Active ingredient
Azelastine
29 finished FDA listings contain Azelastine as their only active ingredient; 7 combination products also contain it.
FDA NDC Directory
- Ingredient names as written by FDA
- AZELASTINE HYDROCHLORIDE
- Dosage forms
- Solution/ Drops, Spray, Metered
- Routes
- Intraocular, Nasal, Ophthalmic
- Manufacturers / labelers
- 23
- Strengths listed
- .5 mg/ml · 1 mg/ml · 137 ug/1 · 205.5 ug/1
- Brand names in FDA listings
- Astepro Allergy, Azelastine Hcl, Azelastine Hydrochloride, Children Astepro Allergy
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 18603
Drugs@FDA applications
Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| ANDA 077954 | APOTEX INC | 2009-04-30 | 4 |
| ANDA 078621 | APOTEX | 2009-08-03 | 1 |
| ANDA 078738 | SUN PHARM | 2010-06-21 | 1 |
| ANDA 090423 | SUN PHARM | 2012-05-23 | 1 |
| ANDA 202305 | SANDOZ | 2012-05-31 | 1 |
| ANDA 208156 | ALKEM LABS LTD | 2017-08-18 | 1 |
| ANDA 204660 | AMNEAL | 2017-08-28 | 2 |
| ANDA 209620 | ALEMBIC | 2019-03-20 | 2 |
| ANDA 207411 | SOMERSET THERAPS LLC | 2019-03-29 | 1 |
| ANDA 210092 | GLAND | 2020-02-25 | 2 |
| ANDA 212289 | AUROBINDO PHARMA LTD | 2020-05-08 | 4 |
| NDA 213872 | BAYER HLTHCARE | 2021-06-17 | 2 |
| ANDA 216421 | APOTEX | 2024-05-29 | 4 |
| ANDA 216576 | AMNEAL | 2024-06-05 | 1 |
| ANDA 216561 | AUROBINDO PHARMA | 2025-01-27 | 2 |
Official labeling on DailyMed
- AZELASTINE HYDROCHLORIDE SPRAY, METERED [APOTEX CORP. ] · version 14 · 2026-09-10
- AZELASTINE HYDROCHLORIDE SOLUTION/ DROPS [APOTEX CORP.] · version 11 · 2026-09-10
- AZELASTINE HYDROCHLORIDE SOLUTION/ DROPS [SANDOZ INC] · version 5 · 2026-09-04
- AZELASTINE HYDROCHLORIDE SPRAY, METERED [AUROHEALTH LLC] · version 3 · 2026-09-02
- AZELASTINE HYDROCHLORIDE SPRAY, METERED [CVS PHARMACY, INC] · version 6 · 2026-08-20
- AZELASTINE HYDROCHLORIDE SPRAY, METERED [YYBA CORP] · version 4 · 2026-07-24
- AZELASTINE HYDROCHLORIDE SOLUTION/ DROPS [FOSUN PHARMA USA INC] · version 6 · 2026-05-11
- AZELASTINE HYDROCHLORIDE SPRAY, METERED [WALGREENS] · version 6 · 2026-04-17
- AZELASTINE SPRAY, METERED [ASCEND LABORATORIES, LLC] · version 12 · 2026-03-27
- AZELASTINE HYDROCHLORIDE SPRAY, METERED [PREFERRED PHARMACEUTICALS INC.] · version 4 · 2026-03-12
- AZELASTINE HYDROCHLORIDE (AZELASTINE) SPRAY, METERED [AVKARE] · version 4 · 2026-01-15
- ASTEPRO ALLERGY (AZELASTINE HCL) SPRAY, METERED [BAYER HEALTHCARE LLC.] · version 8 · 2025-12-05
Showing the 12 most recent of 29 labels.
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.