Drug
Who makes azelastine?
3 companies list azelastine as a human prescription drug. Forms: spray, metered. Routes: nasal.
Labellers from the openFDA NDC Directory. A labeller is the firm named on the label, not necessarily the site that made the product, and a listing is not an FDA approval. Data as of 24 Sept 2026. Methodology
Companies listing azelastine
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| Amneal Ireland LimitedIreland | spray, metered | ANDAANDA204660 | 1 | 1 |
| ASCEND Therapeutics US, LLC | spray, metered | ANDAANDA208156 | 1 | 0 |
| AvKARE | spray, metered | ANDAANDA204660 | 1 | 0 |
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Common questions
- Who makes azelastine?
- 3 companies list azelastine as a human prescription drug in the openFDA NDC Directory, led by Amneal Ireland Limited, ASCEND Therapeutics US, LLC, AvKARE. Each is the labeller, the firm named on the label; the product may be made at a site registered to another company.
- Is there a generic azelastine?
- 3 companies list azelastine under an abbreviated new drug application (ANDA), the application type used for generics. Listing status is from the NDC Directory; it is not a statement of availability.