药品注册申请号：018883
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 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 Yes Yes AT 1984/11/30 1984/11/30 Prescription
002 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 Yes Yes AT 1984/11/30 Prescription
003 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 Yes Yes AT 1984/11/30 Prescription
004 DELFLEX W/ DEXTROSE 1.5% LOW MAGNESIUM 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 Yes Yes AT 1984/11/30 Prescription
005 DELFLEX W/ DEXTROSE 2.5% LOW MAGNESIUM 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 Yes Yes AT 1984/11/30 Prescription
006 DELFLEX W/ DEXTROSE 4.25% LOW MAGNESIUM 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 Yes Yes AT 1984/11/30 Prescription
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
提交状态日期提交号审批结论申请内容分类审评优先级；罕用药状态通知信、审评文件、说明书、包装标签备注
2021/01/26 SUPPL-93（补充） Approval Labeling STANDARD
2016/07/18 SUPPL-61（补充） Approval Manufacturing (CMC) STANDARD
2015/12/28 SUPPL-58（补充） Approval Manufacturing (CMC) STANDARD
2015/01/08 SUPPL-57（补充） Approval Labeling STANDARD
2014/12/08 SUPPL-56（补充） Approval Manufacturing (CMC) STANDARD
2014/08/07 SUPPL-55（补充） Approval Manufacturing (CMC) STANDARD
2014/04/24 SUPPL-51（补充） Approval Labeling STANDARD
2014/04/23 SUPPL-54（补充） Approval Manufacturing (CMC) STANDARD
2014/01/24 SUPPL-53（补充） Approval Manufacturing (CMC) STANDARD
2014/01/13 SUPPL-52（补充） Approval Manufacturing (CMC) STANDARD
2013/08/15 SUPPL-49（补充） Approval Manufacturing (CMC) STANDARD
2013/07/26 SUPPL-50（补充） Approval Manufacturing (CMC) STANDARD
2013/04/18 SUPPL-48（补充） Approval Manufacturing (CMC) STANDARD
2013/02/22 SUPPL-47（补充） Approval Manufacturing (CMC) STANDARD
2013/01/30 SUPPL-44（补充） Approval Labeling UNKNOWN
2009/09/14 SUPPL-33（补充） Approval Manufacturing (CMC) N/A
2008/05/06 SUPPL-32（补充） Approval Manufacturing (CMC) N/A
2003/11/26 SUPPL-28（补充） Approval Manufacturing (CMC) STANDARD
2001/09/26 SUPPL-26（补充） Approval Manufacturing (CMC) STANDARD
1999/05/18 SUPPL-25（补充） Approval Manufacturing (CMC) STANDARD
1997/02/24 SUPPL-24（补充） Approval Manufacturing (CMC) STANDARD
1996/06/14 SUPPL-23（补充） Approval Manufacturing (CMC) STANDARD
1996/02/22 SUPPL-22（补充） Approval Manufacturing (CMC) STANDARD
1996/01/19 SUPPL-21（补充） Approval Manufacturing (CMC) STANDARD
1993/07/07 SUPPL-20（补充） Approval Manufacturing (CMC) STANDARD
1993/07/07 SUPPL-19（补充） Approval Labeling
1993/07/07 SUPPL-18（补充） Approval Manufacturing (CMC) STANDARD
1990/07/11 SUPPL-16（补充） Approval Manufacturing (CMC) STANDARD
1990/01/24 SUPPL-12（补充） Approval Labeling
1990/01/24 SUPPL-11（补充） Approval Manufacturing (CMC) STANDARD
1990/01/24 SUPPL-10（补充） Approval Labeling
1990/01/24 SUPPL-9（补充） Approval Manufacturing (CMC) STANDARD
1989/01/10 SUPPL-15（补充） Approval Manufacturing (CMC) STANDARD
1988/02/05 SUPPL-13（补充） Approval Manufacturing (CMC) STANDARD
1987/10/27 SUPPL-5（补充） Approval Labeling
1987/10/27 SUPPL-4（补充） Approval Manufacturing (CMC) STANDARD
1987/07/21 SUPPL-6（补充） Approval Manufacturing (CMC) STANDARD
1987/04/08 SUPPL-8（补充） Approval Manufacturing (CMC) STANDARD
1987/01/14 SUPPL-7（补充） Approval Labeling
1986/06/16 SUPPL-3（补充） Approval Labeling
1986/06/16 SUPPL-2（补充） Approval Manufacturing (CMC) STANDARD
1985/09/05 SUPPL-1（补充） Approval Manufacturing (CMC) STANDARD
