DESFERAL(DEFEROXAMINE MESYLATE) - 美国FDA药品数据库

药品名称	DESFERAL
申请号	016267	产品号	001
活性成分	DEFEROXAMINE MESYLATE	市场状态	处方药
剂型或给药途径	INJECTABLE;INJECTION	规格	500MG/VIAL
治疗等效代码	AP	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
016267	050	AP	Label	2011/12/20	下载
016267	050	AP	Letter	2011/12/21	下载
016267	047	AP	Letter	2010/09/09	下载
016267	047	AP	Label	2010/09/10	下载
016267	045	AP	Letter	2009/01/30	下载
016267	045	AP	Label	2009/02/04	下载
016267	044	AP	Label	2007/01/24	下载
016267	044	AP	Letter	2007/01/25	下载
016267	039	AP	Letter	2002/02/14	下载
016267	034	AP	Letter	2001/04/09	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
016267	052	AP	2016/04/27	Manufacturing Change or Addition
016267	051	AP	2013/06/14	Manufacturing Change or Addition
016267	050	AP	2011/12/16	Labeling Revision
016267	047	AP	2010/09/07	Labeling Revision
016267	045	AP	2009/01/28	Labeling Revision
016267	044	AP	2007/01/19	Labeling Revision
016267	040	AP	2002/01/15	Manufacturing Change or Addition
016267	039	AP	2002/02/14	Labeling Revision
016267	038	AP	2001/07/05	Control Supplement
016267	037	AP	2002/04/24	Control Supplement
016267	036	AP	2001/01/05	Control Supplement
016267	035	AP	2000/04/28	Manufacturing Change or Addition
016267	034	AP	2001/04/09	Labeling Revision
016267	033	AP	2000/05/25	Package Change
016267	032	AP	1998/10/23	Manufacturing Change or Addition
016267	031	AP	1998/12/22	Manufacturing Change or Addition
016267	030	AP	1998/12/22	Package Change
016267	029	AP	1998/12/22	Manufacturing Change or Addition
016267	028	AP	1997/04/02	Labeling Revision
016267	027	AP	1995/06/19	Labeling Revision
016267	026	AP	1994/08/31	Labeling Revision
016267	025	AP	1998/01/30	Control Supplement
016267	024	AP	1998/01/30	Manufacturing Change or Addition
016267	022	AP	1990/02/12	Package Change
016267	021	AP	1987/09/08	Labeling Revision
016267	020	AP	1987/02/13	Labeling Revision
016267	019	AP	1985/09/27	Control Supplement
016267	018	AP	1986/01/08	Control Supplement
016267	017	AP	1984/01/04	Package Change
016267	016	AP	1984/04/06	Control Supplement
016267	015	AP	1986/04/17	Practioner Draft Labeling
016267	014	AP	1980/09/02	Manufacturing Change or Addition
016267	013	AP	1980/07/08	Package Change
016267	012	AP	1979/06/04	Labeling Revision
016267	011	AP	1979/06/04	General Efficacy (MarkIV)
016267	010	AP	1978/04/06	Manufacturing Change or Addition
016267	009	AP	1978/01/25	Control Supplement
016267	008	AP	1977/03/04	Other Amendment
016267	007	AP	1976/01/20	Labeling Revision
016267	000	AP	1968/04/01	Approval

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