药品名称DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
申请号019631产品号014
活性成分DEXTROSE; SODIUM CHLORIDE市场状态处方药
剂型或给药途径INJECTABLE;INJECTION规格10GM/100ML;450MG/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
019631023APLetter2004/09/29下载
019631023APLabel2004/09/29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
019631034AP2014/01/24Manufacturing Change or Addition
019631031AP2014/08/22Manufacturing Change or Addition
019631023AP2004/09/27Labeling Revision
019631022AP2002/07/23Control Supplement
019631020AP2002/03/08Package Change
019631019AP2001/03/12Control Supplement
019631018AP2000/04/11Control Supplement
019631017AP1998/09/25Control Supplement
019631016AP1995/03/17Control Supplement
019631015AP1994/12/19Control Supplement
019631014AP1993/07/21Control Supplement
019631013AP1992/12/29Manufacturing Change or Addition
019631011AP1991/08/29Control Supplement
019631010AP1990/09/18Control Supplement
019631009AP1990/01/19Labeling Revision
019631008AP1990/04/13Package Change
019631007AP1989/07/26Control Supplement
019631006AP1990/01/19Control Supplement
019631005AP1989/05/05Control Supplement
019631004AP1989/11/21Control Supplement
019631003AP1988/12/21Manufacturing Change or Addition
019631002AP1988/08/25Formulation Revision
019631001AP1988/03/25Labeling Revision
019631000AP1988/02/24Approval