FdaApplication
ANDA 077616
Identifiers
- fda_app_no: ANDA077616
Properties
| Property | Value |
|---|---|
| applicant_name | AUROBINDO PHARMA USA INC |
| application_type | ANDA |
| approval_date | 2007-02-07 |
Products (3)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| SOTALOL HYDROCHLORIDE | SOTALOL HYDROCHLORIDE | 120MG | TABLET;ORAL |
| SOTALOL HYDROCHLORIDE | SOTALOL HYDROCHLORIDE | 80MG | TABLET;ORAL |
| SOTALOL HYDROCHLORIDE | SOTALOL HYDROCHLORIDE | 160MG | TABLET;ORAL |
3 products