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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) 022281 | 001 | ZEGERID OTC | OMEPRAZOLE; SODIUM BICARBONATE | 奥美拉唑;碳酸氢钠 | CAPSULE;ORAL | 20MG;1.1GM | RILEY CONSUMER | 2009-12-01 | Yes | Yes | OTC | |
| (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 | |
| (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 |
| (ANDA) 211091 | 003 | SODIUM BICARBONATE | SODIUM BICARBONATE | 碳酸氢钠 | INJECTABLE;INJECTION | 1MEQ/ML | EXELA PHARMA | 2019-06-20 | No | Yes | RX | AP |
| (NDA) 019797 | 002 | NULYTELY-FLAVORED | POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE | 聚乙二醇3350;氯化钾;碳酸氢钠;氯化钠 | FOR SOLUTION;ORAL | 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT | BRAINTREE | 1994-11-18 | Yes | Yes | RX | AA |
| (NDA) 213593 | 001 | KONVOMEPP | OMEPRAZOLE; SODIUM BICARBONATE | 奥美拉唑;碳酸氢钠 | FOR SUSPENSION;ORAL | 2MG/ML;84MG/ML | AZURITY | 2022-08-30 | Yes | Yes | RX | |
| (NDA) 022283 | 001 | ZEGERID OTC | OMEPRAZOLE; SODIUM BICARBONATE | 奥美拉唑;碳酸氢钠 | FOR SUSPENSION;ORAL | 20MG/PACKET;1.68GM/PACKET | RILEY CONSUMER | 2013-06-17 | Yes | Yes | OTC | |
| (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) 021703 | 006 | PRISMASOL BGK 0/2.5 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;N/A/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML) | VANTIVE US HLTHCARE | 2006-10-25 | Yes | Yes | RX | |
| (NDA) 021703 | 003 | PRISMASOL BGK 2/3.5 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;0.157GM/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML) | VANTIVE US HLTHCARE | 2006-10-25 | Yes | Yes | RX | |
| (NDA) 021703 | 011 | PRISMASOL B22GK 4/0 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;0.314GM/1000ML;2.21GM/1000ML;7.07GM/1000ML (5000ML) | VANTIVE US HLTHCARE | 2008-10-10 | Yes | Yes | RX | |
| (ANDA) 204228 | 002 | OMEPRAZOLE AND SODIUM BICARBONATE | OMEPRAZOLE; SODIUM BICARBONATE | 奥美拉唑;碳酸氢钠 | CAPSULE;ORAL | 40MG;1.1GM | AJANTA PHARMA LTD | 2016-07-15 | No | Yes | RX | AB |
| (NDA) 021703 | 015 | PRISMASOL BGK 4/0/1.2 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;20GM/1000ML;5.4GM/1000ML;2.44GM/1000ML;0.314GM/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML) | VANTIVE US HLTHCARE | 2008-10-10 | Yes | Yes | RX | |
| (NDA) 019011 | 001 | GOLYTELY | POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE ANHYDROUS | 聚乙二醇3350;氯化钾;碳酸氢钠;氯化钠;硫酸钠 | FOR SOLUTION;ORAL | 236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/BOT;22.74GM/BOT | BRAINTREE | 1984-07-13 | Yes | Yes | RX | AA |
| (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 | 004 | PRISMASOL BGK 4/2.5 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;0.314GM/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML) | VANTIVE US HLTHCARE | 2006-10-25 | Yes | Yes | RX | |
| (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) 019797 | 001 | NULYTELY | POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE | 聚乙二醇3350;氯化钾;碳酸氢钠;氯化钠 | FOR SOLUTION;ORAL | 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT | BRAINTREE | 1991-04-22 | Yes | Yes | RX | AA |
| (ANDA) 205545 | 002 | OMEPRAZOLE AND SODIUM BICARBONATE | OMEPRAZOLE; SODIUM BICARBONATE | 奥美拉唑;碳酸氢钠 | FOR SUSPENSION;ORAL | 40MG/PACKET;1.68GM/PACKET | AJANTA PHARMA LTD | 2016-07-27 | No | Yes | RX | AB |
| (NDA) 021703 | 002 | PRISMASOL BGK 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;2.03GM/1000ML;0.157GM/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML) | VANTIVE US HLTHCARE | 2006-10-25 | Yes | Yes | RX |
