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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) 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) 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) 216597 | 002 | MAGNESIUM SULFATE IN PLASTIC CONTAINER | MAGNESIUM SULFATE | 硫酸镁 | INJECTABLE;INJECTION | 4GM/100ML (40MG/ML) | AMNEAL | 2023-02-15 | No | No | RX | AP |
| (ANDA) 216597 | 001 | MAGNESIUM SULFATE IN PLASTIC CONTAINER | MAGNESIUM SULFATE | 硫酸镁 | INJECTABLE;INJECTION | 2GM/50ML (40MG/ML) | AMNEAL | 2023-02-15 | No | No | RX | AP |
| (ANDA) 209932 | 001 | MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER | MAGNESIUM SULFATE | 硫酸镁 | INJECTABLE;INJECTION | 1GM/100ML | NORVIUM BIOSCIENCE | 2018-09-10 | No | No | RX | AP |
| (ANDA) 207349 | 001 | MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER | MAGNESIUM SULFATE | 硫酸镁 | INJECTABLE;INJECTION | 1GM/100ML | HQ SPCLT PHARMA | 2016-03-02 | No | No | RX | AP |
| (NDA) 020488 | 002 | MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER | MAGNESIUM SULFATE | 硫酸镁 | INJECTABLE;INJECTION | 2GM/100ML | HOSPIRA | 1995-07-11 | Yes | Yes | RX | |
| (NDA) 020488 | 001 | MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER | MAGNESIUM SULFATE | 硫酸镁 | INJECTABLE;INJECTION | 1GM/100ML | HOSPIRA | 1995-07-11 | Yes | Yes | RX | AP |
| (ANDA) 206486 | 001 | MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER | MAGNESIUM SULFATE | 硫酸镁 | INJECTABLE;INJECTION | 1GM/100ML | FRESENIUS KABI USA | 2016-03-07 | No | No | RX | AP |
| (ANDA) 211965 | 001 | MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER | MAGNESIUM SULFATE | 硫酸镁 | INJECTABLE;INJECTION | 1GM/100ML | BAXTER HLTHCARE CORP | 2020-08-11 | No | No | RX | AP |
| (ANDA) 207966 | 001 | MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER | MAGNESIUM SULFATE | 硫酸镁 | INJECTABLE;INJECTION | 1GM/100ML | B BRAUN MEDICAL | 2020-10-27 | No | No | RX | AP |
| (ANDA) 207967 | 003 | MAGNESIUM SULFATE | MAGNESIUM SULFATE | 硫酸镁 | INJECTABLE;INJECTION | 4GM/50ML (80MG/ML) | B BRAUN MEDICAL | 2021-04-26 | No | No | RX | AP |
| (ANDA) 207967 | 002 | MAGNESIUM SULFATE | MAGNESIUM SULFATE | 硫酸镁 | INJECTABLE;INJECTION | 4GM/100ML (40MG/ML) | B BRAUN MEDICAL | 2021-04-26 | No | No | RX | AP |
| (ANDA) 211966 | 001 | MAGNESIUM SULFATE IN PLASTIC CONTAINER | MAGNESIUM SULFATE | 硫酸镁 | INJECTABLE;INJECTION | 2GM/50ML (40MG/ML) | BAXTER HLTHCARE CORP | 2020-06-01 | No | No | RX | AP |
