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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) 204553 | 001 | COLPREP KIT | MAGNESIUM SULFATE; POTASSIUM SULFATE; SODIUM SULFATE | 硫酸镁;硫酸钾;硫酸钠 | POWDER;ORAL | 1.6GM/BOT;3.13GM/BOT;17.5GM/BOT | GATOR PHARMS | 2016-12-27 | Yes | No | DISCN | |
(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) 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 | 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 | 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 | |
(ANDA) 219777 | 002 | MAGNESIUM SULFATE | MAGNESIUM SULFATE | 硫酸镁 | SOLUTION;INTRAMUSCULAR, INTRAVENOUS | 5GM/10ML (500MG/ML) | ASPIRO | 2025-05-28 | No | No | RX | AP |
(ANDA) 219777 | 001 | MAGNESIUM SULFATE | MAGNESIUM SULFATE | 硫酸镁 | SOLUTION;INTRAMUSCULAR, INTRAVENOUS | 1GM/2ML (500MG/ML) | ASPIRO | 2025-05-28 | No | No | RX | AP |
(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 | 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 |
(ANDA) 202411 | 001 | MAGNESIUM SULFATE | MAGNESIUM SULFATE | 硫酸镁 | SOLUTION;INTRAMUSCULAR, INTRAVENOUS | 10GM/20ML (500MG/ML) | HOSPIRA | 2015-05-14 | No | No | RX | AP |
(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) 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 |
(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) 207967 | 001 | MAGNESIUM SULFATE | MAGNESIUM SULFATE | 硫酸镁 | INJECTABLE;INJECTION | 2GM/50ML (40MG/ML) | B BRAUN MEDICAL | 2021-04-26 | No | No | RX | AP |
(ANDA) 219777 | 004 | MAGNESIUM SULFATE | MAGNESIUM SULFATE | 硫酸镁 | SOLUTION;INTRAMUSCULAR, INTRAVENOUS | 25GM/50ML (500MG/ML) | ASPIRO | 2025-05-28 | No | No | RX | AP |
(ANDA) 206039 | 001 | MAGNESIUM SULFATE | MAGNESIUM SULFATE | 硫酸镁 | SOLUTION;INTRAMUSCULAR, INTRAVENOUS | 5GM/10ML (500MG/ML) | EXELA PHARMA | 2014-12-18 | No | No | DISCN | |
(ANDA) 219777 | 003 | MAGNESIUM SULFATE | MAGNESIUM SULFATE | 硫酸镁 | SOLUTION;INTRAMUSCULAR, INTRAVENOUS | 10GM/20ML (500MG/ML) | ASPIRO | 2025-05-28 | No | No | RX | AP |