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 48215 条，共 2411 页，当前第 10 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
SPRITAM 207958 003 NDA LEVETIRACETAM TABLET, FOR SUSPENSION;ORAL 750MG Yes No 2015/07/31 APRECIA PHARMS DISCN 详细信息
TAFINLAR 217514 001 NDA DABRAFENIB MESYLATE TABLET, FOR SUSPENSION;ORAL EQ 10MG BASE Yes Yes 2023/03/16 NOVARTIS RX 详细信息
TIVICAY PD 213983 001 NDA DOLUTEGRAVIR SODIUM TABLET, FOR SUSPENSION;ORAL EQ 5MG BASE Yes Yes 2020/06/12 VIIV HLTHCARE RX 详细信息
TRACLEER 209279 001 NDA BOSENTAN TABLET, FOR SUSPENSION;ORAL 32MG Yes Yes AB 2017/09/05 ACTELION RX 详细信息
TRIUMEQ PD 215413 001 NDA ABACAVIR SULFATE; DOLUTEGRAVIR SODIUM; LAMIVUDINE TABLET, FOR SUSPENSION;ORAL EQ 60MG BASE;EQ 5MG BASE;30MG Yes Yes 2022/03/30 VIIV HLTHCARE RX 详细信息
DEXILANT SOLUTAB 208056 001 NDA DEXLANSOPRAZOLE TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL 30MG Yes No 2016/01/26 TAKEDA PHARMS USA DISCN 详细信息
ESOMEPRAZOLE MAGNESIUM 214278 001 NDA ESOMEPRAZOLE MAGNESIUM TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL EQ 20MG BASE Yes No 2020/10/20 DEXCEL DISCN 详细信息
LANSOPRAZOLE 078730 001 ANDA LANSOPRAZOLE TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL 15MG No No 2010/10/15 ANI PHARMS DISCN 详细信息
LANSOPRAZOLE 078730 002 ANDA LANSOPRAZOLE TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL 30MG No No 2010/10/15 ANI PHARMS DISCN 详细信息
LANSOPRAZOLE 207167 001 ANDA LANSOPRAZOLE TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL 15MG No No AB 2023/03/28 AUROBINDO PHARMA LTD RX 详细信息
LANSOPRAZOLE 207167 002 ANDA LANSOPRAZOLE TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL 30MG No No AB 2023/03/28 AUROBINDO PHARMA LTD RX 详细信息
LANSOPRAZOLE 208025 001 NDA LANSOPRAZOLE TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL 15MG No No 2016/06/07 DEXCEL OTC 详细信息
LANSOPRAZOLE 210465 001 ANDA LANSOPRAZOLE TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL 15MG No No AB 2021/02/01 DR REDDYS RX 详细信息
LANSOPRAZOLE 210465 002 ANDA LANSOPRAZOLE TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL 30MG No No AB 2021/02/01 DR REDDYS RX 详细信息
LANSOPRAZOLE 202396 001 ANDA LANSOPRAZOLE TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL 15MG No No AB 2018/11/28 MYLAN RX 详细信息
LANSOPRAZOLE 202396 002 ANDA LANSOPRAZOLE TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL 30MG No No AB 2018/11/28 MYLAN RX 详细信息
LANSOPRAZOLE 208784 001 ANDA LANSOPRAZOLE TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL 15MG No No AB 2017/09/21 TEVA PHARMS USA RX 详细信息
LANSOPRAZOLE 208784 002 ANDA LANSOPRAZOLE TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL 30MG No No AB 2017/09/21 TEVA PHARMS USA RX 详细信息
LANSOPRAZOLE 200816 001 ANDA LANSOPRAZOLE TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL 15MG No No AB 2018/11/27 ZYDUS PHARMS RX 详细信息
LANSOPRAZOLE 200816 002 ANDA LANSOPRAZOLE TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL 30MG No No AB 2018/11/27 ZYDUS PHARMS RX 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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