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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) 018336 | 001 | TIS-U-SOL IN PLASTIC CONTAINER | MAGNESIUM SULFATE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, MONOBASIC; SODIUM CHLORIDE; SODIUM PHOSPHATE | 硫酸镁;氯化钾;磷酸二氢钾;氯化钠;磷酸钠 | SOLUTION;IRRIGATION | 20MG/100ML;40MG/100ML;6.25MG/100ML;800MG/100ML;8.75MG/100ML | BAXTER HLTHCARE | 1982-01-01 | No | No | RX | AT |
| (NDA) 018508 | 001 | TIS-U-SOL | MAGNESIUM SULFATE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, MONOBASIC; SODIUM CHLORIDE; SODIUM PHOSPHATE | 硫酸镁;氯化钾;磷酸二氢钾;氯化钠;磷酸钠 | SOLUTION;IRRIGATION | 20MG/100ML;40MG/100ML;6.25MG/100ML;800MG/100ML;8.75MG/100ML | BAXTER HLTHCARE | 1982-02-19 | No | No | RX | AT |
| (NDA) 213135 | 001 | SUTABP | MAGNESIUM SULFATE; POTASSIUM CHLORIDE; SODIUM SULFATE | 硫酸镁;氯化钾;硫酸钠 | TABLET;ORAL | 0.225GM;0.188GM;1.479GM | BRAINTREE LABS | 2020-11-10 | Yes | Yes | RX | |
| (NDA) 022372 | 001 | SUPREP BOWEL PREP KIT | MAGNESIUM SULFATE; POTASSIUM SULFATE; SODIUM SULFATE | 硫酸镁;硫酸钾;硫酸钠 | SOLUTION;ORAL | 1.6GM/BOT;3.13GM/BOT;17.5GM/BOT | BRAINTREE LABS | 2010-08-05 | Yes | Yes | RX | AA |
| (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) 203595 | 001 | SUCLEAR | MAGNESIUM SULFATE; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; POTASSIUM SULFATE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE | 聚乙二醇3350;硫酸镁;氯化钾;硫酸钾;碳酸氢钠;氯化钠;硫酸钠 | SOLUTION;ORAL | 1.6GM/BOT,3.13GM/BOT,17.5GM/BOT,N/A,N/A,N/A,N/A;N/A,N/A,N/A,210GM,0.74GM,2.86GM,5.6GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | BRAINTREE LABS | 2013-01-18 | Yes | No | DISCN | |
| (ANDA) 215469 | 001 | SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE | MAGNESIUM SULFATE; POTASSIUM SULFATE; SODIUM SULFATE | 硫酸镁;硫酸钾;硫酸钠 | SOLUTION;ORAL | 1.6GM/BOT;3.13GM/BOT;17.5GM/BOT | STRIDES PHARMA | 2023-11-22 | No | No | RX | AA |
| (ANDA) 213924 | 001 | SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE | MAGNESIUM SULFATE; POTASSIUM SULFATE; SODIUM SULFATE | 硫酸镁;硫酸钾;硫酸钠 | SOLUTION;ORAL | 1.6GM/BOT;3.13GM/BOT;17.5GM/BOT | ALKEM LABS LTD | 2023-12-29 | No | No | RX | AA |
| (ANDA) 202511 | 001 | SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE | MAGNESIUM SULFATE; POTASSIUM SULFATE; SODIUM SULFATE | 硫酸镁;硫酸钾;硫酸钠 | SOLUTION;ORAL | 1.6GM/BOT;3.13GM/BOT;17.5GM/BOT | NOVEL LABS INC | 2017-02-23 | No | No | RX | AA |
| (ANDA) 212903 | 001 | SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE | MAGNESIUM SULFATE; POTASSIUM SULFATE; SODIUM SULFATE | 硫酸镁;硫酸钾;硫酸钠 | SOLUTION;ORAL | 1.6GM/BOT;3.13GM/BOT;17.5GM/BOT | ANNORA PHARMA | 2024-10-18 | No | No | RX | AA |
| (ANDA) 206431 | 001 | SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE | MAGNESIUM SULFATE; POTASSIUM SULFATE; SODIUM SULFATE | 硫酸镁;硫酸钾;硫酸钠 | SOLUTION;ORAL | 1.6GM/BOT;3.13GM/BOT;17.5GM/BOT | TARO | 2024-03-19 | No | No | RX | AA |
| (ANDA) 204135 | 001 | SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE | MAGNESIUM SULFATE; POTASSIUM SULFATE; SODIUM SULFATE | 硫酸镁;硫酸钾;硫酸钠 | SOLUTION;ORAL | 1.6GM/BOT;3.13GM/BOT;17.5GM/BOT | BIONPHARMA | 2024-06-24 | No | No | RX | AA |
| (ANDA) 209941 | 001 | SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE | MAGNESIUM SULFATE; POTASSIUM SULFATE; SODIUM SULFATE | 硫酸镁;硫酸钾;硫酸钠 | SOLUTION;ORAL | 1.6GM/BOT;3.13GM/BOT;17.5GM/BOT | PAI HOLDINGS | 2024-07-15 | No | No | RX | AA |
| (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) 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) 020309 | 004 | MAGNESIUM SULFATE IN PLASTIC CONTAINER | MAGNESIUM SULFATE | 硫酸镁 | INJECTABLE;INJECTION | 20GM/500ML (40MG/ML) | HOSPIRA | 1995-01-18 | Yes | No | RX | AP |
| (NDA) 020309 | 002 | MAGNESIUM SULFATE IN PLASTIC CONTAINER | MAGNESIUM SULFATE | 硫酸镁 | INJECTABLE;INJECTION | 4GM/50ML (80MG/ML) | HOSPIRA | 1994-06-24 | Yes | Yes | RX | AP |
| (NDA) 020309 | 003 | MAGNESIUM SULFATE IN PLASTIC CONTAINER | MAGNESIUM SULFATE | 硫酸镁 | INJECTABLE;INJECTION | 2GM/50ML (40MG/ML) | HOSPIRA | 2007-01-26 | Yes | No | RX | AP |
| (ANDA) 206485 | 003 | MAGNESIUM SULFATE IN PLASTIC CONTAINER | MAGNESIUM SULFATE | 硫酸镁 | INJECTABLE;INJECTION | 2GM/50ML (40MG/ML) | FRESENIUS KABI USA | 2016-03-15 | No | No | RX | AP |
