FDA — authorised 13 March 1997
- Application: NDA020490
- Marketing authorisation holder: ALLERGAN
- Local brand name: ALPHAGAN
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
🇺🇸 Alphagan in United States
FDA authorised Alphagan on 13 March 1997
Marketing authorisations
FDA — authorised 15 October 2001
- Application: NDA021262
- Marketing authorisation holder: ABBVIE
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 28 May 2003
- Application: ANDA076260
- Marketing authorisation holder: BAUSCH AND LOMB
- Local brand name: BRIMONIDINE TARTRATE
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 16 September 2003
- Application: ANDA076254
- Marketing authorisation holder: SANDOZ
- Local brand name: BRIMONIDINE TARTRATE
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 10 September 2004
- Application: ANDA076372
- Marketing authorisation holder: TEVA PARENTERAL
- Local brand name: BRIMONIDINE TARTRATE
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 22 May 2006
- Application: NDA021764
- Marketing authorisation holder: SANDOZ
- Local brand name: QOLIANA
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 30 January 2008
- Application: ANDA078075
- Marketing authorisation holder: SANDOZ
- Local brand name: BRIMONIDINE TARTRATE
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 18 November 2014
- Application: ANDA091691
- Marketing authorisation holder: REGCON HOLDINGS
- Local brand name: BRIMONIDINE TARTRATE
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 5 November 2015
- Application: NDA204251
- Marketing authorisation holder: ALCON LABS INC
- Indication: Labeling
- Status: approved
FDA — authorised 11 March 2019
- Application: ANDA208992
- Marketing authorisation holder: SOMERSET THERAPS LLC
- Local brand name: BRIMONIDINE TARTRATE
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 23 September 2021
- Application: ANDA209158
- Marketing authorisation holder: PADAGIS ISRAEL
- Local brand name: BRIMONIDINE TARTRATE
- Indication: GEL — TOPICAL
- Status: approved
FDA — authorised 4 April 2022
- Application: ANDA091087
- Marketing authorisation holder: SANDOZ
- Local brand name: BRIMONIDINE TARTRATE AND TIMOLOL MALEATE
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 20 April 2022
- Application: ANDA091442
- Marketing authorisation holder: APOTEX
- Local brand name: BRIMONIDINE TARTRATE AND TIMOLOL MALEATE
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 4 October 2022
- Application: ANDA201949
- Marketing authorisation holder: REGCON HOLDINGS
- Local brand name: BRIMONIDINE TARTRATE AND TIMOLOL MALEATE
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 31 October 2022
- Application: ANDA091086
- Marketing authorisation holder: SENTISS
- Local brand name: BRIMONIDINE TARTRATE AND TIMOLOL MALEATE
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 12 December 2022
- Application: ANDA215598
- Marketing authorisation holder: UPSHER SMITH LABS
- Local brand name: BRIMONIDINE TARTRATE AND TIMOLOL MALEATE
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 29 March 2023
- Application: ANDA215225
- Marketing authorisation holder: ALEMBIC
- Local brand name: BRIMONIDINE TARTRATE
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 1 August 2023
- Application: ANDA216909
- Marketing authorisation holder: ALEMBIC
- Local brand name: BRIMONIDINE TARTRATE
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 25 August 2023
- Application: ANDA215230
- Marketing authorisation holder: ALEMBIC
- Local brand name: BRIMONIDINE TARTRATE AND TIMOLOL MALEATE
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 22 November 2023
- Application: ANDA217846
- Marketing authorisation holder: MICRO LABS
- Local brand name: BRIMONIDINE TARTRATE
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 4 March 2024
- Application: ANDA203172
- Marketing authorisation holder: SANDOZ
- Local brand name: BRIMONIDINE TARTRATE
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 19 April 2024
- Application: NDA218424
- Marketing authorisation holder: BAUSCH AND LOMB INC
- Local brand name: LUMIFY PRESERVATIVE FREE
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 16 May 2024
- Application: ANDA214987
- Marketing authorisation holder: GLENMARK PHARMS LTD
- Local brand name: BRIMONIDINE TARTRATE AND TIMOLOL MALEATE
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 12 June 2024
- Application: ANDA216772
- Marketing authorisation holder: UPSHER SMITH LABS
- Local brand name: BRIMONIDINE TARTRATE
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 9 August 2024
- Application: ANDA216906
- Marketing authorisation holder: SOMERSET THERAPS LLC
- Local brand name: BRIMONIDINE TARTRATE
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 26 August 2024
- Application: ANDA213215
- Marketing authorisation holder: LUPIN
- Local brand name: BRIMONIDINE TARTRATE
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 10 September 2024
- Application: ANDA216114
- Marketing authorisation holder: SOMERSET
- Local brand name: BRIMONIDINE TARTRATE AND TIMOLOL MALEATE
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 30 December 2024
- Application: ANDA217288
- Marketing authorisation holder: AMNEAL
- Local brand name: BRIMONIDINE TARTRATE AND TIMOLOL MALEATE
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 25 February 2025
- Application: ANDA219093
- Marketing authorisation holder: CAPLIN
- Local brand name: BRIMONIDINE TARTRATE AND TIMOLOL MALEATE
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 30 July 2025
- Application: ANDA217599
- Marketing authorisation holder: UPSHER SMITH LABS
- Local brand name: BRIMONIDINE TARTRATE
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 28 January 2026
- Application: NDA220142
- Marketing authorisation holder: VISUS
- Local brand name: YUVEZZI
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
The FDA approved Alphagan (brinzolamide) ophthalmic solution/drops for the treatment of glaucoma or ocular hypertension. The approval was granted to VISUS under the standard expedited pathway. Alphagan will be marketed under the brand name YUVEZZI in the United States.
FDA — authorised 11 March 2026
- Application: ANDA219219
- Marketing authorisation holder: GLAND
- Local brand name: BRIMONIDINE TARTRATE
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
The FDA approved Alphagan (brimonidine tartrate) solution/drops for ophthalmic use on 11 March 2026. This approval was granted to GLAND under the standard expedited pathway. Alphagan is indicated for the treatment of glaucoma or ocular hypertension.
FDA — authorised 16 April 2026
- Application: ANDA220398
- Marketing authorisation holder: MANKIND PHARMA
- Local brand name: BRIMONIDINE TARTRATE
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
The FDA approved Mankind Pharma's Alphagan (brimonidine tartrate) ophthalmic solution for the treatment of glaucoma and ocular hypertension. This approval was granted under the standard expedited pathway. Alphagan is a brimonidine tartrate solution for ophthalmic use, which is administered as eye drops. The approval was based on the submission of an Abbreviated New Drug Application (ANDA) with the application number ANDA220398.
FDA — authorised 7 May 2026
- Application: ANDA218558
- Marketing authorisation holder: MICRO LABS
- Local brand name: BRIMONIDINE TARTRATE
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA
- Application: ANDA091574
- Marketing authorisation holder: ALCON
- Local brand name: BRIMONIDINE TARTRATE; TIMOLOL MALEATE
- Indication: SOLUTION — OPHTHALMIC
- 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 13 March 1997; FDA authorised it on 15 October 2001; FDA authorised it on 28 May 2003.
Who is the marketing authorisation holder for Alphagan in United States?
ALLERGAN holds the US marketing authorisation.