药品名称DELFLEX W/ DEXTROSE 4.25% IN PLASTIC CONTAINER
申请号018883产品号003
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;4.25GM/100ML;15.2MG/100ML;567MG/100ML;392MG/100ML
治疗等效代码AT参比药物
批准日期1984/11/30申请机构FRESENIUS MEDICAL CARE NORTH AMERICA
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
018883057APLetter2015/01/09下载
018883057APLabel2015/01/12下载
018883051APLetter2014/04/25下载
018883051APLabel2014/04/28下载
018883048APLabel2013/04/19下载
018883044APLabel2013/02/01下载
018883044APLetter2013/02/04下载
018883033APLetter2009/11/13下载
018883028APLetter2003/12/02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
018883061AP2016/07/18Manufacturing Change or Addition
018883060AP2016/10/17Manufacturing Change or Addition
018883058AP2015/12/28Manufacturing Change or Addition
018883057AP2015/01/08Labeling Revision
018883056AP2014/12/08Manufacturing Change or Addition
018883055AP2014/08/07Manufacturing Change or Addition
018883054AP2014/04/23Manufacturing Change or Addition
018883053AP2014/01/24Manufacturing Change or Addition
018883052AP2014/01/13Manufacturing Change or Addition
018883051AP2014/04/24Labeling Revision
018883050AP2013/07/26Manufacturing Change or Addition
018883049AP2013/08/15Manufacturing Change or Addition
018883048AP2013/04/18Manufacturing Change or Addition
018883047AP2013/02/22Manufacturing Change or Addition
018883044AP2013/01/30Labeling Revision
018883033AP2009/09/14Labeling Revision
018883028AP2003/11/26Control Supplement
018883026AP2001/09/26Package Change
018883025AP1999/05/18Package Change
018883024AP1997/02/24Control Supplement
018883023AP1996/06/14Control Supplement
018883022AP1996/02/22Control Supplement
018883021AP1996/01/19Control Supplement
018883020AP1993/07/07Manufacturing Change or Addition
018883019AP1993/07/07Labeling Revision
018883018AP1993/07/07Manufacturing Change or Addition
018883016AP1990/07/11Control Supplement
018883015AP1989/01/10Control Supplement
018883013AP1988/02/05Control Supplement
018883012AP1990/01/24Labeling Revision
018883011AP1990/01/24Control Supplement
018883010AP1990/01/24Labeling Revision
018883009AP1990/01/24Control Supplement
018883008AP1987/04/08Control Supplement
018883007AP1987/01/14Labeling Revision
018883006AP1987/07/21Control Supplement
018883005AP1987/10/27Labeling Revision
018883004AP1987/10/27Control Supplement
018883003AP1986/06/16Labeling Revision
018883002AP1986/06/16Manufacturing Change or Addition
018883001AP1985/09/05Expiration Date Change
018883000AP1984/11/30Approval