药品名称ORTHO EVRA
申请号021180产品号001
活性成分ETHINYL ESTRADIOL; NORELGESTROMIN市场状态停止上市
剂型或给药途径FILM, EXTENDED RELEASE;TRANSDERMAL规格0.035MG/24HR;0.15MG/24HR **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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2001/11/20申请机构JANSSEN PHARMACEUTICALS INC
化学类型审评分类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
58767462015/11/20YU-514PDF格式
历史专利信息
59723772015/06/07U-514PDF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
021180047APLetter2015/10/23下载
021180047APLabel2015/10/26下载
021180046APLetter2014/04/14下载
021180046APLabel2014/04/14下载
021180044APLetter2013/07/03下载
021180044APLabel2013/07/03下载
021180043APLabel2012/08/22下载
021180043APLetter2012/08/24下载
021180040APLabel2011/12/28下载
021180040APLetter2012/01/03下载
021180039APLetter2011/03/25下载
021180039APLabel2011/03/28下载
021180038APLetter2011/07/28下载
021180038APLabel2011/08/12下载
021180035APLetter2010/04/19下载
021180035APLabel2010/04/19下载
021180034APLabel2009/12/02下载
021180034APLetter2010/01/25下载
021180033APLabel2009/09/17下载
021180033APLetter2009/11/10下载
021180031APLetter2008/11/03下载
021180031APLabel2008/11/07下载
021180030APLetter2008/11/03下载
021180030APLabel2008/11/07下载
021180029APLabel2009/08/13下载
021180029APLetter2009/11/10下载
021180028APLabel2008/11/07下载
021180028APLetter2008/11/03下载
021180026APLabel2008/01/18下载
021180022APLabel2006/09/20下载
021180022APLetter2006/09/20下载
021180020APLetter2006/05/21下载
021180019APLabel2005/11/10下载
021180019APLetter2005/11/18下载
021180015APLetter2005/05/17下载
021180015APLabel2005/05/17下载
021180014APLetter2004/12/02下载
021180008APLetter2004/03/02下载
021180008APReview2008/07/31下载
021180005APReview2007/06/29下载
021180004APReview2006/07/11下载
021180003APReview2006/07/11下载
021180002APReview2008/08/01下载
021180001APReview2008/08/01下载
021180000APOther Important Information from FDA2006/09/22下载
021180000APLetter2001/11/20下载
021180000APLabel2001/11/20下载
021180000APReview2001/11/20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
021180047AP2015/10/22Labeling Revision
021180046AP2014/04/11Labeling Revision
021180044AP2013/07/01Labeling Revision
021180043AP2012/08/22Labeling Revision
021180041AP2013/04/12Manufacturing Change or Addition
021180040AP2011/12/28Labeling Revision
021180039AP2011/03/23Labeling Revision
021180038AP2011/07/26Labeling Revision
021180037AP2013/04/12Manufacturing Change or Addition
021180035AP2010/04/13Labeling Revision
021180034AP2009/12/01Labeling Revision
021180033AP2009/09/11Labeling Revision
021180031AP2008/10/30Labeling Revision
021180030AP2008/10/30Labeling Revision
021180029AP2009/07/29Supplement
021180028AP2008/10/30Labeling Revision
021180026AP2008/01/18Labeling Revision
021180022AP2006/09/20Labeling Revision
021180020AP2006/05/17Labeling Revision
021180019AP2005/11/10Labeling Revision
021180015AP2005/05/06Labeling Revision
021180014AP2004/11/24Control Supplement
021180008AP2004/02/04Labeling Revision
021180005AP2002/06/18Control Supplement
021180004AP2002/10/02Manufacturing Change or Addition
021180003AP2002/11/14Manufacturing Change or Addition
021180002AP2002/08/09Manufacturing Change or Addition
021180001AP2002/03/04Control Supplement
021180000AP2001/11/20Approval