🇺🇸 bepotastine besilate ophthalmic solution in United States

FDA authorised bepotastine besilate ophthalmic solution on 5 April 2023

Marketing authorisations

FDA — authorised 5 April 2023

  • Application: ANDA214588
  • Marketing authorisation holder: ALEMBIC
  • Status: approved

FDA

  • Status: approved

bepotastine besilate ophthalmic solution in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Frequently asked questions

Is bepotastine besilate ophthalmic solution approved in United States?

Yes. FDA authorised it on 5 April 2023; FDA has authorised it.

Who is the marketing authorisation holder for bepotastine besilate ophthalmic solution in United States?

ALEMBIC holds the US marketing authorisation.