FDA — authorised 22 May 2000
- Application: NDA021127
- Marketing authorisation holder: RISING
- Local brand name: OPTIVAR
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
🇺🇸 AZELASTINE HYDROCHLORIDE in United States
FDA authorised AZELASTINE HYDROCHLORIDE on 22 May 2000 · 5,098 US adverse-event reports
Marketing authorisations
FDA — authorised 30 April 2009
- Application: ANDA077954
- Marketing authorisation holder: APOTEX INC
- Local brand name: AZELASTINE HYDROCHLORIDE
- Indication: SPRAY, METERED — NASAL
- Status: approved
FDA — authorised 3 August 2009
- Application: ANDA078621
- Marketing authorisation holder: APOTEX
- Local brand name: AZELASTINE HYDROCHLORIDE
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 21 June 2010
- Application: ANDA078738
- Marketing authorisation holder: SUN PHARM
- Local brand name: AZELASTINE HYDROCHLORIDE
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 31 May 2012
- Application: ANDA202305
- Marketing authorisation holder: SANDOZ
- Local brand name: AZELASTINE HYDROCHLORIDE
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 31 August 2012
- Application: ANDA201846
- Marketing authorisation holder: APOTEX INC
- Local brand name: AZELASTINE HYDROCHLORIDE
- Indication: SPRAY, METERED — NASAL
- Status: approved
FDA — authorised 24 October 2014
- Application: ANDA091444
- Marketing authorisation holder: HIKMA
- Local brand name: AZELASTINE HYDROCHLORIDE
- Indication: SPRAY, METERED — NASAL
- Status: approved
FDA — authorised 28 July 2015
- Application: ANDA090176
- Marketing authorisation holder: BIONPHARMA
- Local brand name: AZELASTINE HYDROCHLORIDE
- Indication: SPRAY, METERED — NASAL
- Status: approved
FDA — authorised 8 November 2016
- Application: ANDA203660
- Marketing authorisation holder: EPIC PHARMA LLC
- Local brand name: AZELASTINE HYDROCHLORIDE
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 17 March 2017
- Application: ANDA202609
- Marketing authorisation holder: PADAGIS US
- Local brand name: AZELASTINE HYDROCHLORIDE
- Indication: SPRAY, METERED — NASAL
- Status: approved
FDA — authorised 28 April 2017
- Application: ANDA207712
- Marketing authorisation holder: APOTEX
- Status: supplemented
FDA — authorised 22 September 2017
- Application: ANDA207243
- Marketing authorisation holder: HIKMA
- Local brand name: AZELASTINE HYDROCHLORIDE
- Indication: SPRAY, METERED — NASAL
- Status: approved
FDA — authorised 15 December 2017
- Application: ANDA208199
- Marketing authorisation holder: AMNEAL
- Local brand name: AZELASTINE HYDROCHLORIDE
- Indication: SPRAY, METERED — NASAL
- Status: approved
FDA — authorised 20 March 2019
- Application: ANDA209620
- Marketing authorisation holder: ALEMBIC
- Local brand name: AZELASTINE HYDROCHLORIDE
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 29 March 2019
- Application: ANDA207411
- Marketing authorisation holder: SOMERSET THERAPS LLC
- Local brand name: AZELASTINE HYDROCHLORIDE
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 17 May 2019
- Application: ANDA207610
- Marketing authorisation holder: EPIC PHARMA LLC
- Local brand name: AZELASTINE HYDROCHLORIDE
- Indication: SPRAY, METERED — NASAL
- Status: approved
FDA — authorised 23 August 2019
- Application: ANDA210032
- Marketing authorisation holder: SCIEGEN PHARMS
- Local brand name: AZELASTINE HYDROCHLORIDE
- Indication: SPRAY, METERED — NASAL
- Status: approved
FDA — authorised 25 February 2020
- Application: ANDA210092
- Marketing authorisation holder: GLAND
- Local brand name: AZELASTINE HYDROCHLORIDE
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 8 May 2020
- Application: ANDA212289
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Local brand name: AZELASTINE HYDROCHLORIDE
- Indication: SPRAY, METERED — NASAL
- Status: approved
FDA — authorised 12 November 2020
- Application: ANDA212775
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Local brand name: AZELASTINE HYDROCHLORIDE
- Indication: SPRAY, METERED — NASAL
- Status: approved
FDA — authorised 17 June 2021
- Application: NDA213872
- Marketing authorisation holder: BAYER HLTHCARE
- Local brand name: CHILDREN'S ASTEPRO ALLERGY
- Indication: SPRAY, METERED — NASAL
- Status: approved
FDA — authorised 29 May 2024
- Application: ANDA216421
- Marketing authorisation holder: APOTEX
- Local brand name: AZELASTINE HYDROCHLORIDE ALLERGY
- Indication: SPRAY, METERED — NASAL
- Status: approved
FDA — authorised 5 June 2024
- Application: ANDA216576
- Marketing authorisation holder: AMNEAL
- Local brand name: AZELASTINE HYDROCHLORIDE
- Indication: SPRAY, METERED — NASAL
- Status: approved
FDA — authorised 27 January 2025
- Application: ANDA216561
- Marketing authorisation holder: AUROBINDO PHARMA
- Local brand name: AZELASTINE HYDROCHLORIDE ALLERGY
- Indication: SPRAY, METERED — NASAL
- Status: approved
FDA — authorised 8 April 2025
- Application: ANDA208436
- Marketing authorisation holder: TEVA PHARMS USA INC
- Status: approved
FDA
- Status: approved
Safety signals — FAERS
Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.
- Window: 20 April 2025 – 20 April 2026
- Total reports: 5,098
Most-reported reactions
- Treatment Failure — 782 reports (15.34%)
- Product Dose Omission Issue — 710 reports (13.93%)
- Drug Ineffective — 661 reports (12.97%)
- Fatigue — 510 reports (10%)
- Headache — 447 reports (8.77%)
- Dyspnoea — 445 reports (8.73%)
- Cough — 406 reports (7.96%)
- No Adverse Event — 391 reports (7.67%)
- Product Delivery Mechanism Issue — 381 reports (7.47%)
- Nausea — 365 reports (7.16%)
AZELASTINE HYDROCHLORIDE 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 approved in United States?
Yes. FDA authorised it on 22 May 2000; FDA authorised it on 30 April 2009; FDA authorised it on 3 August 2009.
Who is the marketing authorisation holder for AZELASTINE HYDROCHLORIDE in United States?
RISING holds the US marketing authorisation.