Regulatory PathRegulatory requirements compared

Active substances

Azelastine + Fluticasone

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
DYMISTA1000,365 µg,µgNasal spray, suspension · Inhalation use1 BottleSAR 77.20NCE · PrescriptionViatris Healthcare GmbHValid
Indications — CHI Daman Drug Formulary

ALLERGIC RHINITIS; ALLERGIC RHINITIS-ALLERGIC RHINO-CONJUNCTIVITIS

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

ProductStrengthForm · routeApplicantStatusFirst approved
DYMISTA0.137MG/SPRAY;0.05MG/SPRAYspray, metered · nasalMYLAN SPECIALITY LPPrescription1 May 2012
AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE0.137MG/SPRAY;0.05MG/SPRAYspray, metered · nasalAPOTEXPrescription28 Apr 2017
AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE0.137MG/SPRAY;0.05MG/SPRAYspray, metered · nasalPADAGIS ISRAELPrescription18 Feb 2021
AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE0.137MG/SPRAY;0.05MG/SPRAYspray, metered · nasalTEVA PHARMS USA INCPrescription8 Apr 2025

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
APO-AZELASTINE/FLUTICASONE0254088650 MCG / ACT; 137 MCG / ACTSPRAY (METERED-DOSE) · NASALAPOTEX INC
DYMISTA0243288950 MCG / ACT; 137 MCG / ACTSPRAY (METERED-DOSE) · NASALBGP PHARMA ULC
MYLAN-AZELASTINE/FLUTICASONE0253034150 MCG / ACT; 137 MCG / ACTSPRAY (METERED-DOSE) · NASALMYLAN PHARMACEUTICALS ULC

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
NHS Drug TariffFluticasone propionate 50micrograms/dose / Azelastine 137micrograms/dose nasal spray£3.84120 dose1 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.

Components

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.