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 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
LAMOTRIGINE 217100 001 ANDA LAMOTRIGINE TABLET, ORALLY DISINTEGRATING;ORAL 25MG No No AB 2026/01/08 TORRENT RX 详细信息
LAMOTRIGINE 217100 002 ANDA LAMOTRIGINE TABLET, ORALLY DISINTEGRATING;ORAL 50MG No No AB 2026/01/08 TORRENT RX 详细信息
LAMOTRIGINE 217100 003 ANDA LAMOTRIGINE TABLET, ORALLY DISINTEGRATING;ORAL 100MG No No AB 2026/01/08 TORRENT RX 详细信息
LAMOTRIGINE 217100 004 ANDA LAMOTRIGINE TABLET, ORALLY DISINTEGRATING;ORAL 200MG No No AB 2026/01/08 TORRENT RX 详细信息
LORATADINE 075990 001 ANDA LORATADINE TABLET, ORALLY DISINTEGRATING;ORAL 10MG No No 2003/11/03 ACTAVIS LABS FL INC DISCN 详细信息
LORATADINE 208477 001 ANDA LORATADINE TABLET, ORALLY DISINTEGRATING;ORAL 10MG No No 2018/04/11 AUROBINDO PHARMA LTD OTC 详细信息
LORATADINE 075822 001 ANDA LORATADINE TABLET, ORALLY DISINTEGRATING;ORAL 10MG No No 2003/02/10 GLAXOSMITHKLINE DISCN 详细信息
LORATADINE 212795 001 ANDA LORATADINE TABLET, ORALLY DISINTEGRATING;ORAL 5MG No No 2020/09/18 INSTAPILL OTC 详细信息
LORATADINE 213294 001 ANDA LORATADINE TABLET, ORALLY DISINTEGRATING;ORAL 10MG No No 2020/10/30 INSTAPILL OTC 详细信息
LORATADINE 076011 001 ANDA LORATADINE TABLET, ORALLY DISINTEGRATING;ORAL 10MG No No 2003/09/29 PERRIGO PHARMA INTL OTC 详细信息
LORATADINE 214280 001 ANDA LORATADINE TABLET, ORALLY DISINTEGRATING;ORAL 10MG No No 2020/09/10 RUBICON RESEARCH OTC 详细信息
LORATADINE REDIDOSE 077153 001 ANDA LORATADINE TABLET, ORALLY DISINTEGRATING;ORAL 10MG No No 2007/04/11 SUN PHARM INDS LTD OTC 详细信息
MAXALT-MLT 020865 001 NDA RIZATRIPTAN BENZOATE TABLET, ORALLY DISINTEGRATING;ORAL EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 1998/06/29 ORGANON DISCN 详细信息
MAXALT-MLT 020865 002 NDA RIZATRIPTAN BENZOATE TABLET, ORALLY DISINTEGRATING;ORAL EQ 10MG BASE Yes Yes AB 1998/06/29 ORGANON RX 详细信息
METOCLOPRAMIDE HYDROCHLORIDE 202191 001 ANDA METOCLOPRAMIDE HYDROCHLORIDE TABLET, ORALLY DISINTEGRATING;ORAL EQ 5MG BASE No No 2014/08/15 NOVEL LABS INC RX 详细信息
METOCLOPRAMIDE HYDROCHLORIDE 202191 002 ANDA METOCLOPRAMIDE HYDROCHLORIDE TABLET, ORALLY DISINTEGRATING;ORAL EQ 10MG BASE No Yes 2014/08/15 NOVEL LABS INC RX 详细信息
METOZOLV ODT 022246 001 NDA METOCLOPRAMIDE HYDROCHLORIDE TABLET, ORALLY DISINTEGRATING;ORAL EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 2009/09/04 SALIX PHARMS DISCN 详细信息
METOZOLV ODT 022246 002 NDA METOCLOPRAMIDE HYDROCHLORIDE TABLET, ORALLY DISINTEGRATING;ORAL EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 2009/09/04 SALIX PHARMS DISCN 详细信息
MIRTAZAPINE 076689 001 ANDA MIRTAZAPINE TABLET, ORALLY DISINTEGRATING;ORAL 15MG No No 2005/08/31 ACTAVIS ELIZABETH DISCN 详细信息
MIRTAZAPINE 077959 001 ANDA MIRTAZAPINE TABLET, ORALLY DISINTEGRATING;ORAL 15MG No No 2011/02/14 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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