Data updated: Mar 10, 2026
AZELASTINE HYDROCHLORIDE
AZELASTINE HYDROCHLORIDE
Approved 2009-04-30
25
Indications
--
Phase 3 Trials
16
Years on Market
Details
- Status
- Discontinued
- First Approved
- 2009-04-30
- Routes
- OPHTHALMIC, NASAL
- Dosage Forms
- SOLUTION/DROPS, SPRAY, METERED
Companies
EPIC PHARMA LLC Aurobindo Pharma Apotex BIONPHARMA Hikma ALEMBIC Sun Pharma AMNEAL Novartis SOMERSET THERAPS LLC PADAGIS US ZYDUS PHARMS GLAND PADAGIS ISRAEL ALKEM LABS LTD SCIEGEN PHARMS
Active Ingredient: AZELASTINE HYDROCHLORIDE
Website: ↗
AZELASTINE HYDROCHLORIDE Approval History
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What AZELASTINE HYDROCHLORIDE Treats
25 FDA approvalsOriginally approved for its first indication in 2009 . Covers 25 distinct patient populations.
- Other (25)
Other
(25 approvals)- • Approved indication (Apr 2009)Letter
- • Approved indication (Aug 2009)
- • Approved indication (Jun 2010)
- • Approved indication (May 2012)
- • Approved indication (May 2012)
- • Approved indication (Aug 2012)
- • Approved indication (May 2014)
- • Approved indication (Oct 2014)
- • Approved indication (Jul 2015)
- • Approved indication (Nov 2016)
- • Approved indication (Mar 2017)
- • Approved indication (Aug 2017)
- • Approved indication (Aug 2017)
- • Approved indication (Aug 2017)
- • Approved indication (Sep 2017)
- • Approved indication (Dec 2017)
- • Approved indication (Mar 2019)
- • Approved indication (Mar 2019)
- • Approved indication (May 2019)
- • Approved indication (Aug 2019)
- • Approved indication (Feb 2020)
- • Approved indication (May 2020)
- • Approved indication (Nov 2020)
- • Approved indication (May 2024)
- • Approved indication (Jun 2024)
🔬
Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
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 FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.