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 48215 条，共 2411 页，当前第 12 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
METHYLPHENIDATE 210924 002 ANDA METHYLPHENIDATE TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL 17.3MG No No 2020/06/19 ACTAVIS ELIZABETH DISCN 详细信息
METHYLPHENIDATE 210924 003 ANDA METHYLPHENIDATE TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL 25.9MG No No 2020/06/19 ACTAVIS ELIZABETH DISCN 详细信息
ABILIFY 021729 002 NDA ARIPIPRAZOLE TABLET, ORALLY DISINTEGRATING;ORAL 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 2006/06/07 OTSUKA DISCN 详细信息
ABILIFY 021729 003 NDA ARIPIPRAZOLE TABLET, ORALLY DISINTEGRATING;ORAL 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 2006/06/07 OTSUKA DISCN 详细信息
ABILIFY 021729 004 NDA ARIPIPRAZOLE TABLET, ORALLY DISINTEGRATING;ORAL 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 2006/06/07 OTSUKA DISCN 详细信息
ABILIFY 021729 005 NDA ARIPIPRAZOLE TABLET, ORALLY DISINTEGRATING;ORAL 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 2006/06/07 OTSUKA DISCN 详细信息
ALAVERT 021375 001 NDA LORATADINE TABLET, ORALLY DISINTEGRATING;ORAL 10MG No No 2002/12/19 FDN CONSUMER OTC 详细信息
ALPRAZOLAM 078561 001 ANDA ALPRAZOLAM TABLET, ORALLY DISINTEGRATING;ORAL 0.25MG No No AB 2010/03/16 ACTAVIS ELIZABETH RX 详细信息
ALPRAZOLAM 078561 002 ANDA ALPRAZOLAM TABLET, ORALLY DISINTEGRATING;ORAL 0.5MG No No AB 2010/03/16 ACTAVIS ELIZABETH RX 详细信息
ALPRAZOLAM 078561 003 ANDA ALPRAZOLAM TABLET, ORALLY DISINTEGRATING;ORAL 1MG No No AB 2010/03/16 ACTAVIS ELIZABETH RX 详细信息
ALPRAZOLAM 078561 004 ANDA ALPRAZOLAM TABLET, ORALLY DISINTEGRATING;ORAL 2MG No No AB 2010/03/16 ACTAVIS ELIZABETH RX 详细信息
ALPRAZOLAM 078088 001 ANDA ALPRAZOLAM TABLET, ORALLY DISINTEGRATING;ORAL 0.25MG No No AB 2009/01/09 PH HEALTH RX 详细信息
ALPRAZOLAM 078088 002 ANDA ALPRAZOLAM TABLET, ORALLY DISINTEGRATING;ORAL 0.5MG No No AB 2009/01/09 PH HEALTH RX 详细信息
ALPRAZOLAM 078088 003 ANDA ALPRAZOLAM TABLET, ORALLY DISINTEGRATING;ORAL 1MG No Yes AB 2009/01/09 PH HEALTH RX 详细信息
ALPRAZOLAM 078088 004 ANDA ALPRAZOLAM TABLET, ORALLY DISINTEGRATING;ORAL 2MG No No AB 2009/01/09 PH HEALTH RX 详细信息
AMLODIPINE BESYLATE 022026 001 NDA AMLODIPINE BESYLATE TABLET, ORALLY DISINTEGRATING;ORAL EQ 2.5MG BASE Yes No 2007/09/27 SYNTHON PHARMS DISCN 详细信息
AMLODIPINE BESYLATE 022026 002 NDA AMLODIPINE BESYLATE TABLET, ORALLY DISINTEGRATING;ORAL EQ 5MG BASE Yes No 2007/09/27 SYNTHON PHARMS DISCN 详细信息
AMLODIPINE BESYLATE 022026 003 NDA AMLODIPINE BESYLATE TABLET, ORALLY DISINTEGRATING;ORAL EQ 10MG BASE Yes No 2007/09/27 SYNTHON PHARMS DISCN 详细信息
ARICEPT ODT 021720 001 NDA DONEPEZIL HYDROCHLORIDE TABLET, ORALLY DISINTEGRATING;ORAL 5MG Yes No 2004/10/18 EISAI INC DISCN 详细信息
ARICEPT ODT 021720 002 NDA DONEPEZIL HYDROCHLORIDE TABLET, ORALLY DISINTEGRATING;ORAL 10MG Yes No 2004/10/18 EISAI INC DISCN 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。
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