| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| MEXILETINE HYDROCHLORIDE | 074377 | 001 | ANDA | MEXILETINE HYDROCHLORIDE | CAPSULE;ORAL | 150MG | No | No | 1995/05/16 | 1995/05/16 | TEVA | Prescription |
| MEXILETINE HYDROCHLORIDE | 074377 | 002 | ANDA | MEXILETINE HYDROCHLORIDE | CAPSULE;ORAL | 200MG | No | No | 1995/05/16 | 1995/05/16 | TEVA | Prescription |
| MEXILETINE HYDROCHLORIDE | 074377 | 003 | ANDA | MEXILETINE HYDROCHLORIDE | CAPSULE;ORAL | 250MG | No | Yes | 1995/05/16 | 1995/05/16 | TEVA | Prescription |
| MEXILETINE HYDROCHLORIDE | 074450 | 001 | ANDA | MEXILETINE HYDROCHLORIDE | CAPSULE;ORAL | 150MG | No | No | 1996/05/16 | 1996/05/16 | ANI PHARMS | Prescription |
| MEXILETINE HYDROCHLORIDE | 074450 | 002 | ANDA | MEXILETINE HYDROCHLORIDE | CAPSULE;ORAL | 200MG | No | No | 1996/05/16 | 1996/05/16 | ANI PHARMS | Prescription |
| MEXILETINE HYDROCHLORIDE | 074450 | 003 | ANDA | MEXILETINE HYDROCHLORIDE | CAPSULE;ORAL | 250MG | No | No | 1996/05/16 | 1996/05/16 | ANI PHARMS | Prescription |
| MEXILETINE HYDROCHLORIDE | 074711 | 001 | ANDA | MEXILETINE HYDROCHLORIDE | CAPSULE;ORAL | 150MG | No | No | 1997/02/26 | 1997/02/26 | WATSON LABS | Discontinued |
| MEXILETINE HYDROCHLORIDE | 074711 | 002 | ANDA | MEXILETINE HYDROCHLORIDE | CAPSULE;ORAL | 200MG | No | No | 1997/02/26 | 1997/02/26 | WATSON LABS | Discontinued |
| MEXILETINE HYDROCHLORIDE | 074711 | 003 | ANDA | MEXILETINE HYDROCHLORIDE | CAPSULE;ORAL | 250MG | No | No | 1997/02/26 | 1997/02/26 | WATSON LABS | Discontinued |
| MEXILETINE HYDROCHLORIDE | 074865 | 001 | ANDA | MEXILETINE HYDROCHLORIDE | CAPSULE;ORAL | 150MG | No | No | 1998/04/13 | 1998/04/13 | WATSON LABS | Discontinued |
| MEXILETINE HYDROCHLORIDE | 074865 | 002 | ANDA | MEXILETINE HYDROCHLORIDE | CAPSULE;ORAL | 200MG | No | No | 1998/04/13 | 1998/04/13 | WATSON LABS | Discontinued |
| MEXILETINE HYDROCHLORIDE | 074865 | 003 | ANDA | MEXILETINE HYDROCHLORIDE | CAPSULE;ORAL | 250MG | No | No | 1998/04/13 | 1998/04/13 | WATSON LABS | Discontinued |
| MEXILETINE HYDROCHLORIDE | 213500 | 001 | ANDA | MEXILETINE HYDROCHLORIDE | CAPSULE;ORAL | 150MG | No | No | 2020/07/22 | 2020/07/22 | CROSSMEDIKA SA | Prescription |
| MEXILETINE HYDROCHLORIDE | 213500 | 002 | ANDA | MEXILETINE HYDROCHLORIDE | CAPSULE;ORAL | 200MG | No | No | 2020/07/22 | 2020/07/22 | CROSSMEDIKA SA | Prescription |
| MEXILETINE HYDROCHLORIDE | 213500 | 003 | ANDA | MEXILETINE HYDROCHLORIDE | CAPSULE;ORAL | 250MG | No | No | 2020/07/22 | 2020/07/22 | CROSSMEDIKA SA | Prescription |
| MEXILETINE HYDROCHLORIDE | 214352 | 001 | ANDA | MEXILETINE HYDROCHLORIDE | CAPSULE;ORAL | 150MG | No | No | 2021/01/25 | 2021/01/25 | NOVAST LABS | Prescription |
| MEXILETINE HYDROCHLORIDE | 214352 | 002 | ANDA | MEXILETINE HYDROCHLORIDE | CAPSULE;ORAL | 200MG | No | No | 2021/01/25 | 2021/01/25 | NOVAST LABS | Prescription |
| MEXILETINE HYDROCHLORIDE | 214352 | 003 | ANDA | MEXILETINE HYDROCHLORIDE | CAPSULE;ORAL | 250MG | No | No | 2021/01/25 | 2021/01/25 | NOVAST LABS | Prescription |
| MEXILETINE HYDROCHLORIDE | 214089 | 001 | ANDA | MEXILETINE HYDROCHLORIDE | CAPSULE;ORAL | 150MG | No | No | 2021/10/01 | 2021/10/01 | SENORES PHARMS | Prescription |
| MEXILETINE HYDROCHLORIDE | 214089 | 002 | ANDA | MEXILETINE HYDROCHLORIDE | CAPSULE;ORAL | 200MG | No | No | 2021/10/01 | 2021/10/01 | SENORES PHARMS | Prescription |