| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| SOTALOL HYDROCHLORIDE | 076576 | 002 | ANDA | SOTALOL HYDROCHLORIDE | TABLET;ORAL | 120MG | No | No | 2004/04/08 | 2004/04/08 | SUN PHARM INDUSTRIES | Discontinued |
| SOTALOL HYDROCHLORIDE | 076576 | 003 | ANDA | SOTALOL HYDROCHLORIDE | TABLET;ORAL | 160MG | No | No | 2004/04/08 | 2004/04/08 | SUN PHARM INDUSTRIES | Discontinued |
| SOTALOL HYDROCHLORIDE | 076883 | 001 | ANDA | SOTALOL HYDROCHLORIDE | TABLET;ORAL | 80MG | No | No | 2004/07/26 | 2004/07/26 | TEVA | Discontinued |
| SOTALOL HYDROCHLORIDE | 076883 | 002 | ANDA | SOTALOL HYDROCHLORIDE | TABLET;ORAL | 120MG | No | No | 2004/07/26 | 2004/07/26 | TEVA | Discontinued |
| SOTALOL HYDROCHLORIDE | 076883 | 003 | ANDA | SOTALOL HYDROCHLORIDE | TABLET;ORAL | 160MG | No | No | 2004/07/26 | 2004/07/26 | TEVA | Discontinued |
| SOTALOL HYDROCHLORIDE | 077070 | 001 | ANDA | SOTALOL HYDROCHLORIDE | TABLET;ORAL | 80MG | No | No | 2005/11/04 | 2005/11/04 | EPIC PHARMA LLC | Prescription |
| SOTALOL HYDROCHLORIDE | 077070 | 002 | ANDA | SOTALOL HYDROCHLORIDE | TABLET;ORAL | 120MG | No | No | 2005/11/04 | 2005/11/04 | EPIC PHARMA LLC | Prescription |
| SOTALOL HYDROCHLORIDE | 077070 | 003 | ANDA | SOTALOL HYDROCHLORIDE | TABLET;ORAL | 160MG | No | No | 2005/11/04 | 2005/11/04 | EPIC PHARMA LLC | Prescription |
| SOTALOL HYDROCHLORIDE | 077616 | 001 | ANDA | SOTALOL HYDROCHLORIDE | TABLET;ORAL | 80MG | No | No | 2007/02/07 | 2007/02/07 | AUROBINDO PHARMA USA | Prescription |
| SOTALOL HYDROCHLORIDE | 077616 | 002 | ANDA | SOTALOL HYDROCHLORIDE | TABLET;ORAL | 120MG | No | No | 2007/02/07 | 2007/02/07 | AUROBINDO PHARMA USA | Prescription |
| SOTALOL HYDROCHLORIDE | 077616 | 003 | ANDA | SOTALOL HYDROCHLORIDE | TABLET;ORAL | 160MG | No | No | 2007/02/07 | 2007/02/07 | AUROBINDO PHARMA USA | Prescription |
| SOTALOL HYDROCHLORIDE | 022306 | 001 | NDA | SOTALOL HYDROCHLORIDE | SOLUTION;INTRAVENOUS | 150MG/10ML (15MG/ML) | Yes | Yes | 2009/07/02 | 2009/07/02 | ALTATHERA PHARMS LLC | Prescription |
| SOTALOL HYDROCHLORIDE | 207428 | 001 | ANDA | SOTALOL HYDROCHLORIDE | TABLET;ORAL | 80MG | No | No | 2016/10/21 | 2016/10/21 | BEXIMCO PHARMS USA | Prescription |
| SOTALOL HYDROCHLORIDE | 207428 | 002 | ANDA | SOTALOL HYDROCHLORIDE | TABLET;ORAL | 120MG | No | No | 2016/10/21 | 2016/10/21 | BEXIMCO PHARMS USA | Prescription |
| SOTALOL HYDROCHLORIDE | 207428 | 003 | ANDA | SOTALOL HYDROCHLORIDE | TABLET;ORAL | 160MG | No | No | 2016/10/21 | 2016/10/21 | BEXIMCO PHARMS USA | Prescription |
| SOTALOL HYDROCHLORIDE | 207429 | 001 | ANDA | SOTALOL HYDROCHLORIDE | TABLET;ORAL | 80MG | No | No | 2018/11/02 | 2018/11/02 | BEXIMCO PHARMS USA | Prescription |
| SOTALOL HYDROCHLORIDE | 207429 | 002 | ANDA | SOTALOL HYDROCHLORIDE | TABLET;ORAL | 120MG | No | No | 2018/11/02 | 2018/11/02 | BEXIMCO PHARMS USA | Prescription |
| SOTALOL HYDROCHLORIDE | 207429 | 003 | ANDA | SOTALOL HYDROCHLORIDE | TABLET;ORAL | 160MG | No | No | 2018/11/02 | 2018/11/02 | BEXIMCO PHARMS USA | Prescription |