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 45931 条，共 2297 页，当前第 1 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
BRETYLIUM TOSYLATE IN DEXTROSE 5% IN PLASTIC CONTAINER 019121 002 NDA BRETYLIUM TOSYLATE INJECTABLE;INJECTION 200MG/100ML No No 1986/04/29 B BRAUN DISCN 详细信息
BRETYLIUM TOSYLATE IN DEXTROSE 5% IN PLASTIC CONTAINER 019121 003 NDA BRETYLIUM TOSYLATE INJECTABLE;INJECTION 400MG/100ML No No 1986/04/29 B BRAUN DISCN 详细信息
BRETYLIUM TOSYLATE IN DEXTROSE 5% IN PLASTIC CONTAINER 019837 002 NDA BRETYLIUM TOSYLATE INJECTABLE;INJECTION 200MG/100ML No No 1989/04/12 BAXTER HLTHCARE DISCN 详细信息
BRETYLIUM TOSYLATE IN DEXTROSE 5% IN PLASTIC CONTAINER 019837 001 NDA BRETYLIUM TOSYLATE INJECTABLE;INJECTION 400MG/100ML No No 1989/04/12 BAXTER HLTHCARE DISCN 详细信息
BRETYLIUM TOSYLATE IN DEXTROSE 5% IN PLASTIC CONTAINER 019008 002 NDA BRETYLIUM TOSYLATE INJECTABLE;INJECTION 200MG/100ML No No 1986/04/29 HOSPIRA INC DISCN 详细信息
BRETYLIUM TOSYLATE IN DEXTROSE 5% IN PLASTIC CONTAINER 019008 003 NDA BRETYLIUM TOSYLATE INJECTABLE;INJECTION 400MG/100ML No No 1986/04/29 HOSPIRA INC DISCN 详细信息
BRETYLIUM TOSYLATE IN DEXTROSE 5% IN PLASTIC CONTAINER 019008 001 NDA BRETYLIUM TOSYLATE INJECTABLE;INJECTION 800MG/100ML No No 1986/04/29 HOSPIRA INC DISCN 详细信息
BRETYLOL 017954 001 NDA BRETYLIUM TOSYLATE INJECTABLE;INJECTION 50MG/ML No No Approved Prior to Jan 1, 1982 HOSPIRA DISCN 详细信息
BREVIBLOC 019386 003 NDA ESMOLOL HYDROCHLORIDE INJECTABLE;INJECTION 10MG/ML No No 1988/08/15 BAXTER HLTHCARE DISCN 详细信息
BREVIBLOC 019386 006 NDA ESMOLOL HYDROCHLORIDE INJECTABLE;INJECTION 10MG/ML Yes Yes AP 2003/02/25 BAXTER HLTHCARE RX 详细信息
BREVIBLOC 019386 007 NDA ESMOLOL HYDROCHLORIDE INJECTABLE;INJECTION 20MG/ML No No 2003/05/28 BAXTER HLTHCARE DISCN 详细信息
BREVIBLOC DOUBLE STRENGTH IN PLASTIC CONTAINER 019386 005 NDA ESMOLOL HYDROCHLORIDE INJECTABLE;INJECTION 2GM/100ML Yes Yes AP 2003/01/27 BAXTER HLTHCARE RX 详细信息
BREVIBLOC IN PLASTIC CONTAINER 019386 004 NDA ESMOLOL HYDROCHLORIDE INJECTABLE;INJECTION 1GM/100ML Yes Yes AP 2001/02/16 BAXTER HLTHCARE RX 详细信息
BREVITAL SODIUM 011559 002 NDA METHOHEXITAL SODIUM INJECTABLE;INJECTION 2.5GM/VIAL Yes No Approved Prior to Jan 1, 1982 ENDO OPERATIONS DISCN 详细信息
BREVITAL SODIUM 011559 003 NDA METHOHEXITAL SODIUM INJECTABLE;INJECTION 5GM/VIAL No No Approved Prior to Jan 1, 1982 ENDO OPERATIONS DISCN 详细信息
BREVITAL SODIUM 011559 004 NDA METHOHEXITAL SODIUM INJECTABLE;INJECTION 200MG/VIAL No No 2012/12/21 ENDO OPERATIONS DISCN 详细信息
BREVITAL SODIUM 011559 001 NDA METHOHEXITAL SODIUM INJECTABLE;INJECTION 500MG/VIAL Yes Yes AP Approved Prior to Jan 1, 1982 ENDO OPERATIONS RX 详细信息
BRICANYL 017466 001 NDA TERBUTALINE SULFATE INJECTABLE;INJECTION 1MG/ML No No Approved Prior to Jan 1, 1982 SANOFI AVENTIS US DISCN 详细信息
BRISTAGEN 062288 001 ANDA GENTAMICIN SULFATE INJECTABLE;INJECTION EQ 40MG BASE/ML No No Approved Prior to Jan 1, 1982 BRISTOL DISCN 详细信息
BROMPHENIRAMINE MALEATE 083821 001 ANDA BROMPHENIRAMINE MALEATE INJECTABLE;INJECTION 10MG/ML No No Approved Prior to Jan 1, 1982 WATSON LABS DISCN 详细信息
当前数据更新日期：2024年12月19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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