药品名称REYATAZ
申请号021567产品号001
活性成分ATAZANAVIR SULFATE市场状态停止上市
剂型或给药途径CAPSULE;ORAL规格EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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2003/06/20申请机构BRISTOL MYERS SQUIBB CO
化学类型New molecular entity (NME)审评分类Priority 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
58499112017/06/20YYU-167PDF格式
60873832018/12/21YYPDF格式
5849911*PED2017/12/20PDF格式
6087383*PED2019/06/21PDF格式
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
D-1162011/09/30
D-1302014/02/04
D-892007/07/06
NCE2008/06/20
NPP2011/03/25
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
021567039APLetter2016/09/20下载
021567039APLabel2016/09/20下载
021567038APLetter2015/09/28下载
021567038APLabel2015/12/10下载
021567037APLetter2015/04/01下载
021567037APLabel2015/04/02下载
021567036APLetter2015/02/27下载
021567035APReview2015/04/07下载
021567035APSummary Review2015/04/07下载
021567035APLetter2014/06/03下载
021567035APLabel2014/06/03下载
021567033APLetter2013/08/20下载
021567033APLabel2013/08/21下载
021567032APLetter2013/08/20下载
021567032APLabel2013/08/21下载
021567031APLetter2013/02/04下载
021567028APLetter2012/03/16下载
021567028APLabel2012/03/16下载
021567027APLetter2012/02/23下载
021567027APLabel2012/02/24下载
021567026APLabel2011/10/17下载
021567026APLetter2011/10/19下载
021567025APLabel2011/02/09下载
021567025APLetter2011/02/10下载
021567025APReview2015/07/20下载
021567023APLetter2010/04/29下载
021567023APLabel2010/05/03下载
021567022APLetter2010/01/28下载
021567022APLabel2010/01/24下载
021567019APLetter2010/01/25下载
021567019APLabel2009/11/23下载
021567019APReview2014/08/05下载
021567018APLetter2008/02/22下载
021567018APLabel2008/02/25下载
021567017APLetter2008/10/02下载
021567017APLabel2008/10/03下载
021567016APLetter2008/08/20下载
021567016APLabel2008/08/26下载
021567015APLabel2008/03/27下载
021567015APLetter2008/03/28下载
021567014APLabel2008/01/08下载
021567014APLetter2008/01/09下载
021567012APLetter2007/03/31下载
021567012APLabel2007/03/31下载
021567011APLabel2006/08/11下载
021567011APLetter2006/08/14下载
021567009APLabel2006/10/18下载
021567009APLetter2006/10/23下载
021567008APLetter2006/08/14下载
021567008APLabel2006/08/11下载
021567007APLabel2006/01/25下载
021567007APLetter2006/01/30下载
021567005APLetter2005/07/21下载
021567005APLabel2005/07/21下载
021567004APLetter2004/10/08下载
021567004APLabel2004/10/08下载
021567002APLabel2004/07/07下载
021567002APLetter2004/07/07下载
021567001APLetter2004/03/19下载
021567001APLabel2004/04/05下载
021567000APLabel2003/07/08下载
021567000APLetter2003/08/06下载
021567000APReview2003/09/09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
021567039AP2016/09/15Labeling Revision
021567038AP2015/09/24Efficacy Supplement with Clinical Data to Support
021567037AP2015/03/27Labeling Revision
021567036AP2015/02/26Labeling Revision
021567036AP2015/02/26Labeling Revision
021567035AP2014/06/02Efficacy Supplement with Clinical Data to Support
021567034AP2014/02/26Manufacturing Change or Addition
021567033AP2013/08/15Labeling Revision
021567032AP2013/08/15Labeling Revision
021567031AP2013/01/30Labeling Revision
021567028AP2012/03/14Labeling Revision
021567027AP2012/02/17Labeling Revision
021567026AP2011/10/17New Dosage Regimen
021567025AP2011/02/04Patient Population Altered
021567023AP2010/04/26Labeling Revision
021567022AP2010/01/22Labeling Revision
021567019AP2009/11/05Efficacy Supplement with Clinical Data to Support
021567018AP2008/02/20Labeling Revision
021567017AP2008/09/30Patient Population Altered
021567016AP2008/08/15Labeling Revision
021567015AP2008/03/25Patient Population Altered
021567014AP2007/12/21Labeling Revision
021567012AP2007/03/22Labeling Revision
021567011AP2006/08/09Labeling Revision
021567009AP2006/10/16Formulation Revision
021567008AP2006/08/09Labeling Revision
021567007AP2006/01/25Labeling Revision
021567005AP2005/07/18Labeling Revision
021567004AP2004/10/05Labeling Revision
021567002AP2004/07/06New Dosage Regimen
021567001AP2004/03/16Labeling Revision
021567000AP2003/06/20Approval