FdaApplication
ANDA 207428
Identifiers
- fda_app_no: ANDA207428
Properties
| Property | Value |
|---|---|
| applicant_name | REGCON HOLDINGS LLC |
| application_type | ANDA |
| approval_date | 2016-10-21 |
Products (3)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| SOTALOL HYDROCHLORIDE | SOTALOL HYDROCHLORIDE | 160MG | TABLET;ORAL |
| SOTALOL HYDROCHLORIDE | SOTALOL HYDROCHLORIDE | 120MG | TABLET;ORAL |
| SOTALOL HYDROCHLORIDE | SOTALOL HYDROCHLORIDE | 80MG | TABLET;ORAL |
3 products