药品名称PREMARIN
申请号020216产品号001
活性成分ESTROGENS, CONJUGATED市场状态处方药
剂型或给药途径CREAM;TOPICAL, VAGINAL规格0.625MG/GM
治疗等效代码参比药物
批准日期Approved Prior to Jan 1, 1982申请机构WYETH PHARMACEUTICALS INC
化学类型审评分类
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
I-5792011/11/07
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
020216081APLetter2015/12/30下载
020216081APLabel2015/12/31下载
020216075APLetter2012/02/15下载
020216075APLabel2012/02/17下载
020216074APLabel2012/02/17下载
020216074APLetter2012/02/15下载
020216073APLetter2012/02/15下载
020216073APLabel2012/02/17下载
020216067APLetter2011/04/25下载
020216067APLabel2011/04/26下载
020216060APLabel2008/11/12下载
020216060APLetter2008/11/13下载
020216059APLabel2008/03/05下载
020216059APLetter2008/03/05下载
020216055APLabel2006/07/27下载
020216055APLetter2006/08/04下载
020216054APLetter2005/09/07下载
020216054APLabel2005/09/07下载
020216053APLetter2005/01/21下载
020216053APLabel2005/01/21下载
020216052APLabel2004/04/23下载
020216052APLetter2004/04/29下载
020216033APReview2011/02/15下载
020216030APReview2011/01/07下载
020216018APReview2011/01/07下载
020216000APReview2011/02/15下载
020216000APOther Important Information from FDA2009/06/02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
020216082AP2016/09/15Manufacturing Change or Addition
020216081AP2015/12/28Labeling Revision
020216078AP2014/09/25Manufacturing Change or Addition
020216075AP2012/02/14Labeling Revision
020216074AP2012/02/14Labeling Revision
020216073AP2012/02/14Labeling Revision
020216067AP2011/04/22Labeling Revision
020216060AP2008/11/07New or Modified Indication
020216059AP2008/03/03Labeling Revision
020216056AP2007/12/20Labeling Revision
020216055AP2006/07/26Labeling Revision
020216054AP2005/08/30Labeling Revision
020216053AP2005/01/14Labeling Revision
020216052AP2004/04/20Labeling Revision
020216050AP2002/05/08Manufacturing Change or Addition
020216043AP1998/12/04Formulation Revision
020216040AP1995/12/14Control Supplement
020216039AP1995/07/11Labeling Revision
020216038AP1995/08/30Control Supplement
020216037AP1995/07/11Labeling Revision
020216036AP1995/02/06Manufacturing Change or Addition
020216034AP1994/10/14Manufacturing Change or Addition
020216033AP1993/06/14Formulation Revision
020216031AP1990/06/07Labeling in Effect
020216030AP1990/05/10Labeling
020216026AP1988/02/12Chemistry
020216025AP1988/02/12Chemistry
020216020AP1985/12/17Chemistry
020216019AP1985/12/17Chemistry
020216018AP1985/12/17Chemistry
020216017AP1985/11/07Chemistry
020216015AP1984/05/03Chemistry
020216009AP1982/08/30Chemistry
020216008AP1982/08/30Chemistry
020216007AP1982/08/30Chemistry
020216006AP1982/10/05Chemistry
020216000AP1978/10/16Approval