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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) 018983 | 008 | COLYTE-FLAVORED | 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/BOT;2.82GM/BOT;6.36GM/BOT;5.53GM/BOT;21.5GM/BOT **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | NORVIUM BIOSCIENCE | 1991-11-14 | No | No | DISCN | |
(ANDA) 078966 | 001 | OMEPRAZOLE AND SODIUM BICARBONATE | OMEPRAZOLE; SODIUM BICARBONATE | 奥美拉唑;碳酸氢钠 | CAPSULE;ORAL | 20MG;1.1GM | STRIDES PHARMA | 2010-05-25 | No | No | DISCN | |
(ANDA) 201946 | 001 | OMEPRAZOLE AND SODIUM BICARBONATE | OMEPRAZOLE; SODIUM BICARBONATE | 奥美拉唑;碳酸氢钠 | CAPSULE;ORAL | 20MG;1.1GM | STRIDES PHARMA | 2016-07-15 | No | No | DISCN | |
(ANDA) 078966 | 002 | OMEPRAZOLE AND SODIUM BICARBONATE | OMEPRAZOLE; SODIUM BICARBONATE | 奥美拉唑;碳酸氢钠 | CAPSULE;ORAL | 40MG;1.1GM | STRIDES PHARMA | 2010-05-25 | No | No | DISCN | |
(ANDA) 203345 | 001 | OMEPRAZOLE AND SODIUM BICARBONATE | OMEPRAZOLE; SODIUM BICARBONATE | 奥美拉唑;碳酸氢钠 | CAPSULE;ORAL | 20MG;1.1GM | ZYDUS | 2018-03-16 | No | No | OTC | |
(NDA) 018983 | 005 | COLYTE | 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 | 120GM/PACKET;1.49GM/PACKET;3.36GM/PACKET;2.92GM/PACKET;11.36GM/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | NORVIUM BIOSCIENCE | 1984-10-26 | No | No | DISCN | |
(NDA) 018983 | 004 | COLYTE | 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 **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | NORVIUM BIOSCIENCE | 1984-10-26 | No | No | DISCN | |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) 018983 | 012 | COLYTE WITH FLAVOR PACKS | 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 | 240GM/BOT;2.98GM/BOT;6.72GM/BOT;5.84GM/BOT;22.72GM/BOT | NORVIUM BIOSCIENCE | 1998-10-08 | No | No | DISCN | |
(ANDA) 201361 | 001 | OMEPRAZOLE AND SODIUM BICARBONATE | OMEPRAZOLE; SODIUM BICARBONATE | 奥美拉唑;碳酸氢钠 | CAPSULE;ORAL | 20MG;1.1GM | PERRIGO R AND D | 2016-07-15 | No | No | OTC | |
(NDA) 018983 | 010 | COLYTE | 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/BOT;2.82GM/BOT;6.36GM/BOT;5.53GM/BOT;21.5GM/BOT **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | NORVIUM BIOSCIENCE | 1989-01-31 | No | No | DISCN | |
(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) 018983 | 007 | COLYTE | 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 | 240GM/BOT;2.98GM/BOT;6.72GM/BOT;5.84GM/BOT;22.72GM/BOT **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | NORVIUM BIOSCIENCE | 1987-06-12 | No | No | DISCN | |
(ANDA) 202217 | 001 | PEG-3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL | 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 | NOVEL LABS INC | 2014-08-20 | No | No | DISCN | |
(ANDA) 204923 | 001 | OMEPRAZOLE AND SODIUM BICARBONATE | OMEPRAZOLE; SODIUM BICARBONATE | 奥美拉唑;碳酸氢钠 | CAPSULE;ORAL | 20MG;1.1GM | AUROBINDO PHARMA | 2016-11-07 | No | No | OTC | |
(NDA) 018983 | 006 | COLYTE | 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 | 360GM/PACKET;4.47GM/PACKET;10.08GM/PACKET;8.76GM/PACKET;34.08GM/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | NORVIUM BIOSCIENCE | 1984-10-26 | No | No | DISCN | |
(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 | |
(ANDA) 204137 | 001 | OMEPRAZOLE AND SODIUM BICARBONATE | OMEPRAZOLE; SODIUM BICARBONATE | 奥美拉唑;碳酸氢钠 | CAPSULE;ORAL | 20MG;1.1GM | CHARTWELL RX | 2016-07-15 | No | No | DISCN | |
(ANDA) 090769 | 001 | CLENZ-LYTE | 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 | FOR SOLUTION;ORAL | 236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/BOT;22.74GM/BOT | PADDOCK LLC | 2010-06-07 | No | No | DISCN |