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 9 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
ULTRACET 021123 001 NDA ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE TABLET;ORAL 325MG;37.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 2001/08/15 JANSSEN PHARMS DISCN 详细信息
ULTRAGRIS-165 062645 001 ANDA GRISEOFULVIN, ULTRAMICROCRYSTALLINE TABLET;ORAL 165MG No No 1992/06/30 PLIVA DISCN 详细信息
ULTRAGRIS-330 062646 001 ANDA GRISEOFULVIN, ULTRAMICROCRYSTALLINE TABLET;ORAL 330MG No No 1992/06/30 PLIVA DISCN 详细信息
ULTRAM 020281 002 NDA TRAMADOL HYDROCHLORIDE TABLET;ORAL 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 1995/03/03 JANSSEN PHARMS DISCN 详细信息
ULTRAM 020281 001 NDA TRAMADOL HYDROCHLORIDE TABLET;ORAL 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 1995/03/03 JANSSEN PHARMS DISCN 详细信息
UNIPEN 050462 001 NDA NAFCILLIN SODIUM TABLET;ORAL EQ 500MG BASE No No Approved Prior to Jan 1, 1982 WYETH AYERST DISCN 详细信息
UNIPRES 085893 001 ANDA HYDRALAZINE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE; RESERPINE TABLET;ORAL 25MG;15MG;0.1MG No No Approved Prior to Jan 1, 1982 SOLVAY DISCN 详细信息
UNIPRES 086298 001 ANDA HYDRALAZINE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE; RESERPINE TABLET;ORAL 25MG;15MG;0.1MG No No Approved Prior to Jan 1, 1982 SOLVAY DISCN 详细信息
UNIRETIC 020729 001 NDA HYDROCHLOROTHIAZIDE; MOEXIPRIL HYDROCHLORIDE TABLET;ORAL 12.5MG;7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** No No 1997/06/27 UCB INC DISCN 详细信息
UNIRETIC 020729 003 NDA HYDROCHLOROTHIAZIDE; MOEXIPRIL HYDROCHLORIDE TABLET;ORAL 12.5MG;15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** No No 2002/02/14 UCB INC DISCN 详细信息
UNIRETIC 020729 002 NDA HYDROCHLOROTHIAZIDE; MOEXIPRIL HYDROCHLORIDE TABLET;ORAL 25MG;15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** No No 1997/06/27 UCB INC DISCN 详细信息
UNISOM 018066 001 NDA DOXYLAMINE SUCCINATE TABLET;ORAL 25MG Yes Yes Approved Prior to Jan 1, 1982 CHATTEM OTC 详细信息
UNITENSEN 009217 001 NDA CRYPTENAMINE TANNATES TABLET;ORAL 260CSR UNIT No No Approved Prior to Jan 1, 1982 MEDPOINTE PHARM HLC DISCN 详细信息
UNITHROID 021210 001 NDA LEVOTHYROXINE SODIUM TABLET;ORAL 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Yes No AB1,AB2,AB3 2000/08/21 STEVENS J RX 详细信息
UNITHROID 021210 002 NDA LEVOTHYROXINE SODIUM TABLET;ORAL 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Yes No AB1,AB2,AB3 2000/08/21 STEVENS J RX 详细信息
UNITHROID 021210 003 NDA LEVOTHYROXINE SODIUM TABLET;ORAL 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Yes No AB1,AB2,AB3 2000/08/21 STEVENS J RX 详细信息
UNITHROID 021210 004 NDA LEVOTHYROXINE SODIUM TABLET;ORAL 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Yes No AB1,AB2,AB3 2000/08/21 STEVENS J RX 详细信息
UNITHROID 021210 005 NDA LEVOTHYROXINE SODIUM TABLET;ORAL 0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Yes No AB1,AB2,AB3 2000/08/21 STEVENS J RX 详细信息
UNITHROID 021210 006 NDA LEVOTHYROXINE SODIUM TABLET;ORAL 0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Yes No AB1,AB2,AB3 2000/08/21 STEVENS J RX 详细信息
UNITHROID 021210 007 NDA LEVOTHYROXINE SODIUM TABLET;ORAL 0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Yes No AB1,AB2,AB3 2000/08/21 STEVENS J RX 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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