药品名称POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER
申请号019630产品号016
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;150MG/100ML;330MG/100ML
治疗等效代码AP参比药物
批准日期1988/02/17申请机构B BRAUN MEDICAL INC
化学类型New formulation or new manufacturer审评分类Standard review drug
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
019630026APLetter2005/09/08下载
019630023APLetter2004/09/29下载
019630023APLabel2004/09/29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
019630038AP2013/05/22Manufacturing Change or Addition
019630037AP2013/05/30Manufacturing Change or Addition
019630032AP2014/08/22Manufacturing Change or Addition
019630026AP2005/08/31Labeling Revision
019630023AP2004/09/27Labeling Revision
019630022AP2002/07/23Control Supplement
019630020AP2002/03/08Package Change
019630019AP2001/03/12Control Supplement
019630018AP1999/05/04Control Supplement
019630017AP1998/09/25Control Supplement
019630016AP1995/01/13Control Supplement
019630015AP1994/12/21Control Supplement
019630014AP1993/07/21Control Supplement
019630013AP1992/12/29Manufacturing Change or Addition
019630011AP1991/08/29Control Supplement
019630010AP1990/09/18Control Supplement
019630009AP1992/05/07Labeling Revision
019630008AP1992/05/07Formulation Revision
019630007AP1990/04/13Package Change
019630006AP1989/07/26Control Supplement
019630005AP1989/05/05Control Supplement
019630004AP1989/11/21Control Supplement
019630003AP1988/12/21Manufacturing Change or Addition
019630002AP1988/08/25Formulation Revision
019630001AP1988/03/24Labeling Revision
019630000AP1988/02/17Approval