药品名称EFUDEX
申请号016831产品号003
活性成分FLUOROURACIL市场状态处方药
剂型或给药途径CREAM;TOPICAL规格5%
治疗等效代码AB参比药物
批准日期Approved Prior to Jan 1, 1982申请机构VALEANT PHARMACEUTICALS INTERNATIONAL
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
016831051APLetter2006/05/16下载
016831049APLetter2005/10/19下载
016831049APLabel2005/10/19下载
016831047APLetter2004/06/25下载
016831047APLabel2004/06/25下载
016831046APLetter2004/04/29下载
016831035APReview2011/06/23下载
016831031APReview2011/06/23下载
016831030APReview2011/06/23下载
016831028APReview2011/06/23下载
016831011APReview2011/06/23下载
016831008APReview2011/06/23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
016831059AP2015/11/04Manufacturing Change or Addition
016831058AP2015/08/18Manufacturing Change or Addition
016831057AP2015/05/06Manufacturing Change or Addition
016831056AP2013/07/02Manufacturing Change or Addition
016831055AP2013/12/12Manufacturing Change or Addition
016831051AP2006/05/10Package Change
016831049AP2005/10/13Labeling Revision
016831047AP2004/06/24Labeling Revision
016831046AP2004/04/27Manufacturing Change or Addition
016831043AP2002/11/27Manufacturing Change or Addition
016831042AP2001/08/30Manufacturing Change or Addition
016831041AP2001/07/03Control Supplement
016831040AP2001/07/03Control Supplement
016831039AP2001/02/12Manufacturing Change or Addition
016831038AP2000/06/20Control Supplement
016831037AP2000/07/07Manufacturing Change or Addition
016831036AP2000/07/07Manufacturing Change or Addition
016831035AP2000/04/05Manufacturing Change or Addition
016831033AP1998/11/02Control Supplement
016831032AP1997/02/18Control Supplement
016831031AP1993/08/05Control Supplement
016831030AP1993/03/04Control Supplement
016831029AP1995/03/21Labeling Revision
016831028AP1988/11/30Manufacturing Change or Addition
016831027AP1986/11/14Manufacturing Change or Addition
016831026AP1985/06/10Package Change
016831025AP1985/03/14Control Supplement
016831024AP1984/08/13Control Supplement
016831023AP1984/05/04Control Supplement
016831022AP1983/08/12Control Supplement
016831021AP1983/08/12Control Supplement
016831020AP1983/03/14Control Supplement
016831019AP1982/05/14Control Supplement
016831018AP1982/03/10Labeling Revision
016831017AP1987/03/26Practioner Draft Labeling
016831016AP1979/12/18Control Supplement
016831015AP1979/10/23Control Supplement
016831014AP1978/11/21Manufacturing Change or Addition
016831013AP1977/12/14Control Supplement
016831012AP1977/12/14Control Supplement
016831011AP1975/05/07Control Supplement
016831010AP1975/05/07Control Supplement
016831009AP1974/09/19Control Supplement
016831008AP1975/06/30Control Supplement
016831000AP1970/07/29Approval