FDA — authorised 27 November 2020
- Application: ANDA209406
- Marketing authorisation holder: WATSON LABS INC
- Local brand name: BRINZOLAMIDE
- Indication: SUSPENSION/DROPS — OPHTHALMIC
- Status: approved
🇺🇸 Azopt 1% in United States
FDA authorised Azopt 1% on 27 November 2020
Marketing authorisations
FDA — authorised 18 August 2021
- Application: ANDA204884
- Marketing authorisation holder: BAUSCH AND LOMB
- Local brand name: BRINZOLAMIDE
- Indication: SUSPENSION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 28 July 2023
- Application: ANDA211914
- Marketing authorisation holder: PADAGIS US
- Local brand name: BRINZOLAMIDE
- Indication: SUSPENSION/DROPS — OPHTHALMIC
- Status: approved
FDA
- Application: ANDA212137
- Marketing authorisation holder: PERRIGO PHARMA INTERNATIONAL DAC
- Local brand name: BRINZOLAMIDE; BRIMONIDINE TARTRATE
- Indication: SUSPENSION/DROPS — OPHTHALMIC
- Status: approved
Other Ophthalmology approved in United States
Frequently asked questions
Is Azopt 1% approved in United States?
Yes. FDA authorised it on 27 November 2020; FDA authorised it on 18 August 2021; FDA authorised it on 28 July 2023.
Who is the marketing authorisation holder for Azopt 1% in United States?
WATSON LABS INC holds the US marketing authorisation.