美国FDA药品橙皮书数据库
（U.S. FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations）
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数据记录共 48215 条，共 2411 页，当前第 83 页
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商品名 申请号 产品号 申请类型 活性成分 剂型/给药途径 规格/剂量 是否参比药物 是否生物等效参考标准 治疗等效代码 产品批准日期 申请人 市场状态 专利及市场独占权
PRIMACOR IN DEXTROSE 5% IN PLASTIC CONTAINER 020343 001 NDA MILRINONE LACTATE INJECTABLE;INJECTION EQ 10MG BASE/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 1994/08/09 SANOFI AVENTIS US DISCN 详细信息
PRIMACOR IN DEXTROSE 5% IN PLASTIC CONTAINER 020343 002 NDA MILRINONE LACTATE INJECTABLE;INJECTION EQ 15MG BASE/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 1994/08/09 SANOFI AVENTIS US DISCN 详细信息
PRIMACOR IN DEXTROSE 5% IN PLASTIC CONTAINER 020343 003 NDA MILRINONE LACTATE INJECTABLE;INJECTION EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 1994/08/09 SANOFI AVENTIS US DISCN 详细信息
PRIMACOR IN DEXTROSE 5% IN PLASTIC CONTAINER 020343 004 NDA MILRINONE LACTATE INJECTABLE;INJECTION EQ 40MG BASE/200ML (EQ 0.2MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 1994/08/09 SANOFI AVENTIS US DISCN 详细信息
PRIMAXIN 062756 001 ANDA CILASTATIN SODIUM; IMIPENEM INJECTABLE;INJECTION EQ 250MG BASE/VIAL;250MG/VIAL No No 1987/01/08 MERCK DISCN 详细信息
PRIMAXIN 062756 002 ANDA CILASTATIN SODIUM; IMIPENEM INJECTABLE;INJECTION EQ 500MG BASE/VIAL;500MG/VIAL No No 1987/01/08 MERCK DISCN 详细信息
PRISCOLINE 006403 005 NDA TOLAZOLINE HYDROCHLORIDE INJECTABLE;INJECTION 25MG/ML No No 1985/02/22 NOVARTIS DISCN 详细信息
PRISMASOL B22GK 2/0 IN PLASTIC CONTAINER 021703 010 NDA CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE INJECTABLE;INJECTION N/A/1000ML;20GM/1000ML;5.4GM/1000ML;3.05GM/1000ML;0.157GM/1000ML;2.21GM/1000ML;7.07GM/1000ML (5000ML) Yes No 2008/10/10 VANTIVE US HLTHCARE DISCN 详细信息
PRISMASOL B22GK 2/2.5 IN PLASTIC CONTAINER 021703 012 NDA CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE INJECTABLE;INJECTION 3.68GM/1000ML;20GM/1000ML;5.4GM/1000ML;3.05GM/1000ML;0.157GM/1000ML;2.21GM/1000ML;7.07GM/1000ML (5000ML) No No 2008/10/10 VANTIVE US HLTHCARE DISCN 详细信息
PRISMASOL B22GK 4/0 IN PLASTIC CONTAINER 021703 011 NDA CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE INJECTABLE;INJECTION N/A/1000ML;20GM/1000ML;5.4GM/1000ML;3.05GM/1000ML;0.314GM/1000ML;2.21GM/1000ML;7.07GM/1000ML (5000ML) Yes Yes 2008/10/10 VANTIVE US HLTHCARE RX 详细信息
PRISMASOL B22GK 4/2.5 IN PLASTIC CONTAINER 021703 013 NDA CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE INJECTABLE;INJECTION 3.68GM/1000ML;20GM/1000ML;5.4GM/1000ML;3.05GM/1000ML;0.314GM/1000ML;2.21GM/1000ML;7.07GM/1000ML (5000ML) Yes No 2008/10/10 VANTIVE US HLTHCARE DISCN 详细信息
PRISMASOL BGK 0/2.5 IN PLASTIC CONTAINER 021703 006 NDA CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE INJECTABLE;INJECTION 3.68GM/1000ML;20GM/1000ML;5.4GM/1000ML;3.05GM/1000ML;N/A/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML) Yes Yes 2006/10/25 VANTIVE US HLTHCARE RX 详细信息
PRISMASOL BGK 2/0 IN PLASTIC CONTAINER 021703 002 NDA CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE INJECTABLE;INJECTION N/A/1000ML;20GM/1000ML;5.4GM/1000ML;2.03GM/1000ML;0.157GM/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML) Yes Yes 2006/10/25 VANTIVE US HLTHCARE RX 详细信息
PRISMASOL BGK 2/3.5 IN PLASTIC CONTAINER 021703 003 NDA CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE INJECTABLE;INJECTION 5.15GM/1000ML;20GM/1000ML;5.4GM/1000ML;2.03GM/1000ML;0.157GM/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML) Yes Yes 2006/10/25 VANTIVE US HLTHCARE RX 详细信息
PRISMASOL BGK 4/0 IN PLASTIC CONTAINER 021703 005 NDA CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE INJECTABLE;INJECTION N/A/1000ML;20GM/1000ML;5.4GM/1000ML;3.05GM/1000ML;0.314GM/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML) No No 2006/10/25 VANTIVE US HLTHCARE DISCN 详细信息
PRISMASOL BGK 4/0/1.2 IN PLASTIC CONTAINER 021703 015 NDA CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE INJECTABLE;INJECTION N/A/1000ML;20GM/1000ML;5.4GM/1000ML;2.44GM/1000ML;0.314GM/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML) Yes Yes 2008/10/10 VANTIVE US HLTHCARE RX 详细信息
PRISMASOL BGK 4/2.5 IN PLASTIC CONTAINER 021703 004 NDA CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE INJECTABLE;INJECTION 3.68GM/1000ML;20GM/1000ML;5.4GM/1000ML;3.05GM/1000ML;0.314GM/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML) Yes Yes 2006/10/25 VANTIVE US HLTHCARE RX 详细信息
PRISMASOL BGK 4/3.5 IN PLASTIC CONTAINER 021703 008 NDA CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE INJECTABLE;INJECTION 5.15GM/1000ML;20GM/1000ML;5.4GM/1000ML;2.03GM/1000ML;0.314GM/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML) No No 2006/10/25 VANTIVE US HLTHCARE DISCN 详细信息
PRISMASOL BK 0/0 IN PLASTIC CONTAINER 021703 007 NDA CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE INJECTABLE;INJECTION N/A/1000ML;N/A/1000ML;5.4GM/1000ML;3.05GM/1000ML;N/A/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML) No No 2006/10/25 VANTIVE US HLTHCARE DISCN 详细信息
PRISMASOL BK 0/0/1.2 IN PLASTIC CONTAINER 021703 014 NDA CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE INJECTABLE;INJECTION N/A/1000ML;N/A/1000ML;5.4GM/1000ML;2.44GM/1000ML;N/A/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML) Yes Yes 2008/10/10 VANTIVE US HLTHCARE RX 详细信息
当前数据更新日期：2026年05月28日，更多信息请点击此处查询美国FDA药品数据库
数据库说明：本数据与美国FDA官方药品橙皮书数据库同步，在官方数据基础上，提供更全面的检索方式和更简洁高效、完整的数据展现，并且可以回溯专利及市场独占权（市场排他数据）历史信息。
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