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 67 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
JENTADUETO 201281 001 NDA LINAGLIPTIN; METFORMIN HYDROCHLORIDE TABLET;ORAL 2.5MG;500MG Yes No AB 2012/01/30 BOEHRINGER INGELHEIM RX 详细信息
JENTADUETO 201281 002 NDA LINAGLIPTIN; METFORMIN HYDROCHLORIDE TABLET;ORAL 2.5MG;850MG Yes No AB 2012/01/30 BOEHRINGER INGELHEIM RX 详细信息
JESDUVROQ 216951 001 NDA DAPRODUSTAT TABLET;ORAL 1MG Yes No 2023/02/01 GLAXOSMITHKLINE DISCN 详细信息
JESDUVROQ 216951 002 NDA DAPRODUSTAT TABLET;ORAL 2MG Yes No 2023/02/01 GLAXOSMITHKLINE DISCN 详细信息
JESDUVROQ 216951 003 NDA DAPRODUSTAT TABLET;ORAL 4MG Yes No 2023/02/01 GLAXOSMITHKLINE DISCN 详细信息
JESDUVROQ 216951 004 NDA DAPRODUSTAT TABLET;ORAL 6MG Yes No 2023/02/01 GLAXOSMITHKLINE DISCN 详细信息
JESDUVROQ 216951 005 NDA DAPRODUSTAT TABLET;ORAL 8MG Yes No 2023/02/01 GLAXOSMITHKLINE DISCN 详细信息
JOENJA 217759 001 NDA LENIOLISIB PHOSPHATE TABLET;ORAL EQ 70MG BASE Yes Yes 2023/03/24 PHARMING RX 详细信息
JOURNAVX 219209 001 NDA SUZETRIGINE TABLET;ORAL 50MG Yes Yes 2025/01/30 VERTEX PHARMS INC RX 详细信息
JULUCA 210192 001 NDA DOLUTEGRAVIR SODIUM; RILPIVIRINE HYDROCHLORIDE TABLET;ORAL EQ 50MG BASE;EQ 25MG BASE Yes Yes 2017/11/21 VIIV HLTHCARE RX 详细信息
JUNIOR STRENGTH ADVIL 020267 002 NDA IBUPROFEN TABLET;ORAL 100MG No No 1996/12/13 HALEON US HOLDINGS OTC 详细信息
JUNIOR STRENGTH IBUPROFEN 075367 001 ANDA IBUPROFEN TABLET;ORAL 100MG No No 1999/04/22 L PERRIGO CO DISCN 详细信息
JUNIOR STRENGTH MOTRIN 020602 001 NDA IBUPROFEN TABLET;ORAL 100MG No No 1996/06/10 KENVUE BRANDS OTC 详细信息
JUVISYNC 202343 004 NDA SIMVASTATIN; SITAGLIPTIN PHOSPHATE TABLET;ORAL 10MG;EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 2012/09/18 MERCK SHARP DOHME DISCN 详细信息
JUVISYNC 202343 001 NDA SIMVASTATIN; SITAGLIPTIN PHOSPHATE TABLET;ORAL 10MG;EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 2011/10/07 MERCK SHARP DOHME DISCN 详细信息
JUVISYNC 202343 005 NDA SIMVASTATIN; SITAGLIPTIN PHOSPHATE TABLET;ORAL 20MG;EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 2012/09/18 MERCK SHARP DOHME DISCN 详细信息
JUVISYNC 202343 002 NDA SIMVASTATIN; SITAGLIPTIN PHOSPHATE TABLET;ORAL 20MG;EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 2011/10/07 MERCK SHARP DOHME DISCN 详细信息
JUVISYNC 202343 006 NDA SIMVASTATIN; SITAGLIPTIN PHOSPHATE TABLET;ORAL 40MG;EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 2012/09/18 MERCK SHARP DOHME DISCN 详细信息
JUVISYNC 202343 003 NDA SIMVASTATIN; SITAGLIPTIN PHOSPHATE TABLET;ORAL 40MG;EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 2011/10/07 MERCK SHARP DOHME DISCN 详细信息
JYNARQUE 204441 001 NDA TOLVAPTAN TABLET;ORAL 15MG Yes No AB2 2018/04/23 OTSUKA RX 详细信息
当前数据更新日期：2026年04月04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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