药品名称DURICEF
申请号050512产品号001
活性成分CEFADROXIL/CEFADROXIL HEMIHYDRATE市场状态停止上市
剂型或给药途径CAPSULE;ORAL规格EQ 500MG 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WARNER CHILCOTT INC
化学类型New molecular entity (NME)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
050512046APLetter2007/06/07下载
050512046APLabel2007/06/07下载
050512045APLetter2003/12/19下载
050512045APLabel2003/12/29下载
050512044APLetter2004/06/02下载
050512044APLabel2004/06/02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
050512046AP2007/06/05Labeling Revision
050512045AP2003/12/16Labeling Revision
050512044AP2002/05/03Labeling Revision
050512043AP1996/10/15Labeling Revision
050512040AP1982/01/20Labeling Revision
050512039AP1981/11/02Control Supplement
050512038AP1981/11/02Package Change
050512037AP1981/10/27Manufacturing Change or Addition
050512036AP1981/08/24Package Change
050512035AP1981/08/18Package Change
050512033AP1981/04/21Labeling Revision
050512032AP1981/04/03Labeling Revision
050512031AP1980/02/22Labeling Revision
050512030AP1980/01/31Labeling Revision
050512029AP1980/01/21Expiration Date Change
050512028AP1980/01/24Expiration Date Change
050512027AP1979/12/28Labeling Revision
050512025AP1979/10/25Labeling Revision
050512024AP1979/04/26Package Change
050512023AP1979/11/30Control Supplement
050512022AP1980/05/05Control Supplement
050512021AP1979/02/26Labeling Revision
050512020AP1978/08/14Expiration Date Change
050512019AP1978/07/21Package Change
050512018AP1978/07/07Manufacturing Change or Addition
050512017AP1978/05/08Labeling Revision
050512016AP1978/05/08Labeling Revision
050512014AP1988/09/12Control Supplement
050512013AP1989/05/18Labeling Revision
050512011AP1991/08/30New Dosage Regimen
050512009AP1987/11/18Manufacturing Change or Addition
050512007AP1986/09/12Labeling Revision
050512005AP1982/07/17Expiration Date Change
050512003AP1983/07/08Package Change
050512002AP1982/05/21Control Supplement
050512000AP1978/02/17Approval