药品名称UNASYN
申请号050608产品号005
活性成分AMPICILLIN SODIUM; SULBACTAM SODIUM市场状态处方药
剂型或给药途径INJECTABLE;INJECTION规格EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL
治疗等效代码AP参比药物
批准日期1993/12/10申请机构PFIZER INC
化学类型审评分类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
050608042APLetter2014/11/19下载
050608042APLabel2014/11/20下载
050608041APLetter2014/11/19下载
050608041APLabel2014/11/20下载
050608040APLabel2012/03/07下载
050608040APLetter2012/03/13下载
050608029APLetter2008/04/16下载
050608029APLabel2008/04/23下载
050608026APLetter2004/08/25下载
050608019APReview1997/02/12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
050608043AP2015/02/09Manufacturing Change or Addition
050608042AP2014/11/17Labeling Revision
050608041AP2014/11/17Labeling Revision
050608040AP2012/03/06Labeling Revision
050608038AP2012/12/14Manufacturing Change or Addition
050608029AP2008/04/14Labeling Revision
050608026AP2004/08/19Labeling Revision
050608025AP2002/03/13Manufacturing Change or Addition
050608024AP2001/02/14Control Supplement
050608023AP1998/05/29Manufacturing Change or Addition
050608021AP1996/12/06Manufacturing Change or Addition
050608020AP1996/05/15Control Supplement
050608019AP1997/02/12Patient Population Altered
050608018AP1993/12/10Package Change
050608017AP1993/11/05Labeling Revision
050608016AP1992/10/08Labeling Revision
050608015AP1993/03/24Manufacturing Change or Addition
050608014AP1992/05/08Control Supplement
050608013AP1992/04/23Control Supplement
050608012AP1992/01/02Control Supplement
050608011AP1992/03/27Labeling Revision
050608009AP1991/11/22Chemistry Generic
050608007AP1989/08/03Chemistry Generic
050608000AP1986/12/31Approval