药品注册申请号:018379
申请类型:NDA (新药申请)
申请人:FRESENIUS MEDCL
申请人全名:FRESENIUS MEDICAL CARE NORTH AMERICA
产品信息
产品号商品名活性成分剂型/给药途径规格/剂量参比药物(RLD)生物等效参考标准(RS)治疗等效代码该申请号批准日期该产品号批准日期市场状态
001 DELFLEX W/ DEXTROSE 4.25% IN PLASTIC CONTAINER CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE SOLUTION;INTRAPERITONEAL 25.7MG/100ML;4.25GM/100ML;15.2MG/100ML;567MG/100ML;392MG/100ML No No None 1980/09/03 Approved Prior to Jan 1, 1982 Discontinued
002 DELFLEX W/ DEXTROSE 1.5% IN PLASTIC CONTAINER CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE SOLUTION;INTRAPERITONEAL 25.7MG/100ML;1.5GM/100ML;15.2MG/100ML;567MG/100ML;392MG/100ML No No None Approved Prior to Jan 1, 1982 Discontinued
003 DELFLEX W/ DEXTROSE 2.5% IN PLASTIC CONTAINER CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE SOLUTION;INTRAPERITONEAL 25.7MG/100ML;2.5GM/100ML;15.2MG/100ML;567MG/100ML;392MG/100ML No No None Approved Prior to Jan 1, 1982 Discontinued
004 DELFLEX-LM W/ DEXTROSE 1.5% IN PLASTIC CONTAINER CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE SOLUTION;INTRAPERITONEAL 25.7MG/100ML;1.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML No No None 1982/07/07 Discontinued
005 DELFLEX-LM W/ DEXTROSE 2.5% IN PLASTIC CONTAINER CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE SOLUTION;INTRAPERITONEAL 25.7MG/100ML;2.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML No No None 1982/07/07 Discontinued
006 DELFLEX-LM W/ DEXTROSE 4.25% IN PLASTIC CONTAINER CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE SOLUTION;INTRAPERITONEAL 25.7MG/100ML;4.25GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML No No None 1982/07/07 Discontinued
007 DELFLEX W/ DEXTROSE 3.5% IN PLASTIC CONTAINER CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE SOLUTION;INTRAPERITONEAL 25.7MG/100ML;3.5GM/100ML;15.2MG/100ML;567MG/100ML;392MG/100ML No No None 1988/06/24 Discontinued
008 DELFLEX-LM W/ DEXTROSE 3.5% IN PLASTIC CONTAINER CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE SOLUTION;INTRAPERITONEAL 25.7MG/100ML;3.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML No No None 1988/06/24 Discontinued
批准历史,通知信,药品说明书,综述等审批信息
批准日期申请类型申请提交号审查批准结论申请内容分类审评分类(优先审评;罕用药状态)通知信、综述、标签、说明书备注
2001/11/09 SUPPL 95 Approval Manufacturing (CMC) STANDARD
1999/09/27 SUPPL 96 Approval Manufacturing (CMC) STANDARD
1997/08/14 SUPPL 94 Approval Manufacturing (CMC) STANDARD
1996/11/01 SUPPL 92 Approval Manufacturing (CMC) STANDARD
1996/07/03 SUPPL 93 Approval Manufacturing (CMC) STANDARD
1996/02/07 SUPPL 91 Approval Manufacturing (CMC) STANDARD
1996/01/23 SUPPL 89 Approval Manufacturing (CMC) STANDARD
1992/01/28 SUPPL 84 Approval Manufacturing (CMC) STANDARD
1991/09/10 SUPPL 83 Approval Manufacturing (CMC) STANDARD
1991/08/30 SUPPL 85 Approval Manufacturing (CMC) STANDARD
1990/08/01 SUPPL 80 Approval Manufacturing (CMC) STANDARD
1990/02/22 SUPPL 79 Approval Manufacturing (CMC) STANDARD
1990/01/11 SUPPL 81 Approval Manufacturing (CMC) STANDARD
1989/06/22 SUPPL 32 Approval Manufacturing (CMC) STANDARD
1989/06/14 SUPPL 78 Approval Manufacturing (CMC) STANDARD
1988/06/24 SUPPL 74 Approval Labeling
1988/06/24 SUPPL 73 Approval Manufacturing (CMC) STANDARD
1988/06/24 SUPPL 72 Approval Labeling
1988/06/24 SUPPL 71 Approval Manufacturing (CMC) STANDARD
1988/02/24 SUPPL 77 Approval Manufacturing (CMC) STANDARD
1988/02/02 SUPPL 76 Approval Manufacturing (CMC) STANDARD
1987/07/30 SUPPL 69 Approval Manufacturing (CMC) STANDARD
1987/04/28 SUPPL 64 Approval Labeling
1987/04/28 SUPPL 63 Approval Manufacturing (CMC) STANDARD
