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
批准日期，申请提交历史，通知信，药品说明书，审评文件等信息
>>>原始批准或临时批准<<<
审批日期提交号审批结论提交分类审评优先级；罕用药状态通知信、审评文件、说明书、包装标签备注
1980/09/03 ORIG-1（原始申请） Approval Type 5 - New Formulation or New Manufacturer STANDARD
>>>补充申请<<<
审批日期提交号审批结论补充类别或审批类型审评优先级；罕用药状态通知信、审评文件、说明书、包装标签备注
2001/11/09 SUPPL-95（补充） Approval Manufacturing (CMC)-Formulation STANDARD
1999/09/27 SUPPL-96（补充） Approval Manufacturing (CMC) STANDARD
1997/08/14 SUPPL-94（补充） Approval Manufacturing (CMC) STANDARD
1996/11/01 SUPPL-92（补充） Approval Manufacturing (CMC)-Control STANDARD
1996/07/03 SUPPL-93（补充） Approval Manufacturing (CMC)-Control STANDARD
1996/02/07 SUPPL-91（补充） Approval Manufacturing (CMC) STANDARD
1996/01/23 SUPPL-89（补充） Approval Manufacturing (CMC)-Control STANDARD
1992/01/28 SUPPL-84（补充） Approval Manufacturing (CMC)-Packaging STANDARD
1991/09/10 SUPPL-83（补充） Approval Manufacturing (CMC)-Control STANDARD
1991/08/30 SUPPL-85（补充） Approval Manufacturing (CMC)-Packaging STANDARD
1990/08/01 SUPPL-80（补充） Approval Manufacturing (CMC)-Expiration Date STANDARD
1990/02/22 SUPPL-79（补充） Approval Manufacturing (CMC) STANDARD
1990/01/11 SUPPL-81（补充） Approval Manufacturing (CMC) STANDARD
1989/06/22 SUPPL-32（补充） Approval Manufacturing (CMC)-Control STANDARD
1989/06/14 SUPPL-78（补充） Approval Manufacturing (CMC)-Control STANDARD
1988/06/24 SUPPL-74（补充） Approval Labeling
1988/06/24 SUPPL-73（补充） Approval Manufacturing (CMC) STANDARD
1988/06/24 SUPPL-72（补充） Approval Labeling
1988/06/24 SUPPL-71（补充） Approval Manufacturing (CMC) STANDARD
1988/02/24 SUPPL-77（补充） Approval Manufacturing (CMC)-Formulation STANDARD
1988/02/02 SUPPL-76（补充） Approval Manufacturing (CMC)-Formulation STANDARD
1987/07/30 SUPPL-69（补充） Approval Manufacturing (CMC)-Control STANDARD
1987/04/28 SUPPL-64（补充） Approval Labeling
1987/04/28 SUPPL-63（补充） Approval Manufacturing (CMC)-Control STANDARD
1987/02/27 SUPPL-62（补充） Approval Labeling
1987/02/27 SUPPL-61（补充） Approval Manufacturing (CMC)-Control STANDARD
1987/02/11 SUPPL-66（补充） Approval Manufacturing (CMC)-Control STANDARD
1987/02/11 SUPPL-65（补充） Approval Manufacturing (CMC)-Control STANDARD
1986/11/26 SUPPL-68（补充） Approval Manufacturing (CMC)-Control STANDARD
1986/08/08 SUPPL-67（补充） Approval Manufacturing (CMC)-Control STANDARD
1986/02/26 SUPPL-58（补充） Approval Manufacturing (CMC)-Control STANDARD
1986/02/26 SUPPL-57（补充） Approval Manufacturing (CMC)-Control STANDARD
1986/02/21 SUPPL-60（补充） Approval Manufacturing (CMC)-Control STANDARD
1986/01/31 SUPPL-52（补充） Approval Manufacturing (CMC)-Control STANDARD
1986/01/18 SUPPL-56（补充） Approval Labeling
1986/01/18 SUPPL-55（补充） Approval Manufacturing (CMC)-Packaging STANDARD
1986/01/18 SUPPL-54（补充） Approval Labeling
1986/01/18 SUPPL-53（补充） Approval Manufacturing (CMC)-Packaging STANDARD
1985/12/10 SUPPL-42（补充） Approval Labeling
1985/12/10 SUPPL-41（补充） Approval Manufacturing (CMC)-Control STANDARD
1985/12/06 SUPPL-59（补充） Approval Manufacturing (CMC)-Control STANDARD
1985/10/29 SUPPL-36（补充） Approval Manufacturing (CMC)-Packaging STANDARD
1985/10/24 SUPPL-49（补充） Approval Labeling
