药品名称IMURAN
申请号016324产品号001
活性成分AZATHIOPRINE市场状态处方药
剂型或给药途径TABLET;ORAL规格50MG
治疗等效代码AB参比药物
批准日期Approved Prior to Jan 1, 1982申请机构SEBELA IRELAND LTD
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
016324037APLabel2014/02/07下载
016324037APLetter2014/02/11下载
016324035APLetter2011/05/26下载
016324035APLabel2011/05/25下载
016324034APLetter2011/05/26下载
016324034APLabel2011/05/25下载
016324031APLabel2008/07/10下载
016324031APLetter2008/07/14下载
016324030APLabel2005/07/29下载
016324030APLetter2005/07/29下载
016324026APLetter2004/06/07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
016324037AP2014/02/06Labeling Revision
016324036AP2014/05/21Manufacturing Change or Addition
016324035AP2011/05/24Labeling Revision
016324034AP2011/05/24Labeling Revision
016324031AP2008/07/09Labeling Revision
016324030AP2005/07/26Labeling Revision
016324026AP2002/12/19Labeling Revision
016324022AP1992/10/26Control Supplement
016324021AP1992/04/28Manufacturing Change or Addition
016324020AP1992/07/09Manufacturing Change or Addition
016324017AP1988/04/18Control Supplement
016324016AP1989/10/17Package Change
016324014AP1988/05/24Package Change
016324013AP1987/02/26Control Supplement
016324011AP1994/08/30Labeling Revision
016324010AP1981/04/13General Efficacy (MarkIV)
016324008AP1980/03/21Control Supplement
016324007AP1978/06/07Control Supplement
016324000AP1968/03/20Approval