药品名称TAMIFLU
申请号021246产品号002
活性成分OSELTAMIVIR PHOSPHATE市场状态处方药
剂型或给药途径FOR SUSPENSION;ORAL规格EQ 6MG BASE/ML
治疗等效代码参比药物
批准日期2011/03/21申请机构HOFFMANN LA ROCHE INC
化学类型New dosage form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
57634832016/08/23YYU-1113PDF格式
58666012016/02/02YYPDF格式
5763483*PED2017/02/23PDF格式
5866601*PED2016/08/02PDF格式
5952375*PED2015/08/27PDF格式
历史专利信息
59523752015/02/27YYPDF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
NPP2015/12/21
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
021246051APLabel2016/06/21下载
021246051APLetter2016/06/22下载
021246048APLabel2014/10/15下载
021246048APLetter2014/10/16下载
021246047APLetter2014/06/03下载
021246047APLabel2014/06/03下载
021246045APLabel2012/12/21下载
021246045APLetter2012/12/21下载
021246045APSummary Review2012/12/21下载
021246045APReview2013/04/08下载
021246044APLabel2013/08/12下载
021246044APOther2013/08/12下载
021246044APLetter2013/01/29下载
021246043APLetter2014/11/28下载
021246043APLabel2014/12/03下载
021246042APLabel2012/08/17下载
021246042APLetter2012/08/20下载
021246040APLabel2011/02/07下载
021246040APLetter2011/02/09下载
021246039APLabel2011/03/23下载
021246039APLetter2011/03/24下载
021246039APReview2013/06/03下载
021246038APLabel2010/11/05下载
021246038APLetter2010/11/10下载
021246035APLetter2010/02/26下载
021246035APReview2015/07/20下载
021246035APLabel2010/03/03下载
021246034APReview2015/07/22下载
021246034APLabel2010/03/03下载
021246034APLetter2010/02/26下载
021246033APLetter2009/04/30下载
021246033APLabel2009/04/30下载
021246032APLetter2009/10/19下载
021246031APLabel2010/12/16下载
021246031APLetter2010/12/21下载
021246030APLabel2008/01/18下载
021246030APLetter2008/01/18下载
021246028APLetter2007/10/10下载
021246028APLabel2007/10/10下载
021246027APLetter2007/07/05下载
021246027APLabel2007/07/05下载
021246027APReview2013/06/03下载
021246026APLetter2009/10/21下载
021246025APLetter2009/10/21下载
021246024APLetter2009/10/21下载
021246023APLetter2009/10/19下载
021246022APLetter2009/10/21下载
021246021APLabel2006/11/14下载
021246021APPatient Package Insert2006/11/14下载
021246021APLetter2006/11/16下载
021246020APLetter2009/10/19下载
021246019APLetter2009/10/19下载
021246018APLetter2009/10/19下载
021246017APLabel2006/01/05下载
021246017APPatient Package Insert2006/01/10下载
021246017APLetter2006/01/18下载
021246017APReview2014/07/07下载
021246016APLetter2009/10/19下载
021246014APLetter2009/10/19下载
021246013APLetter2009/10/19下载
021246012APLetter2009/10/19下载
021246011APLetter2009/10/19下载
021246010APReview2007/06/22下载
021246010APLetter2004/07/01下载
021246010APLabel2004/07/01下载
021246008APLetter2009/10/16下载
021246007APReview2007/06/22下载
021246007APLabel2002/04/26下载
021246007APLetter2002/04/26下载
021246006APReview2007/06/22下载
021246004APReview2007/06/22下载
021246004APLabel2003/04/22下载
021246003APLabel2003/05/01下载
021246003APReview2007/06/22下载
021246002APReview2007/06/22下载
021246001APLabel2003/05/01下载
021246001APReview2007/06/22下载
021246000APReview2004/08/09下载
021246000APOther Important Information from FDA2003/12/12下载
021246000APLetter2000/12/14下载
021246000APLabel2000/12/14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
021246051AP2016/06/20Labeling Revision
021246050AP2015/03/16Manufacturing Change or Addition
021246048AP2014/10/14Labeling Revision
021246047AP2014/05/30Labeling Revision
021246046AP2013/02/07Manufacturing Change or Addition
021246045AP2012/12/21Patient Population Altered
021246044AP2013/01/29Supplement
021246043AP2014/11/26Labeling Revision
021246042AP2012/08/16Labeling Revision
021246040AP2011/02/07Labeling Revision
021246039AP2011/03/21Labeling Revision
021246038AP2010/11/05Labeling Revision
021246035AP2010/02/22New Dosage Regimen
021246034AP2010/02/22Labeling Revision
021246033AP2008/09/25Labeling Revision
021246032AP2009/02/23Manufacturing Change or Addition
021246031AP2010/12/15Labeling Revision
021246030AP2008/01/17Labeling Revision
021246028AP2007/10/05Labeling Revision
021246027AP2007/07/02Formulation Revision
021246026AP2007/03/26Manufacturing Change or Addition
021246025AP2007/03/22Facility Addition
021246024AP2007/03/12Facility Addition
021246023AP2006/12/14Manufacturing Revision
021246022AP2007/02/01Manufacturing Change or Addition
021246021AP2006/11/13Labeling Revision
021246020AP2006/06/23Manufacturing Change or Addition
021246019AP2005/12/01Manufacturing Change or Addition
021246018AP2005/10/14Manufacturing Change or Addition
021246017AP2005/12/21Patient Population Altered
021246016AP2005/05/19Facility Addition
021246014AP2005/01/18Manufacturing Change or Addition
021246013AP2004/10/19Facility Addition
021246012AP2004/08/12Facility Addition
021246011AP2004/04/26Other
021246010AP2004/06/24Labeling Revision
021246008AP2003/02/14Comparative Efficacy Claim
021246007AP2002/04/26Labeling Revision
021246006AP2002/03/04Control Supplement
021246004AP2001/11/05Labeling Revision
021246003AP2001/07/24Labeling Revision
021246002AP2001/07/05Control Supplement
021246001AP2001/07/24Labeling Revision
021246000AP2000/12/14Approval