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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) 209381 | 001 | PLENVUP | ASCORBIC ACID; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM ASCORBATE; SODIUM CHLORIDE; SODIUM SULFATE | 维生素C;聚乙二醇3350;氯化钾;维生素C钠;氯化钠;硫酸钠 | FOR SOLUTION;ORAL | 7.54GM;140GM;2.2GM;48.11GM;5.2GM;9GM | SALIX | 2018-05-04 | Yes | Yes | RX | |
| (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) 019011 | 001 | GOLYTELY | POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE ANHYDROUS | 聚乙二醇3350;氯化钾;碳酸氢钠;氯化钠;硫酸钠 | FOR SOLUTION;ORAL | 236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/BOT;22.74GM/BOT | BRAINTREE | 1984-07-13 | Yes | Yes | RX | AA |
| (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) 021881 | 001 | MOVIPREP | ASCORBIC ACID; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM ASCORBATE; SODIUM CHLORIDE; SODIUM SULFATE | 维生素C;聚乙二醇3350;氯化钾;维生素C钠;氯化钠;硫酸钠 | FOR SOLUTION;ORAL | 4.7GM;100GM;1.015GM;5.9GM;2.691GM;7.5GM | SALIX PHARMS | 2006-08-02 | Yes | Yes | RX | AA |
| (NDA) 019797 | 001 | NULYTELY | POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE | 聚乙二醇3350;氯化钾;碳酸氢钠;氯化钠 | FOR SOLUTION;ORAL | 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT | BRAINTREE | 1991-04-22 | Yes | Yes | RX | AA |
| (NDA) 019797 | 002 | NULYTELY-FLAVORED | POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE | 聚乙二醇3350;氯化钾;碳酸氢钠;氯化钠 | FOR SOLUTION;ORAL | 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT | BRAINTREE | 1994-11-18 | Yes | Yes | RX | AA |
| (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 | 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 | 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) 215344 | 001 | SUFLAVEP | MAGNESIUM SULFATE; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM SULFATE | FOR SOLUTION;ORAL | 0.9GM/BOT;178.7GM/BOT;1.12GM/BOT;0.5GM/BOT;7.3GM/BOT | BRAINTREE LABS | 2023-06-15 | 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 | 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 | 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 | 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) 017606 | 001 | DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER | DEXTROSE; SODIUM CHLORIDE | 葡萄糖;氯化钠 | INJECTABLE;INJECTION | 5GM/100ML;225MG/100ML | OTSUKA ICU MEDCL | 1982-01-01 | Yes | Yes | RX | AP |
| (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 | 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 |
