Azelastine Hydrochloride

Sold as Astelin, Optivar, Astepro, Astepro Allergy, Children'S Astepro Allergy. Every FDA application for this active ingredient: 4 branded and 27 generic.

As of Nov 15, 2026, FDA lists 31 applications for Azelastine Hydrochloride (sold as Astelin, Optivar, Astepro and others), first approved Nov 1, 1996, with 6 new uses approved and 0 published complete response letters.

First approved: Nov 1, 1996
Applications: 31
New uses approved: 6
Complete response letters: 0
Medicare spending, 2025: $94.8M

Medicare Spending

CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name

Product	Part	Spending, 2025	Change	Beneficiaries
Azelastine HCl	Part D	$94.8M	+10%	1,542,995

What Pharmacies Pay

Median price per unit across package codes in CMS's weekly NADAC survey, Nov 11, 2026, before rebates; see every drug's price change

AZELASTINE 0.1% (137 MCG) SPRY: $0.266 per MLGeneric · -7% in a year
AZELASTINE HCL 0.05% DROPS: $0.973 per MLGeneric · 0% in a year

Clinical Trials

3 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all


Thermosensitive Gel Nasal Spray With Exosomes, Azelastine, and Interferon for Acute Phase of Chronic SinusitisChronic Rhinosinusitis Without Polyps · The First Affiliated Hospital of Xinxiang Medical College	Early phase 1	Not yet recruiting	Jun 9, 2026
Thermosensitive Gel Nasal Spray With Stem Cell Exosomes, Mupirocin, and DNase I for Chronic SinusitisChronic Rhinosinusitis With Nasal Polyps · The First Affiliated Hospital of Xinxiang Medical College	Early phase 1	Not yet recruiting	Jun 9, 2026
INTRANASAL FLUTICASONE VERSUS FLUTICASONE-AZELASTINE COMBINATIONAllergic Rhinitis · Pamukkale University	Phase 4	Active, not recruiting	Feb 17, 2026

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history


Nov 1, 1996	AstelinNDA 20114 · New molecular entity	Rising	12	Discontinued
May 22, 2000	OptivarNDA 21127 · New dosage form	Rising	7	Discontinued
Oct 15, 2008	AsteproNDA 22203 · New formulation or manufacturer	Viatris	9	Discontinued
Apr 30, 2009	Azelastine HydrochlorideANDA 77954	Apotex Inc	3	Marketed
Aug 3, 2009	Azelastine HydrochlorideANDA 78621	Apotex	0	Marketed
Jun 21, 2010	Azelastine HydrochlorideANDA 78738	Sun Pharm	0	Discontinued
May 23, 2012	Azelastine HydrochlorideANDA 90423	Sun Pharm	3	Discontinued
May 31, 2012	Azelastine HydrochlorideANDA 202305	Sandoz	0	Marketed
Aug 31, 2012	Azelastine HydrochlorideANDA 201846	Apotex Inc	3	Discontinued
May 8, 2014	Azelastine HydrochlorideANDA 202743	Padagis Israel	2	Discontinued
Oct 24, 2014	Azelastine HydrochlorideANDA 91444	Hikma	2	Discontinued
Jul 28, 2015	Azelastine HydrochlorideANDA 90176	Bionpharma	3	Discontinued
Nov 8, 2016	Azelastine HydrochlorideANDA 203660	Epic Pharma LLC	0	Discontinued
Mar 17, 2017	Azelastine HydrochlorideANDA 202609	Padagis US	0	Discontinued
Aug 14, 2017	Azelastine HydrochlorideANDA 91409	Zydus Pharms	1	Marketed
Aug 18, 2017	Azelastine HydrochlorideANDA 208156	Alkem Labs Ltd	1	Marketed
Aug 28, 2017	Azelastine HydrochlorideANDA 204660	Amneal	1	Marketed
Sep 22, 2017	Azelastine HydrochlorideANDA 207243	Hikma	1	Discontinued
Dec 15, 2017	Azelastine HydrochlorideANDA 208199	Amneal	0	Discontinued
Mar 20, 2019	Azelastine HydrochlorideANDA 209620	Alembic	0	Marketed
Mar 29, 2019	Azelastine HydrochlorideANDA 207411	Somerset Theraps LLC	2	Marketed
May 17, 2019	Azelastine HydrochlorideANDA 207610	Epic Pharma LLC	0	Marketed
Aug 23, 2019	Azelastine HydrochlorideANDA 210032	Sciegen Pharms	0	Discontinued
Feb 25, 2020	Azelastine HydrochlorideANDA 210092	Gland	0	Marketed
May 8, 2020	Azelastine HydrochlorideANDA 212289	Aurobindo Pharma Ltd	0	Marketed
Nov 12, 2020	Azelastine HydrochlorideANDA 212775	Aurobindo Pharma Ltd	0	Discontinued
Jun 17, 2021	Astepro Allergy, Children'S Astepro AllergyNDA 213872 · TYPE 8	Bayer Hlthcare	3	Marketed
May 8, 2024	Azelastine HydrochlorideANDA 216801	Padagis Israel	0	Discontinued
May 29, 2024	Azelastine Hydrochloride Allergy, Azelastine Hydrochloride Children'S AllergyANDA 216421	Apotex	0	Marketed
Jun 5, 2024	Azelastine HydrochlorideANDA 216576	Amneal	0	Discontinued
Jan 27, 2025	Azelastine Hydrochloride AllergyANDA 216561	Aurobindo Pharma	0	Marketed

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA