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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) 022456 | 002 | MAGNESIUM HYDROXIDE AND OMEPRAZOLE AND SODIUM BICARBONATE | MAGNESIUM HYDROXIDE; OMEPRAZOLE; SODIUM BICARBONATE | 氢氧化镁;奥美拉唑;碳酸氢钠 | TABLET;ORAL | 343MG;40MG;750MG | SANTARUS | 2009-12-04 | No | No | DISCN | |
(NDA) 022456 | 001 | MAGNESIUM HYDROXIDE AND OMEPRAZOLE AND SODIUM BICARBONATE | MAGNESIUM HYDROXIDE; OMEPRAZOLE; SODIUM BICARBONATE | 氢氧化镁;奥美拉唑;碳酸氢钠 | TABLET;ORAL | 343MG;20MG;750MG | SANTARUS | 2009-12-04 | No | No | DISCN | |
(NDA) 021850 | 001 | ZEGERID | MAGNESIUM HYDROXIDE; OMEPRAZOLE; SODIUM BICARBONATE | 氢氧化镁;奥美拉唑;碳酸氢钠 | TABLET, CHEWABLE;ORAL | 700MG;20MG;600MG | SANTARUS | 2006-03-24 | No | No | DISCN | |
(NDA) 021850 | 002 | ZEGERID | MAGNESIUM HYDROXIDE; OMEPRAZOLE; SODIUM BICARBONATE | 氢氧化镁;奥美拉唑;碳酸氢钠 | TABLET, CHEWABLE;ORAL | 700MG;40MG;600MG | SANTARUS | 2006-03-24 | No | No | DISCN | |
(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**Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | BRAINTREE LABS | 2013-01-18 | Yes | No | DISCN | |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) 019284 | 001 | OCL | POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE | 聚乙二醇3350;氯化钾;碳酸氢钠;氯化钠;硫酸钠 | SOLUTION;ORAL | 6GM/100ML;75MG/100ML;168MG/100ML;146MG/100ML;1.29GM/100ML | HOSPIRA | 1986-04-30 | No | No | DISCN | |
(NDA) 022193 | 001 | NAVSTEL | CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; OXIGLUTATIONE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM PHOSPHATE | 氯化钙;葡萄糖;氯化镁;奥谷胱甘肽;氯化钾;碳酸氢钠;氯化钠;磷酸钠 | SOLUTION;IRRIGATION | 0.154MG/ML;0.92MG/ML;0.2MG/ML;0.184MG/ML;0.38MG/ML;2.1MG/ML;7.14MG/ML;0.42MG/ML | ALCON PHARMS LTD | 2008-07-24 | No | No | DISCN | |
(NDA) 020079 | 001 | METHOTREXATE SODIUM | CALCIUM CHLORIDE; DEXTROSE; GLUTATHIONE DISULFIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM PHOSPHATE | 氯化钙;葡萄糖;奥谷胱甘肽;氯化镁;氯化钾;碳酸氢钠;氯化钠;磷酸钠 | SOLUTION;IRRIGATION | 0.154MG/ML;0.92MG/ML;0.184MG/ML;0.2MG/ML;0.38MG/ML;2.1MG/ML;7.14MG/ML;0.42MG/ML | EPIC PHARMA LLC | 1999-02-26 | No | No | DISCN | |
(NDA) 018469 | 001 | BSS PLUS | CALCIUM CHLORIDE; DEXTROSE; GLUTATHIONE DISULFIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM PHOSPHATE | 氯化钙;葡萄糖;奥谷胱甘肽;氯化镁;氯化钾;碳酸氢钠;氯化钠;磷酸钠 | SOLUTION;IRRIGATION | 0.154MG/ML;0.92MG/ML;0.184MG/ML;0.2MG/ML;0.38MG/ML;2.1MG/ML;7.14MG/ML;0.42MG/ML | ALCON | 1982-01-01 | Yes | Yes | RX | |
(NDA) 021910 | 002 | NORMOCARB HF 35 | MAGNESIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE | 氯化镁;碳酸氢钠;氯化钠 | SOLUTION;INJECTION | 0.21GM/100ML;3.97GM/100ML;8.3GM/100ML | DIALYSIS SUPS | 2006-07-26 | Yes | Yes | RX | |
(NDA) 021910 | 001 | NORMOCARB HF 25 | MAGNESIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE | 氯化镁;碳酸氢钠;氯化钠 | SOLUTION;INJECTION | 0.21GM/100ML;2.8GM/100ML;9.07GM/100ML | DIALYSIS SUPS | 2006-07-26 | 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 | |
(NDA) 021703 | 010 | PRISMASOL B22GK 2/0 IN PLASTIC CONTAINER | CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE | 氯化钙;葡萄糖;乳酸;氯化镁;氯化钾;碳酸氢钠;氯化钠 | INJECTABLE;INJECTION | N/A/1000ML;20GM/1000ML;5.4GM/1000ML;3.05GM/1000ML;0.157GM/1000ML;2.21GM/1000ML;7.07GM/1000ML (5000ML) | VANTIVE US HLTHCARE | 2008-10-10 | Yes | No | DISCN | |
(NDA) 021703 | 014 | PRISMASOL BK 0/0/1.2 IN PLASTIC CONTAINER | CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE | 氯化钙;葡萄糖;乳酸;氯化镁;氯化钾;碳酸氢钠;氯化钠 | INJECTABLE;INJECTION | N/A/1000ML;N/A/1000ML;5.4GM/1000ML;2.44GM/1000ML;N/A/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML) | VANTIVE US HLTHCARE | 2008-10-10 | 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) 021703 | 008 | PRISMASOL BGK 4/3.5 IN PLASTIC CONTAINER | CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE | 氯化钙;葡萄糖;乳酸;氯化镁;氯化钾;碳酸氢钠;氯化钠 | INJECTABLE;INJECTION | 5.15GM/1000ML;20GM/1000ML;5.4GM/1000ML;2.03GM/1000ML;0.314GM/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML) | VANTIVE US HLTHCARE | 2006-10-25 | No | No | DISCN | |
(ANDA) 211091 | 002 | SODIUM BICARBONATE | SODIUM BICARBONATE | 碳酸氢钠 | INJECTABLE;INJECTION | 0.9MEQ/ML | EXELA PHARMA | 2019-06-20 | No | Yes | RX | AP |
(NDA) 021703 | 012 | PRISMASOL B22GK 2/2.5 IN PLASTIC CONTAINER | CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE | 氯化钙;葡萄糖;乳酸;氯化镁;氯化钾;碳酸氢钠;氯化钠 | INJECTABLE;INJECTION | 3.68GM/1000ML;20GM/1000ML;5.4GM/1000ML;3.05GM/1000ML;0.157GM/1000ML;2.21GM/1000ML;7.07GM/1000ML (5000ML) | VANTIVE US HLTHCARE | 2008-10-10 | No | No | DISCN | |
(ANDA) 219701 | 001 | SODIUM BICARBONATE | SODIUM BICARBONATE | 碳酸氢钠 | INJECTABLE;INJECTION | 1MEQ/ML | ANTHEA PHARMA | 2025-06-26 | No | No | RX | AP |
(ANDA) 211091 | 001 | SODIUM BICARBONATE | SODIUM BICARBONATE | 碳酸氢钠 | INJECTABLE;INJECTION | 0.5MEQ/ML | EXELA PHARMA | 2019-06-20 | No | Yes | RX | AP |