Wednesday, July 8, 2026

Drug profile · INN

azelastine hydrochloride

azelastine hydrochloride (DYMISTA) is a histamine h1 receptor antagonist. Associated with Amneal Pharma Europe Ltd. Route of administration: ophthalmic. Current US regulatory status: approved.

FDA: approved
US status approved
Patents linked 0
Pipeline programs 1
News articles 0
Drug details — azelastine hydrochloride
US status
approved
Class
Route
OPHTHALMIC
Patents
0
Programs
1
Data quality
0.89

Quick answer

azelastine hydrochloride (DYMISTA) is a histamine h1 receptor antagonist. Associated with Amneal Pharma Europe Ltd. Route of administration: ophthalmic. Current US regulatory status: approved.

Key facts

INN azelastine hydrochloride
Brand DYMISTA
Mechanism Histamine H1 receptor antagonist
Target Histamine H1 receptor
Route OPHTHALMIC
Formulation SOLUTION/DROPS

Mechanism of action

Histamine H1 receptor antagonist

Primary target: Histamine H1 receptor

Approval history

Authority Status Date
FDA approved

Pipeline programs

  1. Azelastine hydrochloride and Fluticasone propionate Phase 3 · Teva Pharma · Seasonal Allergic Rhinitis

Related & competitor drugs

  1. brompheniramine maleate Histamine H1 receptor antagonist
  2. carbinoxamine maleate Histamine H1 receptor antagonist
  3. cetirizine hydrochloride Histamine H1 receptor antagonist
  4. chlorpheniramine maleate Histamine H1 receptor antagonist
  5. clemastine fumarate Histamine H1 receptor antagonist
  6. cyproheptadine hydrochloride Histamine H1 receptor antagonist

Frequently asked questions

What is azelastine hydrochloride?

azelastine hydrochloride (DYMISTA) is a histamine h1 receptor antagonist. Associated with Amneal Pharma Europe Ltd. Route of administration: ophthalmic. Current US regulatory status: approved.

What is the brand name for azelastine hydrochloride?

DYMISTA is a marketed brand name for azelastine hydrochloride. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of azelastine hydrochloride?

azelastine hydrochloride has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.