← FDA Drug Approvals (Drugs@FDA)
BETAPACE
NDA · New Drug Application · Sponsor: LEGACY PHARMA · Approved 1992-10-30
Drug application
- FDA Application #
NDA019865- Application type
- New Drug Application
- Brand name
- BETAPACE
- Generic name
- SOTALOL HYDROCHLORIDE
- Active ingredients
- SOTALOL HYDROCHLORIDE
- Dosage form
- TABLET
- Route
- ORAL
- Marketing status
- Prescription
- Sponsor
- LEGACY PHARMA
- Manufacturer
- Legacy Pharma USA, Inc.
- First approval
- 1992-10-30
Source
- Authoritative
- Drugs@FDA application overview
- Machine
- JSON-LD · Markdown