approval · primary record
AZELASTINE HYDROCHLORIDE
3 approval events · latest 2025-10-27
| Agency | FDA |
|---|---|
| Submission type | NDA |
| Latest action | 2025-10-27 |
| Approval events | 3 |
| Brand | ASTEPRO ALLERGY |
| Sponsor | BAYER HLTHCARE |
| Route | NASAL |
Approval history
3 actions on record. The drug is the stable record; each action below is an event with its own date, so this URL keeps working as new actions arrive.
| Date | Agency | Type | Brand | Sponsor | Route |
|---|---|---|---|---|---|
| 2025-10-27 | FDA | NDA | ASTEPRO ALLERGY | BAYER HLTHCARE | NASAL |
| 2025-09-18 | FDA | NDA | OPTIVAR | RISING | OPHTHALMIC |
| 2024-12-17 | FDA | NDA | DYMISTA | MYLAN SPECIALITY LP | NASAL |
Provenance
- Source: openFDA Drugs@FDA
- Fetched at: 2026-10-30T00:30:52.955Z
- Licence class: public-domain
- Verdict: primary-source
- Entity id: approval:azelastine-hydrochloride
This record is rendered from the AEaH spine. If the source is unreachable the page is not generated.
Same entity, elsewhere in the suite
- Azelastine Hydrochloride · compound