药品名称SUSTIVA
申请号020972产品号002
活性成分EFAVIRENZ市场状态停止上市
剂型或给药途径CAPSULE;ORAL规格100MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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1998/09/17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
65551332019/04/06U-248PDF格式
69399642018/01/20YPDF格式
62386952019/04/06YPDF格式
66390712018/02/14YPDF格式
6238695*PED2019/10/06PDF格式
6555133*PED2019/10/06PDF格式
6639071*PED2018/08/14PDF格式
6939964*PED2018/07/20PDF格式
历史专利信息
55190212013/05/21YYPDF格式
5519021*PED2013/11/21PDF格式
56631692014/09/02U-257PDF格式
5663169*PED2015/03/02PDF格式
58114232012/08/07YYU-256PDF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
020972053APLetter2016/10/14下载
020972053APLabel2016/10/17下载
020972051APLetter2016/09/02下载
020972051APLabel2016/09/02下载
020972049APLetter2016/04/01下载
020972049APLabel2016/04/01下载
020972048APLetter2015/04/01下载
020972048APLabel2015/04/02下载
020972046APLetter2014/05/27下载
020972046APLabel2014/05/28下载
020972043APLetter2013/05/07下载
020972043APLabel2013/05/21下载
020972042APLetter2012/08/15下载
020972042APLabel2012/08/15下载
020972041APLetter2012/06/26下载
020972041APLabel2012/06/26下载
020972040APLabel2011/12/19下载
020972040APLetter2011/12/21下载
020972038APLabel2011/09/26下载
020972038APLetter2011/09/29下载
020972036APLabel2010/11/29下载
020972036APLetter2010/12/03下载
020972035APLabel2010/04/04下载
020972035APLetter2010/04/05下载
020972033APLabel2009/10/01下载
020972033APLetter2009/11/10下载
020972031APLetter2009/03/12下载
020972031APLabel2009/04/23下载
020972030APLetter2008/08/20下载
020972030APLabel2008/08/26下载
020972029APLabel2007/02/02下载
020972029APLetter2007/02/02下载
020972027APLabel2007/02/05下载
020972027APLetter2006/04/05下载
020972027APReview2007/07/20下载
020972026APLetter2005/04/28下载
020972026APLabel2005/04/28下载
020972024APLetter2004/10/29下载
020972024APLabel2004/11/01下载
020972022APReview2007/07/18下载
020972022APLetter2004/08/25下载
020972022APLabel2004/08/25下载
020972021APLetter2003/11/26下载
020972021APLabel2003/12/01下载
020972019APLetter2003/06/22下载
020972019APLabel2003/06/22下载
020972018APLabel2003/06/22下载
020972018APLetter2003/06/22下载
020972017APLetter2002/09/20下载
020972016APLetter2003/01/29下载
020972016APLabel2003/01/29下载
020972014APReview2007/07/18下载
020972013APLabel2003/04/25下载
020972007APLetter2002/03/01下载
020972001APLabel2000/02/09下载
020972001APReview2004/03/10下载
020972001APLetter2004/06/18下载
020972000APLetter1998/09/17下载
020972000APReview1998/09/17下载
020972000APLabel1998/09/17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
020972053AP2016/10/12Labeling Revision
020972051AP2016/08/31Labeling Revision
020972050AP2016/06/03Manufacturing Change or Addition
020972049AP2016/03/30Labeling Revision
020972048AP2015/03/27Labeling Revision
020972047AP2014/08/14Manufacturing Change or Addition
020972046AP2014/05/23Labeling Revision
020972045AP2014/01/22Manufacturing Change or Addition
020972044AP2014/01/15Manufacturing Change or Addition
020972043AP2013/05/02Supplement
020972042AP2012/08/10Labeling Revision
020972041AP2012/06/22Labeling Revision
020972040AP2011/12/19Labeling Revision
020972038AP2011/09/26Labeling Revision
020972036AP2010/11/30Labeling Revision
020972035AP2010/03/31Labeling Revision
020972033AP2009/09/23Labeling Revision
020972031AP2009/03/10Labeling Revision
020972030AP2008/08/18Labeling Revision
020972029AP2007/01/24Labeling Revision
020972027AP2006/03/28Labeling Revision
020972026AP2005/04/20Labeling Revision
020972024AP2004/10/22Labeling Revision
020972022AP2004/08/13Efficacy Supplement with Clinical Data to Support
020972021AP2003/11/13Labeling Revision
020972019AP2003/06/10Labeling Revision
020972018AP2003/06/10Labeling Revision
020972017AP2002/09/20Labeling Revision
020972016AP2003/01/29Labeling Revision
020972014AP2002/02/28Manufacturing Change or Addition
020972013AP2001/10/16Labeling Revision
020972012AP2001/11/21Manufacturing Change or Addition
020972009AP2001/05/16Manufacturing Change or Addition
020972008AP2001/04/12Control Supplement
020972007AP2002/03/01Labeling Revision
020972006AP2000/11/14Labeling Revision
020972005AP2000/05/31Manufacturing Change or Addition
020972004AP2000/04/18Control Supplement
020972003AP2000/05/31Manufacturing Change or Addition
020972002AP1999/08/27Expiration Date Change
020972001AP2000/02/09Accelerated Approval
020972000AP1998/09/17Approval