药品名称DURICEF
申请号050527产品号002
活性成分CEFADROXIL/CEFADROXIL HEMIHYDRATE市场状态停止上市
剂型或给药途径FOR SUSPENSION;ORAL规格EQ 125MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
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 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
050527022APLetter2007/06/07下载
050527022APLabel2007/06/07下载
050527021APLetter2003/12/19下载
050527021APLabel2003/12/29下载
050527020APLetter2004/06/02下载
050527020APLabel2004/06/02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
050527022AP2007/06/05Labeling Revision
050527021AP2003/12/16Labeling Revision
050527020AP2002/05/03Labeling Revision
050527019AP1999/03/26Package Change
050527017AP1996/10/15Labeling Revision
050527015AP1982/05/21Control Supplement
050527012AP1982/01/20Labeling Revision
050527011AP1989/05/03Labeling Revision
050527010AP1988/09/12Formulation Revision
050527009AP1991/08/30New Dosage Regimen
050527008AP1981/10/27Manufacturing Change or Addition
050527006AP1987/03/05Control Supplement
050527005AP1981/08/07Labeling Revision
050527004AP1981/06/30Labeling Revision
050527003AP1981/03/31Labeling Revision
050527002AP1980/12/08Control Supplement
050527001AP1980/11/04Labeling Revision
050527000AP1980/09/12Approval