FdaApplication
NDA 021151
Identifiers
- fda_app_no: NDA021151
Properties
| Property | Value |
|---|---|
| applicant_name | LEGACY PHARMA INC SEZC |
| application_type | NDA |
| approval_date | 2000-02-22 |
Products (6)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| BETAPACE AF | SOTALOL HYDROCHLORIDE | 80MG | TABLET;ORAL |
| BETAPACE AF | SOTALOL HYDROCHLORIDE | 100MG | TABLET;ORAL |
| BETAPACE AF | SOTALOL HYDROCHLORIDE | 160MG | TABLET;ORAL |
| BETAPACE AF | SOTALOL HYDROCHLORIDE | 60MG | TABLET;ORAL |
| BETAPACE AF | SOTALOL HYDROCHLORIDE | 40MG | TABLET;ORAL |
| BETAPACE AF | SOTALOL HYDROCHLORIDE | 120MG | TABLET;ORAL |
6 products