FDA — authorised 12 June 1959
- Application: NDA011657
- Marketing authorisation holder: FOREST LABS
- Local brand name: BETAPRONE
- Indication: SOLUTION — IRRIGATION
- Status: approved
🇺🇸 Betaprone in United States
FDA authorised Betaprone on 12 June 1959
Marketing authorisations
FDA
- Marketing authorisation holder: FOREST LABS
- Status: approved
Betaprone in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Other approved in United States
Frequently asked questions
Is Betaprone approved in United States?
Yes. FDA authorised it on 12 June 1959; FDA has authorised it.
Who is the marketing authorisation holder for Betaprone in United States?
FOREST LABS holds the US marketing authorisation.