药品名称AMINOSYN II 10%
申请号019438产品号005
活性成分AMINO ACIDS市场状态处方药
剂型或给药途径INJECTABLE;INJECTION规格10% (10GM/100ML)
治疗等效代码参比药物
批准日期1986/04/03申请机构HOSPIRA 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
019438014APLetter2004/05/27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
019438014AP2002/10/25Manufacturing Change or Addition
019438012AP1999/01/22Control Supplement
019438011AP1997/05/05Control Supplement
019438010AP1996/08/27Control Supplement
019438009AP1994/07/11Manufacturing Change or Addition
019438008AP1993/12/30Control Supplement
019438007AP1992/09/28Manufacturing Change or Addition
019438006AP1992/08/18Manufacturing Change or Addition
019438005AP1988/12/30Labeling Revision
019438004AP1992/02/10Manufacturing Change or Addition
019438003AP1987/06/29Labeling Revision
019438002AP1987/12/01Manufacturing Change or Addition
019438000AP1986/04/03Approval