Azelastine Hydrochloride

AvKARE🇺🇸 United States

FDA Page

Effective Date: Jan 14, 2026
Approval ID: bca75501-4140-4d77-e053-2a95a90a019f
Products: 1 registered
Version: 3

Regulatory Information

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Status

Approved

Full Title

AZELASTINE HYDROCHLORIDE nasal spray, for intranasal use These highlights do not include all the information needed to use AZELASTINE HYDROCHLORIDE NASAL SPRAY safely and effectively. See full prescribing information for AZELASTINE HYDROCHLORIDE NASAL SPRAY. Initial U.S. Approval: 1996

Quick Stats

Total Products1

Labelers2

Label Sections21

Regulatory Agency

🇺🇸

U.S. Food and Drug Administration

United States

Data Sources & Disclaimer: Approval information is sourced from official FDA databases. This content is for informational purposes only and does not constitute medical or regulatory advice. Always refer to official FDA websites for the most current information.