药品名称CEFTIN
申请号050672产品号002
活性成分CEFUROXIME AXETIL市场状态处方药
剂型或给药途径FOR SUSPENSION;ORAL规格EQ 250MG BASE/5ML
治疗等效代码参比药物
批准日期1997/04/29申请机构GLAXOSMITHKLINE
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
050672034APLabel2015/08/27下载
050672034APLetter2015/08/28下载
050672033APLabel2015/07/01下载
050672033APLetter2015/07/07下载
050672032APLabel2014/09/22下载
050672032APLetter2014/09/23下载
050672029APLabel2014/09/22下载
050672029APLetter2014/09/23下载
050672028APLabel2007/08/02下载
050672028APLetter2007/08/02下载
050672025APLetter2004/06/07下载
050672025APLabel2004/06/07下载
050672018APLetter2002/04/11下载
050672018APLabel2002/04/11下载
050672014APLetter1999/08/24下载
050672014APReview1999/08/24下载
050672013APLetter2002/03/29下载
050672013APLabel2002/03/29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
050672034AP2015/08/26Labeling Revision
050672033AP2015/06/26Labeling Revision
050672032AP2014/09/20Labeling Revision
050672029AP2014/09/20Labeling Revision
050672028AP2007/08/01Labeling Revision
050672025AP2004/06/03Labeling Revision
050672021AP2001/09/18Control Supplement
050672020AP2001/04/13Control Supplement
050672019AP2001/07/03Manufacturing Change or Addition
050672018AP2002/04/11Labeling Revision
050672017AP2000/09/25Control Supplement
050672016AP1999/04/23Manufacturing Change or Addition
050672015AP1999/03/02Package Change
050672014AP1999/08/24Efficacy Supplement with Clinical Data to Support
050672013AP2002/03/29Labeling Revision
050672012AP1998/03/24Labeling Revision
050672011AP1997/11/19Manufacturing Change or Addition
050672010AP1997/06/04Labeling Revision
050672009AP1996/12/23Labeling Revision
050672008AP1997/04/29Control Supplement
050672007AP1995/11/09Labeling Revision
050672006AP1995/08/08Control Supplement
050672005AP1996/09/13Labeling Revision
050672004AP1996/12/23Labeling Revision
050672003AP1999/07/27Expiration Date Change
050672002AP1995/12/14Labeling Revision
050672001AP1996/09/13Labeling Revision
050672000AP1994/06/30Approval