| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| PIRFENIDONE | 212615 | 001 | ANDA | PIRFENIDONE | TABLET;ORAL | 267MG | No | No | 2021/05/12 (TA) | -- | GRANULES INDIA | None (Tentative Approval) |
| PIRFENIDONE | 212615 | 002 | ANDA | PIRFENIDONE | TABLET;ORAL | 801MG | No | No | 2021/05/12 (TA) | -- | GRANULES INDIA | None (Tentative Approval) |
| PIRFENIDONE | 212569 | 001 | ANDA | PIRFENIDONE | CAPSULE;ORAL | 267MG | No | No | 2022/01/03 | 2022/01/03 | AMNEAL | Prescription |
| PIRFENIDONE | 212731 | 001 | ANDA | PIRFENIDONE | CAPSULE;ORAL | 267MG | No | No | 2022/01/20 | 2022/01/20 | ACCORD HLTHCARE | Prescription |
| PIRFENIDONE | 212730 | 001 | ANDA | PIRFENIDONE | TABLET;ORAL | 267MG | No | No | 2022/01/25 | 2022/01/25 | ACCORD HLTHCARE | Prescription |
| PIRFENIDONE | 212730 | 002 | ANDA | PIRFENIDONE | TABLET;ORAL | 801MG | No | No | 2022/01/25 | 2022/01/25 | ACCORD HLTHCARE | Prescription |
| PIRFENIDONE | 212759 | 001 | ANDA | PIRFENIDONE | TABLET;ORAL | 267MG | No | No | 2022/01/25 | 2022/01/25 | TEVA PHARMS USA | Prescription |
| PIRFENIDONE | 212759 | 002 | ANDA | PIRFENIDONE | TABLET;ORAL | 801MG | No | No | 2022/01/25 | 2022/01/25 | TEVA PHARMS USA | Prescription |
| PIRFENIDONE | 212570 | 001 | ANDA | PIRFENIDONE | TABLET;ORAL | 267MG | No | No | 2022/03/25 | 2022/03/25 | AMNEAL | Prescription |
| PIRFENIDONE | 212570 | 002 | ANDA | PIRFENIDONE | TABLET;ORAL | 801MG | No | No | 2022/03/25 | 2022/03/25 | AMNEAL | Prescription |
| PIRFENIDONE | 212560 | 001 | ANDA | PIRFENIDONE | TABLET;ORAL | 267MG | No | No | 2022/04/28 | 2022/04/28 | SANDOZ | Prescription |
| PIRFENIDONE | 212560 | 002 | ANDA | PIRFENIDONE | TABLET;ORAL | 801MG | No | No | 2022/04/28 | 2022/04/28 | SANDOZ | Prescription |
| PIRFENIDONE | 212680 | 001 | ANDA | PIRFENIDONE | TABLET;ORAL | 267MG | No | No | 2022/05/18 | 2022/05/18 | MICRO LABS | Prescription |
| PIRFENIDONE | 212680 | 002 | ANDA | PIRFENIDONE | TABLET;ORAL | 801MG | No | No | 2022/05/18 | 2022/05/18 | MICRO LABS | Prescription |
| PIRFENIDONE | 212680 | 003 | ANDA | PIRFENIDONE | TABLET;ORAL | 534MG | No | No | 2022/05/18 | -- | MICRO LABS | Prescription |
| PIRFENIDONE | 212708 | 001 | ANDA | PIRFENIDONE | TABLET;ORAL | 267MG | No | No | 2022/05/20 | 2022/05/20 | ALEMBIC | Prescription |
| PIRFENIDONE | 212708 | 002 | ANDA | PIRFENIDONE | TABLET;ORAL | 801MG | No | No | 2022/05/20 | 2022/05/20 | ALEMBIC | Prescription |
| PIRFENIDONE | 212772 | 001 | ANDA | PIRFENIDONE | TABLET;ORAL | 267MG | No | No | 2022/05/24 | 2022/05/24 | MSN | Prescription |
| PIRFENIDONE | 212772 | 002 | ANDA | PIRFENIDONE | TABLET;ORAL | 801MG | No | No | 2022/05/24 | 2022/05/24 | MSN | Prescription |
| PIRFENIDONE | 212600 | 001 | ANDA | PIRFENIDONE | CAPSULE;ORAL | 267MG | No | No | 2022/06/13 | 2022/06/13 | SANDOZ | Prescription |