药品名称CHANTIX
申请号021928产品号002
活性成分VARENICLINE TARTRATE市场状态处方药
剂型或给药途径TABLET;ORAL规格EQ 1MG BASE
治疗等效代码参比药物
批准日期2006/05/10申请机构PFIZER 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
64105502020/05/10YYU-56PDF格式
68909272022/05/06YYU-56PDF格式
72651192022/08/03YYU-56PDF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
M-1442017/10/15
M-1432017/10/15
M-1832019/08/12
历史市场独占权保护信息
M-1052014/07/22
NCE2011/05/10
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
021928041APLetter2016/08/15下载
021928041APLabel2016/08/17下载
021928039APLetter2016/08/15下载
021928039APLabel2016/08/17下载
021928038APLabel2014/09/22下载
021928038APLetter2014/09/24下载
021928037APLetter2014/10/16下载
021928037APLabel2014/10/16下载
021928036APLetter2014/09/24下载
021928036APLabel2014/09/22下载
021928034APLabel2014/10/16下载
021928034APLetter2014/10/16下载
021928033APLabel2014/10/16下载
021928033APLetter2014/10/16下载
021928032APLabel2014/09/22下载
021928032APLetter2014/09/24下载
021928031APLabel2012/12/13下载
021928031APLetter2012/12/13下载
021928030APLabel2013/02/21下载
021928030APLetter2013/03/15下载
021928028APLabel2012/01/24下载
021928028APLetter2012/01/25下载
021928025APLabel2011/11/10下载
021928025APLetter2011/11/14下载
021928024APLetter2011/07/06下载
021928023APLetter2010/12/22下载
021928023APLabel2010/12/22下载
021928021APLetter2011/07/22下载
021928021APLabel2011/07/22下载
021928020APLabel2011/07/22下载
021928020APLetter2011/07/22下载
021928019APLetter2011/07/22下载
021928019APLabel2011/07/22下载
021928018APLetter2011/02/24下载
021928017APLetter2010/04/27下载
021928017APLabel2010/05/03下载
021928015APLetter2010/02/17下载
021928014APLetter2010/04/27下载
021928014APLabel2010/05/03下载
021928013APLetter2009/11/25下载
021928013APLabel2009/07/09下载
021928012APLetter2009/07/08下载
021928012APLabel2009/07/09下载
021928011APLabel2009/10/21下载
021928011APLetter2009/11/24下载
021928008APLabel2008/05/16下载
021928008APLetter2008/05/21下载
021928007APLabel2008/02/01下载
021928007APLetter2008/02/04下载
021928003APLetter2007/11/26下载
021928003APLabel2007/11/26下载
021928000APLabel2006/05/16下载
021928000APLetter2006/05/16下载
021928000APReview2006/06/16下载
021928000APOther Important Information from FDA2006/09/01下载
021928000APMedication Guide2009/05/29下载
021928000APOther2015/07/02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
021928041AP2016/08/12Labeling Revision
021928039AP2016/08/12Efficacy Supplement with Clinical Data to Support
021928038AP2014/09/19Labeling Revision
021928037AP2014/10/15Labeling Revision
021928036AP2014/09/19Efficacy Supplement with Clinical Data to Support
021928035AP2014/07/28Manufacturing Change or Addition
021928034AP2014/10/15Efficacy Supplement with Clinical Data to Support
021928033AP2014/10/15Efficacy Supplement with Clinical Data to Support
021928032AP2014/09/19Efficacy Supplement with Clinical Data to Support
021928031AP2012/12/11Efficacy Supplement with Clinical Data to Support
021928030AP2013/02/19Efficacy Supplement with Clinical Data to Support
021928028AP2012/01/20Labeling Revision
021928025AP2011/11/09Labeling Revision
021928024AP2011/06/29Labeling Revision
021928023AP2010/12/17Labeling Revision
021928021AP2011/07/22Efficacy Supplement with Clinical Data to Support
021928020AP2011/07/22Efficacy Supplement with Clinical Data to Support
021928019AP2011/07/22Efficacy Supplement with Clinical Data to Support
021928018AP2011/02/17Labeling Revision
021928017AP2010/04/22Labeling Revision
021928015AP2010/02/04Labeling Revision
021928014AP2010/04/22Labeling Revision
021928013AP2009/07/01Labeling Revision
021928012AP2009/07/01Labeling Revision
021928011AP2009/10/19Labeling Revision
021928008AP2008/05/16Labeling Revision
021928007AP2008/01/31Labeling Revision
021928003AP2007/11/20Labeling Revision
021928000AP2006/05/10Approval