| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| ESBRIET | 022535 | 001 | NDA | PIRFENIDONE | CAPSULE;ORAL | 267MG | Yes | Yes | 2014/10/15 | 2014/10/15 | GENENTECH INC | Prescription |
| ESBRIET | 208780 | 001 | NDA | PIRFENIDONE | TABLET;ORAL | 267MG | Yes | No | 2017/01/11 | 2017/01/11 | GENENTECH INC | Prescription |
| ESBRIET | 208780 | 002 | NDA | PIRFENIDONE | TABLET;ORAL | 534MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Yes | No | 2017/01/11 | 2017/01/11 | GENENTECH INC | Discontinued |
| ESBRIET | 208780 | 003 | NDA | PIRFENIDONE | TABLET;ORAL | 801MG | Yes | Yes | 2017/01/11 | 2017/01/11 | GENENTECH INC | Prescription |