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 21 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
MIRTAZAPINE 076689 002 ANDA MIRTAZAPINE TABLET, ORALLY DISINTEGRATING;ORAL 30MG No No 2005/08/31 ACTAVIS ELIZABETH DISCN 详细信息
MIRTAZAPINE 077959 002 ANDA MIRTAZAPINE TABLET, ORALLY DISINTEGRATING;ORAL 30MG No No 2011/02/14 ACTAVIS ELIZABETH DISCN 详细信息
MIRTAZAPINE 076689 003 ANDA MIRTAZAPINE TABLET, ORALLY DISINTEGRATING;ORAL 45MG No No 2005/08/31 ACTAVIS ELIZABETH DISCN 详细信息
MIRTAZAPINE 077959 003 ANDA MIRTAZAPINE TABLET, ORALLY DISINTEGRATING;ORAL 45MG No No 2011/02/14 ACTAVIS ELIZABETH DISCN 详细信息
MIRTAZAPINE 076307 001 ANDA MIRTAZAPINE TABLET, ORALLY DISINTEGRATING;ORAL 15MG No No 2003/12/17 ACTAVIS LABS FL INC DISCN 详细信息
MIRTAZAPINE 076307 002 ANDA MIRTAZAPINE TABLET, ORALLY DISINTEGRATING;ORAL 30MG No No 2003/12/17 ACTAVIS LABS FL INC DISCN 详细信息
MIRTAZAPINE 076307 003 ANDA MIRTAZAPINE TABLET, ORALLY DISINTEGRATING;ORAL 45MG No No 2006/02/28 ACTAVIS LABS FL INC DISCN 详细信息
MIRTAZAPINE 077376 002 ANDA MIRTAZAPINE TABLET, ORALLY DISINTEGRATING;ORAL 15MG No No AB 2005/12/08 AUROBINDO PHARMA RX 详细信息
MIRTAZAPINE 077376 003 ANDA MIRTAZAPINE TABLET, ORALLY DISINTEGRATING;ORAL 30MG No No AB 2005/12/08 AUROBINDO PHARMA RX 详细信息
MIRTAZAPINE 077376 004 ANDA MIRTAZAPINE TABLET, ORALLY DISINTEGRATING;ORAL 45MG No No AB 2006/02/28 AUROBINDO PHARMA RX 详细信息
MIRTAZAPINE 076901 001 ANDA MIRTAZAPINE TABLET, ORALLY DISINTEGRATING;ORAL 15MG No No 2005/06/28 IMPAX LABS INC DISCN 详细信息
MIRTAZAPINE 076901 002 ANDA MIRTAZAPINE TABLET, ORALLY DISINTEGRATING;ORAL 30MG No No 2005/06/28 IMPAX LABS INC DISCN 详细信息
MIRTAZAPINE 076901 003 ANDA MIRTAZAPINE TABLET, ORALLY DISINTEGRATING;ORAL 45MG No No 2005/06/28 IMPAX LABS INC DISCN 详细信息
MIRTAZAPINE 205798 001 ANDA MIRTAZAPINE TABLET, ORALLY DISINTEGRATING;ORAL 15MG No No AB 2017/06/01 SQUARE PHARMS PLC RX 详细信息
MIRTAZAPINE 205798 002 ANDA MIRTAZAPINE TABLET, ORALLY DISINTEGRATING;ORAL 30MG No No AB 2017/06/01 SQUARE PHARMS PLC RX 详细信息
MIRTAZAPINE 205798 003 ANDA MIRTAZAPINE TABLET, ORALLY DISINTEGRATING;ORAL 45MG No No AB 2017/06/01 SQUARE PHARMS PLC RX 详细信息
NIRAVAM 021726 001 NDA ALPRAZOLAM TABLET, ORALLY DISINTEGRATING;ORAL 0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 2005/01/19 UCB INC DISCN 详细信息
NIRAVAM 021726 002 NDA ALPRAZOLAM TABLET, ORALLY DISINTEGRATING;ORAL 0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 2005/01/19 UCB INC DISCN 详细信息
NIRAVAM 021726 003 NDA ALPRAZOLAM TABLET, ORALLY DISINTEGRATING;ORAL 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 2005/01/19 UCB INC DISCN 详细信息
NIRAVAM 021726 004 NDA ALPRAZOLAM TABLET, ORALLY DISINTEGRATING;ORAL 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 2005/01/19 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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