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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 | 013 | PRISMASOL B22GK 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;2.21GM/1000ML;7.07GM/1000ML (5000ML) | VANTIVE US HLTHCARE | 2008-10-10 | Yes | No | DISCN | |
(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) 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 |
(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) 021636 | 001 | ZEGERID | OMEPRAZOLE; SODIUM BICARBONATE | 奥美拉唑;碳酸氢钠 | FOR SUSPENSION;ORAL | 20MG/PACKET;1.68GM/PACKET | SALIX | 2004-06-15 | Yes | No | DISCN | |
(NDA) 021636 | 002 | ZEGERID | OMEPRAZOLE; SODIUM BICARBONATE | 奥美拉唑;碳酸氢钠 | FOR SUSPENSION;ORAL | 40MG/PACKET;1.68GM/PACKET | SALIX | 2004-12-21 | Yes | No | DISCN | |
(NDA) 021849 | 001 | ZEGERID | OMEPRAZOLE; SODIUM BICARBONATE | 奥美拉唑;碳酸氢钠 | CAPSULE;ORAL | 20MG;1.1GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SALIX | 2006-02-27 | Yes | No | DISCN | |
(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) 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) 021551 | 003 | HALFLYTELY | BISACODYL; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE | 比沙可啶;聚乙二醇3350;氯化钾;碳酸氢钠;氯化钠 | FOR SOLUTION, TABLET, DELAYED RELEASE;ORAL | 5MG,N/A;N/A,210GM;N/A,0.74GM;N/A,2.86GM;N/A,5.6GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | BRAINTREE | 2010-07-16 | Yes | No | DISCN | |
(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) 019011 | 002 | 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 | 227.1GM/PACKET;2.82GM/PACKET;6.36GM/PACKET;5.53GM/PACKET;21.5GM/PACKET | BRAINTREE | 1992-06-02 | Yes | No | DISCN | |
(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) 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 | |
(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 | |
(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) 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) 021849 | 002 | ZEGERID | OMEPRAZOLE; SODIUM BICARBONATE | 奥美拉唑;碳酸氢钠 | CAPSULE;ORAL | 40MG;1.1GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SALIX | 2006-02-27 | Yes | No | DISCN |