药品名称PLASMA-LYTE M AND DEXTROSE 5% IN PLASTIC CONTAINER
申请号017390产品号001
活性成分CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM LACTATE市场状态停止上市
剂型或给药途径INJECTABLE;INJECTION规格37MG/100ML;5GM/100ML;30MG/100ML;119MG/100ML;161MG/100ML;94MG/100ML;138MG/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BAXTER HEALTHCARE CORP
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审批日期审批内容
017390055AP2001/08/14Manufacturing Change or Addition
017390054AP2001/02/01Labeling Revision
017390053AP1999/11/24Manufacturing Change or Addition
017390052AP2000/11/29Labeling Revision
017390051AP1997/04/29Package Change
017390050AP1994/02/18Control Supplement
017390049AP1994/09/30Control Supplement
017390047AP1991/04/26Control Supplement
017390046AP1991/04/29Control Supplement
017390045AP1991/03/26Control Supplement
017390044AP1991/02/15Control Supplement
017390043AP1989/07/26Control Supplement
017390042AP1987/07/25Package Change
017390041AP1987/05/28Control Supplement
017390039AP1986/02/27Package Change
017390038AP1985/04/15Control Supplement
017390036AP1985/04/18Labeling Revision
017390035AP1985/06/13Control Supplement
017390034AP1984/09/22Control Supplement
017390033AP1984/02/28Control Supplement
017390031AP1985/08/28Control Supplement
017390030AP1985/08/28Control Supplement
017390029AP1984/03/16Control Supplement
017390028AP1985/01/24Control Supplement
017390026AP1982/02/16Control Supplement
017390025AP1983/07/11Practioner Draft Labeling
017390024AP1981/11/20Control Supplement
017390022AP1982/06/03Control Supplement
017390021AP1982/04/16Control Supplement
017390020AP1981/08/26Labeling Revision
017390019AP1981/12/21Control Supplement
017390017AP1981/06/29Control Supplement
017390016AP1981/01/21Control Supplement
017390014AP1980/07/31Control Supplement
017390013AP1980/08/06Control Supplement
017390012AP1981/04/16Control Supplement
017390011AP1980/05/30Control Supplement
017390009AP1980/06/18Control Supplement
017390007AP1980/01/15Control Supplement
017390006AP1979/08/10Control Supplement
017390005AP1980/08/07Control Supplement
017390004AP1979/08/02Control Supplement
017390002AP1980/06/28Control Supplement
017390001AP1980/02/25Control Supplement
017390000AP1979/02/01Approval