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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 | 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 | 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) 019683 | 003 | 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 | HOSPIRA INC | 1988-11-07 | 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) 019683 | 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 | HOSPIRA INC | 1988-11-07 | No | No | DISCN | |
(NDA) 019683 | 004 | 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 | HOSPIRA INC | 1988-11-07 | No | No | DISCN | |
(NDA) 019683 | 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 | HOSPIRA INC | 1988-11-07 | No | No | DISCN | |
(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) 020678 | 012 | CLINIMIX E 4.25/25 SULFITE FREE W/ ELECT IN DEXTROSE 25% W/ CALCIUM IN PLASTIC CONTAINER | AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE | 氨基酸;氯化钙;葡萄糖;氯化镁;磷酸氢二钾;醋酸钠;氯化钠 | INJECTABLE;INJECTION | 4.25%;33MG/100ML;25GM/100ML;51MG/100ML;261MG/100ML;297MG/100ML;77MG/100ML | BAXTER HLTHCARE | 1997-03-26 | Yes | Yes | RX | |
(NDA) 020678 | 011 | CLINIMIX E 4.25/20 SULFITE FREE W/ ELECT IN DEXTROSE 20% W/ CALCIUM IN PLASTIC CONTAINER | AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE | 氨基酸;氯化钙;葡萄糖;氯化镁;磷酸氢二钾;醋酸钠;氯化钠 | INJECTABLE;INJECTION | 4.25%;33MG/100ML;20GM/100ML;51MG/100ML;261MG/100ML;297MG/100ML;77MG/100ML | BAXTER HLTHCARE | 1997-03-26 | Yes | Yes | RX | |
(NDA) 020678 | 009 | CLINIMIX E 4.25/10 SULFITE FREE W/ ELECT IN DEXTROSE 10% W/ CALCIUM IN PLASTIC CONTAINER | AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE | 氨基酸;氯化钙;葡萄糖;氯化镁;磷酸氢二钾;醋酸钠;氯化钠 | INJECTABLE;INJECTION | 4.25%;33MG/100ML;10GM/100ML;51MG/100ML;261MG/100ML;297MG/100ML;77MG/100ML | BAXTER HLTHCARE | 1997-03-26 | Yes | Yes | RX | |
(NDA) 020678 | 001 | CLINIMIX E 2.75/5 SULFITE FREE W/ ELECT IN DEXTROSE 5% W/ CALCIUM IN PLASTIC CONTAINER | AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE | 氨基酸;氯化钙;葡萄糖;氯化镁;磷酸氢二钾;醋酸钠;氯化钠 | INJECTABLE;INJECTION | 2.75%;33MG/100ML;5GM/100ML;51MG/100ML;261MG/100ML;217MG/100ML;112MG/100ML | BAXTER HLTHCARE | 1997-03-26 | Yes | Yes | RX | |
(NDA) 020678 | 005 | CLINIMIX E 2.75/25 SULFITE FREE W/ ELECT IN DEXTROSE 25% W/ CALCIUM IN PLASTIC CONTAINER | AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE | 氨基酸;氯化钙;葡萄糖;氯化镁;磷酸氢二钾;醋酸钠;氯化钠 | INJECTABLE;INJECTION | 2.75%;33MG/100ML;25GM/100ML;51MG/100ML;261MG/100ML;217MG/100ML;112MG/100ML | BAXTER HLTHCARE | 1997-03-26 | Yes | Yes | RX | |
(NDA) 020678 | 002 | CLINIMIX E 2.75/10 SULFITE FREE W/ ELECT IN DEXTROSE 10% W/ CALCIUM IN PLASTIC CONTAINER | AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE | 氨基酸;氯化钙;葡萄糖;氯化镁;磷酸氢二钾;醋酸钠;氯化钠 | INJECTABLE;INJECTION | 2.75%;33MG/100ML;10GM/100ML;51MG/100ML;261MG/100ML;217MG/100ML;112MG/100ML | BAXTER HLTHCARE | 1997-03-26 | Yes | Yes | RX | |
(NDA) 020678 | 019 | CLINIMIX E 5/25 SULFITE FREE W/ ELECT IN DEXTROSE 25% W/ CALCIUM IN PLASTIC CONTAINER | AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE | 氨基酸;氯化钙;葡萄糖;氯化镁;磷酸氢二钾;醋酸钠;氯化钠 | INJECTABLE;INJECTION | 5%;33MG/100ML;25GM/100ML;51MG/100ML;261MG/100ML;340MG/100ML;59MG/100ML | BAXTER HLTHCARE | 1997-03-26 | Yes | Yes | RX | |
(NDA) 020678 | 018 | CLINIMIX E 5/20 SULFITE FREE W/ ELECT IN 20% DEXTROSE W/ CALCIUM IN PLASTIC CONTAINER | AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE | 氨基酸;氯化钙;葡萄糖;氯化镁;磷酸氢二钾;醋酸钠;氯化钠 | INJECTABLE;INJECTION | 5%;33MG/100ML;20GM/100ML;51MG/100ML;261MG/100ML;340MG/100ML;59MG/100ML | BAXTER HLTHCARE | 1997-03-26 | Yes | Yes | RX | |
(NDA) 020678 | 008 | CLINIMIX E 4.25/5 SULFITE FREE W/ ELECT IN DEXTROSE 5% W/ CALCIUM IN PLASTIC CONTAINER | AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE | 氨基酸;氯化钙;葡萄糖;氯化镁;磷酸氢二钾;醋酸钠;氯化钠 | INJECTABLE;INJECTION | 4.25%;33MG/100ML;5GM/100ML;51MG/100ML;261MG/100ML;297MG/100ML;77MG/100ML | BAXTER HLTHCARE | 1997-03-26 | Yes | Yes | RX | |
(NDA) 020678 | 021 | CLINIMIX E 5/35 SULFITE FREE W/ ELECT IN DEXTROSE 35% W/ CALCIUM IN PLASTIC CONTAINER | AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE | 氨基酸;氯化钙;葡萄糖;氯化镁;磷酸氢二钾;醋酸钠;氯化钠 | INJECTABLE;INJECTION | 5%;33MG/100ML;35GM/100ML;51MG/100ML;261MG/100ML;340MG/100ML;59MG/100ML | BAXTER HLTHCARE | 1997-03-26 | Yes | Yes | RX | |
(NDA) 020678 | 017 | CLINIMIX E 5/15 SULFITE FREE W/ ELECT IN DEXTROSE 15% W/ CALCIUM IN PLASTIC CONTAINER | AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE | 氨基酸;氯化钙;葡萄糖;氯化镁;磷酸氢二钾;醋酸钠;氯化钠 | INJECTABLE;INJECTION | 5%;33MG/100ML;15GM/100ML;51MG/100ML;261MG/100ML;340MG/100ML;59MG/100ML | BAXTER HLTHCARE | 1997-03-26 | Yes | Yes | RX | |
(NDA) 020678 | 016 | CLINIMIX E 5/10 SULFITE FREE W/ ELECT IN DEXTROSE 10% W/ CALCIUM IN PLASTIC CONTAINER | AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE | 氨基酸;氯化钙;葡萄糖;氯化镁;磷酸氢二钾;醋酸钠;氯化钠 | INJECTABLE;INJECTION | 5%;33MG/100ML;10GM/100ML;51MG/100ML;261MG/100ML;340MG/100ML;59MG/100ML | BAXTER HLTHCARE | 1997-03-26 | Yes | Yes | RX |