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申请号 | 产品号 | 商品名 | 活性成分 | 活性成分 | 剂型/给药途径 | 规格/剂量 | 申请机构 | 批准时间 | 参比制剂 | 标准制剂 | 市场状态 | TE |
---|---|---|---|---|---|---|---|---|---|---|---|---|
(NDA) 020183 | 002 | DIANEAL LOW CALCIUM W/ DEXTROSE 2.5% IN PLASTIC CONTAINER | CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE | 氯化钙;葡萄糖;氯化镁;氯化钠;乳酸钠 | SOLUTION;INTRAPERITONEAL | 18.3MG/100ML;2.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML | VANTIVE US HLTHCARE | 1992-12-04 | Yes | No | RX | AT |
(NDA) 020742 | 001 | BSS | CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM CITRATE | 氯化钙;氯化镁;氯化钾;醋酸钠;氯化钠;枸橼酸钠 | SOLUTION;IRRIGATION | 0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/ML | ALCON | 1997-12-10 | Yes | Yes | RX | AT |
(NDA) 018883 | 004 | DELFLEX W/ DEXTROSE 1.5% LOW MAGNESIUM IN PLASTIC CONTAINER | CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE | 氯化钙;葡萄糖;氯化镁;氯化钠;乳酸钠 | SOLUTION;INTRAPERITONEAL | 25.7MG/100ML;1.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML | FRESENIUS MEDCL | 1984-11-30 | Yes | Yes | RX | AT |
(NDA) 020171 | 003 | DELFLEX W/ DEXTROSE 4.25% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER | CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE | 氯化钙;葡萄糖;氯化镁;氯化钠;乳酸钠 | SOLUTION;INTRAPERITONEAL | 18.4MG/100ML;4.25GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML | FRESENIUS MEDCL | 1992-08-19 | Yes | Yes | RX | AT |
(NDA) 020183 | 004 | DIANEAL LOW CALCIUM W/ DEXTROSE 4.25% IN PLASTIC CONTAINER | CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE | 氯化钙;葡萄糖;氯化镁;氯化钠;乳酸钠 | SOLUTION;INTRAPERITONEAL | 18.3MG/100ML;4.25GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML | VANTIVE US HLTHCARE | 1992-12-04 | Yes | No | RX | AT |
(NDA) 020183 | 001 | DIANEAL LOW CALCIUM W/ DEXTROSE 1.5% IN PLASTIC CONTAINER | CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE | 氯化钙;葡萄糖;氯化镁;氯化钠;乳酸钠 | SOLUTION;INTRAPERITONEAL | 18.3MG/100ML;1.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML | VANTIVE US HLTHCARE | 1992-12-04 | Yes | No | RX | AT |
(NDA) 017512 | 013 | DIANEAL LOW CALCIUM W/DEXTROSE 2.5% IN PLASTIC CONTAINER | CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE | 氯化钙;葡萄糖;氯化镁;氯化钠;乳酸钠 | SOLUTION;INTRAPERITONEAL | 18.3MG/100ML;2.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML | VANTIVE US HLTHCARE | 1990-07-11 | Yes | No | RX | AT |
(NDA) 017512 | 015 | DIANEAL LOW CALCIUM W/DEXTROSE 4.25% IN PLASTIC CONTAINER | CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE | 氯化钙;葡萄糖;氯化镁;氯化钠;乳酸钠 | SOLUTION;INTRAPERITONEAL | 18.3MG/100ML;4.25GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML | VANTIVE US HLTHCARE | 1990-07-11 | Yes | No | RX | AT |
(NDA) 020171 | 001 | DELFLEX W/ DEXTROSE 1.5% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER | CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE | 氯化钙;葡萄糖;氯化镁;氯化钠;乳酸钠 | SOLUTION;INTRAPERITONEAL | 18.4MG/100ML;1.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML | FRESENIUS MEDCL | 1992-08-19 | Yes | Yes | RX | AT |
(NDA) 018608 | 001 | PLEGISOL IN PLASTIC CONTAINER | CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE | 氯化钙;氯化镁;氯化钾;氯化钠 | SOLUTION;PERFUSION, CARDIAC | 17.6MG/100ML;325.3MG/100ML;119.3MG/100ML;643MG/100ML | HOSPIRA | 1982-02-26 | Yes | Yes | RX | AT |
