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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) 019316 | 002 | MAGNESIUM SULFATE | MAGNESIUM SULFATE | 硫酸镁 | SOLUTION;INTRAMUSCULAR, INTRAVENOUS | 1GM/2ML (500MG/ML) | FRESENIUS KABI USA | 1986-09-08 | Yes | Yes | RX | AP |
(NDA) 019316 | 001 | MAGNESIUM SULFATE | MAGNESIUM SULFATE | 硫酸镁 | SOLUTION;INTRAMUSCULAR, INTRAVENOUS | 5GM/10ML (500MG/ML) | FRESENIUS KABI USA | 1986-09-08 | Yes | Yes | RX | AP |
(NDA) 020309 | 001 | MAGNESIUM SULFATE IN PLASTIC CONTAINER | MAGNESIUM SULFATE | 硫酸镁 | INJECTABLE;INJECTION | 4GM/100ML (40MG/ML) | HOSPIRA | 1994-06-24 | Yes | Yes | 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 | 005 | MAGNESIUM SULFATE IN PLASTIC CONTAINER | MAGNESIUM SULFATE | 硫酸镁 | INJECTABLE;INJECTION | 40GM/1000ML (40MG/ML) | HOSPIRA | 1995-01-18 | Yes | No | RX | AP |
(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) 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 |
(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) 020577 | 001 | ELLIOTTS B SOLUTION | CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM SULFATE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE | 氯化钙;磷酸氢二钠;葡萄糖;硫酸镁;氯化钾;碳酸氢钠;氯化钠 | INJECTABLE;INTRATHECAL | 0.2MG/ML;0.8MG/ML;0.3MG/ML;0.3MG/ML;1.9MG/ML;7.3MG/ML;0.2MG/ML | LUKARE MEDICAL LLC | 1996-09-27 | Yes | Yes | RX | |
(ANDA) 075151 | 001 | MAGNESIUM SULFATE | MAGNESIUM SULFATE | 硫酸镁 | SOLUTION;INTRAMUSCULAR, INTRAVENOUS | 5GM/10ML (500MG/ML) | HOSPIRA | 2000-04-25 | No | 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 |
(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) 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 | |
(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) 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 | 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 |