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 11 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
OMEPRAZOLE 209400 001 NDA OMEPRAZOLE TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL 20MG Yes Yes 2017/07/05 DEXCEL OTC 详细信息
PREVACID 021428 001 NDA LANSOPRAZOLE TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL 15MG Yes No AB 2002/08/30 TAKEDA PHARMS USA RX 详细信息
PREVACID 021428 002 NDA LANSOPRAZOLE TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL 30MG Yes Yes AB 2002/08/30 TAKEDA PHARMS USA RX 详细信息
ADZENYS XR-ODT 204326 001 NDA AMPHETAMINE TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL EQ 3.1MG BASE Yes No AB 2016/01/27 NEOS THERAPS RX 详细信息
ADZENYS XR-ODT 204326 002 NDA AMPHETAMINE TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL EQ 6.3MG BASE Yes No AB 2016/01/27 NEOS THERAPS RX 详细信息
ADZENYS XR-ODT 204326 003 NDA AMPHETAMINE TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL EQ 9.4MG BASE Yes No AB 2016/01/27 NEOS THERAPS RX 详细信息
ADZENYS XR-ODT 204326 004 NDA AMPHETAMINE TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL EQ 12.5MG BASE Yes No AB 2016/01/27 NEOS THERAPS RX 详细信息
ADZENYS XR-ODT 204326 005 NDA AMPHETAMINE TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL EQ 15.7MG BASE Yes No AB 2016/01/27 NEOS THERAPS RX 详细信息
ADZENYS XR-ODT 204326 006 NDA AMPHETAMINE TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL EQ 18.8MG BASE Yes Yes AB 2016/01/27 NEOS THERAPS RX 详细信息
AMPHETAMINE 209253 001 ANDA AMPHETAMINE TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL EQ 3.1MG BASE No No AB 2023/06/22 ACTAVIS LABS FL INC RX 详细信息
AMPHETAMINE 209253 002 ANDA AMPHETAMINE TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL EQ 6.3MG BASE No No AB 2023/06/22 ACTAVIS LABS FL INC RX 详细信息
AMPHETAMINE 209253 003 ANDA AMPHETAMINE TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL EQ 9.4MG BASE No No AB 2023/06/22 ACTAVIS LABS FL INC RX 详细信息
AMPHETAMINE 209253 004 ANDA AMPHETAMINE TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL EQ 12.5MG BASE No No AB 2023/06/22 ACTAVIS LABS FL INC RX 详细信息
AMPHETAMINE 209253 005 ANDA AMPHETAMINE TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL EQ 15.7MG BASE No No AB 2023/06/22 ACTAVIS LABS FL INC RX 详细信息
AMPHETAMINE 209253 006 ANDA AMPHETAMINE TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL EQ 18.8MG BASE No No AB 2023/06/22 ACTAVIS LABS FL INC RX 详细信息
COTEMPLA XR-ODT 205489 001 NDA METHYLPHENIDATE TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL 8.6MG Yes No 2017/06/19 NEOS THERAPS INC RX 详细信息
COTEMPLA XR-ODT 205489 002 NDA METHYLPHENIDATE TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL 17.3MG Yes No 2017/06/19 NEOS THERAPS INC RX 详细信息
COTEMPLA XR-ODT 205489 003 NDA METHYLPHENIDATE TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL 25.9MG Yes Yes 2017/06/19 NEOS THERAPS INC RX 详细信息
COTEMPLA XR-ODT 205489 004 NDA METHYLPHENIDATE TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL 34.6MG Yes No 2024/08/19 NEOS THERAPS INC DISCN 详细信息
METHYLPHENIDATE 210924 001 ANDA METHYLPHENIDATE TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL 8.6MG No No 2020/06/19 ACTAVIS ELIZABETH 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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