Regulatory PathRegulatory requirements compared

Active substance

Epinastine

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
RELESTAT 0.05% EYE DROPS0.05 %Eye drops, solution · Ophthalmic use1 Dropper ContainerSAR 26.20NCE · PrescriptionABBVIE LIMITEDValid
Indications — CHI Daman Drug Formulary

ALLERGIC RHINITIS-ALLERGIC RHINO-CONJUNCTIVITIS

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

ProductStrengthForm · routeApplicantStatusFirst approved
EPINASTINE HYDROCHLORIDE0.05%solution/drops · ophthalmicSOMERSET THERAPS LLCPrescription31 Oct 2011
ELESTAT0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**solution/drops · ophthalmicALLERGANDiscontinued16 Oct 2003
EPINASTINE HYDROCHLORIDE0.05%solution/drops · ophthalmicPHARMOBEDIENTDiscontinued14 Mar 2011
EPINASTINE HYDROCHLORIDE0.05%solution/drops · ophthalmicAPOTEXDiscontinued31 Oct 2011
EPINASTINE HYDROCHLORIDE0.05%solution/drops · ophthalmicSUN PHARM INDSDiscontinued31 Oct 2011
EPINASTINE HYDROCHLORIDE0.05%solution/drops · ophthalmicCHARTWELL RXDiscontinued7 Dec 2016
EPINASTINE HYDROCHLORIDE0.05%solution/drops · ophthalmicEPIC PHARMA LLCDiscontinued5 May 2017

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACEPINASTINE HCL 0.05% EYE DROPS$14.32952per ML23 Sep 2026
NHS Drug TariffEpinastine 500micrograms/ml eye drops£9.905 ml1 Oct 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.

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.