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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) 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5MG,N/A;N/A,210GM;N/A,0.74GM;N/A,2.86GM;N/A,5.6GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | BRAINTREE | 2010-07-16 | Yes | No | DISCN | |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) 020079 | 001 | METHOTREXATE SODIUM | 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 | EPIC PHARMA LLC | 1999-02-26 | No | No | DISCN | |
| (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) 021703 | 001 | PRISMASOL BK 0/3.5 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;N/A/1000ML;5.4GM/1000ML;2.03GM/1000ML;N/A/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML) | VANTIVE US HLTHCARE | 2006-10-25 | 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) 021703 | 012 | PRISMASOL B22GK 2/2.5 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;0.157GM/1000ML;2.21GM/1000ML;7.07GM/1000ML (5000ML) | VANTIVE US HLTHCARE | 2008-10-10 | No | No | DISCN | |
| (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 | 005 | PRISMASOL BGK 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;3.09GM/1000ML;6.46GM/1000ML (5000ML) | VANTIVE US HLTHCARE | 2006-10-25 | No | No | DISCN | |
| (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 | |
| (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 | |
| (NDA) 021703 | 008 | PRISMASOL BGK 4/3.5 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;0.314GM/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML) | VANTIVE US HLTHCARE | 2006-10-25 | No | No | DISCN | |
| (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) 021703 | 007 | PRISMASOL BK 0/0 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;N/A/1000ML;5.4GM/1000ML;3.05GM/1000ML;N/A/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML) | VANTIVE US HLTHCARE | 2006-10-25 | No | No | DISCN | |
| (NDA) 021703 | 009 | PRISMASOL BK 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;N/A/1000ML;5.4GM/1000ML;3.05GM/1000ML;0.314GM/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML) | VANTIVE US HLTHCARE | 2006-10-25 | No | No | DISCN | |
| (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 | 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 | 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) 022193 | 001 | NAVSTEL | CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; OXIGLUTATIONE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM PHOSPHATE | 氯化钙;葡萄糖;氯化镁;奥谷胱甘肽;氯化钾;碳酸氢钠;氯化钠;磷酸钠 | SOLUTION;IRRIGATION | 0.154MG/ML;0.92MG/ML;0.2MG/ML;0.184MG/ML;0.38MG/ML;2.1MG/ML;7.14MG/ML;0.42MG/ML | ALCON PHARMS LTD | 2008-07-24 | No | No | DISCN |
