Active substance
Azelastine
- SFDA 3
- US FDA 33
- US price lines 2
- NHS prices 3
- Safety 3
SFDA Saudi Arabia — SFDA human drug list
| Trade name | Strength | Form · route | Pack | Public price | Type | Company | Status |
|---|---|---|---|---|---|---|---|
| ALLERGODIL NASAL SPRAY WITH SPRAYER | 1 mg/ml | Nasal spray, solution · Nasal use | 1 Bottle | SAR 35.00 | NCE · Prescription | Viatris Healthcare GmbH | Valid |
| AZELASTIN-COMOD 0.5 mg/ml EYE DROP | 0.5 mg/ml | Eye drops, solution · Ophthalmic use | 1 Multidose container | SAR 37.25 | Generic · Prescription | URSAPHARM Arzneimittel GmbH | Valid |
| TEBARAT | 0.5 mg/ml | Eye drops · Ocular use | 30 Ampoule | SAR 38.70 | NCE · Prescription | Laboratories SALVAT, S.A | Valid |
Indications — CHI Daman Drug Formulary
ALLERGIC RHINITIS; ALLERGIC RHINITIS-ALLERGIC RHINO-CONJUNCTIVITIS
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| AZELASTINE HYDROCHLORIDE | 0.137MG/SPRAY | spray, metered · nasal | APOTEX INC | Prescription | 30 Apr 2009 |
| AZELASTINE HYDROCHLORIDE | 0.05% | solution/drops · ophthalmic | APOTEX | Prescription | 3 Aug 2009 |
| AZELASTINE HYDROCHLORIDE | 0.05% | solution/drops · ophthalmic | SANDOZ | Prescription | 31 May 2012 |
| AZELASTINE HYDROCHLORIDE | 0.137MG/SPRAY | spray, metered · nasal | ZYDUS PHARMS | Prescription | 14 Aug 2017 |
| AZELASTINE HYDROCHLORIDE | 0.137MG/SPRAY | spray, metered · nasal | ALKEM LABS LTD | Prescription | 18 Aug 2017 |
| AZELASTINE HYDROCHLORIDE | 0.137MG/SPRAY | spray, metered · nasal | AMNEAL | Prescription | 28 Aug 2017 |
| AZELASTINE HYDROCHLORIDE | 0.05% | solution/drops · ophthalmic | ALEMBIC | Prescription | 20 Mar 2019 |
| AZELASTINE HYDROCHLORIDE | 0.05% | solution/drops · ophthalmic | SOMERSET THERAPS LLC | Prescription | 29 Mar 2019 |
| AZELASTINE HYDROCHLORIDE | 0.137MG/SPRAY | spray, metered · nasal | EPIC PHARMA LLC | Prescription | 17 May 2019 |
| AZELASTINE HYDROCHLORIDE | 0.05% | solution/drops · ophthalmic | GLAND | Prescription | 25 Feb 2020 |
| AZELASTINE HYDROCHLORIDE | 0.137MG/SPRAY | spray, metered · nasal | AUROBINDO PHARMA LTD | Prescription | 8 May 2020 |
| ASTEPRO ALLERGY | 0.2055MG/SPRAY | spray, metered · nasal | BAYER HLTHCARE | Over-the-counter | 17 Jun 2021 |
| CHILDREN'S ASTEPRO ALLERGY | 0.2055MG/SPRAY | spray, metered · nasal | BAYER HLTHCARE | Over-the-counter | 17 Jun 2021 |
| AZELASTINE HYDROCHLORIDE ALLERGY | 0.2055MG/SPRAY | spray, metered · nasal | APOTEX | Over-the-counter | 29 May 2024 |
| AZELASTINE HYDROCHLORIDE CHILDREN'S ALLERGY | 0.2055MG/SPRAY | spray, metered · nasal | APOTEX | Over-the-counter | 29 May 2024 |
| AZELASTINE HYDROCHLORIDE ALLERGY | 0.2055MG/SPRAY | spray, metered · nasal | AUROBINDO PHARMA | Over-the-counter | 27 Jan 2025 |
| ASTELIN | 0.137MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | spray, metered · nasal | RISING | Discontinued | 1 Nov 1996 |
| OPTIVAR | 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | solution/drops · ophthalmic | RISING | Discontinued | 22 May 2000 |
| ASTEPRO | 0.137MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 0.2055MG/SPRAY | spray, metered · nasal | VIATRIS | Discontinued | 15 Oct 2008 |
| AZELASTINE HYDROCHLORIDE | 0.05% | solution/drops · ophthalmic | SUN PHARM | Discontinued | 21 Jun 2010 |
| AZELASTINE HYDROCHLORIDE | 0.137MG/SPRAY | spray, metered · nasal | SUN PHARM | Discontinued | 23 May 2012 |
| AZELASTINE HYDROCHLORIDE | 0.2055MG/SPRAY | spray, metered · nasal | APOTEX INC | Discontinued | 31 Aug 2012 |
| AZELASTINE HYDROCHLORIDE | 0.2055MG/SPRAY | spray, metered · nasal | PADAGIS ISRAEL | Discontinued | 8 May 2014 |
| AZELASTINE HYDROCHLORIDE | 0.137MG/SPRAY | spray, metered · nasal | HIKMA PHARMS | Discontinued | 24 Oct 2014 |
| AZELASTINE HYDROCHLORIDE | 0.137MG/SPRAY | spray, metered · nasal | BIONPHARMA | Discontinued | 28 Jul 2015 |
8 more — full table
Prices — United States and England
| Source | Product as listed | Price | Unit / pack | Date |
|---|---|---|---|---|
| US NADAC | AZELASTINE 0.1% (137 MCG) SPRY | $0.27283 | per ML | 23 Sep 2026 |
| US NADAC | AZELASTINE HCL 0.05% DROPS | $1.01239 | per ML | 23 Sep 2026 |
| NHS Drug Tariff | Azelastine 0.05% eye drops | £6.80 | 8 ml | 1 Oct 2026 |
| NHS Drug Tariff | Azelastine 140micrograms/dose nasal spray | £10.50 | 22 ml | 1 Oct 2026 |
| NHS Drug Tariff | Azelastine 210micrograms/dose nasal spray | £9.90 | 20 ml | 1 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.
Safety signals and safety-related labeling changes
- US FDA 17 Dec 2024 DYMISTA — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - US FDA 28 Jun 2021 ASTEPRO — safety-related labeling change
Labeling sections changed: Use in Specific Populations - US FDA 6 Sep 2018 ASTELIN — safety-related labeling change
Labeling sections changed: Use in Specific Populations
Combinations containing Azelastine
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.