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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) 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) 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) 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**Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | NORVIUM BIOSCIENCE | 1984-10-26 | No | No | DISCN | |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**Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | NORVIUM BIOSCIENCE | 1984-10-26 | No | No | DISCN | |
| (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**Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | NORVIUM BIOSCIENCE | 1984-10-26 | No | No | DISCN | |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) 018509 | 001 | BAROS | SODIUM BICARBONATE; TARTARIC ACID | 碳酸氢钠;酒石酸 | GRANULE, EFFERVESCENT;ORAL | 460MG/GM;420MG/GM | MALLINCKRODT INC | 1985-08-07 | No | 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) 019443 | 002 | SODIUM BICARBONATE IN PLASTIC CONTAINER | SODIUM BICARBONATE | 碳酸氢钠 | INJECTABLE;INJECTION | 1MEQ/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ABBOTT | 1986-06-03 | Yes | No | DISCN | |
| (NDA) 019443 | 001 | SODIUM BICARBONATE IN PLASTIC CONTAINER | SODIUM BICARBONATE | 碳酸氢钠 | INJECTABLE;INJECTION | 0.9MEQ/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ABBOTT | 1986-06-03 | 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) 071320 | 001 | COLOVAGE | 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 SUSPENSION;ORAL | 227.1GM/PACKET;2.82GM/PACKET;6.36GM/PACKET;5.53GM/PACKET;21.5GM/PACKET | DYNAPHARM | 1988-04-20 | No | No | DISCN | |
| (ANDA) 071278 | 001 | E-Z-EM PREP LYTE | 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 SUSPENSION;ORAL | 236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/BOT;22.74GM/BOT | E Z EM | 1988-11-21 | No | No | DISCN | |
| (ANDA) 072319 | 001 | GLYCOPREP | 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 SUSPENSION;ORAL | 236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/BOT;22.74GM/BOT | GOLDLINE | 1988-12-23 | 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) 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) 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 | |
| (ANDA) 073428 | 001 | CO-LAV | 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 SUSPENSION;ORAL | 240GM/BOT;2.98GM/BOT;6.72GM/BOT;5.84GM/BOT;22.72GM/BOT | VINTAGE PHARMS | 1992-01-28 | No | No | DISCN | |
| (ANDA) 073433 | 001 | GO-EVAC | 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 SUSPENSION;ORAL | 236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/BOT;22.74GM/BOT | VINTAGE PHARMS | 1992-04-28 | No | 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 |
