Drug
Who makes azelastine hydrochloride and fluticasone propionate?
4 companies list azelastine hydrochloride and fluticasone propionate as a human prescription drug, including under the names DYMISTA. 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 hydrochloride and fluticasone propionate
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| Viatris Inc.India | spray, metered | NDANDA202236 | 1 | 18 |
| Apotex Inc.Canada | spray, metered | ANDAANDA207712 | 1 | 6 |
| Teva Pharmaceutical Industries Ltd.Canada | spray, metered | ANDAANDA208436 | 1 | 6 |
| Mylan Pharmaceuticals, Inc. | spray, metered | NDA AUTHORIZED GENERICNDA202236 | 1 | 0 |
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Common questions
- Who makes azelastine hydrochloride and fluticasone propionate?
- 4 companies list azelastine hydrochloride and fluticasone propionate as a human prescription drug in the openFDA NDC Directory, led by Viatris Inc., Apotex Inc., Teva Pharmaceutical Industries Ltd., Mylan Pharmaceuticals, Inc.. 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 DYMISTA?
- 2 companies list azelastine hydrochloride and fluticasone propionate under an abbreviated new drug application (ANDA), the application type used for generics, and 1 under an NDA or BLA. Listing status is from the NDC Directory; it is not a statement of availability.