药品名称POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER
申请号019367产品号006
活性成分CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE市场状态处方药
剂型或给药途径INJECTABLE;INJECTION规格20MG/100ML;5GM/100ML;254MG/100ML;600MG/100ML;310MG/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
019367026APLetter2011/10/24下载
019367026APLabel2011/11/04下载
019367022APLetter2005/08/31下载
019367022APLabel2005/08/31下载
019367021APLetter2005/06/08下载
019367021APLabel2005/06/08下载
019367015APLetter2003/01/03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
019367031AP2014/09/30Manufacturing Change or Addition
019367029AP2013/04/26Manufacturing Change or Addition
019367026AP2011/10/19Labeling Revision
019367022AP2005/08/26Package Change
019367021AP2005/06/07Labeling Revision
019367016AP2001/08/14Manufacturing Change or Addition
019367015AP2003/01/03Labeling Revision
019367014AP1999/11/24Manufacturing Change or Addition
019367013AP1997/04/29Package Change
019367012AP1994/02/18Control Supplement
019367011AP1994/09/30Control Supplement
019367010AP1991/12/11Control Supplement
019367008AP1991/04/29Control Supplement
019367007AP1991/03/26Control Supplement
019367006AP1991/02/15Control Supplement
019367005AP1989/07/26Control Supplement
019367003AP1987/07/25Package Change
019367002AP1987/05/28Control Supplement
019367000AP1985/04/05Approval