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
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数据记录共 48215 条，共 2411 页，当前第 73 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
DECADRON 011664 005 NDA DEXAMETHASONE TABLET;ORAL 4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No Approved Prior to Jan 1, 1982 MERCK DISCN 详细信息
DECADRON 011664 006 NDA DEXAMETHASONE TABLET;ORAL 6MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 1982/07/30 MERCK DISCN 详细信息
DECAPRYN 006412 015 NDA DOXYLAMINE SUCCINATE TABLET;ORAL 12.5MG No No Approved Prior to Jan 1, 1982 SANOFI AVENTIS US DISCN 详细信息
DECAPRYN 006412 014 NDA DOXYLAMINE SUCCINATE TABLET;ORAL 25MG No No Approved Prior to Jan 1, 1982 SANOFI AVENTIS US DISCN 详细信息
DECLOMYCIN 050261 001 NDA DEMECLOCYCLINE HYDROCHLORIDE TABLET;ORAL 75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** No No Approved Prior to Jan 1, 1982 COREPHARMA DISCN 详细信息
DECLOMYCIN 050261 002 NDA DEMECLOCYCLINE HYDROCHLORIDE TABLET;ORAL 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** No No Approved Prior to Jan 1, 1982 COREPHARMA DISCN 详细信息
DECLOMYCIN 050261 003 NDA DEMECLOCYCLINE HYDROCHLORIDE TABLET;ORAL 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** No No Approved Prior to Jan 1, 1982 COREPHARMA DISCN 详细信息
DEFERASIROX 208697 001 ANDA DEFERASIROX TABLET;ORAL 90MG No No AB 2019/12/13 ACTAVIS ELIZABETH RX 详细信息
DEFERASIROX 208697 002 ANDA DEFERASIROX TABLET;ORAL 180MG No No AB 2019/12/13 ACTAVIS ELIZABETH RX 详细信息
DEFERASIROX 208697 003 ANDA DEFERASIROX TABLET;ORAL 360MG No No AB 2019/12/13 ACTAVIS ELIZABETH RX 详细信息
DEFERASIROX 211824 001 ANDA DEFERASIROX TABLET;ORAL 90MG No No AB 2019/11/20 ALEMBIC RX 详细信息
DEFERASIROX 211824 003 ANDA DEFERASIROX TABLET;ORAL 180MG No No AB 2020/06/15 ALEMBIC RX 详细信息
DEFERASIROX 211824 002 ANDA DEFERASIROX TABLET;ORAL 360MG No No AB 2019/11/20 ALEMBIC RX 详细信息
DEFERASIROX 210555 001 ANDA DEFERASIROX TABLET;ORAL 90MG No No AB 2020/03/30 ALKEM LABS LTD RX 详细信息
DEFERASIROX 210555 003 ANDA DEFERASIROX TABLET;ORAL 180MG No No AB 2020/07/02 ALKEM LABS LTD RX 详细信息
DEFERASIROX 210555 002 ANDA DEFERASIROX TABLET;ORAL 360MG No No AB 2020/03/30 ALKEM LABS LTD RX 详细信息
DEFERASIROX 214341 001 ANDA DEFERASIROX TABLET;ORAL 90MG No No AB 2021/05/14 ANNORA PHARMA RX 详细信息
DEFERASIROX 214341 002 ANDA DEFERASIROX TABLET;ORAL 180MG No No AB 2021/05/14 ANNORA PHARMA RX 详细信息
DEFERASIROX 214341 003 ANDA DEFERASIROX TABLET;ORAL 360MG No No AB 2021/05/14 ANNORA PHARMA RX 详细信息
DEFERASIROX 214474 001 ANDA DEFERASIROX TABLET;ORAL 90MG No No AB 2023/10/16 AUROBINDO PHARMA LTD 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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