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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) 019714 | 002 | AMINOSYN II 4.25% W/ ELECTROLYTES IN DEXTROSE 20% W/ CALCIUM IN PLASTIC CONTAINER | AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE | 氨基酸;氯化钙;葡萄糖;氯化镁;氯化钾;磷酸氢二钾;氯化钠 | INJECTABLE;INJECTION | 4.25%;36.8MG/100ML;20GM/100ML;51MG/100ML;22.4MG/100ML;261MG/100ML;205MG/100ML | ABBOTT | 1988-09-12 | No | No | DISCN | |
(NDA) 019714 | 003 | AMINOSYN II 5% W/ ELECTROLYTES IN DEXTROSE 25% W/ CALCIUM IN PLASTIC CONTAINER | AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE | 氨基酸;氯化钙;葡萄糖;氯化镁;氯化钾;磷酸氢二钾;氯化钠 | INJECTABLE;INJECTION | 5%;36.8MG/100ML;25GM/100ML;51MG/100ML;22.4MG/100ML;261MG/100ML;205MG/100ML | ABBOTT | 1988-09-12 | No | No | DISCN | |
(NDA) 019485 | 001 | LACTATED RINGER'S IN PLASTIC CONTAINER | CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE | 氯化钙;氯化钾;氯化钠;乳酸钠 | INJECTABLE;INJECTION | 20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML | ABBOTT | 1985-10-24 | No | No | DISCN | |
(NDA) 019714 | 001 | AMINOSYN II 3.5% W/ ELECTROLYTES IN DEXTROSE 25% W/ CALCIUM IN PLASTIC CONTAINER | AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE | 氨基酸;氯化钙;葡萄糖;氯化镁;氯化钾;磷酸氢二钾;氯化钠 | INJECTABLE;INJECTION | 3.5%;36.8MG/100ML;25GM/100ML;51MG/100ML;22.4MG/100ML;261MG/100ML;205MG/100ML | ABBOTT | 1988-09-12 | No | No | DISCN | |
(NDA) 019714 | 004 | AMINOSYN II 4.25% W/ ELECTROLYTES IN DEXTROSE 25% W/ CALCIUM IN PLASTIC CONTAINER | AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE | 氨基酸;氯化钙;葡萄糖;氯化镁;氯化钾;磷酸氢二钾;氯化钠 | INJECTABLE;INJECTION | 4.25%;36.8MG/100ML;25GM/100ML;51MG/100ML;22.4MG/100ML;261MG/100ML;205MG/100ML | ABBOTT | 1988-09-12 | No | No | DISCN | |
(NDA) 018462 | 001 | RINGER'S IN PLASTIC CONTAINER | CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE | 氯化钙;氯化钾;氯化钠 | SOLUTION;IRRIGATION | 33MG/100ML;30MG/100ML;860MG/100ML | ABBOTT | 1982-01-01 | No | No | DISCN | |
(NDA) 019399 | 001 | TPN ELECTROLYTES IN PLASTIC CONTAINER | CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE | 氯化钙;氯化镁;氯化钾;醋酸钠;氯化钠 | INJECTABLE;INJECTION | 16.5MG/ML;25.4MG/ML;74.6MG/ML;121MG/ML;16.1MG/ML | ABBOTT | 1986-06-16 | No | No | DISCN | |
(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) 018469 | 001 | BSS PLUS | CALCIUM CHLORIDE; DEXTROSE; GLUTATHIONE DISULFIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM PHOSPHATE | 氯化钙;葡萄糖;奥谷胱甘肽;氯化镁;氯化钾;碳酸氢钠;氯化钠;磷酸钠 | SOLUTION;IRRIGATION | 0.154MG/ML;0.92MG/ML;0.184MG/ML;0.2MG/ML;0.38MG/ML;2.1MG/ML;7.14MG/ML;0.42MG/ML | ALCON | 1982-01-01 | Yes | Yes | RX | |
