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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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| (ANDA) 203935 | 001 | FLUDEOXYGLUCOSE F18 | FLUDEOXYGLUCOSE F-18 | 氟[18F]脱氧葡糖 | INJECTABLE;INTRAVENOUS | 20-300mCi/ML | WUSM CYCLOTRON | 2014-02-05 | No | No | RX | AP |
| (ANDA) 203709 | 001 | FLUDEOXYGLUCOSE F18 | FLUDEOXYGLUCOSE F-18 | 氟[18F]脱氧葡糖 | INJECTABLE;INTRAVENOUS | 20-500mCi/ML | WISCONSIN | 2013-10-23 | No | No | RX | AP |
| (NDA) 021768 | 001 | FLUDEOXYGLUCOSE F18 | FLUDEOXYGLUCOSE F-18 | 氟[18F]脱氧葡糖 | INJECTABLE;INTRAVENOUS | 10-100mCi/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | WEILL MEDCL COLL | 2004-08-05 | No | No | DISCN | |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 | 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 | 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 | 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 | 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) 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) 017512 | 003 | DIANEAL 137 W/ DEXTROSE 2.5% IN PLASTIC CONTAINER | CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE | 氯化钙;葡萄糖;氯化镁;氯化钠;乳酸钠 | SOLUTION;INTRAPERITONEAL | 25.7MG/100ML;2.5GM/100ML;15.2MG/100ML;567MG/100ML;392MG/100ML | VANTIVE US HLTHCARE | 1982-01-01 | No | 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 | 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 | 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 | 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 | 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) 017512 | 001 | DIANEAL 137 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER | CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE | 氯化钙;葡萄糖;氯化镁;氯化钠;乳酸钠 | SOLUTION;INTRAPERITONEAL | 25.7MG/100ML;1.5GM/100ML;15.2MG/100ML;567MG/100ML;392MG/100ML | VANTIVE US HLTHCARE | 1982-01-01 | No | No | DISCN | |
| (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 | 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 | 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 | 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 |
