药品注册申请号:020171
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% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE SOLUTION;INTRAPERITONEAL 18.4MG/100ML;1.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML No No AT 1992/08/19 1992/08/19 Prescription
002 DELFLEX W/ DEXTROSE 2.5% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE SOLUTION;INTRAPERITONEAL 18.4MG/100ML;2.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML No No AT 1992/08/19 Prescription
003 DELFLEX W/ DEXTROSE 4.25% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE SOLUTION;INTRAPERITONEAL 18.4MG/100ML;4.25GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML No No AT 1992/08/19 Prescription
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
2016/03/24 SUPPL 41 Approval Manufacturing (CMC) STANDARD
2015/01/08 SUPPL 39 Approval Labeling STANDARD
2014/04/24 SUPPL 33 Approval Labeling STANDARD
2014/04/23 SUPPL 36 Approval Manufacturing (CMC) STANDARD
2014/01/24 SUPPL 35 Approval Manufacturing (CMC) STANDARD
2014/01/13 SUPPL 34 Approval Manufacturing (CMC) STANDARD
2013/04/18 SUPPL 30 Approval Manufacturing (CMC) STANDARD
2013/02/22 SUPPL 29 Approval Manufacturing (CMC) STANDARD
2013/01/30 SUPPL 26 Approval Labeling UNKNOWN
2009/09/14 SUPPL 15 Approval Manufacturing (CMC) N/A
2008/05/06 SUPPL 14 Approval Manufacturing (CMC) N/A
2003/11/26 SUPPL 10 Approval Manufacturing (CMC) STANDARD
2001/09/26 SUPPL 8 Approval Manufacturing (CMC) STANDARD
1999/05/18 SUPPL 7 Approval Manufacturing (CMC) STANDARD
1997/02/24 SUPPL 6 Approval Manufacturing (CMC) STANDARD
1996/06/14 SUPPL 5 Approval Manufacturing (CMC) STANDARD
1996/03/08 SUPPL 2 Approval Manufacturing (CMC) STANDARD
1996/02/22 SUPPL 4 Approval Manufacturing (CMC) STANDARD
1996/01/19 SUPPL 3 Approval Manufacturing (CMC) STANDARD
1994/03/10 SUPPL 1 Approval Manufacturing (CMC) STANDARD
1992/08/19 ORIG 1 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
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
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:18.4MG/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
020171 001 NDA DELFLEX W/ DEXTROSE 1.5% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE SOLUTION;INTRAPERITONEAL 18.4MG/100ML;1.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML Prescription No No AT 1992/08/19 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:18.4MG/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
020171 002 NDA DELFLEX W/ DEXTROSE 2.5% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE SOLUTION;INTRAPERITONEAL 18.4MG/100ML;2.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML Prescription No No AT 1992/08/19 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:18.4MG/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
020171 003 NDA DELFLEX W/ DEXTROSE 4.25% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE SOLUTION;INTRAPERITONEAL 18.4MG/100ML;4.25GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML Prescription No No AT 1992/08/19 FRESENIUS MEDCL
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