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申请号 | 产品号 | 商品名 | 活性成分 | 活性成分 | 剂型/给药途径 | 规格/剂量 | 申请机构 | 批准时间 | 参比制剂 | 标准制剂 | 市场状态 | TE |
---|---|---|---|---|---|---|---|---|---|---|---|---|
(ANDA) 076689 | 001 | MIRTAZAPINE | MIRTAZAPINE | 米氮平 | TABLET, ORALLY DISINTEGRATING;ORAL | 15MG | ACTAVIS ELIZABETH | 2005-08-31 | No | No | DISCN | |
(ANDA) 076901 | 001 | MIRTAZAPINE | MIRTAZAPINE | 米氮平 | TABLET, ORALLY DISINTEGRATING;ORAL | 15MG | IMPAX LABS INC | 2005-06-28 | No | No | DISCN | |
(ANDA) 076901 | 002 | MIRTAZAPINE | MIRTAZAPINE | 米氮平 | TABLET, ORALLY DISINTEGRATING;ORAL | 30MG | IMPAX LABS INC | 2005-06-28 | No | No | DISCN | |
(ANDA) 076901 | 003 | MIRTAZAPINE | MIRTAZAPINE | 米氮平 | TABLET, ORALLY DISINTEGRATING;ORAL | 45MG | IMPAX LABS INC | 2005-06-28 | No | No | DISCN | |
(ANDA) 205798 | 001 | MIRTAZAPINE | MIRTAZAPINE | 米氮平 | TABLET, ORALLY DISINTEGRATING;ORAL | 15MG | SQUARE PHARMS | 2017-06-01 | No | No | RX | AB |
(ANDA) 205798 | 002 | MIRTAZAPINE | MIRTAZAPINE | 米氮平 | TABLET, ORALLY DISINTEGRATING;ORAL | 30MG | SQUARE PHARMS | 2017-06-01 | No | No | RX | AB |
(ANDA) 205798 | 003 | MIRTAZAPINE | MIRTAZAPINE | 米氮平 | TABLET, ORALLY DISINTEGRATING;ORAL | 45MG | SQUARE PHARMS | 2017-06-01 | No | No | RX | AB |
(NDA) 020415 | 003 | REMERON | MIRTAZAPINE | 米氮平 | TABLET;ORAL | 45MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ORGANON | 1997-03-17 | Yes | No | DISCN | |
(NDA) 021208 | 002 | REMERON SOLTAB | MIRTAZAPINE | 米氮平 | TABLET, ORALLY DISINTEGRATING;ORAL | 30MG | ORGANON USA ORGANON | 2001-01-12 | Yes | No | RX | AB |
(ANDA) 077376 | 004 | MIRTAZAPINE | MIRTAZAPINE | 米氮平 | TABLET, ORALLY DISINTEGRATING;ORAL | 45MG | AUROBINDO PHARMA | 2006-02-28 | No | No | RX | AB |
(ANDA) 077376 | 003 | MIRTAZAPINE | MIRTAZAPINE | 米氮平 | TABLET, ORALLY DISINTEGRATING;ORAL | 30MG | AUROBINDO PHARMA | 2005-12-08 | No | No | RX | AB |
(ANDA) 077376 | 002 | MIRTAZAPINE | MIRTAZAPINE | 米氮平 | TABLET, ORALLY DISINTEGRATING;ORAL | 15MG | AUROBINDO PHARMA | 2005-12-08 | No | No | RX | AB |
(ANDA) 077959 | 001 | MIRTAZAPINE | MIRTAZAPINE | 米氮平 | TABLET, ORALLY DISINTEGRATING;ORAL | 15MG | ACTAVIS ELIZABETH | 2011-02-14 | No | No | DISCN | |
(ANDA) 076689 | 002 | MIRTAZAPINE | MIRTAZAPINE | 米氮平 | TABLET, ORALLY DISINTEGRATING;ORAL | 30MG | ACTAVIS ELIZABETH | 2005-08-31 | No | No | DISCN | |
(ANDA) 077959 | 002 | MIRTAZAPINE | MIRTAZAPINE | 米氮平 | TABLET, ORALLY DISINTEGRATING;ORAL | 30MG | ACTAVIS ELIZABETH | 2011-02-14 | No | No | DISCN | |
(ANDA) 076689 | 003 | MIRTAZAPINE | MIRTAZAPINE | 米氮平 | TABLET, ORALLY DISINTEGRATING;ORAL | 45MG | ACTAVIS ELIZABETH | 2005-08-31 | No | No | DISCN | |
(ANDA) 077959 | 003 | MIRTAZAPINE | MIRTAZAPINE | 米氮平 | TABLET, ORALLY DISINTEGRATING;ORAL | 45MG | ACTAVIS ELIZABETH | 2011-02-14 | No | No | DISCN | |
(ANDA) 076307 | 001 | MIRTAZAPINE | MIRTAZAPINE | 米氮平 | TABLET, ORALLY DISINTEGRATING;ORAL | 15MG | ACTAVIS LABS FL INC | 2003-12-17 | No | No | DISCN | |
(ANDA) 076307 | 002 | MIRTAZAPINE | MIRTAZAPINE | 米氮平 | TABLET, ORALLY DISINTEGRATING;ORAL | 30MG | ACTAVIS LABS FL INC | 2003-12-17 | No | No | DISCN | |
(ANDA) 076307 | 003 | MIRTAZAPINE | MIRTAZAPINE | 米氮平 | TABLET, ORALLY DISINTEGRATING;ORAL | 45MG | ACTAVIS LABS FL INC | 2006-02-28 | No | No | DISCN |