FDA — authorised 19 December 1985
- Marketing authorisation holder: ALLERGAN
- Status: approved
🇺🇸 Betagan in United States
FDA authorised Betagan on 19 December 1985
Marketing authorisations
FDA — authorised 19 December 1985
- Application: NDA019219
- Marketing authorisation holder: ALLERGAN
- Local brand name: BETAGAN
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 28 June 1989
- Application: NDA019814
- Marketing authorisation holder: ALLERGAN
- Local brand name: BETAGAN
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 7 June 1999
- Application: ANDA074326
- Marketing authorisation holder: BAUSCH AND LOMB
- Indication: Manufacturing (CMC)
- Status: approved
Betagan in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Cardiovascular approved in United States
Frequently asked questions
Is Betagan approved in United States?
Yes. FDA authorised it on 19 December 1985; FDA authorised it on 19 December 1985; FDA authorised it on 28 June 1989.
Who is the marketing authorisation holder for Betagan in United States?
ALLERGAN holds the US marketing authorisation.