药品名称FORTAZ
申请号050578产品号002
活性成分CEFTAZIDIME市场状态处方药
剂型或给药途径INJECTABLE;INJECTION规格1GM/VIAL
治疗等效代码AP参比药物
批准日期1985/07/19申请机构IGI LABORATORIES INC
化学类型New molecular entity (NME)审评分类Priority 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
050578055APLetter2014/09/26下载
050578055APLabel2014/09/26下载
050578053APLabel2007/07/10下载
050578053APLetter2007/07/16下载
050578051APLabel2007/03/15下载
050578046APLetter2004/05/26下载
050578046APLabel2004/05/27下载
050578042APLetter2002/03/22下载
050578040APLetter2002/03/29下载
050578040APLabel2002/03/29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
050578060AP2015/03/03Manufacturing Change or Addition
050578055AP2014/09/24Labeling Revision
050578053AP2007/07/09Labeling Revision
050578051AP2007/03/14Labeling Revision
050578046AP2004/05/19Labeling Revision
050578044AP2002/10/23Control Supplement
050578043AP2002/02/22Control Supplement
050578042AP2002/03/22Labeling Revision
050578040AP2002/03/29Labeling Revision
050578039AP1997/11/25Control Supplement
050578038AP1997/04/03Manufacturing Change or Addition
050578037AP1996/12/24Labeling Revision
050578036AP1996/10/04Control Supplement
050578035AP1995/11/03Manufacturing Change or Addition
050578034AP1996/06/20Labeling Revision
050578033AP1996/06/20Labeling Revision
050578032AP1998/01/26Labeling Revision
050578031AP1996/08/20Labeling Revision
050578030AP1996/09/11Labeling Revision
050578029AP1993/02/18Manufacturing Change or Addition
050578028AP1992/12/31Labeling Revision
050578027AP1994/10/20Labeling Revision
050578026AP1991/08/09Manufacturing Change or Addition
050578024AP1992/02/13Package Change
050578022AP1994/09/07Labeling Revision
050578021AP1992/02/13Control Supplement
050578020AP1990/03/22Manufacturing Change or Addition
050578018AP1990/04/10Chemistry Generic
050578017AP1993/04/29Labeling Revision
050578015AP1993/04/29Labeling Revision
050578000AP1985/07/19Approval