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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) 200656 | 004 | KABIVEN IN PLASTIC CONTAINER | AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM SULFATE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM GLYCEROPHOSPHATE; SOYBEAN OIL | 氨基酸;氯化钙;葡萄糖;硫酸镁;氯化钾;醋酸钠;甘油磷酸钠;豆油 | EMULSION;INTRAVENOUS | 3.3%;29MG/100ML;9.8GM/100ML;96MG/100ML;174MG/100ML;239MG/100ML ;147MG/100ML;3.9GM/100ML (1026ML) | FRESENIUS KABI USA | 2014-08-25 | Yes | No | 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 | 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) 019626 | 004 | DEXTROSE 10% IN PLASTIC CONTAINER | DEXTROSE | 葡萄糖 | INJECTABLE;INJECTION | 10GM/100ML | B BRAUN | 1988-02-02 | Yes | Yes | RX | AP |
| (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 | 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 | 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 | 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 | 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 | |
| (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) 200656 | 005 | KABIVEN IN PLASTIC CONTAINER | AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM SULFATE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM GLYCEROPHOSPHATE; SOYBEAN OIL | 氨基酸;氯化钙;葡萄糖;硫酸镁;氯化钾;醋酸钠;甘油磷酸钠;豆油 | EMULSION;INTRAVENOUS | 3.3%;29MG/100ML;9.8GM/100ML;96MG/100ML;174MG/100ML;239MG/100ML;147MG/100ML;3.9GM/100ML (1540ML) | FRESENIUS KABI USA | 2014-08-25 | Yes | No | RX | |
| (NDA) 200656 | 006 | KABIVEN IN PLASTIC CONTAINER | AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM SULFATE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM GLYCEROPHOSPHATE; SOYBEAN OIL | 氨基酸;氯化钙;葡萄糖;硫酸镁;氯化钾;醋酸钠;甘油磷酸钠;豆油 | EMULSION;INTRAVENOUS | 3.3%;29MG/100ML;9.8GM/100ML;96MG/100ML;174MG/100ML;239MG/100ML;147MG/100ML;3.9GM/100ML (2053ML) | FRESENIUS KABI USA | 2014-08-25 | Yes | No | RX | |
| (NDA) 200656 | 007 | KABIVEN IN PLASTIC CONTAINER | AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM SULFATE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM GLYCEROPHOSPHATE; SOYBEAN OIL | 氨基酸;氯化钙;葡萄糖;硫酸镁;氯化钾;醋酸钠;甘油磷酸钠;豆油 | EMULSION;INTRAVENOUS | 3.3%;29MG/100ML;9.8GM/100ML;96MG/100ML;174MG/100ML;239MG/100ML;147MG/100ML;3.9GM/100ML (2566ML) | FRESENIUS KABI USA | 2014-08-25 | Yes | Yes | RX | |
| (NDA) 200656 | 001 | PERIKABIVEN IN PLASTIC CONTAINER | AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM SULFATE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM GLYCEROPHOSPHATE; SOYBEAN OIL | 氨基酸;氯化钙;葡萄糖;硫酸镁;氯化钾;醋酸钠;甘油磷酸钠;豆油 | EMULSION;INTRAVENOUS | 2.4%;20MG/100ML;6.8GM/100ML;68MG/100ML;124MG/100ML;170MG/100ML;105MG/100ML;3.5GM/100ML (1440ML) | FRESENIUS KABI USA | 2014-08-25 | Yes | No | RX | |
| (NDA) 200656 | 002 | PERIKABIVEN IN PLASTIC CONTAINER | AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM SULFATE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM GLYCEROPHOSPHATE; SOYBEAN OIL | 氨基酸;氯化钙;葡萄糖;硫酸镁;氯化钾;醋酸钠;甘油磷酸钠;豆油 | EMULSION;INTRAVENOUS | 2.4%;20MG/100ML;6.8GM/100ML;68MG/100ML;124MG/100ML;170MG/100ML;105MG/100ML;3.5GM/100ML (1920ML) | FRESENIUS KABI USA | 2014-08-25 | Yes | No | RX | |
| (NDA) 200656 | 003 | PERIKABIVEN IN PLASTIC CONTAINER | AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM SULFATE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM GLYCEROPHOSPHATE; SOYBEAN OIL | 氨基酸;氯化钙;葡萄糖;硫酸镁;氯化钾;醋酸钠;甘油磷酸钠;豆油 | EMULSION;INTRAVENOUS | 2.4%;20MG/100ML;6.8GM/100ML;68MG/100ML;124MG/100ML;170MG/100ML ;105MG/100ML;3.5GM/100ML (2400ML) | FRESENIUS KABI USA | 2014-08-25 | 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 | 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 | 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 |
