药品名称ISOLYTE E W/ DEXTROSE 5% IN PLASTIC CONTAINER
申请号018269产品号002
活性成分CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM CITRATE市场状态停止上市
剂型或给药途径INJECTABLE;INJECTION规格35MG/100ML;5GM/100ML;30MG/100ML;74MG/100ML;640MG/100ML;500MG/100ML;74MG/100ML
治疗等效代码参比药物
批准日期1983/01/17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
018269016AP1990/09/11Package Change
018269014AP1987/12/28Labeling Revision
018269013AP1987/07/09Labeling Revision
018269012AP1985/11/25Labeling Revision
018269011AP1985/04/03Control Supplement
018269010AP1985/06/28Package Change
018269009AP1986/02/18Control Supplement
018269008AP1983/01/17Labeling Revision
018269007AP1981/10/26Manufacturing Change or Addition
018269006AP1984/12/10Control Supplement
018269005AP1981/12/16Labeling Revision
018269004AP1980/12/30Control Supplement
018269003AP1980/12/10Control Supplement
018269002AP1980/12/11Control Supplement
018269001AP1981/01/02Manufacturing Change or Addition
018269000AP1980/10/03Approval