药品名称DELFLEX W/ DEXTROSE 1.5% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER
申请号020171产品号001
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18.4MG/100ML;1.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML
治疗等效代码AT参比药物
批准日期1992/08/19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
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历史专利信息
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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
020171039APLetter2015/01/09下载
020171039APLabel2015/01/12下载
020171033APLetter2014/04/25下载
020171033APLabel2014/04/28下载
020171030APLabel2013/04/19下载
020171026APLabel2013/02/01下载
020171026APLetter2013/02/04下载
020171015APLetter2009/11/13下载
020171010APLetter2003/12/02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
020171041AP2016/03/24Manufacturing Change or Addition
020171039AP2015/01/08Labeling Revision
020171036AP2014/04/23Manufacturing Change or Addition
020171035AP2014/01/24Manufacturing Change or Addition
020171034AP2014/01/13Manufacturing Change or Addition
020171033AP2014/04/24Labeling Revision
020171030AP2013/04/18Manufacturing Change or Addition
020171029AP2013/02/22Manufacturing Change or Addition
020171026AP2013/01/30Labeling Revision
020171015AP2009/09/14Labeling Revision
020171010AP2003/11/26Control Supplement
020171008AP2001/09/26Package Change
020171007AP1999/05/18Package Change
020171006AP1997/02/24Control Supplement
020171005AP1996/06/14Control Supplement
020171004AP1996/02/22Control Supplement
020171003AP1996/01/19Control Supplement
020171002AP1996/03/08Control Supplement
020171001AP1994/03/10Control Supplement
020171000AP1992/08/19Approval