药品名称CLINIMIX E 4.25/20 SULFITE FREE W/ ELECT IN DEXTROSE 20% W/ CALCIUM IN PLASTIC CONTAINER
申请号020678产品号011
活性成分AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE市场状态处方药
剂型或给药途径INJECTABLE;INJECTION规格4.25%;33MG/100ML;20GM/100ML;51MG/100ML;261MG/100ML;297MG/100ML;77MG/100ML
治疗等效代码参比药物
批准日期1997/03/26申请机构BAXTER HEALTHCARE CORP
化学类型New combination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
020678027APLabel2016/09/29下载
020678027APLetter2016/09/30下载
020678021APLetter2010/01/20下载
020678014APLetter2004/02/02下载
020678013APLetter2003/06/08下载
020678011APLetter2002/07/25下载
020678010APLetter2002/07/25下载
020678003APLetter2000/04/12下载
020678003APReview2000/04/12下载
020678000APReview2010/01/05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
020678033AP2016/09/09Manufacturing Change or Addition
020678031AP2015/09/01Manufacturing Change or Addition
020678030AP2015/02/09Manufacturing Change or Addition
020678029AP2014/09/30Manufacturing Change or Addition
020678028AP2014/08/29Manufacturing Change or Addition
020678027AP2016/09/27Labeling Revision
020678024AP2014/09/15Manufacturing Change or Addition
020678021AP2009/11/02Labeling Revision
020678014AP2004/01/23Labeling Revision
020678013AP2003/05/21Control Supplement
020678011AP2002/07/25Labeling Revision
020678010AP2002/07/25Control Supplement
020678009AP2002/02/15Package Change
020678007AP2001/04/04Control Supplement
020678006AP2000/10/19Package Change
020678005AP2000/03/24Control Supplement
020678004AP2000/02/25Package Change
020678003AP2000/04/12Efficacy Supplement with Clinical Data to Support
020678002AP1999/05/25Manufacturing Change or Addition
020678001AP1999/04/15Control Supplement
020678000AP1997/03/26Approval