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 59 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
CORTISONE ACETATE 008284 001 NDA CORTISONE ACETATE TABLET;ORAL 25MG No No Approved Prior to Jan 1, 1982 PANRAY DISCN 详细信息
CORTISONE ACETATE 008126 003 NDA CORTISONE ACETATE TABLET;ORAL 5MG No No Approved Prior to Jan 1, 1982 PHARMACIA AND UPJOHN DISCN 详细信息
CORTISONE ACETATE 008126 004 NDA CORTISONE ACETATE TABLET;ORAL 10MG No No Approved Prior to Jan 1, 1982 PHARMACIA AND UPJOHN DISCN 详细信息
CORTISONE ACETATE 008126 001 NDA CORTISONE ACETATE TABLET;ORAL 25MG No No Approved Prior to Jan 1, 1982 PHARMACIA AND UPJOHN DISCN 详细信息
CORTISONE ACETATE 080493 001 ANDA CORTISONE ACETATE TABLET;ORAL 25MG No No Approved Prior to Jan 1, 1982 PUREPAC PHARM DISCN 详细信息
CORTISONE ACETATE 080333 001 ANDA CORTISONE ACETATE TABLET;ORAL 25MG No No Approved Prior to Jan 1, 1982 VITARINE DISCN 详细信息
CORTISONE ACETATE 085884 001 ANDA CORTISONE ACETATE TABLET;ORAL 25MG No No Approved Prior to Jan 1, 1982 WATSON LABS DISCN 详细信息
CORTISONE ACETATE 080341 001 ANDA CORTISONE ACETATE TABLET;ORAL 25MG No No Approved Prior to Jan 1, 1982 WHITEWORTH TOWN PLSN DISCN 详细信息
CORTONE 007750 003 NDA CORTISONE ACETATE TABLET;ORAL 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No Approved Prior to Jan 1, 1982 MERCK DISCN 详细信息
CORTRIL 009127 005 NDA HYDROCORTISONE TABLET;ORAL 10MG No No Approved Prior to Jan 1, 1982 PFIZER DISCN 详细信息
CORTRIL 009127 003 NDA HYDROCORTISONE TABLET;ORAL 20MG No No Approved Prior to Jan 1, 1982 PFIZER DISCN 详细信息
CORZIDE 018647 001 NDA BENDROFLUMETHIAZIDE; NADOLOL TABLET;ORAL 5MG;40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 1983/05/25 KING PHARMS LLC DISCN 详细信息
CORZIDE 018647 002 NDA BENDROFLUMETHIAZIDE; NADOLOL TABLET;ORAL 5MG;80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 1983/05/25 KING PHARMS LLC DISCN 详细信息
COTELLIC 206192 001 NDA COBIMETINIB FUMARATE TABLET;ORAL EQ 20MG BASE Yes Yes 2015/11/10 GENENTECH INC RX 详细信息
COTRIM 070034 001 ANDA SULFAMETHOXAZOLE; TRIMETHOPRIM TABLET;ORAL 400MG;80MG No No 1985/05/16 TEVA DISCN 详细信息
COTRIM D.S. 070048 001 ANDA SULFAMETHOXAZOLE; TRIMETHOPRIM TABLET;ORAL 800MG;160MG No No 1985/03/18 TEVA DISCN 详细信息
COUMADIN 009218 022 NDA WARFARIN SODIUM TABLET;ORAL 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 1990/03/01 BRISTOL MYERS SQUIBB DISCN 详细信息
COUMADIN 009218 013 NDA WARFARIN SODIUM TABLET;ORAL 2MG Yes No Approved Prior to Jan 1, 1982 BRISTOL MYERS SQUIBB DISCN 详细信息
COUMADIN 009218 018 NDA WARFARIN SODIUM TABLET;ORAL 2.5MG Yes No Approved Prior to Jan 1, 1982 BRISTOL MYERS SQUIBB DISCN 详细信息
COUMADIN 009218 025 NDA WARFARIN SODIUM TABLET;ORAL 3MG Yes No 1996/11/18 BRISTOL MYERS SQUIBB 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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