药品名称DEXTROSE 2.5% IN HALF-STRENGTH LACTATED RINGER'S IN PLASTIC CONTAINER
申请号019634产品号001
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10MG/100ML;2.5GM/100ML;15MG/100ML;300MG/100ML;160MG/100ML
治疗等效代码参比药物
批准日期1988/02/24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
019634033APLabel2013/02/14下载
019634033APLetter2013/02/15下载
019634021APLetter2004/10/04下载
019634021APLabel2004/10/04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
019634033AP2013/02/13Labeling Revision
019634029AP2014/08/22Manufacturing Change or Addition
019634021AP2004/09/27Labeling Revision
019634020AP2002/07/23Control Supplement
019634018AP2002/03/08Package Change
019634017AP2001/03/12Control Supplement
019634016AP2000/04/11Control Supplement
019634015AP1999/05/04Control Supplement
019634014AP1998/09/25Control Supplement
019634012AP1993/04/26Control Supplement
019634011AP1993/07/21Control Supplement
019634010AP1992/12/29Manufacturing Change or Addition
019634008AP1991/08/29Control Supplement
019634007AP1990/09/18Control Supplement
019634006AP1990/04/13Package Change
019634005AP1989/07/26Control Supplement
019634004AP1989/05/05Control Supplement
019634003AP1989/11/21Control Supplement
019634002AP1988/12/21Manufacturing Change or Addition
019634001AP1988/03/25Labeling Revision
019634000AP1988/02/24Approval