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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|
CABENUVA KIT | 212888 | 001 | NDA | CABOTEGRAVIR; RILPIVIRINE | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 400MG/2ML (200MG/ML);600MG/2ML (300MG/ML) | Yes | Yes | 2021/01/21 | 2021/01/21 | VIIV HLTHCARE | Prescription |
CABENUVA KIT | 212888 | 002 | NDA | CABOTEGRAVIR; RILPIVIRINE | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 600MG/3ML (200MG/ML);900MG/3ML (300MG/ML) | Yes | Yes | 2021/01/21 | 2021/01/21 | VIIV HLTHCARE | Prescription |