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
*Search by Trade Name,Active Ingredient,Application Number.
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数据记录共 48215 条，共 2411 页，当前第 18 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
FLUXID 021712 002 NDA FAMOTIDINE TABLET, ORALLY DISINTEGRATING;ORAL 40MG No No 2004/09/24 UCB INC DISCN 详细信息
KEMSTRO 021589 001 NDA BACLOFEN TABLET, ORALLY DISINTEGRATING;ORAL 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 2003/10/30 UCB INC DISCN 详细信息
KEMSTRO 021589 002 NDA BACLOFEN TABLET, ORALLY DISINTEGRATING;ORAL 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 2003/10/30 UCB INC DISCN 详细信息
KLONOPIN RAPIDLY DISINTEGRATING 020813 001 NDA CLONAZEPAM TABLET, ORALLY DISINTEGRATING;ORAL 0.125MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 1997/12/23 ROCHE DISCN 详细信息
KLONOPIN RAPIDLY DISINTEGRATING 020813 002 NDA CLONAZEPAM TABLET, ORALLY DISINTEGRATING;ORAL 0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 1997/12/23 ROCHE DISCN 详细信息
KLONOPIN RAPIDLY DISINTEGRATING 020813 003 NDA CLONAZEPAM TABLET, ORALLY DISINTEGRATING;ORAL 0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 1997/12/23 ROCHE DISCN 详细信息
KLONOPIN RAPIDLY DISINTEGRATING 020813 004 NDA CLONAZEPAM TABLET, ORALLY DISINTEGRATING;ORAL 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 1997/12/23 ROCHE DISCN 详细信息
KLONOPIN RAPIDLY DISINTEGRATING 020813 005 NDA CLONAZEPAM TABLET, ORALLY DISINTEGRATING;ORAL 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 1997/12/23 ROCHE DISCN 详细信息
LAMICTAL ODT 022251 001 NDA LAMOTRIGINE TABLET, ORALLY DISINTEGRATING;ORAL 25MG Yes No AB 2009/05/08 GLAXOSMITHKLINE LLC RX 详细信息
LAMICTAL ODT 022251 002 NDA LAMOTRIGINE TABLET, ORALLY DISINTEGRATING;ORAL 50MG Yes Yes AB 2009/05/08 GLAXOSMITHKLINE LLC RX 详细信息
LAMICTAL ODT 022251 003 NDA LAMOTRIGINE TABLET, ORALLY DISINTEGRATING;ORAL 100MG Yes No AB 2009/05/08 GLAXOSMITHKLINE LLC RX 详细信息
LAMICTAL ODT 022251 004 NDA LAMOTRIGINE TABLET, ORALLY DISINTEGRATING;ORAL 200MG Yes No AB 2009/05/08 GLAXOSMITHKLINE LLC RX 详细信息
LAMOTRIGINE 213271 001 ANDA LAMOTRIGINE TABLET, ORALLY DISINTEGRATING;ORAL 25MG No No AB 2021/01/19 AJANTA PHARMA LTD RX 详细信息
LAMOTRIGINE 213271 002 ANDA LAMOTRIGINE TABLET, ORALLY DISINTEGRATING;ORAL 50MG No No AB 2021/01/19 AJANTA PHARMA LTD RX 详细信息
LAMOTRIGINE 213271 003 ANDA LAMOTRIGINE TABLET, ORALLY DISINTEGRATING;ORAL 100MG No No AB 2021/01/19 AJANTA PHARMA LTD RX 详细信息
LAMOTRIGINE 213271 004 ANDA LAMOTRIGINE TABLET, ORALLY DISINTEGRATING;ORAL 200MG No No AB 2021/01/19 AJANTA PHARMA LTD RX 详细信息
LAMOTRIGINE 217278 001 ANDA LAMOTRIGINE TABLET, ORALLY DISINTEGRATING;ORAL 25MG No No AB 2026/02/25 ALEMBIC RX 详细信息
LAMOTRIGINE 217278 002 ANDA LAMOTRIGINE TABLET, ORALLY DISINTEGRATING;ORAL 50MG No No AB 2026/02/25 ALEMBIC RX 详细信息
LAMOTRIGINE 217278 003 ANDA LAMOTRIGINE TABLET, ORALLY DISINTEGRATING;ORAL 100MG No No AB 2026/02/25 ALEMBIC RX 详细信息
LAMOTRIGINE 217278 004 ANDA LAMOTRIGINE TABLET, ORALLY DISINTEGRATING;ORAL 200MG No No AB 2026/02/25 ALEMBIC 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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