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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) 021314 | 001 | IDKIT:HP | CITRIC ACID; UREA C-13 | 枸橼酸;尿素[13C] | FOR SOLUTION, TABLET, FOR SOLUTION;ORAL | 4GM;75MG | MERIDIAN BIOSCIENCE | 2002-12-17 | Yes | Yes | RX | |
(ANDA) 083947 | 001 | CALMURID HC | HYDROCORTISONE; UREA | 氢化可的松;尿素 | CREAM;TOPICAL | 1%;10% | PHARMACIA AND UPJOHN | 1982-01-01 | No | No | DISCN | |
(ANDA) 086008 | 001 | ALPHADERM | HYDROCORTISONE; UREA | 氢化可的松;尿素 | CREAM;TOPICAL | 1%;10% | BIOGLAN | 1982-01-01 | No | No | DISCN | |
(NDA) 016295 | 002 | DROXIA | HYDROXYUREA | 羟基脲 | CAPSULE;ORAL | 200MG | CHEPLAPHARM | 1998-02-25 | Yes | No | DISCN | |
(NDA) 208843 | 002 | SIKLOS | HYDROXYUREA | 羟基脲 | TABLET;ORAL | 1GM | THERAVIA | 2017-12-21 | Yes | Yes | RX | |
(ANDA) 075734 | 001 | HYDROXYUREA | HYDROXYUREA | 羟基脲 | TABLET;ORAL | 1GM | BARR | 2000-08-29 | No | No | DISCN | |
(NDA) 216593 | 001 | XROMI | HYDROXYUREA | 羟基脲 | SOLUTION;ORAL | 100MG/ML | NOVA LABS LTD | 2024-04-04 | Yes | Yes | RX | |
(ANDA) 074476 | 001 | HYDROXYUREA | HYDROXYUREA | 羟基脲 | CAPSULE;ORAL | 500MG | ROXANE | 1995-08-18 | No | No | DISCN | |
(ANDA) 218021 | 001 | HYDROXYUREA | HYDROXYUREA | 羟基脲 | CAPSULE;ORAL | 500MG | QILU | 2024-03-06 | No | No | RX | AB |
(ANDA) 213438 | 001 | HYDROXYUREA | HYDROXYUREA | 羟基脲 | CAPSULE;ORAL | 500MG | LEADING | 2020-04-08 | No | No | RX | AB |
(ANDA) 075340 | 001 | HYDROXYUREA | HYDROXYUREA | 羟基脲 | CAPSULE;ORAL | 500MG | ENDO OPERATIONS | 1999-02-24 | No | No | RX | AB |
(NDA) 016295 | 003 | DROXIA | HYDROXYUREA | 羟基脲 | CAPSULE;ORAL | 300MG | CHEPLAPHARM | 1998-02-25 | Yes | No | DISCN | |
(NDA) 016295 | 004 | DROXIA | HYDROXYUREA | 羟基脲 | CAPSULE;ORAL | 400MG | CHEPLAPHARM | 1998-02-25 | Yes | No | DISCN | |
(NDA) 016295 | 001 | HYDREA | HYDROXYUREA | 羟基脲 | CAPSULE;ORAL | 500MG | CHEPLAPHARM | 1982-01-01 | Yes | Yes | RX | AB |
(ANDA) 075143 | 002 | HYDROXYUREA | HYDROXYUREA | 羟基脲 | CAPSULE;ORAL | 250MG | BARR | 2000-09-21 | No | No | DISCN | |
(ANDA) 075143 | 001 | HYDROXYUREA | HYDROXYUREA | 羟基脲 | CAPSULE;ORAL | 500MG | BARR | 1998-10-16 | No | No | RX | AB |
(ANDA) 075020 | 002 | HYDROXYUREA | HYDROXYUREA | 羟基脲 | CAPSULE;ORAL | 250MG | BARR LABS INC | 2000-06-26 | No | No | DISCN | |
(ANDA) 075020 | 001 | HYDROXYUREA | HYDROXYUREA | 羟基脲 | CAPSULE;ORAL | 500MG | BARR LABS INC | 1998-07-30 | No | No | DISCN | |
(NDA) 208843 | 001 | SIKLOS | HYDROXYUREA | 羟基脲 | TABLET;ORAL | 100MG | THERAVIA | 2017-12-21 | Yes | No | RX | |
(NDA) 012154 | 001 | UREAPHIL | UREA | 尿素 | INJECTABLE;INJECTION | 40GM/VIAL | HOSPIRA | 1982-01-01 | No | No | DISCN |