药品名称PLEGISOL IN PLASTIC CONTAINER
申请号018608产品号001
活性成分CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE市场状态处方药
剂型或给药途径SOLUTION;PERFUSION, CARDIAC规格17.6MG/100ML;325.3MG/100ML;119.3MG/100ML;643MG/100ML
治疗等效代码AT参比药物
批准日期1982/02/26申请机构HOSPIRA INC
化学类型New dosage form审评分类Priority review drug
与本品相关的专利信息(来自橙皮书Orange Book)
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历史专利信息
与本品相关的市场独占权保护信息
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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
018608031APLetter2002/12/16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
018608035AP2000/12/12Control Supplement
018608034AP1999/10/18Labeling Revision
018608033AP1997/11/14Package Change
018608032AP1997/09/05Manufacturing Change or Addition
018608031AP2002/12/16Labeling Revision
018608030AP1997/03/20Control Supplement
018608029AP1997/03/20Control Supplement
018608026AP1992/01/28Package Change
018608025AP1991/09/10Control Supplement
018608023AP1990/01/11Manufacturing Change or Addition
018608022AP1990/02/22Manufacturing Change or Addition
018608019AP1986/11/26Control Supplement
018608018AP1986/08/08Control Supplement
018608017AP1986/01/31Control Supplement
018608016AP1986/01/31Control Supplement
018608015AP1984/11/09Resubmission - Chemistry (MarkIV)
018608014AP1984/10/22Control Supplement
018608013AP1985/09/26Package Change
018608011AP1985/10/29Package Change
018608010AP1987/03/09Labeling Revision
018608009AP1989/09/13Control Supplement
018608008AP1984/10/17Control Supplement
018608007AP1984/03/21Control Supplement
018608005AP1987/03/09Control Supplement
018608004AP1982/07/26Control Supplement
018608003AP1984/03/01Control Supplement
018608002AP1982/06/18Control Supplement
018608001AP1982/10/21Labeling Revision
018608000AP1982/02/26Approval