| 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 | 214089 | 003 | ANDA | MEXILETINE HYDROCHLORIDE | CAPSULE;ORAL | 250MG | No | No | 2021/10/01 | 2021/10/01 | SENORES PHARMS | Prescription |
| MEXILETINE HYDROCHLORIDE | 215315 | 001 | ANDA | MEXILETINE HYDROCHLORIDE | CAPSULE;ORAL | 150MG | No | No | 2022/08/26 | 2022/08/26 | RISING | Prescription |
| MEXILETINE HYDROCHLORIDE | 215315 | 002 | ANDA | MEXILETINE HYDROCHLORIDE | CAPSULE;ORAL | 200MG | No | No | 2022/08/26 | 2022/08/26 | RISING | Prescription |
| MEXILETINE HYDROCHLORIDE | 215315 | 003 | ANDA | MEXILETINE HYDROCHLORIDE | CAPSULE;ORAL | 250MG | No | No | 2022/08/26 | 2022/08/26 | RISING | Prescription |
| MEXILETINE HYDROCHLORIDE | 216463 | 001 | ANDA | MEXILETINE HYDROCHLORIDE | CAPSULE;ORAL | 150MG | No | No | 2022/11/09 | 2022/11/09 | ANNORA PHARMA | Prescription |
| MEXILETINE HYDROCHLORIDE | 216463 | 002 | ANDA | MEXILETINE HYDROCHLORIDE | CAPSULE;ORAL | 200MG | No | No | 2022/11/09 | 2022/11/09 | ANNORA PHARMA | Prescription |
| MEXILETINE HYDROCHLORIDE | 216463 | 003 | ANDA | MEXILETINE HYDROCHLORIDE | CAPSULE;ORAL | 250MG | No | No | 2022/11/09 | 2022/11/09 | ANNORA PHARMA | Prescription |
| MEXILETINE HYDROCHLORIDE | 215876 | 001 | ANDA | MEXILETINE HYDROCHLORIDE | CAPSULE;ORAL | 150MG | No | No | 2023/02/27 | 2023/02/27 | LEADING | Prescription |
| MEXILETINE HYDROCHLORIDE | 215876 | 002 | ANDA | MEXILETINE HYDROCHLORIDE | CAPSULE;ORAL | 200MG | No | No | 2023/02/27 | 2023/02/27 | LEADING | Prescription |
| MEXILETINE HYDROCHLORIDE | 215876 | 003 | ANDA | MEXILETINE HYDROCHLORIDE | CAPSULE;ORAL | 250MG | No | No | 2023/02/27 | 2023/02/27 | LEADING | Prescription |