TheraRadar
Data updated: May 26, 2026

AZELASTINE HYDROCHLORIDE ALLERGY (azelastine hydrochloride)

Respiratory Approved 2024-05-29
Jump to: Indications Approvals Trials Competitors Safety Patents
2
Indications
--
Phase 3 Trials
1
Years on Market

Details

Status
Over-the-counter
First Approved
2024-05-29
Routes
NASAL
Dosage Forms
SPRAY, METERED

Companies

Aurobindo Pharma Apotex
Active Ingredient: AZELASTINE HYDROCHLORIDE

AZELASTINE HYDROCHLORIDE ALLERGY Approval History

2025
2026
Original
New Indication
New Form
Label Update
2 FDA actions from 2024 to 2025
Jan 2025 ORIGINAL
Update
FDA Letter
May 2024 ORIGINAL
Update
FDA Letter

What AZELASTINE HYDROCHLORIDE ALLERGY Treats

2 FDA approvals

Originally approved for its first indication in 2024 . Covers 2 distinct patient populations.

  • Other (2)
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Clinical Trial Registry

3 trials
Trial Sponsor ID Phase Status Title
NCT05887843 SAN-0791 2023-000362-34 Ph 1 terminated Study to Compare the Pharmacokinetics of Fixed-Dose Combination of Mometasone + Azelastine Nasal Spray to Mometasone and Azelastine Nasal Sprays in Adolescents and Young Adults With Seasonal Allergic Rhinitis
NCT04729517 HILARIA Aİ-2019-01 Ph 3 completed Efficacy and Safety Study of AI201901 in Allergic Rhinitis Patients
NCT00612118 IPR110982 Ph 2 completed A Phase II Study Evaluating Intranasal GSK256066 and Azelastine Hydrochloride in Subjects With Seasonal Allergic Rhinitis
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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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📊

Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

AZELASTINE HYDROCHLORIDE ALLERGY FDA Label Details

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Data Sources

FDA Approval: ANDA216561 → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.