药品名称AMINOSYN II 3.5% M IN DEXTROSE 5% IN PLASTIC CONTAINER
申请号019682产品号001
活性成分AMINO ACIDS; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE市场状态停止上市
剂型或给药途径INJECTABLE;INJECTION规格3.5%;5GM/100ML;30MG/100ML;97MG/100ML;120MG/100ML;49.3MG/100ML
治疗等效代码参比药物
批准日期1988/11/01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
019682020APLetter2004/05/27下载
019682018APLetter2004/05/27下载
019682015APLetter2004/05/27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
019682020AP2003/01/31Control Supplement
019682019AP2002/11/08Control Supplement
019682018AP2002/08/21Labeling Revision
019682017AP1998/10/29Control Supplement
019682016AP1998/12/29Control Supplement
019682015AP2002/08/21Labeling Revision
019682014AP1997/06/11Manufacturing Change or Addition
019682013AP1997/05/05Control Supplement
019682012AP1996/03/04Control Supplement
019682011AP1997/03/04Control Supplement
019682010AP1995/08/18Manufacturing Change or Addition
019682009AP1996/08/27Control Supplement
019682008AP1994/07/11Manufacturing Change or Addition
019682006AP1993/12/30Control Supplement
019682005AP1992/09/28Manufacturing Change or Addition
019682004AP1991/08/30Package Change
019682003AP1992/01/28Package Change
019682002AP1992/08/18Manufacturing Change or Addition
019682001AP1990/01/11Manufacturing Change or Addition
019682000AP1988/11/01Approval