药品名称CLIMARA
申请号020375产品号005
活性成分ESTRADIOL市场状态处方药
剂型或给药途径FILM, EXTENDED RELEASE;TRANSDERMAL规格0.0375MG/24HR
治疗等效代码AB参比药物
批准日期2003/05/27申请机构BAYER HEALTHCARE PHARMACEUTICALS INC
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
52232612010/06/29PDF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
020375028APLetter2013/10/31下载
020375027APLetter2013/10/11下载
020375027APLabel2013/10/17下载
020375026APLabel2008/01/08下载
020375026APLetter2008/01/09下载
020375023APLabel2006/01/05下载
020375023APLetter2006/01/06下载
020375022APLetter2005/06/24下载
020375022APLabel2005/06/24下载
020375021APLetter2005/03/23下载
020375020APLetter2004/02/02下载
020375020APLabel2004/02/12下载
020375016APReview2004/09/21下载
020375016APLetter2001/04/05下载
020375016APLabel2003/04/24下载
020375014APLabel2001/04/11下载
020375014APLetter2001/04/11下载
020375013APReview1999/05/20下载
020375012APReview2003/05/15下载
020375011APLetter1999/03/05下载
020375011APLabel1999/03/05下载
020375011APReview1999/03/05下载
020375010APReview2003/05/22下载
020375009APReview1998/03/23下载
020375009APLetter1998/03/23下载
020375009APLabel1998/03/23下载
020375008APReview2003/05/15下载
020375007APReview2003/08/08下载
020375005APReview2003/08/08下载
020375004APReview2003/08/08下载
020375003APReview2003/08/08下载
020375002APReview2003/08/08下载
020375001APReview2003/08/08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
020375031AP2015/08/06Manufacturing Change or Addition
020375030AP2013/05/14Manufacturing Change or Addition
020375028AP2013/10/10Labeling Revision
020375027AP2013/10/09Labeling Revision
020375026AP2008/01/03Labeling Revision
020375024AP2007/03/28Control Supplement
020375023AP2005/12/28Labeling Revision
020375022AP2005/06/22Labeling Revision
020375021AP2005/03/18Labeling Revision
020375020AP2004/01/22Labeling Revision
020375018AP2002/12/19Manufacturing Change or Addition
020375017AP2002/09/13Manufacturing Change or Addition
020375016AP2001/04/05New or Modified Indication
020375014AP2001/04/04Labeling Revision
020375013AP1999/05/20Labeling Revision
020375012AP1998/06/11Expiration Date Change
020375011AP1999/03/05Labeling Revision
020375010AP1998/06/11Control Supplement
020375009AP1998/03/23Control Supplement
020375008AP1998/02/27Formulation Revision
020375007AP1997/09/16Control Supplement
020375006AP1997/04/11New Route of Administration
020375005AP1996/05/17Manufacturing Change or Addition
020375004AP1995/10/10Control Supplement
020375003AP1995/09/22Manufacturing Change or Addition
020375002AP1995/02/28Manufacturing Change or Addition
020375001AP1995/04/25Control Supplement
020375000AP1994/12/22Approval