| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| TRISENOX | 021248 | 001 | NDA | ARSENIC TRIOXIDE | INJECTABLE;INJECTION | 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Yes | No | 2000/09/25 | 2000/09/25 | CEPHALON | Discontinued |
| TRISENOX | 021248 | 002 | NDA | ARSENIC TRIOXIDE | INJECTABLE;INJECTION | 2MG/ML | Yes | Yes | 2000/09/25 | 2017/10/13 | CEPHALON | Prescription |