药品名称DIANEAL PD-2 W/ DEXTROSE 2.5% IN PLASTIC CONTAINER
申请号020163产品号002
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25.7MG/100ML;2.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML
治疗等效代码AT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
020163028APLabel2016/08/17下载
020163028APLetter2016/08/18下载
020163027APLetter2015/09/04下载
020163027APLabel2015/09/04下载
020163025APLetter2015/02/10下载
020163025APLabel2015/02/10下载
020163020APLabel2013/04/23下载
020163020APLetter2013/04/24下载
020163013APLetter2005/08/11下载
020163012APLetter2005/08/11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
020163028AP2016/08/16Labeling Revision
020163027AP2015/09/01Labeling Revision
020163026AP2015/06/05Manufacturing Change or Addition
020163025AP2015/02/09Labeling Revision
020163024AP2014/09/30Manufacturing Change or Addition
020163023AP2013/04/26Manufacturing Change or Addition
020163020AP2013/04/19Labeling Revision
020163013AP2005/08/09Package Change
020163012AP2005/08/09Labeling Revision
020163008AP2002/02/12Package Change
020163007AP2001/08/22Control Supplement
020163006AP1997/04/29Package Change
020163005AP1996/11/22Package Change
020163004AP1995/02/09Control Supplement
020163003AP1994/06/01Control Supplement
020163002AP1994/02/18Control Supplement
020163001AP1994/09/30Control Supplement
020163000AP1992/12/04Approval