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 47588 条，共 2380 页，当前第 8 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
TYBOST 203094 001 NDA COBICISTAT TABLET;ORAL 150MG Yes Yes 2014/09/24 GILEAD SCIENCES INC RX 详细信息
TYCOLET 089385 001 ANDA ACETAMINOPHEN; HYDROCODONE BITARTRATE TABLET;ORAL 500MG;5MG No No 1986/08/27 ORTHO MCNEIL PHARM DISCN 详细信息
TYDEMY 205948 001 ANDA DROSPIRENONE; ETHINYL ESTRADIOL; LEVOMEFOLATE CALCIUM TABLET;ORAL 3MG,N/A;0.03MG,N/A;0.451MG,0.451MG No No AB 2017/12/12 LUPIN LTD RX 详细信息
TYKERB 022059 001 NDA LAPATINIB DITOSYLATE TABLET;ORAL EQ 250MG BASE Yes Yes AB 2007/03/13 NOVARTIS RX 详细信息
TYLENOL W/ CODEINE 085056 001 ANDA ACETAMINOPHEN; CODEINE PHOSPHATE TABLET;ORAL 325MG;7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** No No Approved Prior to Jan 1, 1982 ORTHO MCNEIL PHARM DISCN 详细信息
TYLENOL W/ CODEINE 085056 002 ANDA ACETAMINOPHEN; CODEINE PHOSPHATE TABLET;ORAL 325MG;15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** No No Approved Prior to Jan 1, 1982 ORTHO MCNEIL PHARM DISCN 详细信息
TYLENOL W/ CODEINE 085056 003 ANDA ACETAMINOPHEN; CODEINE PHOSPHATE TABLET;ORAL 325MG;30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** No No Approved Prior to Jan 1, 1982 ORTHO MCNEIL PHARM DISCN 详细信息
TYLENOL W/ CODEINE 085056 004 ANDA ACETAMINOPHEN; CODEINE PHOSPHATE TABLET;ORAL 325MG;60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** No No Approved Prior to Jan 1, 1982 ORTHO MCNEIL PHARM DISCN 详细信息
TYLENOL W/ CODEINE NO. 1 085055 001 ANDA ACETAMINOPHEN; CODEINE PHOSPHATE TABLET;ORAL 300MG;7.5MG No No Approved Prior to Jan 1, 1982 JANSSEN PHARMS DISCN 详细信息
TYLENOL W/ CODEINE NO. 2 085055 002 ANDA ACETAMINOPHEN; CODEINE PHOSPHATE TABLET;ORAL 300MG;15MG Yes No Approved Prior to Jan 1, 1982 JANSSEN PHARMS DISCN 详细信息
TYLENOL W/ CODEINE NO. 3 085055 003 ANDA ACETAMINOPHEN; CODEINE PHOSPHATE TABLET;ORAL 300MG;30MG Yes No Approved Prior to Jan 1, 1982 JANSSEN PHARMS DISCN 详细信息
TYLENOL W/ CODEINE NO. 4 085055 004 ANDA ACETAMINOPHEN; CODEINE PHOSPHATE TABLET;ORAL 300MG;60MG Yes No Approved Prior to Jan 1, 1982 JANSSEN PHARMS DISCN 详细信息
TYZEKA 022011 001 NDA TELBIVUDINE TABLET;ORAL 600MG Yes No 2006/10/25 NOVARTIS DISCN 详细信息
UBRELVY 211765 001 NDA UBROGEPANT TABLET;ORAL 50MG Yes No 2019/12/23 ABBVIE RX 详细信息
UBRELVY 211765 002 NDA UBROGEPANT TABLET;ORAL 100MG Yes Yes 2019/12/23 ABBVIE RX 详细信息
UKONIQ 213176 001 NDA UMBRALISIB TOSYLATE TABLET;ORAL EQ 200MG BASE Yes No 2021/02/05 TG THERAPS DISCN 详细信息
ULORIC 021856 001 NDA FEBUXOSTAT TABLET;ORAL 40MG Yes No AB 2009/02/13 TAKEDA PHARMS USA RX 详细信息
ULORIC 021856 002 NDA FEBUXOSTAT TABLET;ORAL 80MG Yes Yes AB 2009/02/13 TAKEDA PHARMS USA RX 详细信息
ULTRACEF 062390 001 ANDA CEFADROXIL/CEFADROXIL HEMIHYDRATE TABLET;ORAL EQ 1GM BASE No No 1982/06/10 APOTHECON DISCN 详细信息
ULTRACEF 062408 001 ANDA CEFADROXIL/CEFADROXIL HEMIHYDRATE TABLET;ORAL EQ 1GM BASE No No 1982/08/31 BRISTOL DISCN 详细信息
当前数据更新日期：2026年02月10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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