FDA — authorised 30 October 1992
- Application: NDA019865
- Marketing authorisation holder: LEGACY PHARMA
- Local brand name: BETAPACE
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 sotolol in United States
FDA authorised sotolol on 30 October 1992
Marketing authorisation
Other Other approved in United States
Frequently asked questions
Is sotolol approved in United States?
Yes. FDA authorised it on 30 October 1992.
Who is the marketing authorisation holder for sotolol in United States?
LEGACY PHARMA holds the US marketing authorisation.