(NDA) 022193 | 001 | NAVSTEL | CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; OXIGLUTATIONE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM PHOSPHATE | 氯化钙;葡萄糖;氯化镁;奥谷胱甘肽;氯化钾;碳酸氢钠;氯化钠;磷酸钠 | SOLUTION;IRRIGATION | 0.154MG/ML;0.92MG/ML;0.2MG/ML;0.184MG/ML;0.38MG/ML;2.1MG/ML;7.14MG/ML;0.42MG/ML | ALCON PHARMS LTD | 2008-07-24 | No | No | DISCN | |
(ANDA) 209088 | 001 | CALCIUM CHLORIDE 10% | CALCIUM CHLORIDE | 氯化钙 | INJECTABLE;INJECTION | 100MG/ML | AM REGENT | 2017-07-27 | No | No | RX | AP |
(ANDA) 217524 | 001 | CALCIUM CHLORIDE 10% | CALCIUM CHLORIDE | 氯化钙 | INJECTABLE;INJECTION | 100MG/ML | AMNEAL | 2024-07-08 | No | No | RX | AP |
(NDA) 017510 | 001 | DEXTROSE 5% IN 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 | B BRAUN | 1982-01-01 | No | No | DISCN | |
(NDA) 019864 | 001 | ISOLYTE R IN DEXTROSE 5% IN PLASTIC CONTAINER | CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE | 氯化钙;葡萄糖;氯化镁;氯化钾;醋酸钠;氯化钠 | INJECTABLE;INJECTION | 37MG/100ML;5GM/100ML;31MG/100ML;120MG/100ML;330MG/100ML;88MG/100ML | B BRAUN | 1993-06-10 | No | No | DISCN | |
(NDA) 019634 | 003 | DEXTROSE 5% IN 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 | B BRAUN | 1988-02-24 | No | No | RX | AP |
(NDA) 018899 | 001 | ISOLYTE E IN PLASTIC CONTAINER | 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 | INJECTABLE;INJECTION | 35MG/100ML;30MG/100ML;74MG/100ML;640MG/100ML;500MG/100ML;74MG/100ML | B BRAUN | 1983-10-31 | No | No | DISCN | |
(NDA) 019718 | 001 | ISOLYTE E IN PLASTIC CONTAINER | 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 | INJECTABLE;INJECTION | 35MG/100ML;30MG/100ML;74MG/100ML;640MG/100ML;500MG/100ML;74MG/100ML | B BRAUN | 1989-09-29 | No | No | DISCN | |
(NDA) 018256 | 001 | DEXTROSE 5% IN RINGER'S IN PLASTIC CONTAINER | CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE | 氯化钙;葡萄糖;氯化钾;氯化钠 | INJECTABLE;INJECTION | 33MG/100ML;5GM/100ML;30MG/100ML;860MG/100ML | B BRAUN | 1982-01-01 | No | No | DISCN | |
(NDA) 018271 | 001 | ISOLYTE R W/ DEXTROSE 5% IN PLASTIC CONTAINER | CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE | 氯化钙;葡萄糖;氯化镁;氯化钾;醋酸钠;氯化钠 | INJECTABLE;INJECTION | 37MG/100ML;5GM/100ML;31MG/100ML;120MG/100ML;330MG/100ML;88MG/100ML | B BRAUN | 1982-01-01 | No | No | DISCN | |
(NDA) 018269 | 002 | ISOLYTE E W/ DEXTROSE 5% IN PLASTIC CONTAINER | CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM CITRATE | 氯化钙;葡萄糖;氯化镁;氯化钾;醋酸钠;氯化钠;枸橼酸钠 | INJECTABLE;INJECTION | 35MG/100ML;5GM/100ML;30MG/100ML;74MG/100ML;640MG/100ML;500MG/100ML;74MG/100ML | B BRAUN | 1983-01-17 | No | No | DISCN |