FDA — authorised 26 January 1978
- Marketing authorisation holder: SCHERING
- Status: approved
🇺🇸 Betalone in United States
FDA authorised Betalone on 26 January 1978
Marketing authorisations
FDA — authorised 26 January 1978
- Application: NDA016053
- Marketing authorisation holder: SCHERING
- Local brand name: BETAPAR
- Indication: TABLET — ORAL
- Status: approved
Betalone in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Immunology approved in United States
Frequently asked questions
Is Betalone approved in United States?
Yes. FDA authorised it on 26 January 1978; FDA authorised it on 26 January 1978.
Who is the marketing authorisation holder for Betalone in United States?
SCHERING holds the US marketing authorisation.