药品名称VIRACEPT
申请号020779产品号001
活性成分NELFINAVIR MESYLATE市场状态处方药
剂型或给药途径TABLET;ORAL规格EQ 250MG BASE
治疗等效代码参比药物
批准日期1997/03/14申请机构AGOURON PHARMACEUTICALS INC
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
历史专利信息
54849262013/10/07PDF格式
5484926*PED2014/04/07PDF格式
59523432013/10/07U-257PDF格式
5952343*PED2014/04/07PDF格式
5952343*PED2014/04/07U-257PDF格式
61628122013/10/07U-248PDF格式
6162812*PED2014/04/07PDF格式
6162812*PED2014/04/07U-248PDF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
020779062APLetter2016/09/20下载
020779062APLabel2016/09/20下载
020779061APLetter2015/03/31下载
020779061APLabel2015/04/07下载
020779059APLetter2013/05/31下载
020779059APLabel2013/06/04下载
020779058APLabel2012/02/24下载
020779058APLetter2012/02/27下载
020779057APLabel2012/04/09下载
020779057APLetter2012/04/11下载
020779056APLetter2011/02/28下载
020779056APLabel2011/03/10下载
020779055APLetter2010/04/28下载
020779055APLabel2010/05/03下载
020779054APLetter2010/04/28下载
020779054APLabel2010/05/03下载
020779053APLetter2008/11/26下载
020779050APLetter2008/02/14下载
020779050APLabel2008/02/14下载
020779048APLabel2007/12/03下载
020779046APLabel2006/12/28下载
020779046APLetter2007/01/08下载
020779045APReview2007/08/06下载
020779045APLabel2005/09/30下载
020779045APLetter2005/10/20下载
020779044APLetter2004/06/07下载
020779044APLabel2004/06/07下载
020779042APLetter2004/03/24下载
020779042APLabel2004/04/05下载
020779042APReview2007/08/06下载
020779041APLabel2003/08/28下载
020779041APLetter2003/08/29下载
020779039APLabel2003/04/04下载
020779039APLetter2003/07/30下载
020779038APLetter2002/02/05下载
020779037APLetter2002/02/05下载
020779036APReview2007/08/06下载
020779035APReview2007/08/06下载
020779032APLetter2001/04/11下载
020779026APReview2007/08/06下载
020779022APReview2003/04/30下载
020779022APLetter2003/04/30下载
020779020APReview2007/08/06下载
020779011APReview2003/04/30下载
020779011APLetter2003/04/30下载
020779000APReview1997/03/14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
020779062AP2016/09/15Labeling Revision
020779061AP2015/03/27Labeling Revision
020779059AP2013/05/28Labeling Revision
020779058AP2012/02/17Labeling Revision
020779057AP2012/04/06Labeling Revision
020779056AP2011/02/25Labeling Revision
020779055AP2010/04/26Labeling Revision
020779054AP2010/04/26Labeling Revision
020779053AP2008/11/25Labeling Revision
020779050AP2008/02/13Labeling Revision
020779048AP2007/07/31Labeling Revision
020779046AP2006/12/22Labeling Revision
020779045AP2005/09/28Labeling Revision
020779044AP2004/06/04Labeling Revision
020779042AP2004/03/19Patient Population Altered
020779041AP2003/08/22Labeling Revision
020779039AP2002/12/20Labeling Revision
020779038AP2002/02/05Labeling Revision
020779037AP2002/02/05Control Supplement
020779036AP2001/10/26Manufacturing Change or Addition
020779035AP2001/10/26Manufacturing Change or Addition
020779034AP2001/09/28Manufacturing Change or Addition
020779033AP2001/06/19Control Supplement
020779032AP2001/04/05Labeling Revision
020779031AP2000/11/08Expiration Date Change
020779030AP2000/09/15Control Supplement
020779029AP2000/03/28Labeling Revision
020779028AP2000/02/07Control Supplement
020779027AP1999/11/24Formulation Revision
020779026AP2000/05/17Accelerated Approval
020779025AP1999/08/17Manufacturing Change or Addition
020779024AP1999/08/06Manufacturing Change or Addition
020779023AP1999/07/16Control Supplement
020779022AP1999/11/24New Dosage Regimen
020779021AP1999/03/19Control Supplement
020779020AP1999/05/25Labeling Revision
020779019AP1998/12/01Control Supplement
020779018AP1998/10/30Expiration Date Change
020779016AP1998/09/14Control Supplement
020779015AP1998/07/17Control Supplement
020779014AP1998/06/12Manufacturing Change or Addition
020779013AP1998/06/05Control Supplement
020779012AP1998/05/04Manufacturing Change or Addition
020779011AP1998/05/04Manufacturing Change or Addition
020779010AP1997/11/21Control Supplement
020779009AP1998/02/03Manufacturing Change or Addition
020779008AP1997/11/21Manufacturing Change or Addition
020779007AP1997/09/30Labeling Revision
020779006AP1997/11/26Manufacturing Change or Addition
020779005AP1997/08/29Expiration Date Change
020779004AP1997/08/29Control Supplement
020779003AP1997/07/31Labeling Revision
020779002AP1997/06/04Control Supplement
020779001AP1997/06/16Manufacturing Change or Addition
020779000AP1997/03/14Approval