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 47926 条，共 2397 页，当前第 52 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
INDAPAMIDE 074665 001 ANDA INDAPAMIDE TABLET;ORAL 1.25MG No No 1997/04/04 TEVA DISCN 详细信息
INDAPAMIDE 074665 002 ANDA INDAPAMIDE TABLET;ORAL 2.5MG No No 1997/04/04 TEVA DISCN 详细信息
INDAPAMIDE 074585 001 ANDA INDAPAMIDE TABLET;ORAL 1.25MG No No 1996/09/26 WATSON LABS DISCN 详细信息
INDAPAMIDE 074585 002 ANDA INDAPAMIDE TABLET;ORAL 2.5MG No No 1996/09/26 WATSON LABS DISCN 详细信息
INDERAL 016418 001 NDA PROPRANOLOL HYDROCHLORIDE TABLET;ORAL 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No Approved Prior to Jan 1, 1982 WYETH PHARMS DISCN 详细信息
INDERAL 016418 003 NDA PROPRANOLOL HYDROCHLORIDE TABLET;ORAL 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No Approved Prior to Jan 1, 1982 WYETH PHARMS DISCN 详细信息
INDERAL 016418 002 NDA PROPRANOLOL HYDROCHLORIDE TABLET;ORAL 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No Approved Prior to Jan 1, 1982 WYETH PHARMS DISCN 详细信息
INDERAL 016418 009 NDA PROPRANOLOL HYDROCHLORIDE TABLET;ORAL 60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 1982/10/18 WYETH PHARMS DISCN 详细信息
INDERAL 016418 004 NDA PROPRANOLOL HYDROCHLORIDE TABLET;ORAL 80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No Approved Prior to Jan 1, 1982 WYETH PHARMS DISCN 详细信息
INDERAL 016418 010 NDA PROPRANOLOL HYDROCHLORIDE TABLET;ORAL 90MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 1982/10/18 WYETH PHARMS DISCN 详细信息
INDERIDE-40/25 018031 001 NDA HYDROCHLOROTHIAZIDE; PROPRANOLOL HYDROCHLORIDE TABLET;ORAL 25MG;40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No Approved Prior to Jan 1, 1982 WYETH PHARMS INC DISCN 详细信息
INDERIDE-80/25 018031 002 NDA HYDROCHLOROTHIAZIDE; PROPRANOLOL HYDROCHLORIDE TABLET;ORAL 25MG;80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No Approved Prior to Jan 1, 1982 WYETH PHARMS INC DISCN 详细信息
INH 080935 001 ANDA ISONIAZID TABLET;ORAL 300MG No No Approved Prior to Jan 1, 1982 NOVARTIS DISCN 详细信息
INLURIYO 218881 001 NDA IMLUNESTRANT TOSYLATE TABLET;ORAL EQ 200MG BASE Yes Yes 2025/09/25 ELI LILLY AND CO RX 详细信息
INLYTA 202324 001 NDA AXITINIB TABLET;ORAL 1MG Yes No AB 2012/01/27 PF PRISM CV RX 详细信息
INLYTA 202324 002 NDA AXITINIB TABLET;ORAL 5MG Yes Yes AB 2012/01/27 PF PRISM CV RX 详细信息
INNOFEM 040312 001 ANDA ESTRADIOL TABLET;ORAL 0.5MG No No 1999/11/19 NOVO NORDISK INC DISCN 详细信息
INNOFEM 040312 002 ANDA ESTRADIOL TABLET;ORAL 1MG No No 1999/11/19 NOVO NORDISK INC DISCN 详细信息
INNOFEM 040312 003 ANDA ESTRADIOL TABLET;ORAL 2MG No No 1999/11/19 NOVO NORDISK INC DISCN 详细信息
INPEFA 216203 001 NDA SOTAGLIFLOZIN TABLET;ORAL 200MG Yes No 2023/05/26 LEXICON PHARMS INC RX 详细信息
当前数据更新日期：2026年04月03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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