| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| TIZANIDINE HYDROCHLORIDE | 213544 | 002 | ANDA | TIZANIDINE HYDROCHLORIDE | CAPSULE;ORAL | EQ 4MG BASE | No | No | 2020/03/24 | 2020/03/24 | AUROBINDO PHARMA LTD | Prescription |
| TIZANIDINE HYDROCHLORIDE | 213544 | 003 | ANDA | TIZANIDINE HYDROCHLORIDE | CAPSULE;ORAL | EQ 6MG BASE | No | No | 2020/03/24 | 2020/03/24 | AUROBINDO PHARMA LTD | Prescription |
| TIZANIDINE HYDROCHLORIDE | 213798 | 001 | ANDA | TIZANIDINE HYDROCHLORIDE | CAPSULE;ORAL | EQ 2MG BASE | No | No | 2020/05/27 | 2020/05/27 | RUBICON | Prescription |
| TIZANIDINE HYDROCHLORIDE | 213798 | 002 | ANDA | TIZANIDINE HYDROCHLORIDE | CAPSULE;ORAL | EQ 4MG BASE | No | No | 2020/05/27 | 2020/05/27 | RUBICON | Prescription |
| TIZANIDINE HYDROCHLORIDE | 213798 | 003 | ANDA | TIZANIDINE HYDROCHLORIDE | CAPSULE;ORAL | EQ 6MG BASE | No | No | 2020/05/27 | 2020/05/27 | RUBICON | Prescription |
| TIZANIDINE HYDROCHLORIDE | 213365 | 001 | ANDA | TIZANIDINE HYDROCHLORIDE | CAPSULE;ORAL | EQ 4MG BASE | No | No | 2024/05/13 | 2024/05/13 | SOMERSET THERAPS LLC | Prescription |
| TIZANIDINE HYDROCHLORIDE | 213365 | 002 | ANDA | TIZANIDINE HYDROCHLORIDE | CAPSULE;ORAL | EQ 6MG BASE | No | No | 2024/05/13 | 2024/05/13 | SOMERSET THERAPS LLC | Prescription |
| TIZANIDINE HYDROCHLORIDE | 218920 | 001 | ANDA | TIZANIDINE HYDROCHLORIDE | TABLET;ORAL | EQ 2MG BASE | No | No | 2024/08/07 | 2024/08/07 | GRAVITI PHARMS | Prescription |
| TIZANIDINE HYDROCHLORIDE | 218920 | 002 | ANDA | TIZANIDINE HYDROCHLORIDE | TABLET;ORAL | EQ 4MG BASE | No | No | 2024/08/07 | 2024/08/07 | GRAVITI PHARMS | Prescription |