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FDA NDA · NDA213872

ASTEPRO ALLERGY

azelastine hcl

Sponsor: BAYER HLTHCARE

APPLICATION
NDA213872
TYPE
NDA
ORIGINAL APPROVAL
2021-06-17
LATEST ACTION
2025-10-27
ROUTE
NASAL
DOSAGE FORM
SPRAY, METERED
MARKETING STATUS
Over-the-counter

Products

ASTEPRO ALLERGY · ReferenceOver-the-counter
AZELASTINE HYDROCHLORIDE 0.2055MG/SPRAY · SPRAY, METERED · NASAL
CHILDREN'S ASTEPRO ALLERGY · ReferenceOver-the-counter
AZELASTINE HYDROCHLORIDE 0.2055MG/SPRAY · SPRAY, METERED · NASAL

Approval history

2025-10-27Labeling · Supplement 5 · standard — Label ↗AP
2023-11-20Labeling · Supplement 4 · standard — Letter ↗AP
2021-11-01Manufacturing (CMC) · Supplement 1 — Letter ↗AP
2021-06-17Type 8 - Partial Rx to OTC Switch · Original · standard — Letter ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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