药品名称METOPIRONE
申请号012911产品号001
活性成分METYRAPONE市场状态停止上市
剂型或给药途径TABLET;ORAL规格250MG
治疗等效代码参比药物
批准日期Approved Prior to Jan 1, 1982申请机构HRA PHARMA LLC
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
012911033APLetter2014/03/04下载
012911033APLabel2014/03/04下载
012911026APLetter2010/11/08下载
012911026APLabel2010/11/04下载
012911023APLetter2004/05/07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
012911034AP2014/08/14Manufacturing Change or Addition
012911033AP2013/09/05Manufacturing Change or Addition
012911032AP2013/09/20Manufacturing Change or Addition
012911031AP2013/06/28Manufacturing Change or Addition
012911030AP2013/01/19Manufacturing Change or Addition
012911026AP2010/11/04Labeling Revision
012911023AP2004/05/07Labeling Revision
012911020AP1999/04/21Package Change
012911019AP1999/02/09Manufacturing Change or Addition
012911018AP1996/06/27Formulation Revision
012911017AP1995/08/09Control Supplement
012911016AP1992/06/12Control Supplement
012911015AP1992/03/13Labeling Revision
012911014AP1992/03/26Control Supplement
012911013AP1986/02/10Labeling Revision
012911012AP1986/01/10Labeling Revision
012911011AP1984/08/29Control Supplement
012911010AP1982/04/26Labeling Revision
012911009AP1978/02/03Package Change
012911008AP1976/03/02Labeling Revision
012911000AP1961/12/04Approval