FDA — authorised 27 November 2020
- Application: ANDA209406
- Marketing authorisation holder: WATSON LABS INC
- Local brand name: BRINZOLAMIDE
- Indication: SUSPENSION/DROPS — OPHTHALMIC
- Status: approved
🇺🇸 Azopt in United States
FDA authorised Azopt on 27 November 2020
Marketing authorisations
FDA
- Status: approved
FDA
- Application: ANDA212137
- Marketing authorisation holder: PERRIGO PHARMA INTERNATIONAL DAC
- Local brand name: BRINZOLAMIDE; BRIMONIDINE TARTRATE
- Indication: SUSPENSION/DROPS — OPHTHALMIC
- Status: approved
Azopt 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 Azopt approved in United States?
Yes. FDA authorised it on 27 November 2020; FDA has authorised it; FDA has authorised it.
Who is the marketing authorisation holder for Azopt in United States?
WATSON LABS INC holds the US marketing authorisation.