	Manufacturing Change or Addition
016831	041	AP	2001/07/03	Control Supplement
016831	040	AP	2001/07/03	Control Supplement
016831	039	AP	2001/02/12	Manufacturing Change or Addition
016831	038	AP	2000/06/20	Control Supplement
016831	037	AP	2000/07/07	Manufacturing Change or Addition
016831	036	AP	2000/07/07	Manufacturing Change or Addition
016831	035	AP	2000/04/05	Manufacturing Change or Addition
016831	033	AP	1998/11/02	Control Supplement
016831	032	AP	1997/02/18	Control Supplement
016831	031	AP	1993/08/05	Control Supplement
016831	030	AP	1993/03/04	Control Supplement
016831	029	AP	1995/03/21	Labeling Revision
016831	028	AP	1988/11/30	Manufacturing Change or Addition
016831	027	AP	1986/11/14	Manufacturing Change or Addition
016831	026	AP	1985/06/10	Package Change
016831	025	AP	1985/03/14	Control Supplement
016831	024	AP	1984/08/13	Control Supplement
016831	023	AP	1984/05/04	Control Supplement
016831	022	AP	1983/08/12	Control Supplement
016831	021	AP	1983/08/12	Control Supplement
016831	020	AP	1983/03/14	Control Supplement
016831	019	AP	1982/05/14	Control Supplement
016831	018	AP	1982/03/10	Labeling Revision
016831	017	AP	1987/03/26	Practioner Draft Labeling
016831	016	AP	1979/12/18	Control Supplement
016831	015	AP	1979/10/23	Control Supplement
016831	014	AP	1978/11/21	Manufacturing Change or Addition
016831	013	AP	1977/12/14	Control Supplement
016831	012	AP	1977/12/14	Control Supplement
016831	011	AP	1975/05/07	Control Supplement
016831	010	AP	1975/05/07	Control Supplement
016831	009	AP	1974/09/19	Control Supplement
016831	008	AP	1975/06/30	Control Supplement
016831	000	AP	1970/07/29	Approval

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