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 48215 条，共 2411 页，当前第 17 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
DONEPEZIL HYDROCHLORIDE 201787 002 ANDA DONEPEZIL HYDROCHLORIDE TABLET, ORALLY DISINTEGRATING;ORAL 10MG No Yes AB 2012/12/14 MACLEODS PHARMS LTD RX 详细信息
DONEPEZIL HYDROCHLORIDE 077975 002 ANDA DONEPEZIL HYDROCHLORIDE TABLET, ORALLY DISINTEGRATING;ORAL 5MG No No 2009/12/11 SUN PHARM INDUSTRIES DISCN 详细信息
DONEPEZIL HYDROCHLORIDE 077975 001 ANDA DONEPEZIL HYDROCHLORIDE TABLET, ORALLY DISINTEGRATING;ORAL 10MG No No 2009/12/11 SUN PHARM INDUSTRIES DISCN 详细信息
DONEPEZIL HYDROCHLORIDE 204831 001 ANDA DONEPEZIL HYDROCHLORIDE TABLET, ORALLY DISINTEGRATING;ORAL 5MG No No 2016/11/10 UNICHEM DISCN 详细信息
DONEPEZIL HYDROCHLORIDE 204831 002 ANDA DONEPEZIL HYDROCHLORIDE TABLET, ORALLY DISINTEGRATING;ORAL 10MG No No 2016/11/10 UNICHEM DISCN 详细信息
DONEPEZIL HYDROCHLORIDE 090175 001 ANDA DONEPEZIL HYDROCHLORIDE TABLET, ORALLY DISINTEGRATING;ORAL 5MG No No 2011/05/10 ZYDUS PHARMS USA INC DISCN 详细信息
DONEPEZIL HYDROCHLORIDE 090175 002 ANDA DONEPEZIL HYDROCHLORIDE TABLET, ORALLY DISINTEGRATING;ORAL 10MG No No 2011/05/10 ZYDUS PHARMS USA INC DISCN 详细信息
EVEKEO ODT 209905 005 NDA AMPHETAMINE SULFATE TABLET, ORALLY DISINTEGRATING;ORAL 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 2021/04/16 AZURITY DISCN 详细信息
EVEKEO ODT 209905 001 NDA AMPHETAMINE SULFATE TABLET, ORALLY DISINTEGRATING;ORAL 5MG Yes No 2019/01/30 AZURITY DISCN 详细信息
EVEKEO ODT 209905 002 NDA AMPHETAMINE SULFATE TABLET, ORALLY DISINTEGRATING;ORAL 10MG Yes No 2019/01/30 AZURITY DISCN 详细信息
EVEKEO ODT 209905 003 NDA AMPHETAMINE SULFATE TABLET, ORALLY DISINTEGRATING;ORAL 15MG Yes No 2019/01/30 AZURITY DISCN 详细信息
EVEKEO ODT 209905 004 NDA AMPHETAMINE SULFATE TABLET, ORALLY DISINTEGRATING;ORAL 20MG Yes No 2019/01/30 AZURITY DISCN 详细信息
FAZACLO ODT 021590 004 NDA CLOZAPINE TABLET, ORALLY DISINTEGRATING;ORAL 12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 2007/05/30 JAZZ DISCN 详细信息
FAZACLO ODT 021590 001 NDA CLOZAPINE TABLET, ORALLY DISINTEGRATING;ORAL 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 2004/02/10 JAZZ DISCN 详细信息
FAZACLO ODT 021590 003 NDA CLOZAPINE TABLET, ORALLY DISINTEGRATING;ORAL 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 2005/06/03 JAZZ DISCN 详细信息
FAZACLO ODT 021590 002 NDA CLOZAPINE TABLET, ORALLY DISINTEGRATING;ORAL 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 2004/02/10 JAZZ DISCN 详细信息
FAZACLO ODT 021590 005 NDA CLOZAPINE TABLET, ORALLY DISINTEGRATING;ORAL 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 2010/07/09 JAZZ DISCN 详细信息
FAZACLO ODT 021590 006 NDA CLOZAPINE TABLET, ORALLY DISINTEGRATING;ORAL 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 2010/07/09 JAZZ DISCN 详细信息
FEMLYV 218718 001 NDA ETHINYL ESTRADIOL; NORETHINDRONE ACETATE TABLET, ORALLY DISINTEGRATING;ORAL 0.02MG;1MG Yes Yes 2024/07/22 MILLICENT PR RX 详细信息
FLUXID 021712 001 NDA FAMOTIDINE TABLET, ORALLY DISINTEGRATING;ORAL 20MG No No 2004/09/24 UCB INC DISCN 详细信息
当前数据更新日期：2026年05月23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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