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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) 019912 | 001 | BRONCHO SALINE | SODIUM CHLORIDE | 氯化钠 | AEROSOL, METERED;INHALATION | 0.9% | BLAIREX | 1992-09-03 | Yes | 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5MG,N/A;N/A,210GM;N/A,0.74GM;N/A,2.86GM;N/A,5.6GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | BRAINTREE | 2010-07-16 | Yes | No | DISCN | |
| (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 | |
| (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 |
| (ANDA) 079232 | 001 | LAX-LYTE WITH FLAVOR PACKS | 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 | L PERRIGO CO | 2010-02-25 | No | No | DISCN | |
| (NDA) 021881 | 001 | MOVIPREP | ASCORBIC ACID; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM ASCORBATE; SODIUM CHLORIDE; SODIUM SULFATE | 维生素C;聚乙二醇3350;氯化钾;维生素C钠;氯化钠;硫酸钠 | FOR SOLUTION;ORAL | 4.7GM;100GM;1.015GM;5.9GM;2.691GM;7.5GM | SALIX PHARMS | 2006-08-02 | Yes | Yes | RX | AA |
| (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 |
| (ANDA) 090928 | 001 | PEG 3350 AND ELECTROLYTES | 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 | EXTROVIS | 2010-01-28 | No | No | DISCN | |
| (ANDA) 090231 | 001 | PEG 3350 AND ELECTROLYTES | 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 | NOVEL LABS INC | 2009-06-01 | No | No | RX | AA |
| (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) 018983 | 009 | 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 | 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 | 1991-11-14 | No | No | DISCN | |
| (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 | |
| (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 | |
| (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) 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 | |
| (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) 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) 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 | |
| (ANDA) 090186 | 001 | PEG 3350 AND ELECTROLYTES | 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 | NOVEL LABS INC | 2009-06-01 | No | No | RX |
