药品名称POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
申请号019308产品号004
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;75MG/100ML;900MG/100ML
治疗等效代码AP参比药物
批准日期1985/04/05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
019308027APLabel2013/09/11下载
019308027APLetter2013/09/12下载
019308023APLabel2007/04/25下载
019308023APLetter2007/05/01下载
019308022APLabel2005/08/31下载
019308022APLetter2005/08/31下载
019308020APLetter2004/06/07下载
019308017APLetter2003/05/29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
019308027AP2013/09/10Labeling Revision
019308023AP2007/04/20Labeling Revision
019308022AP2005/08/26Package Change
019308020AP2004/06/02Labeling Revision
019308018AP2001/08/14Manufacturing Change or Addition
019308017AP2003/04/14Labeling Revision
019308016AP1999/11/24Manufacturing Change or Addition
019308015AP1997/04/29Package Change
019308014AP1994/02/18Control Supplement
019308013AP1994/09/30Control Supplement
019308012AP1991/12/11Control Supplement
019308010AP1991/04/29Control Supplement
019308009AP1991/03/26Control Supplement
019308008AP1991/02/15Control Supplement
019308007AP1989/07/26Control Supplement
019308006AP1989/01/12Control Supplement
019308004AP1987/07/25Package Change
019308003AP1987/05/28Control Supplement
019308000AP1985/04/05Approval