美国FDA药品橙皮书数据库
（U.S. FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations）
请输入需要查询的英文药品商品名，活性成分，申请号
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数据记录共 47926 条，共 2397 页，当前第 61 页
可点击列名称排序
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
ISONIAZID 080132 004 ANDA ISONIAZID TABLET;ORAL 100MG No No 1982/07/14 PUREPAC PHARM DISCN 详细信息
ISONIAZID 080136 001 ANDA ISONIAZID TABLET;ORAL 100MG No No Approved Prior to Jan 1, 1982 SUN PHARM INDUSTRIES DISCN 详细信息
ISONIAZID 083633 001 ANDA ISONIAZID TABLET;ORAL 300MG No No Approved Prior to Jan 1, 1982 SUN PHARM INDUSTRIES DISCN 详细信息
ISONIAZID 202610 001 ANDA ISONIAZID TABLET;ORAL 100MG No No AA 2014/10/29 THEPHARMANETWORK LLC RX 详细信息
ISONIAZID 202610 002 ANDA ISONIAZID TABLET;ORAL 300MG No No AA 2014/10/29 THEPHARMANETWORK LLC RX 详细信息
ISONIAZID 080522 001 ANDA ISONIAZID TABLET;ORAL 50MG No No Approved Prior to Jan 1, 1982 WATSON LABS DISCN 详细信息
ISONIAZID 080401 001 ANDA ISONIAZID TABLET;ORAL 100MG No No Approved Prior to Jan 1, 1982 WATSON LABS DISCN 详细信息
ISONIAZID 080523 001 ANDA ISONIAZID TABLET;ORAL 100MG No No Approved Prior to Jan 1, 1982 WATSON LABS DISCN 详细信息
ISONIAZID 085790 001 ANDA ISONIAZID TABLET;ORAL 100MG No No Approved Prior to Jan 1, 1982 WATSON LABS DISCN 详细信息
ISONIAZID 080521 001 ANDA ISONIAZID TABLET;ORAL 300MG No No Approved Prior to Jan 1, 1982 WATSON LABS DISCN 详细信息
ISONIAZID 083178 001 ANDA ISONIAZID TABLET;ORAL 300MG No No Approved Prior to Jan 1, 1982 WATSON LABS DISCN 详细信息
ISONIAZID 085784 001 ANDA ISONIAZID TABLET;ORAL 300MG No No Approved Prior to Jan 1, 1982 WATSON LABS DISCN 详细信息
ISONIAZID 080120 002 ANDA ISONIAZID TABLET;ORAL 100MG No No Approved Prior to Jan 1, 1982 WHITEWORTH TOWN PLSN DISCN 详细信息
ISOPTIN 018593 003 NDA VERAPAMIL HYDROCHLORIDE TABLET;ORAL 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 1987/11/23 MT ADAMS DISCN 详细信息
ISOPTIN 018593 001 NDA VERAPAMIL HYDROCHLORIDE TABLET;ORAL 80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 1982/03/08 MT ADAMS DISCN 详细信息
ISOPTIN 018593 002 NDA VERAPAMIL HYDROCHLORIDE TABLET;ORAL 120MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 1982/03/08 MT ADAMS DISCN 详细信息
ISORDIL 012093 007 NDA ISOSORBIDE DINITRATE TABLET;ORAL 5MG Yes No AB 1988/07/29 BAUSCH RX 详细信息
ISORDIL 012093 002 NDA ISOSORBIDE DINITRATE TABLET;ORAL 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 1988/07/29 BAUSCH DISCN 详细信息
ISORDIL 012093 006 NDA ISOSORBIDE DINITRATE TABLET;ORAL 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 1988/07/29 BAUSCH DISCN 详细信息
ISORDIL 012093 005 NDA ISOSORBIDE DINITRATE TABLET;ORAL 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 1988/07/29 BAUSCH DISCN 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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