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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) 018358 | 001 | DEXTROSE 2.5% IN PLASTIC CONTAINER | DEXTROSE | 葡萄糖 | INJECTABLE;INJECTION | 2.5GM/100ML | B BRAUN | 1982-01-01 | No | No | DISCN | |
(NDA) 018030 | 001 | DEXTROSE 2.5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER | DEXTROSE; SODIUM CHLORIDE | 葡萄糖;氯化钠 | INJECTABLE;INJECTION | 2.5GM/100ML;450MG/100ML | B BRAUN | 1982-01-01 | No | No | DISCN | |
(NDA) 018386 | 001 | DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER | DEXTROSE; SODIUM CHLORIDE | 葡萄糖;氯化钠 | INJECTABLE;INJECTION | 10GM/100ML;200MG/100ML | B BRAUN | 1982-01-01 | No | No | DISCN | |
(NDA) 017608 | 001 | DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER | CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE | 氯化钙;葡萄糖;氯化钾;氯化钠;乳酸钠 | INJECTABLE;INJECTION | 20MG/100ML;5GM/100ML;30MG/100ML;600MG/100ML;310MG/100ML | ICU MEDICAL INC | 1982-01-01 | Yes | No | RX | AP |
(NDA) 016697 | 001 | DEXTROSE 2.5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER | DEXTROSE; SODIUM CHLORIDE | 葡萄糖;氯化钠 | INJECTABLE;INJECTION | 2.5GM/100ML;450MG/100ML | BAXTER HLTHCARE | 1982-01-01 | Yes | Yes | RX | AP |
(NDA) 018080 | 001 | DEXTROSE 10% IN PLASTIC CONTAINER | DEXTROSE | 葡萄糖 | INJECTABLE;INJECTION | 10GM/100ML | ICU MEDICAL INC | 1982-01-01 | Yes | Yes | RX | AP |
(NDA) 018376 | 001 | DEXTROSE 2.5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | DEXTROSE; SODIUM CHLORIDE | 葡萄糖;氯化钠 | INJECTABLE;INJECTION | 2.5GM/100ML;900MG/100ML | B BRAUN | 1982-01-01 | No | No | DISCN | |
(NDA) 018046 | 001 | DEXTROSE 10% IN PLASTIC CONTAINER | DEXTROSE | 葡萄糖 | INJECTABLE;INJECTION | 10GM/100ML | B BRAUN | 1982-01-01 | No | No | DISCN | |
(NDA) 017521 | 004 | DEXTROSE 20% IN PLASTIC CONTAINER | DEXTROSE | 葡萄糖 | INJECTABLE;INJECTION | 20GM/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | BAXTER HLTHCARE | 1982-01-01 | Yes | No | DISCN | |
(NDA) 018055 | 001 | DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER | DEXTROSE; SODIUM CHLORIDE | 葡萄糖;氯化钠 | INJECTABLE;INJECTION | 3.3GM/100ML;300MG/100ML | ABBOTT | 1982-01-01 | No | No | DISCN | |
(NDA) 017484 | 001 | DEXTROSE 5% AND ELECTROLYTE NO. 48 IN PLASTIC CONTAINER | DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, MONOBASIC; SODIUM CHLORIDE; SODIUM LACTATE | 葡萄糖;氯化镁;氯化钾;磷酸二氢钾;氯化钠;乳酸钠 | INJECTABLE;INJECTION | 5GM/100ML;31MG/100ML;141MG/100ML;20MG/100ML;12MG/100ML;260MG/100ML | BAXTER HLTHCARE | 1982-01-01 | No | No | RX | |
(NDA) 018229 | 001 | DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER | DEXTROSE; SODIUM CHLORIDE | 葡萄糖;氯化钠 | INJECTABLE;INJECTION | 10GM/100ML;450MG/100ML | B BRAUN | 1982-01-01 | No | No | DISCN | |
(NDA) 018096 | 001 | DEXTROSE 2.5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER | DEXTROSE; SODIUM CHLORIDE | 葡萄糖;氯化钠 | INJECTABLE;INJECTION | 2.5GM/100ML;450MG/100ML | HOSPIRA | 1982-01-01 | No | No | DISCN | |
(NDA) 016696 | 001 | DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | DEXTROSE; SODIUM CHLORIDE | 葡萄糖;氯化钠 | INJECTABLE;INJECTION | 10GM/100ML;900MG/100ML | BAXTER HLTHCARE | 1982-01-01 | No | No | DISCN | |
(NDA) 018047 | 001 | DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | DEXTROSE; SODIUM CHLORIDE | 葡萄糖;氯化钠 | INJECTABLE;INJECTION | 10GM/100ML;900MG/100ML | B BRAUN | 1982-01-01 | No | No | DISCN | |
(NDA) 017521 | 003 | DEXTROSE 30% IN PLASTIC CONTAINER | DEXTROSE | 葡萄糖 | INJECTABLE;INJECTION | 30GM/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | BAXTER HLTHCARE | 1982-01-01 | Yes | No | DISCN | |
(NDA) 016694 | 001 | DEXTROSE 10% IN PLASTIC CONTAINER | DEXTROSE | 葡萄糖 | INJECTABLE;INJECTION | 10GM/100ML | BAXTER HLTHCARE | 1982-01-01 | Yes | Yes | RX | AP |
(NDA) 017521 | 002 | DEXTROSE 40% IN PLASTIC CONTAINER | DEXTROSE | 葡萄糖 | INJECTABLE;INJECTION | 40GM/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | BAXTER HLTHCARE | 1982-01-01 | Yes | No | DISCN | |
(NDA) 017634 | 004 | DEXTROSE 5% AND POTASSIUM CHLORIDE 0.075% IN PLASTIC CONTAINER | DEXTROSE; POTASSIUM CHLORIDE | 葡萄糖;氯化钾 | INJECTABLE;INJECTION | 5GM/100ML;75MG/100ML | BAXTER HLTHCARE | 1982-01-01 | Yes | No | RX | AP |
(NDA) 018504 | 001 | DEXTROSE 10% IN PLASTIC CONTAINER | DEXTROSE | 葡萄糖 | INJECTABLE;INJECTION | 10GM/100ML | MILES | 1982-01-01 | No | No | DISCN |