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 77 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
DELTA-CORTEF 009987 004 NDA PREDNISOLONE TABLET;ORAL 5MG No No Approved Prior to Jan 1, 1982 PHARMACIA AND UPJOHN DISCN 详细信息
DELTA-DOME 080293 001 ANDA PREDNISONE TABLET;ORAL 5MG No No Approved Prior to Jan 1, 1982 BAYER PHARMS DISCN 详细信息
DELTASONE 009986 005 NDA PREDNISONE TABLET;ORAL 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No Approved Prior to Jan 1, 1982 PHARMACIA AND UPJOHN DISCN 详细信息
DELTASONE 009986 002 NDA PREDNISONE TABLET;ORAL 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No Approved Prior to Jan 1, 1982 PHARMACIA AND UPJOHN DISCN 详细信息
DELTASONE 009986 006 NDA PREDNISONE TABLET;ORAL 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No Approved Prior to Jan 1, 1982 PHARMACIA AND UPJOHN DISCN 详细信息
DELTASONE 009986 007 NDA PREDNISONE TABLET;ORAL 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No Approved Prior to Jan 1, 1982 PHARMACIA AND UPJOHN DISCN 详细信息
DELTASONE 009986 008 NDA PREDNISONE TABLET;ORAL 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No Approved Prior to Jan 1, 1982 PHARMACIA AND UPJOHN DISCN 详细信息
DEMADEX 020136 001 NDA TORSEMIDE TABLET;ORAL 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 1993/08/23 PHARMOBEDIENT DISCN 详细信息
DEMADEX 020136 002 NDA TORSEMIDE TABLET;ORAL 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 1993/08/23 PHARMOBEDIENT DISCN 详细信息
DEMADEX 020136 003 NDA TORSEMIDE TABLET;ORAL 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 1993/08/23 PHARMOBEDIENT DISCN 详细信息
DEMADEX 020136 004 NDA TORSEMIDE TABLET;ORAL 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 1993/08/23 PHARMOBEDIENT DISCN 详细信息
DEMECLOCYCLINE HYDROCHLORIDE 065425 001 ANDA DEMECLOCYCLINE HYDROCHLORIDE TABLET;ORAL 150MG No No AB 2008/02/27 AMNEAL PHARM RX 详细信息
DEMECLOCYCLINE HYDROCHLORIDE 065425 002 ANDA DEMECLOCYCLINE HYDROCHLORIDE TABLET;ORAL 300MG No Yes AB 2008/02/27 AMNEAL PHARM RX 详细信息
DEMECLOCYCLINE HYDROCHLORIDE 065171 001 ANDA DEMECLOCYCLINE HYDROCHLORIDE TABLET;ORAL 150MG No No 2004/12/13 BARR DISCN 详细信息
DEMECLOCYCLINE HYDROCHLORIDE 065171 002 ANDA DEMECLOCYCLINE HYDROCHLORIDE TABLET;ORAL 300MG No No 2004/12/13 BARR DISCN 详细信息
DEMECLOCYCLINE HYDROCHLORIDE 065389 001 ANDA DEMECLOCYCLINE HYDROCHLORIDE TABLET;ORAL 150MG No No AB 2008/12/01 EPIC PHARMA LLC RX 详细信息
DEMECLOCYCLINE HYDROCHLORIDE 065447 001 ANDA DEMECLOCYCLINE HYDROCHLORIDE TABLET;ORAL 150MG No No AB 2015/08/18 EPIC PHARMA LLC RX 详细信息
DEMECLOCYCLINE HYDROCHLORIDE 065389 002 ANDA DEMECLOCYCLINE HYDROCHLORIDE TABLET;ORAL 300MG No No AB 2008/12/01 EPIC PHARMA LLC RX 详细信息
DEMECLOCYCLINE HYDROCHLORIDE 065447 002 ANDA DEMECLOCYCLINE HYDROCHLORIDE TABLET;ORAL 300MG No No AB 2015/08/18 EPIC PHARMA LLC RX 详细信息
DEMECLOCYCLINE HYDROCHLORIDE 065094 001 ANDA DEMECLOCYCLINE HYDROCHLORIDE TABLET;ORAL 150MG No No 2004/03/22 IMPAX LABS DISCN 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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