药品名称DESFERAL
申请号016267产品号002
活性成分DEFEROXAMINE MESYLATE市场状态处方药
剂型或给药途径INJECTABLE;INJECTION规格2GM/VIAL
治疗等效代码AP参比药物
批准日期2000/05/25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
历史专利信息
与本品相关的市场独占权保护信息
独占权代码失效日期
历史市场独占权保护信息
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
016267050APLabel2011/12/20下载
016267050APLetter2011/12/21下载
016267047APLetter2010/09/09下载
016267047APLabel2010/09/10下载
016267045APLetter2009/01/30下载
016267045APLabel2009/02/04下载
016267044APLabel2007/01/24下载
016267044APLetter2007/01/25下载
016267039APLetter2002/02/14下载
016267034APLetter2001/04/09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
016267052AP2016/04/27Manufacturing Change or Addition
016267051AP2013/06/14Manufacturing Change or Addition
016267050AP2011/12/16Labeling Revision
016267047AP2010/09/07Labeling Revision
016267045AP2009/01/28Labeling Revision
016267044AP2007/01/19Labeling Revision
016267040AP2002/01/15Manufacturing Change or Addition
016267039AP2002/02/14Labeling Revision
016267038AP2001/07/05Control Supplement
016267037AP2002/04/24Control Supplement
016267036AP2001/01/05Control Supplement
016267035AP2000/04/28Manufacturing Change or Addition
016267034AP2001/04/09Labeling Revision
016267033AP2000/05/25Package Change
016267032AP1998/10/23Manufacturing Change or Addition
016267031AP1998/12/22Manufacturing Change or Addition
016267030AP1998/12/22Package Change
016267029AP1998/12/22Manufacturing Change or Addition
016267028AP1997/04/02Labeling Revision
016267027AP1995/06/19Labeling Revision
016267026AP1994/08/31Labeling Revision
016267025AP1998/01/30Control Supplement
016267024AP1998/01/30Manufacturing Change or Addition
016267022AP1990/02/12Package Change
016267021AP1987/09/08Labeling Revision
016267020AP1987/02/13Labeling Revision
016267019AP1985/09/27Control Supplement
016267018AP1986/01/08Control Supplement
016267017AP1984/01/04Package Change
016267016AP1984/04/06Control Supplement
016267015AP1986/04/17Practioner Draft Labeling
016267014AP1980/09/02Manufacturing Change or Addition
016267013AP1980/07/08Package Change
016267012AP1979/06/04Labeling Revision
016267011AP1979/06/04General Efficacy (MarkIV)
016267010AP1978/04/06Manufacturing Change or Addition
016267009AP1978/01/25Control Supplement
016267008AP1977/03/04Other Amendment
016267007AP1976/01/20Labeling Revision
016267000AP1968/04/01Approval