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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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|
(ANDA) 218133 | 001 | CALCIUM CHLORIDE 10% | CALCIUM CHLORIDE | 氯化钙 | INJECTABLE;INJECTION | 100MG/ML | SOMERSET | 2024-12-17 | No | No | RX | AP |
(ANDA) 219342 | 001 | CALCIUM CHLORIDE 10% | CALCIUM CHLORIDE | 氯化钙 | INJECTABLE;INJECTION | 100MG/ML | EXTROVIS | 2024-11-27 | No | No | RX | AP |
(ANDA) 217524 | 001 | CALCIUM CHLORIDE 10% | CALCIUM CHLORIDE | 氯化钙 | INJECTABLE;INJECTION | 100MG/ML | AMNEAL | 2024-07-08 | No | No | RX | AP |
(ANDA) 210332 | 001 | DEXTROSE 5% AND LACTATED RINGER'S | CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE | 氯化钙;葡萄糖;氯化钾;氯化钠;乳酸钠 | INJECTABLE;INJECTION | 20MG/100ML;5GM/100ML;30MG/100ML;600MG/100ML;310MG/100ML | FRESENIUS KABI USA | 2022-03-28 | No | No | DISCN | |
(ANDA) 214623 | 001 | CARDIOPLEGIC IN PLASTIC CONTAINER | CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE | 氯化钙;氯化镁;氯化钾;氯化钠 | SOLUTION;PERFUSION, CARDIAC | 17.6MG/100ML;325.3MG/100ML;119.3MG/100ML;643MG/100ML | FRESENIUS KABI USA | 2022-02-18 | No | No | RX | AT |
(ANDA) 211428 | 001 | POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER | CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE | 氯化钙;葡萄糖;氯化钾;氯化钠;乳酸钠 | INJECTABLE;INJECTION | 20MG/100ML;5GM/100ML;179MG/100ML;600MG/100ML;310MG/100ML | FRESENIUS KABI USA | 2021-11-09 | No | No | DISCN | |
(ANDA) 211553 | 001 | CALCIUM CHLORIDE 10% | CALCIUM CHLORIDE | 氯化钙 | INJECTABLE;INJECTION | 100MG/ML | MEDEFIL INC | 2019-05-01 | No | No | RX | AP |
(ANDA) 209338 | 001 | LACTATED RINGER'S IN PLASTIC CONTAINER | CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE | 氯化钙;氯化钾;氯化钠;乳酸钠 | INJECTABLE;INJECTION | 20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML | FRESENIUS KABI USA | 2019-01-28 | No | No | RX | AP |
(ANDA) 203477 | 001 | CALCIUM CHLORIDE 10% | CALCIUM CHLORIDE | 氯化钙 | INJECTABLE;INJECTION | 100MG/ML | INTL MEDICATION SYS | 2018-05-09 | No | No | RX | AP |
(ANDA) 209088 | 001 | CALCIUM CHLORIDE 10% | CALCIUM CHLORIDE | 氯化钙 | INJECTABLE;INJECTION | 100MG/ML | AM REGENT | 2017-07-27 | No | No | RX | AP |
(NDA) 207026 | 002 | PHOXILLUM B22K 4/0 IN PLASTIC CONTAINER | CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM PHOSPHATE | 氯化钙;氯化镁;氯化钾;碳酸氢钠;氯化钠;磷酸钠 | INJECTABLE;INJECTION | N/A/1000ML;3.05GM/1000ML;0.314GM/1000ML;2.21GM/1000ML;6.95GM/1000ML;0.187GM/1000ML (5000ML) | VANTIVE US HLTHCARE | 2015-01-13 | Yes | Yes | RX | |
(NDA) 207026 | 001 | PHOXILLUM BK 4/2.5 IN PLASTIC CONTAINER | CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM PHOSPHATE | 氯化钙;氯化镁;氯化钾;碳酸氢钠;氯化钠;磷酸钠 | INJECTABLE;INJECTION | 3.68GM/1000ML;3.05GM/1000ML;0.314GM/1000ML ;3.09GM/1000ML;6.34GM/1000ML;0.187GM/1000ML (5000ML) | VANTIVE US HLTHCARE | 2015-01-13 | Yes | Yes | 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 | 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 | 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 | 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 | |
(ANDA) 091387 | 001 | BALANCED SALT | CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM CITRATE | 氯化钙;氯化镁;氯化钾;醋酸钠;氯化钠;枸橼酸钠 | SOLUTION;IRRIGATION | 0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/ML | B BRAUN | 2010-02-03 | No | No | RX | AT |