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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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|
(NDA) 217369 | 001 | ZURZUVAEP | ZURANOLONE | 珠兰诺隆 | CAPSULE;ORAL | 20MG | BIOGEN INC | 2023-10-31 | Yes | No | RX | |
(NDA) 217369 | 003 | ZURZUVAEP | ZURANOLONE | 珠兰诺隆 | CAPSULE;ORAL | 30MG | BIOGEN INC | 2023-10-31 | Yes | Yes | RX | |
(NDA) 217369 | 002 | ZURZUVAEP | ZURANOLONE | 珠兰诺隆 | CAPSULE;ORAL | 25MG | BIOGEN INC | 2023-10-31 | Yes | No | RX | |
(ANDA) 077639 | 001 | ZONISAMIDE | ZONISAMIDE | 唑尼沙胺 | CAPSULE;ORAL | 25MG | ANI PHARMS | 2005-12-22 | No | No | DISCN | |
(ANDA) 077642 | 001 | ZONISAMIDE | ZONISAMIDE | 唑尼沙胺 | CAPSULE;ORAL | 25MG | APOTEX INC | 2005-12-22 | No | No | RX | AB |
(ANDA) 077641 | 002 | ZONISAMIDE | ZONISAMIDE | 唑尼沙胺 | CAPSULE;ORAL | 50MG | ANI PHARMS | 2005-12-22 | No | No | DISCN | |
(ANDA) 077639 | 003 | ZONISAMIDE | ZONISAMIDE | 唑尼沙胺 | CAPSULE;ORAL | 100MG | ANI PHARMS | 2005-12-22 | No | No | DISCN | |
(ANDA) 077813 | 002 | ZONISAMIDE | ZONISAMIDE | 唑尼沙胺 | CAPSULE;ORAL | 50MG | BIONPHARMA | 2006-08-16 | No | No | RX | AB |
(ANDA) 077813 | 001 | ZONISAMIDE | ZONISAMIDE | 唑尼沙胺 | CAPSULE;ORAL | 25MG | BIONPHARMA | 2006-08-16 | No | No | RX | AB |
(ANDA) 077813 | 003 | ZONISAMIDE | ZONISAMIDE | 唑尼沙胺 | CAPSULE;ORAL | 100MG | BIONPHARMA | 2006-08-16 | No | No | RX | AB |
(ANDA) 077641 | 003 | ZONISAMIDE | ZONISAMIDE | 唑尼沙胺 | CAPSULE;ORAL | 25MG | ANI PHARMS | 2005-12-22 | No | No | DISCN | |
(ANDA) 077641 | 001 | ZONISAMIDE | ZONISAMIDE | 唑尼沙胺 | CAPSULE;ORAL | 100MG | ANI PHARMS | 2005-12-22 | No | No | DISCN | |
(ANDA) 077876 | 001 | ZONISAMIDE | ZONISAMIDE | 唑尼沙胺 | CAPSULE;ORAL | 25MG | EPIC PHARMA LLC | 2007-02-21 | No | No | DISCN | |
(ANDA) 077645 | 002 | ZONISAMIDE | ZONISAMIDE | 唑尼沙胺 | CAPSULE;ORAL | 25MG | AUROBINDO PHARMA LTD | 2006-09-29 | No | No | RX | AB |
(NDA) 020789 | 001 | ZONEGRAN | ZONISAMIDE | 唑尼沙胺 | CAPSULE;ORAL | 100MG | ADVANZ PHARMA | 2000-03-27 | Yes | Yes | RX | AB |
(ANDA) 077645 | 003 | ZONISAMIDE | ZONISAMIDE | 唑尼沙胺 | CAPSULE;ORAL | 50MG | AUROBINDO PHARMA LTD | 2006-09-29 | No | No | RX | AB |
(ANDA) 077642 | 002 | ZONISAMIDE | ZONISAMIDE | 唑尼沙胺 | CAPSULE;ORAL | 50MG | APOTEX INC | 2005-12-22 | No | No | RX | AB |
(NDA) 020789 | 002 | ZONEGRAN | ZONISAMIDE | 唑尼沙胺 | CAPSULE;ORAL | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ADVANZ PHARMA | 2003-08-22 | Yes | No | DISCN | |
(NDA) 020789 | 003 | ZONEGRAN | ZONISAMIDE | 唑尼沙胺 | CAPSULE;ORAL | 25MG | ADVANZ PHARMA | 2003-08-22 | Yes | No | RX | AB |
(ANDA) 077645 | 001 | ZONISAMIDE | ZONISAMIDE | 唑尼沙胺 | CAPSULE;ORAL | 100MG | AUROBINDO PHARMA LTD | 2005-12-22 | No | No | RX | AB |