药品名称AMINOSYN II 3.5% M
申请号019437产品号007
活性成分AMINO ACIDS; 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%;30MG/100ML;97MG/100ML;120MG/100ML;49MG/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
019437015APLetter2004/05/27下载
019437014APLetter2003/07/06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
019437038AP2016/06/06Manufacturing Change or Addition
019437034AP2013/07/31Manufacturing Change or Addition
019437015AP2002/10/25Manufacturing Change or Addition
019437014AP2003/06/23Labeling Revision
019437013AP1999/01/22Control Supplement
019437012AP1997/05/05Control Supplement
019437011AP1996/08/27Control Supplement
019437010AP1994/07/11Manufacturing Change or Addition
019437009AP1993/12/30Control Supplement
019437008AP1992/09/28Manufacturing Change or Addition
019437007AP1992/08/18Manufacturing Change or Addition
019437006AP1992/02/10Manufacturing Change or Addition
019437005AP1988/06/17Labeling Revision
019437004AP1987/12/01Manufacturing Change or Addition
019437002AP1986/12/04Labeling Revision
019437001AP1986/12/04Control Supplement
019437000AP1986/04/03Approval