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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) 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) 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) 019316 | 003 | MAGNESIUM SULFATE | MAGNESIUM SULFATE | 硫酸镁 | SOLUTION;INTRAMUSCULAR, INTRAVENOUS | 10GM/20ML (500MG/ML) | FRESENIUS KABI USA | 2016-01-29 | 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) 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) 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 |
(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 | |
(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) 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 | |
(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) 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) 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 | 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) 019316 | 004 | MAGNESIUM SULFATE | MAGNESIUM SULFATE | 硫酸镁 | SOLUTION;INTRAMUSCULAR, INTRAVENOUS | 25GM/50ML (500MG/ML) | FRESENIUS KABI USA | 2016-01-29 | Yes | Yes | RX | AP |
(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 | 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 | |
(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 |