药品名称POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER
申请号018365产品号002
活性成分DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE市场状态处方药
剂型或给药途径INJECTABLE;INJECTION规格5GM/100ML;74.5MG/100ML;225MG/100ML
治疗等效代码参比药物
批准日期1983/07/05申请机构HOSPIRA INC
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)
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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
018365091AP2013/09/05Manufacturing Change or Addition
018365070AP2001/08/24Labeling Revision
018365069AP1999/01/22Control Supplement
018365068AP1998/10/29Control Supplement
018365066AP1997/06/11Manufacturing Change or Addition
018365065AP1997/08/20Labeling Revision
018365064AP1996/08/06Control Supplement
018365063AP1996/03/04Control Supplement
018365062AP1995/08/18Manufacturing Change or Addition
018365061AP1996/08/29Control Supplement
018365060AP1996/08/27Control Supplement
018365059AP1995/08/14Control Supplement
018365056AP1991/08/30Package Change
018365055AP1992/01/28Package Change
018365054AP1991/09/10Control Supplement
018365052AP1990/01/11Manufacturing Change or Addition
018365051AP1990/02/22Manufacturing Change or Addition
018365049AP1988/03/28Labeling Revision
018365048AP1988/03/28Control Supplement
018365046AP1986/11/26Control Supplement
018365045AP1986/08/08Control Supplement
018365044AP1986/01/31Control Supplement
018365043AP1985/06/10Control Supplement
018365042AP1986/01/31Control Supplement
018365040AP1985/10/26Labeling Revision
018365039AP1985/05/03Control Supplement
018365038AP1985/10/26Control Supplement
018365037AP1984/11/09Resubmission - Chemistry (MarkIV)
018365034AP1984/10/22Control Supplement
018365033AP1985/09/26Package Change
018365031AP1985/11/29Labeling Revision
018365030AP1985/11/29Control Supplement
018365029AP1985/10/29Package Change
018365028AP1984/11/28Control Supplement
018365027AP1989/06/22Control Supplement
018365026AP1984/04/09Control Supplement
018365025AP1984/10/17Control Supplement
018365024AP1984/03/21Control Supplement
018365023AP1983/07/05Labeling Revision
018365022AP1983/07/05Control Supplement
018365021AP1983/12/08Control Supplement
018365020AP1984/02/17Control Supplement
018365019AP1984/10/10Labeling Revision
018365018AP1984/10/10Package Change
018365017AP1982/07/26Control Supplement
018365016AP1984/03/01Control Supplement
018365015AP1983/02/15Manufacturing Change or Addition
018365014AP1982/06/18Control Supplement
018365013AP1982/07/08Control Supplement
018365012AP1982/02/01Control Supplement
018365011AP1982/01/08Control Supplement
018365010AP1982/06/09Control Supplement
018365009AP1981/10/07Control Supplement
018365008AP1981/07/27Labeling Revision
018365006AP1981/06/20Practioner Draft Labeling
018365005AP1981/04/08Labeling Revision
018365004AP1981/04/08Control Supplement
018365003AP1981/01/07Control Supplement
018365002AP1980/09/15Control Supplement
018365001AP1980/08/13Control Supplement
018365000AP1980/05/29Approval