药品名称AMINOSYN II 5% IN DEXTROSE 25% IN PLASTIC CONTAINER
申请号019681产品号006
活性成分AMINO ACIDS; DEXTROSE市场状态停止上市
剂型或给药途径INJECTABLE;INJECTION规格5%;25GM/100ML
治疗等效代码参比药物
批准日期1988/11/01申请机构HOSPIRA WORLDWIDE, INC
化学类型New formulation or new manufacturer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
019681020APLetter2004/05/27下载
019681018APLetter2004/05/27下载
019681015APLetter2004/05/27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
019681020AP2003/02/19Control Supplement
019681019AP2002/11/08Control Supplement
019681018AP2002/08/21Labeling Revision
019681017AP1998/10/29Control Supplement
019681016AP1998/12/29Control Supplement
019681015AP2002/08/21Labeling Revision
019681014AP1997/08/20Control Supplement
019681013AP1997/06/11Manufacturing Change or Addition
019681012AP1997/05/05Control Supplement
019681011AP1996/03/04Control Supplement
019681010AP1997/03/04Control Supplement
019681009AP1995/08/18Manufacturing Change or Addition
019681008AP1996/08/27Control Supplement
019681007AP1994/07/11Manufacturing Change or Addition
019681005AP1993/12/30Control Supplement
019681004AP1992/09/28Manufacturing Change or Addition
019681003AP1991/08/30Package Change
019681002AP1992/01/28Package Change
019681001AP1992/08/18Manufacturing Change or Addition
019681000AP1988/11/01Approval