药品名称VAGIFEM
申请号020908产品号001
活性成分ESTRADIOL市场状态停止上市
剂型或给药途径TABLET;VAGINAL规格25MCG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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否
批准日期1999/03/26申请机构NOVO NORDISK 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
无
历史专利信息
无
与本品相关的市场独占权保护信息
独占权代码失效日期
无
历史市场独占权保护信息
无
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
020908017APLetter2012/04/13下载
020908017APLabel2012/04/17下载
020908016APLetter2011/05/19下载
020908013APLabel2009/12/02下载
020908000APLetter1999/03/26下载
020908000APLabel1999/03/26下载
020908000APReview2005/07/15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
020908023AP2016/04/04Manufacturing Change or Addition
020908022AP2016/05/27Manufacturing Change or Addition
020908021AP2015/01/12Manufacturing Change or Addition
020908020AP2012/11/09Manufacturing Change or Addition
020908017AP2012/04/11Labeling Revision
020908016AP2011/05/17Labeling Revision
020908013AP2009/11/25New Dosage Regimen
020908008AP2002/11/06Control Supplement
020908007AP2002/09/05Manufacturing Change or Addition
020908006AP2002/07/12Manufacturing Change or Addition
020908005AP2001/09/06Manufacturing Change or Addition
020908004AP2001/04/17Control Supplement
020908003AP2000/11/14Manufacturing Change or Addition
020908002AP2000/05/11Control Supplement
020908001AP1999/11/03Manufacturing Change or Addition
020908000AP1999/03/26Approval