FdaApplication
ANDA 076140
Identifiers
- fda_app_no: ANDA076140
Properties
| Property | Value |
|---|---|
| applicant_name | APOTEX INC |
| application_type | ANDA |
| approval_date | 2002-09-26 |
Products (4)
| 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 |
| SOTALOL HYDROCHLORIDE | SOTALOL HYDROCHLORIDE | 240MG | TABLET;ORAL |
4 products