美国FDA药品橙皮书数据库
(U.S. FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations)
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
BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE 076560 002 ANDA ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE CAPSULE;ORAL 300MG;50MG;40MG;30MG No No AB 2012/07/19 LGM PHARMA RX 详细信息
BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE 076560 001 ANDA ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE CAPSULE;ORAL 325MG;50MG;40MG;30MG No No AB 2004/06/10 LGM PHARMA RX 详细信息
BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE 075929 001 ANDA ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE CAPSULE;ORAL 325MG;50MG;40MG;30MG No No 2002/04/22 PHARMOBEDIENT DISCN 详细信息
BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE 204649 001 ANDA ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE CAPSULE;ORAL 325MG;50MG;40MG;30MG No No 2020/07/08 STRIDES PHARMA DISCN 详细信息
BUTALBITAL, ASPIRIN AND CAFFEINE 205230 001 ANDA ASPIRIN; BUTALBITAL; CAFFEINE CAPSULE;ORAL 500MG;50MG;40MG No No 2021/10/18 LGM PHARMA DISCN 详细信息
BUTALBITAL, ASPIRIN AND CAFFEINE 078149 001 ANDA ASPIRIN; BUTALBITAL; CAFFEINE CAPSULE;ORAL 325MG;50MG;40MG No No AA 2007/06/13 MPP PHARMA RX 详细信息
BUTALBITAL, ASPIRIN AND CAFFEINE 086231 002 ANDA ASPIRIN; BUTALBITAL; CAFFEINE CAPSULE;ORAL 325MG;50MG;40MG No No 1985/02/12 WATSON LABS DISCN 详细信息
BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE 203335 001 ANDA ASPIRIN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE CAPSULE;ORAL 325MG;50MG;40MG;30MG No No 2015/10/30 DR REDDYS LABS SA DISCN 详细信息
BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE 075231 001 ANDA ASPIRIN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE CAPSULE;ORAL 325MG;50MG;40MG;30MG No No AB 2001/11/30 LGM PHARMA RX 详细信息
BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE 075351 001 ANDA ASPIRIN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE CAPSULE;ORAL 325MG;50MG;40MG;30MG No No 1999/03/05 NOVITIUM PHARMA DISCN 详细信息
BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE 074951 001 ANDA ASPIRIN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE CAPSULE;ORAL 325MG;50MG;40MG;30MG No Yes AB 1998/08/31 STEVENS J RX 详细信息
BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE 074359 001 ANDA ASPIRIN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE CAPSULE;ORAL 325MG;50MG;40MG;30MG No No 1995/08/31 WATSON LABS DISCN 详细信息
BUTAZOLIDIN 008319 009 NDA PHENYLBUTAZONE CAPSULE;ORAL 100MG No No Approved Prior to Jan 1, 1982 NOVARTIS DISCN 详细信息
BUTICAPS 085381 001 ANDA BUTABARBITAL SODIUM CAPSULE;ORAL 15MG No No Approved Prior to Jan 1, 1982 MEDPOINTE PHARM HLC DISCN 详细信息
BUTICAPS 085381 002 ANDA BUTABARBITAL SODIUM CAPSULE;ORAL 30MG No No Approved Prior to Jan 1, 1982 MEDPOINTE PHARM HLC DISCN 详细信息
BUTICAPS 085381 003 ANDA BUTABARBITAL SODIUM CAPSULE;ORAL 50MG No No Approved Prior to Jan 1, 1982 MEDPOINTE PHARM HLC DISCN 详细信息
BUTICAPS 085381 004 ANDA BUTABARBITAL SODIUM CAPSULE;ORAL 100MG No No Approved Prior to Jan 1, 1982 MEDPOINTE PHARM HLC DISCN 详细信息
BYLVAY 215498 002 NDA ODEVIXIBAT CAPSULE;ORAL 0.4MG Yes No 2021/07/20 IPSEN RX 详细信息
BYLVAY 215498 004 NDA ODEVIXIBAT CAPSULE;ORAL 1.2MG Yes Yes 2021/07/20 IPSEN RX 详细信息
CALCITRIOL 203289 002 ANDA CALCITRIOL CAPSULE;ORAL 0.25MCG No No AB 2017/06/14 AMNEAL PHARMS RX 详细信息
当前数据更新日期:2026年04月02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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