药品名称CEFTIN
申请号050605产品号001
活性成分CEFUROXIME AXETIL市场状态处方药
剂型或给药途径TABLET;ORAL规格EQ 125MG BASE
治疗等效代码AB参比药物
批准日期1987/12/28申请机构GLAXOSMITHKLINE
化学类型New active ingredient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
050605048APLabel2015/08/27下载
050605048APLetter2015/08/28下载
050605047APLabel2015/07/01下载
050605047APLetter2015/07/07下载
050605046APLetter2014/09/23下载
050605046APLabel2014/09/22下载
050605043APLetter2014/09/23下载
050605043APLabel2014/09/22下载
050605042APLabel2007/07/24下载
050605042APLetter2007/07/27下载
050605039APLetter2004/06/07下载
050605039APLabel2004/06/07下载
050605037APLetter2002/07/24下载
050605033APLetter2002/04/11下载
050605033APLabel2002/04/11下载
050605032APLetter1999/08/24下载
050605032APReview1999/08/24下载
050605031APLetter2002/03/29下载
050605031APLabel2002/03/29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
050605048AP2015/08/26Labeling Revision
050605047AP2015/06/26Labeling Revision
050605046AP2014/09/20Labeling Revision
050605043AP2014/09/20Labeling Revision
050605042AP2007/07/23Labeling Revision
050605039AP2004/06/03Labeling Revision
050605037AP2002/07/24Labeling Revision
050605036AP2001/12/20Manufacturing Change or Addition
050605035AP2001/04/13Control Supplement
050605034AP2001/07/03Manufacturing Change or Addition
050605033AP2002/04/11Labeling Revision
050605032AP1999/08/24Efficacy Supplement with Clinical Data to Support
050605031AP2002/03/29Labeling Revision
050605030AP1998/03/24Labeling Revision
050605029AP1998/01/16Manufacturing Change or Addition
050605028AP1997/11/19Manufacturing Change or Addition
050605027AP1997/06/04Labeling Revision
050605026AP1996/12/23Labeling Revision
050605025AP1997/09/17New Dosage Regimen
050605024AP1996/12/06New or Modified Indication
050605023AP1996/09/13Labeling Revision
050605022AP1996/09/13Labeling Revision
050605021AP1996/12/23Labeling Revision
050605020AP1995/08/30Manufacturing Change or Addition
050605019AP1994/06/30Labeling Revision
050605017AP1996/12/19New or Modified Indication
050605016AP1993/06/28Control Supplement
050605015AP1993/10/18Labeling Revision
050605014AP1992/01/31Manufacturing Change or Addition
050605013AP1993/01/27Labeling Revision
050605012AP1991/08/09Manufacturing Change or Addition
050605011AP1993/01/27Labeling Revision
050605009AP1991/08/19Labeling Revision
050605008AP1992/01/31New or Modified Indication
050605007AP1996/03/13New or Modified Indication
050605006AP1991/08/19Labeling Revision
050605005AP1991/08/19Labeling Revision
050605000AP1987/12/28Approval