药品名称PREMPRO
申请号020527产品号005
活性成分ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE市场状态处方药
剂型或给药途径TABLET;ORAL-28规格0.3MG;1.5MG
治疗等效代码参比药物
批准日期2003/06/04申请机构WYETH PHARMACEUTICALS INC
化学类型New dosage form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
55479482015/01/17PDF格式
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
020527062APLetter2015/09/04下载
020527062APLabel2015/09/04下载
020527056APLetter2012/02/07下载
020527056APLabel2012/02/06下载
020527054APLabel2012/02/06下载
020527054APLetter2012/02/07下载
020527052APLetter2012/02/07下载
020527052APLabel2012/02/06下载
020527051APLabel2012/02/06下载
020527051APLetter2012/02/07下载
020527046APReview2013/01/24下载
020527046APLetter2009/05/26下载
020527046APLabel2009/06/05下载
020527045APLabel2010/01/04下载
020527045APLetter2010/01/06下载
020527043APLabel2008/03/05下载
020527043APLetter2008/03/05下载
020527037APLabel2006/08/04下载
020527037APLetter2006/08/04下载
020527036APLabel2005/07/07下载
020527036APLetter2005/07/08下载
020527035APLetter2004/04/29下载
020527035APLabel2004/12/29下载
020527034APLabel2004/04/23下载
020527034APLetter2004/04/29下载
020527031APLetter2003/06/08下载
020527031APLabel2003/06/08下载
020527031APReview2011/01/07下载
020527030APLetter2003/01/07下载
020527030APLabel2003/01/07下载
020527029APLetter2002/11/27下载
020527029APLabel2002/11/27下载
020527026APLetter2003/06/08下载
020527026APLabel2003/06/08下载
020527026APReview2011/01/07下载
020527024APLabel2003/06/08下载
020527024APLetter2003/06/08下载
020527024APReview2011/01/07下载
020527018APLetter2002/02/11下载
020527017APLetter2003/03/18下载
020527017APLabel2003/03/20下载
020527017APReview2003/09/11下载
020527013APReview1998/05/12下载
020527006APLetter1998/01/09下载
020527006APReview1998/01/09下载
020527004APReview1997/07/31下载
020527000APOther 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
020527063AP2016/05/04Manufacturing Change or Addition
020527062AP2015/08/31Labeling Revision
020527061AP2016/02/25Manufacturing Change or Addition
020527059AP2014/07/01Manufacturing Change or Addition
020527056AP2012/02/02Labeling Revision
020527054AP2012/02/02Labeling Revision
020527052AP2012/02/02Manufacturing Change or Addition
020527051AP2012/02/02Labeling Revision
020527046AP2009/05/18Formulation Revision
020527045AP2009/12/30Labeling Revision
020527043AP2008/03/03Labeling Revision
020527037AP2006/07/27Labeling Revision
020527036AP2005/06/30Labeling Revision
020527035AP2004/04/20Labeling Revision
020527034AP2004/04/20Labeling Revision
020527031AP2003/06/04Labeling Revision
020527030AP2003/01/07Labeling Revision
020527029AP2002/11/27Labeling Revision
020527026AP2003/06/04Labeling Revision
020527025AP2002/07/10Manufacturing Change or Addition
020527024AP2003/06/04New or Modified Indication
020527021AP2001/12/03Control Supplement
020527018AP2002/02/11Labeling Revision
020527017AP2003/03/12New Dosage Regimen
020527015AP2000/01/06Labeling Revision
020527014AP1999/03/18Control Supplement
020527013AP1998/05/12Labeling Revision
020527009AP1998/03/10Labeling Revision
020527008AP1997/08/08Expiration Date Change
020527007AP1997/06/30Control Supplement
020527006AP1998/01/09New Dosage Regimen
020527005AP1997/01/24Control Supplement
020527004AP1997/07/31Labeling Revision
020527003AP1996/06/28Control Supplement
020527002AP1996/06/27Control Supplement
020527001AP1996/12/18Control Supplement
020527000AP1995/11/17Approval