| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| SAMSCA | 022275 | 001 | NDA | TOLVAPTAN | TABLET;ORAL | 15MG | Yes | No | 2009/05/19 | 2009/05/19 | OTSUKA | Prescription |
| SAMSCA | 022275 | 002 | NDA | TOLVAPTAN | TABLET;ORAL | 30MG | Yes | Yes | 2009/05/19 | 2009/05/19 | OTSUKA | Prescription |
| SAMSCA | 022275 | 003 | NDA | TOLVAPTAN | TABLET;ORAL | 60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Yes | No | 2009/05/19 | 2009/05/19 | OTSUKA | Discontinued |