药品名称DEPO-PROVERA
申请号020246产品号001
活性成分MEDROXYPROGESTERONE ACETATE市场状态处方药
剂型或给药途径INJECTABLE;INJECTION规格150MG/ML
治疗等效代码AB参比药物
批准日期1992/10/29申请机构PHARMACIA AND UPJOHN CO
化学类型New formulation or new manufacturer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
020246054APLetter2015/01/26下载
020246054APLabel2015/01/29下载
020246053APLetter2015/02/02下载
020246053APLabel2015/02/03下载
020246052APReview2014/08/05下载
020246050APReview2014/08/05下载
020246049APReview2014/08/05下载
020246048APReview2014/08/05下载
020246036APLetter2010/10/19下载
020246036APLabel2010/10/19下载
020246035APLetter2011/08/01下载
020246035APLabel2011/08/05下载
020246025APLetter2004/12/02下载
020246025APLabel2004/12/03下载
020246019APLetter2003/06/08下载
020246019APLabel2003/06/08下载
020246013APLabel2005/11/01下载
020246013APLetter2005/11/01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
020246054AP2015/01/23Labeling Revision
020246053AP2015/01/30Labeling Revision
020246052AP2014/06/09Manufacturing Change or Addition
020246050AP2013/09/27Manufacturing Change or Addition
020246049AP2013/09/10Manufacturing Change or Addition
020246048AP2013/03/25Manufacturing Change or Addition
020246040AP2016/02/24Manufacturing Change or Addition
020246036AP2010/10/15Efficacy Supplement with Clinical Data to Support
020246035AP2011/07/28Efficacy Supplement with Clinical Data to Support
020246025AP2004/11/17Labeling Revision
020246019AP2003/05/23Control Supplement
020246018AP2002/05/23Control Supplement
020246017AP2002/04/26Control Supplement
020246015AP2001/06/07Manufacturing Change or Addition
020246014AP2000/04/03Manufacturing Change or Addition
020246013AP2005/10/28Labeling Revision
020246012AP1998/08/12Labeling Revision
020246011AP1997/01/31Labeling Revision
020246009AP1996/03/20Labeling Revision
020246008AP1995/11/28Control Supplement
020246007AP1995/05/03Control Supplement
020246006AP1996/02/01Control Supplement
020246004AP1994/12/01Labeling Revision
020246003AP1994/12/01Labeling Revision
020246002AP1994/02/17Manufacturing Change or Addition
020246000AP1992/10/29Approval