药品名称NAPROSYN
申请号018965产品号001
活性成分NAPROXEN市场状态处方药
剂型或给药途径SUSPENSION;ORAL规格25MG/ML
治疗等效代码AB参比药物
批准日期1987/03/23申请机构ATNAHS PHARMA US LTD
化学类型New dosage form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
018965023APLabel2016/05/11下载
018965023APLetter2016/05/12下载
018965022APLabel2016/05/11下载
018965022APLetter2016/05/12下载
018965020APLabel2013/03/26下载
018965020APLetter2013/03/26下载
018965018APLabel2008/07/29下载
018965018APLetter2008/07/30下载
018965016APLetter2007/09/25下载
018965016APLabel2007/09/26下载
018965015APLetter2007/04/25下载
018965014APLabel2006/01/25下载
018965014APLetter2006/01/30下载
018965013APLabel2006/03/14下载
018965013APLetter2006/03/23下载
018965010APLetter2004/11/16下载
018965010APLabel2004/11/16下载
018965009APLabel2004/11/16下载
018965009APLetter2004/11/16下载
018965007APLetter2003/05/29下载
018965000APMedication Guide2009/11/19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
018965024AP2016/05/09Manufacturing Change or Addition
018965023AP2016/05/09Labeling Revision
018965022AP2016/05/09Labeling Revision
018965021AP2015/07/30Manufacturing Change or Addition
018965020AP2013/03/22Labeling Revision
018965018AP2008/07/25Labeling Revision
018965016AP2007/09/20Labeling Revision
018965015AP2007/04/19Labeling Revision
018965014AP2006/01/24Labeling Revision
018965013AP2006/03/10Labeling Revision
018965012AP2002/02/22Manufacturing Change or Addition
018965011AP2001/01/05Manufacturing Change or Addition
018965010AP2004/11/10Labeling Revision
018965009AP2004/11/10Labeling Revision
018965008AP1996/11/14Manufacturing Change or Addition
018965007AP2003/04/14Labeling Revision
018965006AP1994/09/12Control Supplement
018965004AP1993/01/27Manufacturing Change or Addition
018965000AP1987/03/23Approval