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 47386 条，共 2370 页，当前第 20 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
NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE 091332 001 ANDA ETHINYL ESTRADIOL; NORETHINDRONE TABLET;ORAL 0.035MG;0.4MG No No AB 2016/03/23 LUPIN LTD RX 详细信息
NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE 207066 001 ANDA ETHINYL ESTRADIOL; NORETHINDRONE TABLET;ORAL 0.035MG;0.4MG No No AB 2017/03/29 NAARI PTE RX 详细信息
NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE 202086 001 ANDA ETHINYL ESTRADIOL; NORETHINDRONE TABLET;ORAL 0.035MG;0.4MG No Yes AB 2015/04/01 XIROMED RX 详细信息
NORGESIC 013416 003 NDA ASPIRIN; CAFFEINE; ORPHENADRINE CITRATE TABLET;ORAL 385MG;30MG;25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 1982/10/27 BAUSCH DISCN 详细信息
NORGESIC FORTE 013416 004 NDA ASPIRIN; CAFFEINE; ORPHENADRINE CITRATE TABLET;ORAL 770MG;60MG;50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 1982/10/27 BAUSCH DISCN 详细信息
NORLUTATE 012184 002 NDA NORETHINDRONE ACETATE TABLET;ORAL 5MG No No Approved Prior to Jan 1, 1982 PARKE DAVIS DISCN 详细信息
NORLUTIN 010895 002 NDA NORETHINDRONE TABLET;ORAL 5MG No No Approved Prior to Jan 1, 1982 PARKE DAVIS DISCN 详细信息
NORMODYNE 018687 001 NDA LABETALOL HYDROCHLORIDE TABLET;ORAL 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 1987/08/31 SCHERING DISCN 详细信息
NORMODYNE 018687 002 NDA LABETALOL HYDROCHLORIDE TABLET;ORAL 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 1984/08/01 SCHERING DISCN 详细信息
NORMODYNE 018687 003 NDA LABETALOL HYDROCHLORIDE TABLET;ORAL 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 1984/08/01 SCHERING DISCN 详细信息
NORMODYNE 018687 004 NDA LABETALOL HYDROCHLORIDE TABLET;ORAL 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 1984/08/01 SCHERING DISCN 详细信息
NORMOZIDE 019046 001 NDA HYDROCHLOROTHIAZIDE; LABETALOL HYDROCHLORIDE TABLET;ORAL 25MG;100MG No No 1987/04/06 SCHERING DISCN 详细信息
NORMOZIDE 019046 002 NDA HYDROCHLOROTHIAZIDE; LABETALOL HYDROCHLORIDE TABLET;ORAL 25MG;200MG No No 1987/04/06 SCHERING DISCN 详细信息
NORMOZIDE 019046 003 NDA HYDROCHLOROTHIAZIDE; LABETALOL HYDROCHLORIDE TABLET;ORAL 25MG;300MG No No 1987/04/06 SCHERING DISCN 详细信息
NORMOZIDE 019046 004 NDA HYDROCHLOROTHIAZIDE; LABETALOL HYDROCHLORIDE TABLET;ORAL 25MG;400MG No No 1987/04/06 SCHERING DISCN 详细信息
NOROXIN 019384 002 NDA NORFLOXACIN TABLET;ORAL 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 1986/10/31 MERCK DISCN 详细信息
NORPRAMIN 014399 007 NDA DESIPRAMINE HYDROCHLORIDE TABLET;ORAL 10MG Yes No AB 1982/02/11 VALIDUS PHARMS RX 详细信息
NORPRAMIN 014399 001 NDA DESIPRAMINE HYDROCHLORIDE TABLET;ORAL 25MG Yes No AB Approved Prior to Jan 1, 1982 VALIDUS PHARMS RX 详细信息
NORPRAMIN 014399 003 NDA DESIPRAMINE HYDROCHLORIDE TABLET;ORAL 50MG Yes No AB Approved Prior to Jan 1, 1982 VALIDUS PHARMS RX 详细信息
NORPRAMIN 014399 004 NDA DESIPRAMINE HYDROCHLORIDE TABLET;ORAL 75MG Yes No AB Approved Prior to Jan 1, 1982 VALIDUS PHARMS RX 详细信息
当前数据更新日期：2025年12月09日，更多信息请点击此处查询美国FDA药品数据库
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