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 | RLD | RS | 申请号原始批准/暂定批准日期 | 产品号批准日期 | 申请人 | 市场状态 |
---|---|---|---|---|---|---|---|---|---|---|---|---|
XOFLUZA | 210854 | 001 | NDA | BALOXAVIR MARBOXIL | TABLET;ORAL | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Yes | No | 2018/10/24 | 2018/10/24 | GENENTECH INC | Discontinued |
XOFLUZA | 210854 | 002 | NDA | BALOXAVIR MARBOXIL | TABLET;ORAL | 40MG | Yes | No | 2018/10/24 | 2018/10/24 | GENENTECH INC | Prescription |
XOFLUZA | 210854 | 003 | NDA | BALOXAVIR MARBOXIL | TABLET;ORAL | 80MG | Yes | Yes | 2018/10/24 | 2021/03/18 | GENENTECH INC | Prescription |
XOFLUZA | 214410 | 001 | NDA | BALOXAVIR MARBOXIL | FOR SUSPENSION;ORAL | 2MG/ML | Yes | Yes | 2020/11/23 | 2020/11/23 | GENENTECH INC | Prescription |
XOFLUZA | 214410 | 001 | NDA | BALOXAVIR MARBOXIL | FOR SUSPENSION;ORAL | 2MG/ML | Yes | Yes | 2022/08/11 | 2020/11/23 | GENENTECH INC | Prescription |