药品名称NEURONTIN
申请号020235产品号002
活性成分GABAPENTIN市场状态处方药
剂型或给药途径CAPSULE;ORAL规格300MG
治疗等效代码AB参比药物
批准日期1993/12/30申请机构PFIZER PHARMACEUTICALS LTD
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
60544822017/04/25PDF格式
6054482*PED2017/10/25PDF格式
历史专利信息
48944762008/05/02PDF格式
4894476*PED2008/11/02PDF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
020235061APLabel2015/04/27下载
020235061APLetter2015/05/11下载
020235060APLetter2015/09/17下载
020235060APLabel2015/09/23下载
020235057APLetter2014/08/20下载
020235057APLabel2014/08/20下载
020235056APLetter2013/05/07下载
020235056APLabel2013/05/09下载
020235055APLabel2013/05/09下载
020235055APLetter2013/05/07下载
020235054APLetter2013/05/07下载
020235054APLabel2013/05/09下载
020235050APLabel2011/08/11下载
020235050APLetter2011/08/12下载
020235043APLabel2010/10/11下载
020235043APLetter2010/10/13下载
020235041APLabel2009/04/28下载
020235041APLetter2009/05/01下载
020235036APLabel2011/03/04下载
020235036APLetter2011/03/07下载
020235035APLetter2006/05/05下载
020235029APLetter2005/02/23下载
020235029APLabel2005/02/23下载
020235023APLetter2004/06/10下载
020235022APLetter2002/01/30下载
020235015APLetter2000/10/12下载
020235015APLabel2000/10/12下载
020235015APReview2004/05/06下载
020235011APLetter1998/09/29下载
020235011APReview1998/09/29下载
020235011APLabel1998/09/29下载
020235000APMedication Guide2010/10/13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
020235061AP2015/04/21Labeling Revision
020235060AP2015/09/14Labeling Revision
020235057AP2014/08/18Labeling Revision
020235056AP2013/05/01Labeling Revision
020235055AP2013/05/01Labeling Revision
020235054AP2013/05/01Labeling Revision
020235050AP2011/08/10Labeling Revision
020235043AP2010/10/11Labeling Revision
020235041AP2009/04/23Labeling Revision
020235036AP2011/03/01Labeling Revision
020235035AP2006/05/03Labeling Revision
020235029AP2005/02/18Labeling Revision
020235026AP2002/12/19Control Supplement
020235024AP2002/10/24Manufacturing Change or Addition
020235023AP2002/08/15Efficacy Supplement with Clinical Data to Support
020235022AP2002/01/30Labeling Revision
020235021AP2002/01/18Control Supplement
020235020AP2001/02/08Manufacturing Change or Addition
020235019AP2001/02/08Manufacturing Change or Addition
020235018AP2001/01/18Manufacturing Change or Addition
020235017AP2000/08/16Manufacturing Change or Addition
020235016AP2000/07/21Control Supplement
020235015AP2000/10/12New or Modified Indication
020235014AP2000/05/15Manufacturing Change or Addition
020235011AP1998/09/29New Dosage Regimen
020235009AP1998/02/12Manufacturing Change or Addition
020235005AP1996/12/09Manufacturing Change or Addition
020235004AP1996/05/28Manufacturing Change or Addition
020235003AP1996/04/09Package Change
020235001AP1994/11/14Labeling Revision
020235000AP1993/12/30Approval