FDA — authorised 8 September 2009
- Application: NDA022288
- Marketing authorisation holder: BAUSCH AND LOMB INC
- Local brand name: BEPREVE
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
🇺🇸 Bepreve in United States
FDA authorised Bepreve on 8 September 2009
Marketing authorisations
FDA — authorised 5 March 2019
- Application: ANDA206066
- Marketing authorisation holder: APOTEX
- Local brand name: BEPOTASTINE BESILATE
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 5 April 2023
- Application: ANDA214588
- Marketing authorisation holder: ALEMBIC
- Local brand name: BEPOTASTINE BESILATE
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 14 August 2024
- Application: ANDA217770
- Marketing authorisation holder: SOMERSET THERAPS LLC
- Local brand name: BEPOTASTINE BESILATE
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA
- Status: approved
FDA
- Application: ANDA206080
- Marketing authorisation holder: SANDOZ INC
- Local brand name: BEPOTASTINE BESILATE
- Indication: SOLUTION — OPHTHALMIC
- Status: approved
Other Other approved in United States
Frequently asked questions
Is Bepreve approved in United States?
Yes. FDA authorised it on 8 September 2009; FDA authorised it on 5 March 2019; FDA authorised it on 5 April 2023.
Who is the marketing authorisation holder for Bepreve in United States?
BAUSCH AND LOMB INC holds the US marketing authorisation.