美国FDA药品橙皮书数据库
（U.S. FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations）
请输入需要查询的英文药品商品名，活性成分，申请号
*Search by Trade Name,Active Ingredient,Application Number.
高级搜索
数据记录共 47486 条，共 2375 页，当前第 27 页
可点击列名称排序
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
ACYCLOVIR 204314 002 ANDA ACYCLOVIR TABLET;ORAL 800MG No No AB 2014/08/19 ZYDUS PHARMS RX 详细信息
ACYLANID 009436 001 NDA ACETYLDIGITOXIN TABLET;ORAL 0.1MG No No Approved Prior to Jan 1, 1982 NOVARTIS DISCN 详细信息
ADCIRCA 022332 001 NDA TADALAFIL TABLET;ORAL 20MG Yes Yes AB2 2009/05/22 ELI LILLY CO RX 详细信息
ADDERALL 10 011522 007 NDA AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TABLET;ORAL 2.5MG;2.5MG;2.5MG;2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 1996/02/13 TEVA WOMENS DISCN 详细信息
ADDERALL 12.5 011522 012 NDA AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TABLET;ORAL 3.125MG;3.125MG;3.125MG;3.125MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 2000/08/31 TEVA WOMENS DISCN 详细信息
ADDERALL 15 011522 013 NDA AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TABLET;ORAL 3.75MG;3.75MG;3.75MG;3.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 2000/08/31 TEVA WOMENS DISCN 详细信息
ADDERALL 20 011522 008 NDA AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TABLET;ORAL 5MG;5MG;5MG;5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 1996/02/13 TEVA WOMENS DISCN 详细信息
ADDERALL 30 011522 010 NDA AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TABLET;ORAL 7.5MG;7.5MG;7.5MG;7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 1997/05/12 TEVA WOMENS DISCN 详细信息
ADDERALL 5 011522 009 NDA AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TABLET;ORAL 1.25MG;1.25MG;1.25MG;1.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 1997/05/12 TEVA WOMENS DISCN 详细信息
ADDERALL 7.5 011522 011 NDA AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TABLET;ORAL 1.875MG;1.875MG;1.875MG;1.875MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 2000/08/31 TEVA WOMENS DISCN 详细信息
ADDYI 022526 001 NDA FLIBANSERIN TABLET;ORAL 100MG Yes Yes 2015/08/18 SPROUT PHARMS RX 详细信息
ADEFOVIR DIPIVOXIL 205459 001 ANDA ADEFOVIR DIPIVOXIL TABLET;ORAL 10MG No No AB 2018/07/06 APOTEX RX 详细信息
ADEFOVIR DIPIVOXIL 202051 001 ANDA ADEFOVIR DIPIVOXIL TABLET;ORAL 10MG No Yes AB 2013/08/29 SIGMAPHARM LABS LLC RX 详细信息
ADEMPAS 204819 001 NDA RIOCIGUAT TABLET;ORAL 0.5MG Yes No AB 2013/10/08 BAYER HLTHCARE RX 详细信息
ADEMPAS 204819 002 NDA RIOCIGUAT TABLET;ORAL 1MG Yes No AB 2013/10/08 BAYER HLTHCARE RX 详细信息
ADEMPAS 204819 003 NDA RIOCIGUAT TABLET;ORAL 1.5MG Yes No AB 2013/10/08 BAYER HLTHCARE RX 详细信息
ADEMPAS 204819 004 NDA RIOCIGUAT TABLET;ORAL 2MG Yes No AB 2013/10/08 BAYER HLTHCARE RX 详细信息
ADEMPAS 204819 005 NDA RIOCIGUAT TABLET;ORAL 2.5MG Yes Yes AB 2013/10/08 BAYER HLTHCARE RX 详细信息
ADIPEX-P 085128 001 ANDA PHENTERMINE HYDROCHLORIDE TABLET;ORAL 37.5MG Yes Yes AA Approved Prior to Jan 1, 1982 TEVA RX 详细信息
ADPHEN 083655 001 ANDA PHENDIMETRAZINE TARTRATE TABLET;ORAL 35MG No No Approved Prior to Jan 1, 1982 FERNDALE LABS DISCN 详细信息
当前数据更新日期：2025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。
©2006-2025 DrugFuture->U.S. FDA Orange Book