药品名称DELFLEX-LM W/ DEXTROSE 4.25% IN PLASTIC CONTAINER
申请号018379产品号006
活性成分CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE市场状态停止上市
剂型或给药途径SOLUTION;INTRAPERITONEAL规格25.7MG/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1982/07/07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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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
018379096AP1999/09/27Manufacturing Change or Addition
018379095AP2001/11/09Formulation Revision
018379094AP1997/08/14Manufacturing Change or Addition
018379093AP1996/07/03Control Supplement
018379092AP1996/11/01Control Supplement
018379091AP1996/02/07Manufacturing Change or Addition
018379089AP1996/01/23Control Supplement
018379085AP1991/08/30Package Change
018379084AP1992/01/28Package Change
018379083AP1991/09/10Control Supplement
018379081AP1990/01/11Manufacturing Change or Addition
018379080AP1990/08/01Expiration Date Change
018379079AP1990/02/22Manufacturing Change or Addition
018379078AP1989/06/14Control Supplement
018379077AP1988/02/24Formulation Revision
018379076AP1988/02/02Formulation Revision
018379074AP1988/06/24Labeling Revision
018379073AP1988/06/24Manufacturing Change or Addition
018379072AP1988/06/24Labeling Revision
018379071AP1988/06/24Manufacturing Change or Addition
018379069AP1987/07/30Control Supplement
018379068AP1986/11/26Control Supplement
018379067AP1986/08/08Control Supplement
018379066AP1987/02/11Control Supplement
018379065AP1987/02/11Control Supplement
018379064AP1987/04/28Labeling Revision
018379063AP1987/04/28Control Supplement
018379062AP1987/02/27Labeling Revision
018379061AP1987/02/27Control Supplement
018379060AP1986/02/21Control Supplement
018379059AP1985/12/06Control Supplement
018379058AP1986/02/26Control Supplement
018379057AP1986/02/26Control Supplement
018379056AP1986/01/18Labeling Revision
018379055AP1986/01/18Package Change
018379054AP1986/01/18Labeling Revision
018379053AP1986/01/18Package Change
018379052AP1986/01/31Control Supplement
018379051AP1985/10/02Labeling Revision
018379050AP1985/10/02Control Supplement
018379049AP1985/10/24Labeling Revision
018379048AP1985/10/24Control Supplement
018379047AP1985/10/02Control Supplement
018379046AP1985/09/06Control Supplement
018379045AP1985/10/02Manufacturing Change or Addition
018379044AP1985/10/02Labeling Revision
018379043AP1985/10/02Control Supplement
018379042AP1985/12/10Labeling Revision
018379041AP1985/12/10Control Supplement
018379040AP1984/10/22Control Supplement
018379039AP1985/09/26Package Change
018379037AP1985/05/01Control Supplement
018379036AP1985/10/29Package Change
018379035AP1984/11/28Control Supplement
018379034AP1984/09/08Control Supplement
018379033AP1984/06/08Control Supplement
018379032AP1989/06/22Control Supplement
018379031AP1984/10/17Control Supplement
018379030AP1984/03/21Control Supplement
018379029AP1985/03/15Control Supplement
018379028AP1984/01/25Package Change
018379027AP1984/01/25Control Supplement
018379026AP1984/02/17Control Supplement
018379025AP1982/07/26Control Supplement
018379024AP1982/07/21Control Supplement
018379023AP1984/03/01Control Supplement
018379022AP1984/10/10Labeling Revision
018379021AP1984/10/10Package Change
018379020AP1983/07/05Control Supplement
018379019AP1982/07/04Labeling Revision
018379018AP1982/07/04Formulation Revision
018379017AP1982/06/09Expiration Date Change
018379016AP1982/07/07Labeling Revision
018379015AP1982/07/07Control Supplement
018379014AP1982/08/05Labeling Revision
018379013AP1982/08/05Control Supplement
018379012AP1982/02/01Control Supplement
018379011AP1982/01/08Control Supplement
018379010AP1982/03/11Labeling Revision
018379009AP1982/03/11Formulation Revision
018379008AP1982/06/09Control Supplement
018379007AP1981/10/01Labeling Revision
018379005AP1981/04/23Control Supplement
018379004AP1981/09/16Control Supplement
018379003AP1982/04/09Practioner Draft Labeling
018379002AP1981/01/19Control Supplement
018379001AP1980/10/31Control Supplement
018379000AP1980/09/03Approval