药品名称SUPRAX
申请号050621产品号001
活性成分CEFIXIME市场状态停止上市
剂型或给药途径TABLET;ORAL规格200MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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1989/04/28申请机构LEDERLE LABORATORIES DIV AMERICAN CYANAMID CO
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
050621026APLetter2003/08/28下载
050621026APLabel2003/08/28下载
050621023APLabel2004/04/05下载
050621023APLetter2004/04/07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
050621026AP2003/08/20Labeling Revision
050621024AP2002/08/16Manufacturing Change or Addition
050621023AP2004/03/29Labeling Revision
050621021AP1998/02/27Labeling Revision
050621019AP1994/03/10Control Supplement
050621017AP1992/11/13Manufacturing Change or Addition
050621013AP1992/09/10Manufacturing Change or Addition
050621012AP1992/02/28Package Change
050621010AP1993/02/05New or Modified Indication
050621009AP1992/02/27Package Change
050621008AP1993/01/19Labeling Revision
050621007AP1990/07/12Chemistry Generic
050621006AP1990/10/31Chemistry Generic
050621005AP1992/03/09Package Change
050621003AP1990/04/18Chemistry Generic
050621002AP1991/06/25Manufacturing Change or Addition
050621001AP1989/05/31Labeling Revision
050621000AP1989/04/28Approval