FdaApplication
NDA 019865
Identifiers
- fda_app_no: NDA019865
Properties
| Property | Value |
|---|---|
| applicant_name | LEGACY PHARMA INC SEZC |
| application_type | NDA |
| approval_date | 1992-10-30 |
Products (5)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| BETAPACE | SOTALOL HYDROCHLORIDE | 320MG | TABLET;ORAL |
| BETAPACE | SOTALOL HYDROCHLORIDE | 80MG | TABLET;ORAL |
| BETAPACE | SOTALOL HYDROCHLORIDE | 120MG | TABLET;ORAL |
| BETAPACE | SOTALOL HYDROCHLORIDE | 240MG | TABLET;ORAL |
| BETAPACE | SOTALOL HYDROCHLORIDE | 160MG | TABLET;ORAL |
5 products