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 76 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
DEFLAZACORT 217173 003 ANDA DEFLAZACORT TABLET;ORAL 30MG No No AB 2025/12/12 AMNEAL RX 详细信息
DEFLAZACORT 217173 004 ANDA DEFLAZACORT TABLET;ORAL 36MG No No AB 2025/12/12 AMNEAL RX 详细信息
DEFLAZACORT 217123 001 ANDA DEFLAZACORT TABLET;ORAL 6MG No No AB 2024/02/09 AUROBINDO PHARMA LTD RX 详细信息
DEFLAZACORT 217123 002 ANDA DEFLAZACORT TABLET;ORAL 18MG No No AB 2024/02/09 AUROBINDO PHARMA LTD RX 详细信息
DEFLAZACORT 217123 003 ANDA DEFLAZACORT TABLET;ORAL 30MG No No AB 2024/02/09 AUROBINDO PHARMA LTD RX 详细信息
DEFLAZACORT 217123 004 ANDA DEFLAZACORT TABLET;ORAL 36MG No No AB 2024/02/09 AUROBINDO PHARMA LTD RX 详细信息
DEFLAZACORT 217741 001 ANDA DEFLAZACORT TABLET;ORAL 6MG No No AB 2025/03/18 SUN PHARM RX 详细信息
DEFLAZACORT 217741 002 ANDA DEFLAZACORT TABLET;ORAL 18MG No No AB 2025/03/18 SUN PHARM RX 详细信息
DEFLAZACORT 217741 003 ANDA DEFLAZACORT TABLET;ORAL 30MG No No AB 2025/03/18 SUN PHARM RX 详细信息
DEFLAZACORT 217741 004 ANDA DEFLAZACORT TABLET;ORAL 36MG No No AB 2025/03/18 SUN PHARM RX 详细信息
DEFLAZACORT 216720 001 ANDA DEFLAZACORT TABLET;ORAL 6MG No No AB 2024/11/05 UPSHER SMITH LABS RX 详细信息
DEFLAZACORT 216720 002 ANDA DEFLAZACORT TABLET;ORAL 18MG No No AB 2024/11/05 UPSHER SMITH LABS RX 详细信息
DEFLAZACORT 216720 003 ANDA DEFLAZACORT TABLET;ORAL 30MG No No AB 2024/11/05 UPSHER SMITH LABS RX 详细信息
DEFLAZACORT 216720 004 ANDA DEFLAZACORT TABLET;ORAL 36MG No No AB 2024/11/05 UPSHER SMITH LABS RX 详细信息
DELAXIN 085454 001 ANDA METHOCARBAMOL TABLET;ORAL 500MG No No Approved Prior to Jan 1, 1982 FERNDALE LABS DISCN 详细信息
DELCOBESE 083563 004 ANDA AMPHETAMINE ADIPATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE ADIPATE; 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SULFATE TABLET;ORAL 1.25MG;1.25MG;1.25MG;1.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** No No Approved Prior to Jan 1, 1982 TEVA DISCN 详细信息
DELCOBESE 083563 003 ANDA AMPHETAMINE ADIPATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE ADIPATE; 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SULFATE TABLET;ORAL 2.5MG;2.5MG;2.5MG;2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** No No Approved Prior to Jan 1, 1982 TEVA DISCN 详细信息
DELCOBESE 083563 002 ANDA AMPHETAMINE ADIPATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE ADIPATE; 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** No No Approved Prior to Jan 1, 1982 TEVA DISCN 详细信息
DELCOBESE 083563 001 ANDA AMPHETAMINE ADIPATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE ADIPATE; DEXTROAMPHETAMINE SULFATE TABLET;ORAL 5MG;5MG;5MG;5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** No No Approved Prior to Jan 1, 1982 TEVA DISCN 详细信息
DELSTRIGO 210807 001 NDA DORAVIRINE; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE TABLET;ORAL 100MG;300MG;300MG Yes Yes 2018/08/30 MSD MERCK CO RX 详细信息
当前数据更新日期：2026年05月28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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