Regulatory PathRegulatory requirements compared

Active substance

Zafirlukast

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
ACCOLATE 20 MG F.C.TAB20 mgFilm-coated tablet · Oral use56 BlisterSAR 142.50NCE · PrescriptionAstraZenecaWithdrawn by MAH · Not Marketed

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

ProductStrengthForm · routeApplicantStatusFirst approved
ACCOLATE20MG; 10MGtablet · oralSTRIDES PHARMA INTLPrescription26 Sep 1996
ZAFIRLUKAST10MG; 20MGtablet · oralDR REDDYS LABS LTDPrescription18 Nov 2010
ZAFIRLUKAST10MG; 20MGtablet · oralANNORA PHARMAPrescription10 Sep 2020
ZAFIRLUKAST10MG; 20MGtablet · oralRISING PHARMSPrescription25 Aug 2022
ZAFIRLUKAST10MG; 20MGtablet · oralAUROBINDO PHARMAPrescription27 Nov 2023

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACZAFIRLUKAST 10 MG TABLET$0.51691per EA23 Sep 2026
US NADACZAFIRLUKAST 20 MG TABLET$0.62337per EA23 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.

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.