FdaApplication
ANDA 075237
Identifiers
- fda_app_no: ANDA075237
Properties
| Property | Value |
|---|---|
| applicant_name | NOVITIUM PHARMA LLC |
| application_type | ANDA |
| approval_date | 2000-05-01 |
Products (4)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| SOTALOL HYDROCHLORIDE | SOTALOL HYDROCHLORIDE | 120MG | TABLET;ORAL |
| SOTALOL HYDROCHLORIDE | SOTALOL HYDROCHLORIDE | 80MG | TABLET;ORAL |
| SOTALOL HYDROCHLORIDE | SOTALOL HYDROCHLORIDE | 240MG | TABLET;ORAL |
| SOTALOL HYDROCHLORIDE | SOTALOL HYDROCHLORIDE | 160MG | TABLET;ORAL |
4 products