1987/02/27 SUPPL 62 Approval Labeling
1987/02/27 SUPPL 61 Approval Manufacturing (CMC) STANDARD
1987/02/11 SUPPL 66 Approval Manufacturing (CMC) STANDARD
1987/02/11 SUPPL 65 Approval Manufacturing (CMC) STANDARD
1986/11/26 SUPPL 68 Approval Manufacturing (CMC) STANDARD
1986/08/08 SUPPL 67 Approval Manufacturing (CMC) STANDARD
1986/02/26 SUPPL 58 Approval Manufacturing (CMC) STANDARD
1986/02/26 SUPPL 57 Approval Manufacturing (CMC) STANDARD
1986/02/21 SUPPL 60 Approval Manufacturing (CMC) STANDARD
1986/01/31 SUPPL 52 Approval Manufacturing (CMC) STANDARD
1986/01/18 SUPPL 56 Approval Labeling
1986/01/18 SUPPL 55 Approval Manufacturing (CMC) STANDARD
1986/01/18 SUPPL 54 Approval Labeling
1986/01/18 SUPPL 53 Approval Manufacturing (CMC) STANDARD
1985/12/10 SUPPL 42 Approval Labeling
1985/12/10 SUPPL 41 Approval Manufacturing (CMC) STANDARD
1985/12/06 SUPPL 59 Approval Manufacturing (CMC) STANDARD
1985/10/29 SUPPL 36 Approval Manufacturing (CMC) STANDARD
1985/10/24 SUPPL 49 Approval Labeling
1985/10/24 SUPPL 48 Approval Manufacturing (CMC) STANDARD
1985/10/02 SUPPL 51 Approval Labeling
1985/10/02 SUPPL 50 Approval Manufacturing (CMC) STANDARD
1985/10/02 SUPPL 47 Approval Manufacturing (CMC) STANDARD
1985/10/02 SUPPL 45 Approval Manufacturing (CMC) STANDARD
1985/10/02 SUPPL 44 Approval Labeling
1985/10/02 SUPPL 43 Approval Manufacturing (CMC) STANDARD
1985/09/26 SUPPL 39 Approval Manufacturing (CMC) STANDARD
1985/09/06 SUPPL 46 Approval Manufacturing (CMC) STANDARD
1985/05/01 SUPPL 37 Approval Manufacturing (CMC) STANDARD
1985/03/15 SUPPL 29 Approval Manufacturing (CMC) STANDARD
1984/11/28 SUPPL 35 Approval Manufacturing (CMC) STANDARD
1984/10/22 SUPPL 40 Approval Manufacturing (CMC) STANDARD
1984/10/17 SUPPL 31 Approval Manufacturing (CMC) STANDARD
1984/10/10 SUPPL 22 Approval Labeling
1984/10/10 SUPPL 21 Approval Manufacturing (CMC) STANDARD
1984/09/08 SUPPL 34 Approval Manufacturing (CMC) STANDARD
1984/06/08 SUPPL 33 Approval Manufacturing (CMC) STANDARD
1984/03/21 SUPPL 30 Approval Manufacturing (CMC) STANDARD
1984/03/01 SUPPL 23 Approval Manufacturing (CMC) STANDARD
1984/02/17 SUPPL 26 Approval Manufacturing (CMC) STANDARD
1984/01/25 SUPPL 28 Approval Manufacturing (CMC) STANDARD
1984/01/25 SUPPL 27 Approval Manufacturing (CMC) STANDARD
1983/07/05 SUPPL 20 Approval Manufacturing (CMC) STANDARD
1982/08/05 SUPPL 14 Approval Labeling
1982/08/05 SUPPL 13 Approval Manufacturing (CMC) STANDARD
1982/07/26 SUPPL 25 Approval Manufacturing (CMC) STANDARD
1982/07/21 SUPPL 24 Approval Manufacturing (CMC) STANDARD
1982/07/07 SUPPL 16 Approval Labeling
1982/07/07 SUPPL 15 Approval Manufacturing (CMC) STANDARD
1982/07/04 SUPPL 19 Approval Labeling
1982/07/04 SUPPL 18 Approval Manufacturing (CMC) STANDARD
1982/06/09 SUPPL 17 Approval Manufacturing (CMC) STANDARD
1982/06/09 SUPPL 8 Approval Manufacturing (CMC) STANDARD
1982/04/09 SUPPL 3 Approval Labeling
1982/03/11 SUPPL 10 Approval Labeling
1982/03/11 SUPPL 9 Approval Manufacturing (CMC) STANDARD
1982/02/01 SUPPL 12 Approval Manufacturing (CMC) STANDARD
1982/01/08 SUPPL 11 Approval Manufacturing (CMC) STANDARD
1981/10/01 SUPPL 7 Approval Labeling
1981/09/16 SUPPL 4 Approval Manufacturing (CMC) STANDARD
1981/04/23 SUPPL 5 Approval Manufacturing (CMC) STANDARD
1981/01/19 SUPPL 2 Approval Manufacturing (CMC) STANDARD
1980/10/31 SUPPL 1 Approval Manufacturing (CMC) STANDARD
1980/09/03 ORIG 1 Approval Type 5 - New Formulation or New Manufacturer STANDARD
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