药品名称NICORETTE (MINT)
申请号018612产品号003
活性成分NICOTINE POLACRILEX市场状态非处方药
剂型或给药途径GUM, CHEWING;BUCCAL规格EQ 2MG BASE
治疗等效代码参比药物
批准日期1998/12/23申请机构GLAXOSMITHKLINE
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
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
018612076APLetter2015/10/02下载
018612076APLabel2015/11/02下载
018612074APLetter2014/11/03下载
018612074APLabel2014/11/07下载
018612073APLetter2014/06/12下载
018612073APLabel2014/08/05下载
018612072APLabel2014/08/05下载
018612072APLetter2014/06/12下载
018612068APLetter2013/10/31下载
018612068APLabel2013/11/07下载
018612065APLabel2014/01/16下载
018612065APLetter2012/07/18下载
018612061APLetter2012/02/17下载
018612061APLabel2012/03/28下载
018612060APLetter2012/02/03下载
018612057APLetter2011/09/29下载
018612056APLetter2011/05/19下载
018612052APLetter2009/05/08下载
018612050APLetter2008/06/16下载
018612050APReview2012/03/27下载
018612049APLabel2007/06/27下载
018612049APLetter2007/07/05下载
018612043APLetter2006/05/05下载
018612042APLabel2005/12/13下载
018612042APLetter2005/12/13下载
018612037APLetter2004/06/23下载
018612035APLetter2004/06/24下载
018612034APLetter2004/04/29下载
018612034APReview2007/07/06下载
018612031APLetter2002/08/09下载
018612025APLetter1998/12/23下载
018612025APLabel1998/12/23下载
018612025APReview1998/12/23下载
018612022APReview2005/05/02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
018612077AP2015/09/10Manufacturing Change or Addition
018612076AP2015/09/30Labeling Revision
018612075AP2015/01/05Manufacturing Change or Addition
018612074AP2014/10/30Labeling Revision
018612073AP2014/06/11Labeling Revision
018612072AP2014/06/11Labeling Revision
018612071AP2014/02/21Manufacturing Change or Addition
018612070AP2014/04/17Manufacturing Change or Addition
018612069AP2013/10/11Manufacturing Change or Addition
018612068AP2013/10/30Labeling Revision
018612067AP2012/08/01Manufacturing Change or Addition
018612065AP2012/07/16Labeling Revision
018612061AP2012/02/15Labeling Revision
018612060AP2012/02/01Labeling Revision
018612058AP2011/09/12Manufacturing Change or Addition
018612057AP2011/09/27Labeling Revision
018612056AP2011/05/17Labeling Revision
018612052AP2009/05/06Efficacy Supplement with Clinical Data to Support
018612050AP2008/06/13Formulation Revision
018612049AP2007/06/26Labeling Revision
018612043AP2006/05/04Package Change
018612042AP2005/12/02Formulation Revision
018612037AP2004/06/18Formulation Revision
018612035AP2004/06/23Labeling Revision
018612034AP2004/04/23Formulation Revision
018612032AP2002/11/15Control Supplement
018612031AP2002/08/09Labeling Revision
018612028AP2000/09/25Formulation Revision
018612026AP2001/08/24Labeling Revision
018612025AP1998/12/23Comparative Efficacy Claim
018612024AP1998/11/04Control Supplement
018612022AP1996/02/09OTC Labeling
018612019AP1991/08/22Control Supplement
018612016AP1991/08/22Control Supplement
018612012AP1988/09/30Control Supplement
018612010AP1989/09/28Manufacturing Change or Addition
018612009AP1989/04/17Manufacturing Change or Addition
018612008AP1985/07/23Labeling Revision
018612007AP1988/09/12Labeling Revision
018612006AP1986/02/26Control Supplement
018612005AP1985/07/23Package Change
018612004AP1986/02/26Manufacturing Change or Addition
018612003AP1988/09/12Labeling Revision
018612002AP1984/03/02Labeling Revision
018612001AP1984/02/21Labeling Revision
018612000AP1984/01/13Approval