| 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 | 076533 | 001 | ANDA | TIZANIDINE HYDROCHLORIDE | TABLET;ORAL | EQ 2MG BASE | No | No | 2004/01/16 | 2004/01/16 | APOTEX | Prescription |
| TIZANIDINE HYDROCHLORIDE | 076533 | 002 | ANDA | TIZANIDINE HYDROCHLORIDE | TABLET;ORAL | EQ 4MG BASE | No | No | 2004/01/16 | 2004/01/16 | APOTEX | Prescription |
| TIZANIDINE HYDROCHLORIDE | 076321 | 001 | ANDA | TIZANIDINE HYDROCHLORIDE | TABLET;ORAL | EQ 2MG BASE | No | No | 2004/09/30 | 2004/09/30 | ANI PHARMS | Discontinued |
| TIZANIDINE HYDROCHLORIDE | 076321 | 002 | ANDA | TIZANIDINE HYDROCHLORIDE | TABLET;ORAL | EQ 4MG BASE | No | No | 2004/09/30 | 2004/09/30 | ANI PHARMS | Discontinued |
| TIZANIDINE HYDROCHLORIDE | 078868 | 001 | ANDA | TIZANIDINE HYDROCHLORIDE | CAPSULE;ORAL | EQ 2MG BASE | No | No | 2012/02/03 | 2012/02/03 | APOTEX INC | Prescription |
| TIZANIDINE HYDROCHLORIDE | 078868 | 002 | ANDA | TIZANIDINE HYDROCHLORIDE | CAPSULE;ORAL | EQ 4MG BASE | No | No | 2012/02/03 | 2012/02/03 | APOTEX INC | Prescription |
| TIZANIDINE HYDROCHLORIDE | 078868 | 003 | ANDA | TIZANIDINE HYDROCHLORIDE | CAPSULE;ORAL | EQ 6MG BASE | No | No | 2012/02/03 | 2012/02/03 | APOTEX INC | Prescription |
| TIZANIDINE HYDROCHLORIDE | 091502 | 001 | ANDA | TIZANIDINE HYDROCHLORIDE | CAPSULE;ORAL | EQ 2MG BASE | No | No | 2012/11/09 | 2012/11/09 | NORVIUM BIOSCIENCE | Discontinued |
| TIZANIDINE HYDROCHLORIDE | 091502 | 002 | ANDA | TIZANIDINE HYDROCHLORIDE | CAPSULE;ORAL | EQ 4MG BASE | No | No | 2012/11/09 | 2012/11/09 | NORVIUM BIOSCIENCE | Discontinued |
| TIZANIDINE HYDROCHLORIDE | 091502 | 003 | ANDA | TIZANIDINE HYDROCHLORIDE | CAPSULE;ORAL | EQ 6MG BASE | No | No | 2012/11/09 | 2012/11/09 | NORVIUM BIOSCIENCE | Discontinued |
| TIZANIDINE HYDROCHLORIDE | 091283 | 001 | ANDA | TIZANIDINE HYDROCHLORIDE | TABLET;ORAL | EQ 2MG BASE | No | No | 2012/11/28 | 2012/11/28 | UNICHEM LABS LTD | Prescription |
| TIZANIDINE HYDROCHLORIDE | 091283 | 002 | ANDA | TIZANIDINE HYDROCHLORIDE | TABLET;ORAL | EQ 4MG BASE | No | No | 2012/11/28 | 2012/11/28 | UNICHEM LABS LTD | Prescription |
| TIZANIDINE HYDROCHLORIDE | 207170 | 001 | ANDA | TIZANIDINE HYDROCHLORIDE | TABLET;ORAL | EQ 2MG BASE | No | No | 2017/01/26 | 2017/01/26 | ENDO OPERATIONS | Discontinued |
| TIZANIDINE HYDROCHLORIDE | 207170 | 002 | ANDA | TIZANIDINE HYDROCHLORIDE | TABLET;ORAL | EQ 4MG BASE | No | No | 2017/01/26 | 2017/01/26 | ENDO OPERATIONS | Discontinued |
| TIZANIDINE HYDROCHLORIDE | 208622 | 001 | ANDA | TIZANIDINE HYDROCHLORIDE | CAPSULE;ORAL | EQ 2MG BASE | No | No | 2017/03/03 | 2017/03/03 | ZYDUS PHARMS | Prescription |
| TIZANIDINE HYDROCHLORIDE | 208622 | 002 | ANDA | TIZANIDINE HYDROCHLORIDE | CAPSULE;ORAL | EQ 4MG BASE | No | No | 2017/03/03 | 2017/03/03 | ZYDUS PHARMS | Prescription |
| TIZANIDINE HYDROCHLORIDE | 208622 | 003 | ANDA | TIZANIDINE HYDROCHLORIDE | CAPSULE;ORAL | EQ 6MG BASE | No | No | 2017/03/03 | 2017/03/03 | ZYDUS PHARMS | Prescription |
| TIZANIDINE HYDROCHLORIDE | 207199 | 001 | ANDA | TIZANIDINE HYDROCHLORIDE | CAPSULE;ORAL | EQ 2MG BASE | No | No | 2017/03/14 | 2017/03/14 | ENDO OPERATIONS | Discontinued |
| TIZANIDINE HYDROCHLORIDE | 207199 | 002 | ANDA | TIZANIDINE HYDROCHLORIDE | CAPSULE;ORAL | EQ 4MG BASE | No | No | 2017/03/14 | 2017/03/14 | ENDO OPERATIONS | Discontinued |
| TIZANIDINE HYDROCHLORIDE | 207199 | 003 | ANDA | TIZANIDINE HYDROCHLORIDE | CAPSULE;ORAL | EQ 6MG BASE | No | No | 2017/03/14 | 2017/03/14 | ENDO OPERATIONS | Discontinued |