药品名称ISOLYTE M W/ DEXTROSE 5% IN PLASTIC CONTAINER
申请号018270产品号001
活性成分DEXTROSE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE市场状态停止上市
剂型或给药途径INJECTABLE;INJECTION规格5GM/100ML;150MG/100ML;130MG/100ML;280MG/100ML;91MG/100ML
治疗等效代码参比药物
批准日期Approved Prior to Jan 1, 1982申请机构B BRAUN MEDICAL INC
化学类型New formulation or new manufacturer审评分类Standard review drug
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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
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
018270018AP1990/09/11Package Change
018270016AP1988/04/22Labeling Revision
018270015AP1987/12/31Labeling Revision
018270014AP1986/06/10Labeling Revision
018270013AP1986/06/10Control Supplement
018270012AP1985/11/25Labeling Revision
018270011AP1985/04/03Control Supplement
018270010AP1985/06/28Package Change
018270009AP1986/02/18Control Supplement
018270008AP1983/01/17Labeling Revision
018270007AP1981/10/26Manufacturing Change or Addition
018270006AP1984/12/10Control Supplement
018270005AP1981/12/16Labeling Revision
018270004AP1980/12/30Control Supplement
018270003AP1980/12/10Control Supplement
018270002AP1980/12/11Control Supplement
018270001AP1981/01/02Manufacturing Change or Addition
018270000AP1980/10/03Approval