FDA — authorised 1 May 2012
- Application: NDA202236
- Marketing authorisation holder: MYLAN SPECIALITY LP
- Local brand name: DYMISTA
- Indication: SPRAY, METERED — NASAL
- Status: approved
🇺🇸 Azelastine hydrochloride and Fluticasone propionate in United States
FDA authorised Azelastine hydrochloride and Fluticasone propionate on 1 May 2012
Marketing authorisations
FDA — authorised 28 April 2017
- Application: ANDA207712
- Marketing authorisation holder: APOTEX
- Local brand name: AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE
- Indication: SPRAY, METERED — NASAL
- Status: approved
FDA — authorised 18 February 2021
- Application: ANDA208111
- Marketing authorisation holder: PADAGIS ISRAEL
- Local brand name: AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE
- Indication: SPRAY, METERED — NASAL
- Status: approved
FDA — authorised 8 April 2025
- Application: ANDA208436
- Marketing authorisation holder: TEVA PHARMS USA INC
- Local brand name: AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE
- Indication: SPRAY, METERED — NASAL
- Status: approved
Azelastine hydrochloride and Fluticasone propionate 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 Azelastine hydrochloride and Fluticasone propionate approved in United States?
Yes. FDA authorised it on 1 May 2012; FDA authorised it on 28 April 2017; FDA authorised it on 18 February 2021.
Who is the marketing authorisation holder for Azelastine hydrochloride and Fluticasone propionate in United States?
MYLAN SPECIALITY LP holds the US marketing authorisation.