Regulatory PathRegulatory requirements compared

Active substance

Levobunolol

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
BETAGAN 0.5% LIQUIFILM OPTH.SOLN.0.5 %Eye drops · Ophthalmic use1 Dropper ContainerSAR 13.65NCE · PrescriptionALLERGAN PHARMACEUTICALS LTDWithdrawn by MAH · Not Marketed

US FDA United States — FDA approvals (Drugs@FDA)

ProductStrengthForm · routeApplicantStatusFirst approved
BETAGAN0.5%solution/drops · ophthalmicALLERGANPrescription19 Dec 1985
LEVOBUNOLOL HYDROCHLORIDE0.5%solution/drops · ophthalmicBAUSCH AND LOMB INCPrescription4 Mar 1994
BETAGAN0.25% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**solution/drops · ophthalmicALLERGANDiscontinued28 Jun 1989
LEVOBUNOLOL HYDROCHLORIDE0.25%solution/drops · ophthalmicBAUSCH AND LOMBDiscontinued4 Mar 1994
LEVOBUNOLOL HYDROCHLORIDE0.5%solution/drops · ophthalmicCHARTWELL RXDiscontinued28 Oct 1996
LEVOBUNOLOL HYDROCHLORIDE0.25%solution/drops · ophthalmicALCON LABS INCDiscontinued28 Oct 1996
AKBETA0.25%solution/drops · ophthalmicEPIC PHARMA LLCDiscontinued29 Oct 1996
AKBETA0.5%solution/drops · ophthalmicEPIC PHARMA LLCDiscontinued29 Oct 1996
LEVOBUNOLOL HYDROCHLORIDE0.25%solution/drops · ophthalmicAPOTEX INCDiscontinued3 Aug 2000
LEVOBUNOLOL HYDROCHLORIDE0.5%solution/drops · ophthalmicAPOTEX INCDiscontinued3 Aug 2000

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACLEVOBUNOLOL 0.5% EYE DROPS$2.81863per ML23 Sep 2026

NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.

Safety signals and safety-related labeling changes

All safety entries for levobunolol →

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.