药品名称DIANEAL LOW CALCIUM W/ DEXTROSE 4.25% IN PLASTIC CONTAINER
申请号020183产品号004
活性成分CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE市场状态处方药
剂型或给药途径SOLUTION;INTRAPERITONEAL规格18.3MG/100ML;4.25GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML
治疗等效代码参比药物
批准日期1992/12/04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
020183027APLabel2016/08/17下载
020183027APLetter2016/08/18下载
020183026APLetter2015/09/04下载
020183026APLabel2015/09/04下载
020183024APLetter2015/02/10下载
020183024APLabel2015/02/10下载
020183019APLabel2013/04/23下载
020183019APLetter2013/04/24下载
020183015APReview2007/11/19下载
020183012APLetter2005/08/11下载
020183011APLetter2005/08/11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
020183027AP2016/08/16Labeling Revision
020183026AP2015/09/01Labeling Revision
020183024AP2015/02/09Labeling Revision
020183023AP2014/09/30Manufacturing Change or Addition
020183022AP2013/04/26Manufacturing Change or Addition
020183019AP2013/04/19Labeling Revision
020183015AP2006/08/08Supplement
020183012AP2005/08/09Package Change
020183011AP2005/08/09Labeling Revision
020183007AP2002/02/12Package Change
020183006AP2001/08/22Control Supplement
020183005AP1997/04/29Package Change
020183004AP1996/11/22Package Change
020183003AP1994/06/01Control Supplement
020183002AP1994/02/18Control Supplement
020183001AP1994/09/30Control Supplement
020183000AP1992/12/04Approval