APPLICATION
ANDA216561
TYPE
ANDA
ORIGINAL APPROVAL
2025-01-27
LATEST ACTION
2025-01-27
ROUTE
NASAL
DOSAGE FORM
SPRAY, METERED
MARKETING STATUS
Over-the-counter
Products
AZELASTINE HYDROCHLORIDE ALLERGYOver-the-counter
AZELASTINE HYDROCHLORIDE 0.2055MG/SPRAY · SPRAY, METERED · NASAL
Approval history
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
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