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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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| (ANDA) 207498 | 001 | PEG-3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM ASCORBATE AND ASCORBIC ACID | 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 | TARO | 2024-06-28 | No | No | RX | AA |
| (ANDA) 213688 | 001 | SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | SODIUM CHLORIDE | 氯化钠 | SOLUTION;IRRIGATION | 900MG/100ML | FRESENIUS KABI USA | 2024-06-24 | No | No | RX | AT |
| (ANDA) 217535 | 002 | SODIUM CHLORIDE 0.9% | SODIUM CHLORIDE | 氯化钠 | SOLUTION;INJECTION | 180MG/20ML (9MG/ML) | NEXUS | 2023-08-23 | No | No | RX | AP |
| (ANDA) 217535 | 001 | SODIUM CHLORIDE 0.9% | SODIUM CHLORIDE | 氯化钠 | SOLUTION;INJECTION | 90MG/10ML (9MG/ML) | NEXUS | 2023-08-23 | No | No | RX | AP |
| (ANDA) 217796 | 001 | SODIUM CHLORIDE 23.4% | SODIUM CHLORIDE | 氯化钠 | INJECTABLE;INJECTION | 234MG/ML | FRESENIUS KABI USA | 2023-07-11 | No | No | RX | AP |
| (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 | ||
| (ANDA) 213523 | 005 | POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% | DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE | 葡萄糖;氯化钾;氯化钠 | INJECTABLE;INJECTION | 5GM/100ML;149MG/100ML;450MG/100ML | FRESENIUS KABI USA | 2022-10-11 | No | No | RX | AP |
| (ANDA) 215370 | 001 | MULTIPLE ELECTROLYTES INJECTION TYPE 1 USP PH 5.5 | MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATE | 氯化镁;氯化钾;醋酸钠;氯化钠;葡萄糖酸钠 | INJECTABLE;INJECTION | 30MG/100ML;37MG/100ML;368MG/100ML;526MG/100ML;502MG/100ML | FRESENIUS KABI USA | 2022-06-29 | No | No | DISCN | |
| (ANDA) 215371 | 001 | MULTIPLE ELECTROLYTES INJECTION TYPE 1 USP PH 7.4 | MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATE | 氯化镁;氯化钾;醋酸钠;氯化钠;葡萄糖酸钠 | INJECTABLE;INJECTION | 30MG/100ML;37MG/100ML;368MG/100ML;526MG/100ML;502MG/100ML | FRESENIUS KABI USA | 2022-06-08 | No | No | RX | AP |
| (ANDA) 210332 | 001 | DEXTROSE 5% AND LACTATED RINGER'S | 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 | FRESENIUS KABI USA | 2022-03-28 | No | No | DISCN | |
| (ANDA) 214623 | 001 | CARDIOPLEGIC 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 | FRESENIUS KABI USA | 2022-02-18 | No | No | RX | AT |
| (ANDA) 212070 | 003 | SODIUM CHLORIDE 23.4% | SODIUM CHLORIDE | 氯化钠 | SOLUTION;INTRAVENOUS | 400MEQ/100ML (4MEQ/ML) | FRESENIUS KABI USA | 2022-02-14 | No | No | RX | AP |
| (ANDA) 211428 | 001 | POTASSIUM CHLORIDE 20MEQ IN 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;179MG/100ML;600MG/100ML;310MG/100ML | FRESENIUS KABI USA | 2021-11-09 | No | No | DISCN | |
| (ANDA) 212348 | 001 | POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER | DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE | 葡萄糖;氯化钾;氯化钠 | INJECTABLE;INJECTION | 5GM/100ML;149MG/100ML;225MG/100ML | FRESENIUS KABI USA | 2021-07-30 | No | No | RX | AP |
| (ANDA) 212348 | 002 | POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER | DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE | 葡萄糖;氯化钾;氯化钠 | INJECTABLE;INJECTION | 5GM/100ML;149MG/100ML;225MG/100ML | FRESENIUS KABI USA | 2021-07-30 | No | No | RX | AP |
| (ANDA) 212347 | 003 | POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.9% | POTASSIUM CHLORIDE; SODIUM CHLORIDE | 氯化钾;氯化钠 | INJECTABLE;INJECTION | 150MG/100ML;900MG/100ML | FRESENIUS KABI USA | 2021-06-02 | No | No | RX | AP |
| (ANDA) 212248 | 001 | SODIUM CHLORIDE 23.4% | SODIUM CHLORIDE | 氯化钠 | INJECTABLE;INJECTION | 234MG/ML | FRESENIUS KABI USA | 2021-04-28 | No | No | RX | AP |
| (ANDA) 212070 | 002 | SODIUM CHLORIDE 14.6% | SODIUM CHLORIDE | 氯化钠 | SOLUTION;INTRAVENOUS | 100MEQ/40ML (2.5MEQ/ML) | FRESENIUS KABI USA | 2021-04-28 | No | No | RX | AP |
| (ANDA) 212070 | 001 | SODIUM CHLORIDE 14.6% | SODIUM CHLORIDE | 氯化钠 | SOLUTION;INTRAVENOUS | 50MEQ/20ML (2.5MEQ/ML) | FRESENIUS KABI USA | 2021-04-28 | No | No | RX | |
| (ANDA) 213523 | 004 | POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% | DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE | 葡萄糖;氯化钾;氯化钠 | INJECTABLE;INJECTION | 5GM/100ML;298MG/100ML;450MG/100ML | FRESENIUS KABI USA | 2021-03-09 | No | No | RX | AP |
