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 47926 条，共 2397 页，当前第 37 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
BRONKODYL 085264 001 ANDA THEOPHYLLINE CAPSULE;ORAL 100MG No No Approved Prior to Jan 1, 1982 SANOFI AVENTIS US DISCN 详细信息
BRONKODYL 085264 002 ANDA THEOPHYLLINE CAPSULE;ORAL 200MG No No Approved Prior to Jan 1, 1982 SANOFI AVENTIS US DISCN 详细信息
BRUKINSA 213217 001 NDA ZANUBRUTINIB CAPSULE;ORAL 80MG Yes No 2019/11/14 BEONE MEDICINES USA DISCN 详细信息
BUCAPSOL 218628 001 ANDA BUSPIRONE HYDROCHLORIDE CAPSULE;ORAL 7.5MG No No 2025/03/13 EPIC PHARMA LLC RX 详细信息
BUCAPSOL 218628 002 ANDA BUSPIRONE HYDROCHLORIDE CAPSULE;ORAL 10MG No No 2025/03/13 EPIC PHARMA LLC RX 详细信息
BUCAPSOL 218628 003 ANDA BUSPIRONE HYDROCHLORIDE CAPSULE;ORAL 15MG No Yes 2025/03/13 EPIC PHARMA LLC RX 详细信息
BUCET 088991 001 ANDA ACETAMINOPHEN; BUTALBITAL CAPSULE;ORAL 650MG;50MG No No 1985/06/28 MALLINCKRODT DISCN 详细信息
BUSPAR 021190 001 NDA BUSPIRONE HYDROCHLORIDE CAPSULE;ORAL 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 2000/12/20 BRISTOL MYERS SQUIBB DISCN 详细信息
BUSPAR 021190 002 NDA BUSPIRONE HYDROCHLORIDE CAPSULE;ORAL 7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 2000/12/20 BRISTOL MYERS SQUIBB DISCN 详细信息
BUSPAR 021190 003 NDA BUSPIRONE HYDROCHLORIDE CAPSULE;ORAL 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 2000/12/20 BRISTOL MYERS SQUIBB DISCN 详细信息
BUSPAR 021190 004 NDA BUSPIRONE HYDROCHLORIDE CAPSULE;ORAL 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 2000/12/20 BRISTOL MYERS SQUIBB DISCN 详细信息
BUTALBITAL AND ACETAMINOPHEN 207313 001 ANDA ACETAMINOPHEN; BUTALBITAL CAPSULE;ORAL 300MG;50MG No Yes AA 2017/12/27 DR REDDYS LABS SA RX 详细信息
BUTALBITAL AND ACETAMINOPHEN 213115 001 ANDA ACETAMINOPHEN; BUTALBITAL CAPSULE;ORAL 300MG;50MG No No AA 2019/11/22 GRANULES RX 详细信息
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE 204733 001 ANDA ACETAMINOPHEN; BUTALBITAL; CAFFEINE CAPSULE;ORAL 325MG;50MG;40MG No No AA 2018/09/26 AUROLIFE PHARMA LLC RX 详细信息
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE 210817 001 ANDA ACETAMINOPHEN; BUTALBITAL; CAFFEINE CAPSULE;ORAL 300MG;50MG;40MG No No AA 2019/12/17 DR REDDYS LABS SA RX 详细信息
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE 089007 001 ANDA ACETAMINOPHEN; BUTALBITAL; CAFFEINE CAPSULE;ORAL 325MG;50MG;40MG No Yes AA 1986/03/17 DR REDDYS LABS SA RX 详细信息
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE 088825 001 ANDA ACETAMINOPHEN; BUTALBITAL; CAFFEINE CAPSULE;ORAL 325MG;50MG;40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 1984/12/05 GILBERT LABS DISCN 详细信息
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE 088743 001 ANDA ACETAMINOPHEN; BUTALBITAL; CAFFEINE CAPSULE;ORAL 325MG;50MG;40MG No No 1985/07/18 GRAHAM DM DISCN 详细信息
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE 088765 001 ANDA ACETAMINOPHEN; BUTALBITAL; CAFFEINE CAPSULE;ORAL 325MG;50MG;40MG No No 1985/03/27 GRAHAM DM DISCN 详细信息
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE 089067 001 ANDA ACETAMINOPHEN; BUTALBITAL; CAFFEINE CAPSULE;ORAL 325MG;50MG;40MG No No 1985/04/19 GRAHAM DM DISCN 详细信息
当前数据更新日期：2026年04月03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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