1984/11/30 ORIG-1（原始申请） Approval Type 5 - New Formulation or New Manufacturer STANDARD
与本品相关的专利信息（来自FDA橙皮书Orange Book）
关联产品号专利号专利过期日是否物质专利是否产品专利专利用途代码撤销请求提交日期专利下载备注
无
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
无
与本品治疗等效的药品
活性成分:CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE 剂型/给药途径:SOLUTION;INTRAPERITONEAL 规格:25.7MG/100ML;1.5GM/100ML;15.2MG/100ML;567MG/100ML;392MG/100ML 治疗等效代码:AT
申请号产品号申请类型商品名活性成分剂型/给药途径规格市场状态RLDRSTE Code产品号批准日期申请人
018883 001 NDA 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 Prescription Yes Yes AT 1984/11/30 FRESENIUS MEDCL
活性成分:CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE 剂型/给药途径:SOLUTION;INTRAPERITONEAL 规格:25.7MG/100ML;2.5GM/100ML;15.2MG/100ML;567MG/100ML;392MG/100ML 治疗等效代码:AT
申请号产品号申请类型商品名活性成分剂型/给药途径规格市场状态RLDRSTE Code产品号批准日期申请人
018883 002 NDA 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 Prescription Yes Yes AT 1984/11/30 FRESENIUS MEDCL
活性成分:CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE 剂型/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
申请号产品号申请类型商品名活性成分剂型/给药途径规格市场状态RLDRSTE Code产品号批准日期申请人
018883 003 NDA 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 Prescription Yes Yes AT 1984/11/30 FRESENIUS MEDCL
活性成分:CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE 剂型/给药途径:SOLUTION;INTRAPERITONEAL 规格:25.7MG/100ML;1.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML 治疗等效代码:AT
申请号产品号申请类型商品名活性成分剂型/给药途径规格市场状态RLDRSTE Code产品号批准日期申请人
017512 004 NDA DIANEAL PD-2 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 Prescription Yes No AT Approved Prior to Jan 1, 1982 BAXTER HLTHCARE
018883 004 NDA DELFLEX W/ DEXTROSE 1.5% LOW MAGNESIUM 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 Prescription Yes Yes AT 1984/11/30 FRESENIUS MEDCL
020163 001 NDA DIANEAL PD-2 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 Prescription Yes No AT 1992/12/04 BAXTER HLTHCARE
活性成分:CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE 剂型/给药途径:SOLUTION;INTRAPERITONEAL 规格:25.7MG/100ML;2.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML 治疗等效代码:AT
申请号产品号申请类型商品名活性成分剂型/给药途径规格市场状态RLDRSTE Code产品号批准日期申请人
017512 005 NDA DIANEAL PD-2 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 Prescription Yes No AT Approved Prior to Jan 1, 1982 BAXTER HLTHCARE
018883 005 NDA DELFLEX W/ DEXTROSE 2.5% LOW MAGNESIUM 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 Prescription Yes Yes AT 1984/11/30 FRESENIUS MEDCL
020163 002 NDA DIANEAL PD-2 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 Prescription Yes No AT 1992/12/04 BAXTER HLTHCARE
活性成分:CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE 剂型/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:AT
申请号产品号申请类型商品名活性成分剂型/给药途径规格市场状态RLDRSTE Code产品号批准日期申请人
017512 006 NDA DIANEAL PD-2 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 Prescription Yes No AT Approved Prior to Jan 1, 1982 BAXTER HLTHCARE
018883 006 NDA DELFLEX W/ DEXTROSE 4.25% LOW MAGNESIUM 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 Prescription Yes Yes AT 1984/11/30 FRESENIUS MEDCL
020163 003 NDA DIANEAL PD-2 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 Prescription Yes No AT 1992/12/04 BAXTER HLTHCARE
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