药品名称ANAPROX DS
申请号018164产品号003
活性成分NAPROXEN SODIUM市场状态处方药
剂型或给药途径TABLET;ORAL规格EQ 500MG BASE
治疗等效代码AB参比药物
批准日期1987/09/30申请机构ATNAHS PHARMA US LTD
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
018164062APLetter2016/05/11下载
018164062APLabel2016/05/11下载
018164061APLabel2013/03/26下载
018164061APLetter2013/03/26下载
018164060APLabel2008/07/29下载
018164060APLetter2008/07/30下载
018164058APLetter2007/09/25下载
018164058APLabel2007/09/26下载
018164057APLetter2007/04/25下载
018164056APLabel2006/01/25下载
018164056APLetter2006/01/30下载
018164055APLabel2006/03/14下载
018164055APLetter2006/03/23下载
018164051APLetter2004/11/16下载
018164051APLabel2004/11/16下载
018164050APLabel2004/11/16下载
018164050APLetter2004/11/16下载
018164049APLetter2003/05/29下载
018164000APOther Important Information from FDA2005/07/28下载
018164000APMedication Guide2009/11/16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
018164062AP2016/05/09Labeling Revision
018164061AP2013/03/22Labeling Revision
018164060AP2008/07/25Labeling Revision
018164058AP2007/09/20Labeling Revision
018164057AP2007/04/19Labeling Revision
018164056AP2006/01/24Labeling Revision
018164055AP2006/03/10Labeling Revision
018164054AP2002/02/22Manufacturing Change or Addition
018164053AP2001/11/09Package Change
018164052AP2000/12/08Manufacturing Change or Addition
018164051AP2004/11/10Labeling Revision
018164050AP2004/11/10Labeling Revision
018164049AP2003/04/14Labeling Revision
018164048AP1994/09/06Manufacturing Change or Addition
018164047AP1995/02/08Formulation Revision
018164046AP1993/12/15Labeling Revision
018164045AP1992/08/12Manufacturing Change or Addition
018164043AP1992/05/08Package Change
018164042AP1990/10/02Control Supplement
018164036AP1987/09/30New or Modified Indication
018164035AP1987/09/30New Dosage Regimen
018164034AP1987/09/30Labeling Revision
018164033AP1986/06/10Package Change
018164031AP1985/09/24Labeling Revision
018164028AP1985/05/03Manufacturing Change or Addition
018164026AP1987/09/30Formulation Revision
018164025AP1985/04/29Manufacturing Change or Addition
018164021AP1983/09/09Labeling Revision
018164020AP1986/08/29Control Supplement
018164018AP1983/02/22Control Supplement
018164017AP1982/12/07Labeling Revision
018164016AP1982/12/07Labeling Revision
018164015AP1987/09/30Labeling Revision
018164014AP1985/04/23Formulation Revision
018164013AP1982/10/18Control Supplement
018164012AP1983/09/09Labeling Revision
018164011AP1982/04/22Manufacturing Change or Addition
018164010AP1982/04/22Manufacturing Change or Addition
018164009AP1982/04/22Manufacturing Change or Addition
018164006AP1982/05/10Package Change
018164005AP1982/01/07Package Change
018164004AP1982/01/07Package Change
018164003AP1981/10/13Control Supplement
018164002AP1981/10/13Control Supplement
018164001AP1981/04/13Labeling Revision
018164000AP1980/09/04Approval