药品名称ESTRADIOL
申请号020538产品号001
活性成分ESTRADIOL市场状态停止上市
剂型或给药途径Film, Extended Release; Transdermal规格0.0375MG/24HR
治疗等效代码参比药物
批准日期申请机构NOVARTIS
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
020538032APLetter2014/08/01下载
020538032APLabel2014/08/01下载
020538030APLabel2013/05/21下载
020538030APLetter2013/05/21下载
020538029APLetter2013/05/21下载
020538029APLabel2013/05/21下载
020538028APLetter2013/05/21下载
020538028APLabel2013/05/21下载
020538024APLetter2004/08/10下载
020538024APLabel2004/08/10下载
020538019APLetter2004/02/02下载
020538019APLabel2004/02/03下载
020538015APReview2006/05/16下载
020538015APLetter2002/05/03下载
020538015APLabel2002/05/03下载
020538014APLabel2002/05/03下载
020538014APLetter2002/05/03下载
020538012APLetter2002/05/03下载
020538012APLabel2002/05/03下载
020538006APReview1999/01/08下载
020538006APLetter1999/01/08下载
020538006APLabel1999/01/08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
020538034AP2016/08/29Manufacturing Change or Addition
020538033AP2015/09/01Manufacturing Change or Addition
020538032AP2014/07/31Labeling Revision
020538031AP2013/04/24Manufacturing Change or Addition
020538030AP2013/05/16Labeling Revision
020538029AP2013/05/16Labeling Revision
020538028AP2013/05/16Labeling Revision
020538024AP2004/08/06Labeling Revision
020538019AP2004/01/28Labeling Revision
020538017AP2002/03/28Control Supplement
020538016AP2002/02/22Control Supplement
020538015AP2002/05/03New or Modified Indication
020538014AP2002/05/03Efficacy Supplement with Clinical Data to Support
020538013AP2001/07/09Manufacturing Change or Addition
020538012AP2002/05/03Labeling Revision
020538010AP2000/09/29Control Supplement
020538009AP1999/10/29Control Supplement
020538008AP1999/03/26Labeling Revision
020538007AP1999/07/30Control Supplement
020538006AP1999/01/08Formulation Revision
020538005AP1997/09/26Manufacturing Change or Addition
020538004AP1997/09/25Control Supplement
020538003AP1997/09/23Control Supplement
020538002AP1997/09/15Control Supplement
020538001AP1997/09/15Control Supplement
020538000AP1996/07/31Approval