药品名称NALFON
申请号017604产品号002
活性成分FENOPROFEN CALCIUM市场状态停止上市
剂型或给药途径CAPSULE;ORAL规格EQ 300MG BASE
治疗等效代码参比药物
批准日期Approved Prior to Jan 1, 1982申请机构XSPIRE LLC
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
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
017604046APLetter2016/05/11下载
017604046APLabel2016/05/11下载
017604043APLetter2009/07/23下载
017604043APLabel2009/07/24下载
017604041APLetter2007/08/14下载
017604041APLabel2007/08/14下载
017604040APLabel2006/01/20下载
017604040APLetter2006/01/20下载
017604000APMedication 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
017604047AP2016/10/07Manufacturing Change or Addition
017604046AP2016/05/09Labeling Revision
017604043AP2009/07/21Formulation Revision
017604041AP2007/08/07Labeling Revision
017604040AP2006/01/18Labeling Revision
017604038AP2001/08/21Control Supplement
017604037AP1999/11/24Control Supplement
017604035AP1998/09/30Manufacturing Change or Addition
017604033AP1998/04/02Package Change
017604032AP1997/12/22Control Supplement
017604029AP1996/01/22Control Supplement
017604028AP1994/04/25Manufacturing Change or Addition
017604027AP1995/03/29Labeling Revision
017604024AP1987/07/15Control Supplement
017604023AP1987/07/23Manufacturing Change or Addition
017604022AP1986/06/09Labeling Revision
017604019AP1987/12/11Manufacturing Change or Addition
017604018AP1983/03/31Labeling Revision
017604017AP1983/07/29Package Change
017604016AP1983/08/09Labeling Revision
017604015AP1981/07/14Labeling Revision
017604014AP1980/05/06Formulation Revision
017604013AP1983/08/09Labeling Revision
017604012AP1980/10/15Control Supplement
017604009AP1980/10/15General Efficacy (MarkIV)
017604007AP1978/10/24Expiration Date Change
017604006AP1977/04/01Control Supplement
017604003AP1976/09/23Expiration Date Change
017604000AP1976/03/16Approval