| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| IVABRADINE HYDROCHLORIDE | 214051 | 001 | ANDA | IVABRADINE HYDROCHLORIDE | TABLET;ORAL | EQ 5MG BASE | No | No | 2021/12/30 | 2021/12/30 | INGENUS PHARMS LLC | Prescription |
| IVABRADINE HYDROCHLORIDE | 214051 | 002 | ANDA | IVABRADINE HYDROCHLORIDE | TABLET;ORAL | EQ 7.5MG BASE | No | No | 2021/12/30 | 2021/12/30 | INGENUS PHARMS LLC | Prescription |
| IVABRADINE HYDROCHLORIDE | 213366 | 001 | ANDA | IVABRADINE HYDROCHLORIDE | TABLET;ORAL | EQ 5MG BASE | No | No | 2022/10/05 | 2022/10/05 | ANNORA PHARMA | Prescription |
| IVABRADINE HYDROCHLORIDE | 213366 | 002 | ANDA | IVABRADINE HYDROCHLORIDE | TABLET;ORAL | EQ 7.5MG BASE | No | No | 2022/10/05 | 2022/10/05 | ANNORA PHARMA | Prescription |
| IVABRADINE HYDROCHLORIDE | 213442 | 001 | ANDA | IVABRADINE HYDROCHLORIDE | TABLET;ORAL | EQ 5MG BASE | No | No | 2023/11/29 | 2023/11/29 | ZYDUS PHARMS | Prescription |
| IVABRADINE HYDROCHLORIDE | 213442 | 002 | ANDA | IVABRADINE HYDROCHLORIDE | TABLET;ORAL | EQ 7.5MG BASE | No | No | 2023/11/29 | 2023/11/29 | ZYDUS PHARMS | Prescription |
| IVABRADINE HYDROCHLORIDE | 213276 | 001 | ANDA | IVABRADINE HYDROCHLORIDE | TABLET;ORAL | EQ 5MG BASE | No | No | 2024/09/05 | 2024/09/05 | BIONPHARMA | Prescription |
| IVABRADINE HYDROCHLORIDE | 213276 | 002 | ANDA | IVABRADINE HYDROCHLORIDE | TABLET;ORAL | EQ 7.5MG BASE | No | No | 2024/09/05 | 2024/09/05 | BIONPHARMA | Prescription |
| IVABRADINE HYDROCHLORIDE | 215238 | 001 | ANDA | IVABRADINE HYDROCHLORIDE | TABLET;ORAL | EQ 5MG BASE | No | No | 2024/11/08 | 2024/11/08 | ALEMBIC | Prescription |
| IVABRADINE HYDROCHLORIDE | 215238 | 002 | ANDA | IVABRADINE HYDROCHLORIDE | TABLET;ORAL | EQ 7.5MG BASE | No | No | 2024/11/08 | 2024/11/08 | ALEMBIC | Prescription |