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 48215 条，共 2411 页，当前第 31 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
RIZATRIPTAN BENZOATE 078173 002 ANDA RIZATRIPTAN BENZOATE TABLET, ORALLY DISINTEGRATING;ORAL EQ 10MG BASE No No 2012/12/31 PHARMOBEDIENT DISCN 详细信息
RIZATRIPTAN BENZOATE 207835 001 ANDA RIZATRIPTAN BENZOATE TABLET, ORALLY DISINTEGRATING;ORAL EQ 5MG BASE No No 2017/03/07 UNICHEM DISCN 详细信息
RIZATRIPTAN BENZOATE 207835 002 ANDA RIZATRIPTAN BENZOATE TABLET, ORALLY DISINTEGRATING;ORAL EQ 10MG BASE No No 2017/03/07 UNICHEM DISCN 详细信息
RYBIX ODT 021693 001 NDA TRAMADOL HYDROCHLORIDE TABLET, ORALLY DISINTEGRATING;ORAL 50MG No No 2005/05/05 SHIONOGI INC DISCN 详细信息
SIMVASTATIN 021961 001 NDA SIMVASTATIN TABLET, ORALLY DISINTEGRATING;ORAL 10MG Yes No 2007/10/09 SYNTHON PHARMS DISCN 详细信息
SIMVASTATIN 021961 002 NDA SIMVASTATIN TABLET, ORALLY DISINTEGRATING;ORAL 20MG Yes No 2007/10/09 SYNTHON PHARMS DISCN 详细信息
SIMVASTATIN 021961 003 NDA SIMVASTATIN TABLET, ORALLY DISINTEGRATING;ORAL 40MG Yes No 2007/10/09 SYNTHON PHARMS DISCN 详细信息
SIMVASTATIN 021961 004 NDA SIMVASTATIN TABLET, ORALLY DISINTEGRATING;ORAL 80MG Yes No 2007/10/09 SYNTHON PHARMS DISCN 详细信息
STAXYN 200179 001 NDA VARDENAFIL HYDROCHLORIDE TABLET, ORALLY DISINTEGRATING;ORAL 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 2010/06/17 BAYER HLTHCARE DISCN 详细信息
SUPRENZA 202088 001 NDA PHENTERMINE HYDROCHLORIDE TABLET, ORALLY DISINTEGRATING;ORAL 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** No No 2011/06/13 CITIUS PHARMS DISCN 详细信息
SUPRENZA 202088 002 NDA PHENTERMINE HYDROCHLORIDE TABLET, ORALLY DISINTEGRATING;ORAL 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** No No 2011/06/13 CITIUS PHARMS DISCN 详细信息
PRAMIPEXOLE DIHYDROCHLORIDE 078920 005 ANDA PRAMIPEXOLE DIHYDROCHLORIDE TABLET;ORAL 1.5MG No No AB 2010/07/06 ZYDUS PHARMS USA INC RX 详细信息
PRANDIMET 022386 001 NDA METFORMIN HYDROCHLORIDE; REPAGLINIDE TABLET;ORAL 500MG;1MG Yes No 2008/06/23 NOVO NORDISK INC DISCN 详细信息
PRANDIMET 022386 002 NDA METFORMIN HYDROCHLORIDE; REPAGLINIDE TABLET;ORAL 500MG;2MG Yes No 2008/06/23 NOVO NORDISK INC DISCN 详细信息
PRANDIN 020741 001 NDA REPAGLINIDE TABLET;ORAL 0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 1997/12/22 GEMINI LABS LLC DISCN 详细信息
PRANDIN 020741 002 NDA REPAGLINIDE TABLET;ORAL 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 1997/12/22 GEMINI LABS LLC DISCN 详细信息
PRANDIN 020741 003 NDA REPAGLINIDE TABLET;ORAL 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 1997/12/22 GEMINI LABS LLC DISCN 详细信息
PRANTAL 008114 004 NDA DIPHEMANIL METHYLSULFATE TABLET;ORAL 100MG No No Approved Prior to Jan 1, 1982 SCHERING DISCN 详细信息
PRASUGREL 205987 001 ANDA PRASUGREL HYDROCHLORIDE TABLET;ORAL EQ 5MG BASE No No AB 2018/02/02 ACCORD HLTHCARE RX 详细信息
PRASUGREL 205987 002 ANDA PRASUGREL HYDROCHLORIDE TABLET;ORAL EQ 10MG BASE No No AB 2018/02/02 ACCORD HLTHCARE RX 详细信息
当前数据更新日期：2026年05月23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。
©2006-2026 DrugFuture->U.S. FDA Orange Book