药品名称ALEVE
申请号020204产品号002
活性成分NAPROXEN SODIUM市场状态非处方药
剂型或给药途径TABLET;ORAL规格EQ 200MG BASE
治疗等效代码参比药物
批准日期1994/01/11申请机构BAYER HEALTHCARE LLC
化学类型New dosage form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
020204048APLabel2016/06/17下载
020204044APLetter2013/04/23下载
020204044APLabel2013/11/21下载
020204042APLetter2013/01/07下载
020204040APLetter2012/03/19下载
020204039APLetter2012/03/19下载
020204038APLetter2013/02/08下载
020204038APLabel2014/01/14下载
020204037APLetter2011/04/11下载
020204036APLetter2011/02/24下载
020204035APLetter2010/11/08下载
020204032APLetter2009/04/21下载
020204031APLetter2008/11/26下载
020204023APLetter2006/01/20下载
020204021APLetter2005/05/05下载
020204021APLabel2005/05/05下载
020204019APLetter2004/03/24下载
020204016APLetter2002/08/30下载
020204008APLetter2002/03/19下载
020204007APLetter2001/03/06下载
020204000APOther Important Information from FDA2005/07/28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
020204049AP2016/07/28Manufacturing Change or Addition
020204048AP2016/02/25Manufacturing Change or Addition
020204046AP2015/02/04Manufacturing Change or Addition
020204044AP2013/04/18Labeling Revision
020204043AP2013/01/07Manufacturing Change or Addition
020204042AP2013/01/03Manufacturing Change or Addition
020204041AP2012/11/13Manufacturing Change or Addition
020204040AP2012/03/16Labeling Revision
020204039AP2012/03/15Labeling Revision
020204038AP2013/02/07Labeling Revision
020204037AP2011/04/08Labeling Revision
020204036AP2011/02/18Labeling Revision
020204035AP2010/11/03Labeling Revision
020204032AP2009/04/15Labeling Revision
020204031AP2008/11/24Labeling Revision
020204023AP2006/01/05Labeling Revision
020204021AP2005/05/04Labeling Revision
020204019AP2004/03/22Labeling Revision
020204016AP2002/08/30Manufacturing Change or Addition
020204015AP2001/12/21Control Supplement
020204014AP2001/03/27Manufacturing Change or Addition
020204013AP2001/01/03Manufacturing Change or Addition
020204012AP2000/06/07Manufacturing Change or Addition
020204011AP2000/05/11Manufacturing Change or Addition
020204010AP2000/08/23Labeling Revision
020204008AP2002/03/19Labeling Revision
020204007AP2001/03/06Labeling Revision
020204006AP1998/11/20Package Change
020204005AP1998/04/16Formulation Revision
020204003AP1996/08/01Manufacturing Change or Addition
020204002AP1995/02/10Package Change
020204001AP1994/08/12Manufacturing Change or Addition
020204000AP1994/01/11Approval