1985/10/24 SUPPL-48（补充） Approval Manufacturing (CMC)-Control STANDARD
1985/10/02 SUPPL-51（补充） Approval Labeling
1985/10/02 SUPPL-50（补充） Approval Manufacturing (CMC)-Control STANDARD
1985/10/02 SUPPL-47（补充） Approval Manufacturing (CMC)-Control STANDARD
1985/10/02 SUPPL-45（补充） Approval Manufacturing (CMC) STANDARD
1985/10/02 SUPPL-44（补充） Approval Labeling
1985/10/02 SUPPL-43（补充） Approval Manufacturing (CMC)-Control STANDARD
1985/09/26 SUPPL-39（补充） Approval Manufacturing (CMC)-Packaging STANDARD
1985/09/06 SUPPL-46（补充） Approval Manufacturing (CMC)-Control STANDARD
1985/05/01 SUPPL-37（补充） Approval Manufacturing (CMC)-Control STANDARD
1985/03/15 SUPPL-29（补充） Approval Manufacturing (CMC)-Control STANDARD
1984/11/28 SUPPL-35（补充） Approval Manufacturing (CMC)-Control STANDARD
1984/10/22 SUPPL-40（补充） Approval Manufacturing (CMC)-Control STANDARD
1984/10/17 SUPPL-31（补充） Approval Manufacturing (CMC)-Control STANDARD
1984/10/10 SUPPL-22（补充） Approval Labeling
1984/10/10 SUPPL-21（补充） Approval Manufacturing (CMC)-Packaging STANDARD
1984/09/08 SUPPL-34（补充） Approval Manufacturing (CMC)-Control STANDARD
1984/06/08 SUPPL-33（补充） Approval Manufacturing (CMC)-Control STANDARD
1984/03/21 SUPPL-30（补充） Approval Manufacturing (CMC)-Control STANDARD
1984/03/01 SUPPL-23（补充） Approval Manufacturing (CMC)-Control STANDARD
1984/02/17 SUPPL-26（补充） Approval Manufacturing (CMC)-Control STANDARD
1984/01/25 SUPPL-28（补充） Approval Manufacturing (CMC)-Packaging STANDARD
1984/01/25 SUPPL-27（补充） Approval Manufacturing (CMC)-Control STANDARD
1983/07/05 SUPPL-20（补充） Approval Manufacturing (CMC)-Control STANDARD
1982/08/05 SUPPL-14（补充） Approval Labeling
1982/08/05 SUPPL-13（补充） Approval Manufacturing (CMC)-Control STANDARD
1982/07/26 SUPPL-25（补充） Approval Manufacturing (CMC)-Control STANDARD
1982/07/21 SUPPL-24（补充） Approval Manufacturing (CMC)-Control STANDARD
1982/07/07 SUPPL-16（补充） Approval Labeling
1982/07/07 SUPPL-15（补充） Approval Manufacturing (CMC)-Control STANDARD
1982/07/04 SUPPL-19（补充） Approval Labeling
1982/07/04 SUPPL-18（补充） Approval Manufacturing (CMC)-Formulation STANDARD
1982/06/09 SUPPL-17（补充） Approval Manufacturing (CMC)-Expiration Date STANDARD
1982/06/09 SUPPL-8（补充） Approval Manufacturing (CMC)-Control STANDARD
1982/04/09 SUPPL-3（补充） Approval Labeling
1982/03/11 SUPPL-10（补充） Approval Labeling
1982/03/11 SUPPL-9（补充） Approval Manufacturing (CMC)-Formulation STANDARD
1982/02/01 SUPPL-12（补充） Approval Manufacturing (CMC)-Control STANDARD
1982/01/08 SUPPL-11（补充） Approval Manufacturing (CMC)-Control STANDARD
1981/10/01 SUPPL-7（补充） Approval Labeling
1981/09/16 SUPPL-4（补充） Approval Manufacturing (CMC)-Control STANDARD
1981/04/23 SUPPL-5（补充） Approval Manufacturing (CMC)-Control STANDARD
1981/01/19 SUPPL-2（补充） Approval Manufacturing (CMC)-Control STANDARD
1980/10/31 SUPPL-1（补充） Approval Manufacturing (CMC)-Control STANDARD
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与本品相关的市场独占权保护信息
关联产品号独占权代码失效日期备注
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与本品治疗等效的药品
本品无治疗等效药品
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