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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) 018608 | 001 | PLEGISOL IN PLASTIC CONTAINER | CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE | 氯化钙;氯化镁;氯化钾;氯化钠 | SOLUTION;PERFUSION, CARDIAC | 17.6MG/100ML;325.3MG/100ML;119.3MG/100ML;643MG/100ML | HOSPIRA | 1982-02-26 | Yes | Yes | RX | AT |
(ANDA) 214623 | 001 | CARDIOPLEGIC IN PLASTIC CONTAINER | CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE | 氯化钙;氯化镁;氯化钾;氯化钠 | SOLUTION;PERFUSION, CARDIAC | 17.6MG/100ML;325.3MG/100ML;119.3MG/100ML;643MG/100ML | FRESENIUS KABI USA | 2022-02-18 | No | No | RX | AT |
(ANDA) 075323 | 001 | CARDIOPLEGIC IN PLASTIC CONTAINER | CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE | 氯化钙;氯化镁;氯化钾;氯化钠 | SOLUTION;PERFUSION, CARDIAC | 17.6MG/100ML;325.3MG/100ML;119.3MG/100ML;643MG/100ML | BAXTER HLTHCARE | 2000-04-21 | No | No | RX | AT |
(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) 203595 | 001 | SUCLEAR | MAGNESIUM SULFATE; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; POTASSIUM SULFATE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE | 聚乙二醇3350;硫酸镁;氯化钾;硫酸钾;碳酸氢钠;氯化钠;硫酸钠 | SOLUTION;ORAL | 1.6GM/BOT,3.13GM/BOT,17.5GM/BOT,N/A,N/A,N/A,N/A;N/A,N/A,N/A,210GM,0.74GM,2.86GM,5.6GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | BRAINTREE LABS | 2013-01-18 | Yes | No | DISCN | |
(NDA) 018681 | 001 | LACTATED RINGER'S IN PLASTIC CONTAINER | CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE | 氯化钙;氯化钾;氯化钠;乳酸钠 | SOLUTION;IRRIGATION | 20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML | B BRAUN | 1982-12-27 | Yes | Yes | RX | AT |
(NDA) 020742 | 001 | BSS | CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM CITRATE | 氯化钙;氯化镁;氯化钾;醋酸钠;氯化钠;枸橼酸钠 | SOLUTION;IRRIGATION | 0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/ML | ALCON | 1997-12-10 | Yes | Yes | RX | AT |
(ANDA) 075503 | 001 | BALANCED SALT | CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM CITRATE | 氯化钙;氯化镁;氯化钾;醋酸钠;氯化钠;枸橼酸钠 | SOLUTION;IRRIGATION | 0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/ML | EPIC PHARMA LLC | 2006-09-27 | No | No | DISCN | |
(NDA) 018494 | 001 | LACTATED RINGER'S IN PLASTIC CONTAINER | CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE | 氯化钙;氯化钾;氯化钠;乳酸钠 | SOLUTION;IRRIGATION | 20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML | BAXTER HLTHCARE | 1982-02-19 | No | No | RX | AT |
(NDA) 019933 | 001 | LACTATED RINGER'S IN PLASTIC CONTAINER | CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE | 氯化钙;氯化钾;氯化钠;乳酸钠 | SOLUTION;IRRIGATION | 20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML | BAXTER HLTHCARE | 1989-08-29 | No | No | DISCN | |
(NDA) 019024 | 001 | PHYSIOLYTE IN PLASTIC CONTAINER | MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATE | 氯化镁;氯化钾;醋酸钠;氯化钠;葡萄糖酸钠 | SOLUTION;IRRIGATION | 30MG/100ML;37MG/100ML;370MG/100ML;530MG/100ML;500MG/100ML | B BRAUN | 1984-06-08 | No | No | RX | |
(NDA) 019416 | 001 | LACTATED RINGER'S IN PLASTIC CONTAINER | CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE | 氯化钙;氯化钾;氯化钠;乳酸钠 | SOLUTION;IRRIGATION | 20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML | OTSUKA ICU MEDCL | 1986-01-17 | Yes | Yes | RX | AT |
(NDA) 018156 | 001 | RINGER'S IN PLASTIC CONTAINER | CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE | 氯化钙;氯化钾;氯化钠 | SOLUTION;IRRIGATION | 33MG/100ML;30MG/100ML;860MG/100ML | B BRAUN | 1982-01-01 | No | No | RX | AT |
(NDA) 018495 | 001 | RINGER'S IN PLASTIC CONTAINER | CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE | 氯化钙;氯化钾;氯化钠 | SOLUTION;IRRIGATION | 33MG/100ML;30MG/100ML;860MG/100ML | BAXTER HLTHCARE | 1982-02-19 | No | No | RX | AT |
(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) 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 | |
(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) 018406 | 001 | PHYSIOSOL IN PLASTIC CONTAINER | MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATE | 氯化镁;氯化钾;醋酸钠;氯化钠;葡萄糖酸钠 | SOLUTION;IRRIGATION | 14MG/100ML;37MG/100ML;222MG/100ML;526MG/100ML;502MG/100ML | HOSPIRA INC | 1982-01-01 | No | No | DISCN | |
(NDA) 018921 | 001 | LACTATED RINGER'S IN PLASTIC CONTAINER | CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE | 氯化钙;氯化钾;氯化钠;乳酸钠 | SOLUTION;IRRIGATION | 20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML | BAXTER HLTHCARE | 1984-04-03 | Yes | Yes | RX | AT |
(NDA) 017637 | 002 | PHYSIOSOL IN PLASTIC CONTAINER | MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATE | 氯化镁;氯化钾;醋酸钠;氯化钠;葡萄糖酸钠 | SOLUTION;IRRIGATION | 30MG/100ML;37MG/100ML;222MG/100ML;526MG/100ML;502MG/100ML | OTSUKA ICU MEDCL | 1982-07-08 | No | No | RX |