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Medicines · US (FDA)
Corticosteroids

FDA 2020

Antiallergic agents, excl. corticosteroids

Azelastine Hydrochloride

Approved 12 Nov 2020NasalSpray, metered

The FDA lists this product in 25 strengths and forms.

Official labelAsk Osler about it

On this page

Composition
Strengths and forms
Official product information

The table holds no label text for this product yet, only the facts beside it. The official product information has the full text.

Composition

Active ingredients: AZELASTINE HYDROCHLORIDE 0.2055MG/SPRAY

Strengths and forms

The FDA lists each strength of a product separately; these pages share one label.

AZELASTINE HYDROCHLORIDE 0.137MG/SPRAY · Spray, meteredANDA077954-001 · Prescription
AZELASTINE HYDROCHLORIDE 0.2055MG/SPRAY · Spray, meteredANDA210032-001 · Discontinued
AZELASTINE HYDROCHLORIDE 0.05% · Solution/dropsANDA210092-001 · Prescription
AZELASTINE HYDROCHLORIDE 0.2055MG/SPRAY · Spray, meteredThis page
AZELASTINE HYDROCHLORIDE 0.05% · Solution/dropsANDA078738-001 · Discontinued
AZELASTINE HYDROCHLORIDE 0.137MG/SPRAY · Spray, meteredANDA090176-001 · Discontinued
AZELASTINE HYDROCHLORIDE 0.05% · Solution/dropsANDA202305-001 · Prescription
AZELASTINE HYDROCHLORIDE 0.137MG/SPRAY · Spray, meteredANDA212289-001 · Prescription
AZELASTINE HYDROCHLORIDE 0.05% · Solution/dropsANDA209620-001 · Prescription

More in corticosteroids

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Two medicines in one question?

Name two or more medicines and Osler runs an interaction check. A severe interaction is stated at the very top of the answer.

AZELASTINE HYDROCHLORIDE 0.137MG/SPRAY · Spray, meteredANDA090423-001 · Discontinued

AZELASTINE HYDROCHLORIDE 0.137MG/SPRAY · Spray, meteredANDA091444-001 · Discontinued

AZELASTINE HYDROCHLORIDE 0.137MG/SPRAY · Spray, meteredANDA202609-001 · Discontinued

AZELASTINE HYDROCHLORIDE 0.137MG/SPRAY · Spray, meteredANDA204660-001 · Prescription

AZELASTINE HYDROCHLORIDE 0.137MG/SPRAY · Spray, meteredANDA208156-001 · Prescription

AZELASTINE HYDROCHLORIDE 0.2055MG/SPRAY · Spray, meteredANDA202743-001 · Discontinued

AZELASTINE HYDROCHLORIDE 0.2055MG/SPRAY · Spray, meteredANDA216801-001 · Discontinued

AZELASTINE HYDROCHLORIDE 0.137MG/SPRAY · Spray, meteredANDA091409-001 · Prescription

AZELASTINE HYDROCHLORIDE 0.2055MG/SPRAY · Spray, meteredANDA201846-001 · Discontinued

AZELASTINE HYDROCHLORIDE 0.05% · Solution/dropsANDA203660-001 · Discontinued

AZELASTINE HYDROCHLORIDE 0.2055MG/SPRAY · Spray, meteredANDA208199-001 · Discontinued

AZELASTINE HYDROCHLORIDE 0.05% · Solution/dropsANDA078621-001 · Prescription

AZELASTINE HYDROCHLORIDE 0.137MG/SPRAY · Spray, meteredANDA207610-001 · Prescription

AZELASTINE HYDROCHLORIDE 0.2055MG/SPRAY · Spray, meteredANDA207243-001 · Discontinued

AZELASTINE HYDROCHLORIDE 0.05% · Solution/dropsANDA207411-001 · Prescription

AZELASTINE HYDROCHLORIDE 0.2055MG/SPRAY · Spray, meteredANDA216576-001 · Discontinued

Official product information

Drugs@FDA lists the approved labels, letters and reviews for application ANDA212775.

Prognia shows this product information for reference and learning. It is not treatment advice and can lag behind the official text. Always check the current product information and local protocols before prescribing.

At a glance

Brand name: Azelastine Hydrochloride
Drug class: Antiallergic agents, excl. corticosteroids, Other antihistamines for systemic use, Other antiallergics
Group: Corticosteroids
Route: Nasal
Dosage form: Spray, metered
Applicant: Aurobindo Pharma LTD
Status: Discontinued
FDA approval: 12 Nov 2020
Application: ANDA212775-001
RxCUI: 235824

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