药品名称DEXTROSE 5% AND ELECTROLYTE NO. 48 IN PLASTIC CONTAINER
申请号017484产品号001
活性成分DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, MONOBASIC; SODIUM CHLORIDE; SODIUM LACTATE市场状态处方药
剂型或给药途径INJECTABLE;INJECTION规格5GM/100ML;31MG/100ML;141MG/100ML;20MG/100ML;12MG/100ML;260MG/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
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
017484062APLabel2005/08/31下载
017484062APLetter2005/08/31下载
017484061APLetter2005/06/08下载
017484061APLabel2005/06/08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
017484072AP2016/03/24Manufacturing Change or Addition
017484071AP2015/11/13Manufacturing Change or Addition
017484070AP2015/02/03Manufacturing Change or Addition
017484069AP2013/04/26Manufacturing Change or Addition
017484062AP2005/08/26Package Change
017484061AP2005/06/07Labeling Revision
017484057AP2001/08/14Manufacturing Change or Addition
017484056AP1999/11/24Manufacturing Change or Addition
017484055AP2000/11/29Labeling Revision
017484054AP1997/04/29Package Change
017484053AP1994/02/18Control Supplement
017484052AP1994/09/30Control Supplement
017484050AP1991/04/26Control Supplement
017484049AP1991/04/29Control Supplement
017484048AP1991/03/26Control Supplement
017484047AP1991/02/15Control Supplement
017484046AP1989/07/26Control Supplement
017484045AP1989/01/12Control Supplement
017484044AP1987/07/25Package Change
017484043AP1987/05/28Control Supplement
017484040AP1986/02/27Package Change
017484039AP1985/04/15Control Supplement
017484037AP1985/04/17Labeling Revision
017484036AP1985/06/13Control Supplement
017484035AP1984/09/22Control Supplement
017484034AP1984/02/28Control Supplement
017484032AP1985/08/28Control Supplement
017484031AP1985/08/28Control Supplement
017484030AP1984/03/16Control Supplement
017484029AP1985/01/24Control Supplement
017484027AP1982/02/16Control Supplement
017484026AP1981/11/20Control Supplement
017484024AP1982/06/03Control Supplement
017484023AP1983/07/11Practioner Draft Labeling
017484022AP1982/04/16Control Supplement
017484021AP1981/08/26Labeling Revision
017484020AP1981/12/21Control Supplement
017484018AP1981/06/29Control Supplement
017484017AP1981/01/21Control Supplement
017484015AP1980/07/31Control Supplement
017484014AP1981/09/09Labeling Revision
017484013AP1981/09/09Control Supplement
017484012AP1980/08/06Control Supplement
017484011AP1981/04/16Control Supplement
017484009AP1980/06/18Control Supplement
017484007AP1980/05/30Control Supplement
017484006AP1980/08/07Control Supplement
017484005AP1979/08/02Control Supplement
017484003AP1980/06/28Control Supplement
017484002AP1979/06/14Control Supplement
017484001AP1980/02/25Control Supplement
017484000AP1979/02/02Approval