(NDA) 017512 | 006 | DIANEAL PD-2 W/ DEXTROSE 4.25% IN PLASTIC CONTAINER | CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE | 氯化钙;葡萄糖;氯化镁;氯化钠;乳酸钠 | SOLUTION;INTRAPERITONEAL | 25.7MG/100ML;4.25GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML | VANTIVE US HLTHCARE | 1982-01-01 | Yes | No | RX | AT |
(NDA) 017512 | 004 | DIANEAL PD-2 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER | CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE | 氯化钙;葡萄糖;氯化镁;氯化钠;乳酸钠 | SOLUTION;INTRAPERITONEAL | 25.7MG/100ML;1.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML | VANTIVE US HLTHCARE | 1982-01-01 | Yes | No | RX | AT |
(NDA) 017512 | 012 | DIANEAL LOW CALCIUM W/DEXTROSE 1.5% IN PLASTIC CONTAINER | CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE | 氯化钙;葡萄糖;氯化镁;氯化钠;乳酸钠 | SOLUTION;INTRAPERITONEAL | 18.3MG/100ML;1.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML | VANTIVE US HLTHCARE | 1989-01-10 | Yes | No | RX | AT |
(NDA) 020163 | 003 | DIANEAL PD-2 W/ DEXTROSE 4.25% IN PLASTIC CONTAINER | CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE | 氯化钙;葡萄糖;氯化镁;氯化钠;乳酸钠 | SOLUTION;INTRAPERITONEAL | 25.7MG/100ML;4.25GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML | VANTIVE US HLTHCARE | 1992-12-04 | Yes | No | RX | AT |
(NDA) 018883 | 005 | DELFLEX W/ DEXTROSE 2.5% LOW MAGNESIUM IN PLASTIC CONTAINER | CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE | 氯化钙;葡萄糖;氯化镁;氯化钠;乳酸钠 | SOLUTION;INTRAPERITONEAL | 25.7MG/100ML;2.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML | FRESENIUS MEDCL | 1984-11-30 | Yes | Yes | RX | AT |
(NDA) 020163 | 001 | DIANEAL PD-2 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER | CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE | 氯化钙;葡萄糖;氯化镁;氯化钠;乳酸钠 | SOLUTION;INTRAPERITONEAL | 25.7MG/100ML;1.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML | VANTIVE US HLTHCARE | 1992-12-04 | Yes | No | RX | AT |
(NDA) 020163 | 002 | DIANEAL PD-2 W/ DEXTROSE 2.5% IN PLASTIC CONTAINER | CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE | 氯化钙;葡萄糖;氯化镁;氯化钠;乳酸钠 | SOLUTION;INTRAPERITONEAL | 25.7MG/100ML;2.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML | VANTIVE US HLTHCARE | 1992-12-04 | Yes | No | RX | AT |
(ANDA) 091387 | 001 | BALANCED SALT | CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM CITRATE | 氯化钙;氯化镁;氯化钾;醋酸钠;氯化钠;枸橼酸钠 | SOLUTION;IRRIGATION | 0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/ML | B BRAUN | 2010-02-03 | No | No | RX | AT |
(NDA) 020171 | 002 | DELFLEX W/ DEXTROSE 2.5% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER | CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE | 氯化钙;葡萄糖;氯化镁;氯化钠;乳酸钠 | SOLUTION;INTRAPERITONEAL | 18.4MG/100ML;2.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML | FRESENIUS MEDCL | 1992-08-19 | Yes | Yes | RX | AT |
(NDA) 017512 | 005 | DIANEAL PD-2 W/ DEXTROSE 2.5% IN PLASTIC CONTAINER | CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE | 氯化钙;葡萄糖;氯化镁;氯化钠;乳酸钠 | SOLUTION;INTRAPERITONEAL | 25.7MG/100ML;2.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML | VANTIVE US HLTHCARE | 1982-01-01 | Yes | No | RX | AT |