药品名称NICORETTE
申请号020066产品号004
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 4MG BASE
治疗等效代码参比药物
批准日期2000/09/25申请机构GLAXOSMITHKLINE
化学类型New formulation or new manufacturer审评分类Standard 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
020066057APLetter2015/10/02下载
020066057APLabel2015/11/02下载
020066055APLetter2014/11/03下载
020066055APLabel2014/11/07下载
020066054APLabel2014/08/05下载
020066054APLetter2014/06/12下载
020066053APLabel2014/08/05下载
020066053APLetter2014/06/12下载
020066049APLetter2013/10/31下载
020066049APLabel2013/11/07下载
020066046APLabel2014/01/16下载
020066046APLetter2012/07/18下载
020066042APLabel2012/03/28下载
020066042APLetter2012/02/17下载
020066041APLetter2012/02/03下载
020066038APLetter2011/09/29下载
020066037APLetter2011/05/19下载
020066033APLetter2009/05/08下载
020066031APReview2012/03/27下载
020066031APLetter2008/06/16下载
020066030APLabel2007/06/27下载
020066030APLetter2007/07/05下载
020066024APLetter2006/05/05下载
020066023APLabel2005/12/13下载
020066023APLetter2005/12/13下载
020066019APLetter2004/06/23下载
020066017APLetter2004/06/24下载
020066016APReview2007/04/11下载
020066016APLetter2004/04/29下载
020066013APLetter2002/08/09下载
020066010APLetter2000/09/25下载
020066010APLabel2000/09/25下载
020066010APReview2000/09/25下载
020066007APLetter1998/12/13下载
020066007APLabel1998/12/23下载
020066007APReview1998/12/23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
020066057AP2015/09/30Labeling Revision
020066055AP2014/10/30Labeling Revision
020066054AP2014/06/11Labeling Revision
020066053AP2014/06/11Labeling Revision
020066051AP2014/04/17Manufacturing Change or Addition
020066049AP2013/10/30Labeling Revision
020066048AP2012/08/01Manufacturing Change or Addition
020066046AP2012/07/16Labeling Revision
020066042AP2012/02/15Labeling Revision
020066041AP2012/02/01Labeling Revision
020066038AP2011/09/27Labeling Revision
020066037AP2011/05/17Labeling Revision
020066033AP2009/05/06Efficacy Supplement with Clinical Data to Support
020066031AP2008/06/13Formulation Revision
020066030AP2007/06/26Formulation Revision
020066024AP2006/05/04Package Change
020066023AP2005/12/02Formulation Revision
020066019AP2004/06/18Formulation Revision
020066017AP2004/06/23Labeling Revision
020066016AP2004/04/23Formulation Revision
020066014AP2002/11/15Control Supplement
020066013AP2002/08/09Labeling Revision
020066010AP2000/09/25Formulation Revision
020066008AP2001/08/24Labeling Revision
020066007AP1998/12/23Comparative Efficacy Claim
020066006AP1998/11/04Control Supplement
020066004AP1996/02/09OTC Labeling
020066003AP1993/03/22Manufacturing Change or Addition
020066001AP1993/03/22Manufacturing Change or Addition
020066000AP1992/06/08Approval