药品名称AZACTAM
申请号050580产品号003
活性成分AZTREONAM市场状态处方药
剂型或给药途径INJECTABLE;INJECTION规格2GM/VIAL
治疗等效代码AP参比药物
批准日期1986/12/31申请机构BRISTOL MYERS SQUIBB
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
050580042APLabel2013/06/17下载
050580042APLetter2013/06/18下载
050580040APLetter2008/01/24下载
050580040APLabel2008/01/24下载
050580037APLetter2004/12/30下载
050580033APLetter2002/03/25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
050580043AP2014/09/30Manufacturing Change or Addition
050580042AP2013/06/17Labeling Revision
050580040AP2008/01/22Labeling Revision
050580037AP2004/12/16Labeling Revision
050580036AP2002/11/27Manufacturing Change or Addition
050580035AP2002/09/13Control Supplement
050580034AP2002/06/24Manufacturing Change or Addition
050580033AP2002/03/25Labeling Revision
050580032AP1999/12/29Manufacturing Change or Addition
050580031AP1999/02/16Labeling Revision
050580030AP1997/11/07Manufacturing Change or Addition
050580029AP1997/06/12Manufacturing Change or Addition
050580028AP1999/02/16Labeling Revision
050580027AP1998/07/28Control Supplement
050580026AP1996/04/03Control Supplement
050580025AP1994/05/23Control Supplement
050580024AP1993/02/18Control Supplement
050580023AP1994/05/23Control Supplement
050580022AP1996/08/20Labeling Revision
050580021AP1996/08/20Labeling Revision
050580020AP1991/09/30Labeling Revision
050580019AP1992/06/25Labeling Revision
050580018AP1989/04/10Chemistry Generic
050580017AP1990/09/18Manufacturing Change or Addition
050580008AP1996/11/01New or Modified Indication
050580000AP1986/12/31Approval