FDA — authorised 15 October 2001
- Application: NDA021262
- Marketing authorisation holder: ABBVIE
- Indication: Manufacturing (CMC)
- Status: approved
🇺🇸 Alphagan in United States
FDA authorised Alphagan on 15 October 2001
Marketing authorisations
FDA — authorised 9 June 2022
- Application: ANDA209158
- Marketing authorisation holder: PADAGIS ISRAEL
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 4 October 2022
- Application: ANDA201949
- Marketing authorisation holder: REGCON HOLDINGS
- Indication: Not Applicable
- Status: approved
FDA — authorised 16 May 2024
- Application: ANDA214987
- Marketing authorisation holder: GLENMARK PHARMS LTD
- Status: approved
FDA — authorised 25 February 2025
- Application: ANDA219093
- Marketing authorisation holder: CAPLIN
- Status: approved
Alphagan 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 Alphagan approved in United States?
Yes. FDA authorised it on 15 October 2001; FDA authorised it on 9 June 2022; FDA authorised it on 4 October 2022.
Who is the marketing authorisation holder for Alphagan in United States?
ABBVIE holds the US marketing authorisation.