药品名称DEPO-PROVERA
申请号012541产品号002
活性成分MEDROXYPROGESTERONE ACETATE市场状态停止上市
剂型或给药途径INJECTABLE;INJECTION规格100MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
治疗等效代码参比药物
批准日期Approved Prior to Jan 1, 1982申请机构PHARMACIA AND UPJOHN CO
化学类型New formulation or new manufacturer审评分类Standard 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
012541084APLabel2016/06/13下载
012541084APLetter2016/06/14下载
012541083APLetter2015/06/12下载
012541083APLabel2015/06/12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
012541084AP2016/06/10Labeling Revision
012541083AP2015/06/11Labeling Revision
012541082AP2014/06/09Manufacturing Change or Addition
012541078AP2012/11/20Manufacturing Change or Addition
012541069AP2000/04/03Manufacturing Change or Addition
012541067AP1997/11/28Labeling Revision
012541066AP1995/11/28Control Supplement
012541065AP1995/04/18Control Supplement
012541064AP1995/04/12Package Change
012541063AP1994/07/27Control Supplement
012541062AP1994/06/16Control Supplement
012541061AP1994/02/17Control Supplement
012541060AP1994/02/18Labeling Revision
012541058AP1993/06/23Control Supplement
012541057AP1995/09/07Labeling Revision
012541056AP1990/02/20Labeling Revision
012541049AP1980/05/20Manufacturing Change or Addition
012541042AP1978/12/04Labeling Revision
012541041AP1976/11/01Expiration Date Change
012541039AP1976/11/01Control Supplement
012541038AP1976/11/01Labeling Revision
012541037AP1979/01/19Control Supplement
012541000AP1960/09/23Approval