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Last Updated: December 18, 2025

Details for New Drug Application (NDA): 216561


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NDA 216561 describes AZELASTINE HYDROCHLORIDE ALLERGY, which is a drug marketed by Apotex and Aurobindo Pharma and is included in two NDAs. It is available from four suppliers. Additional details are available on the AZELASTINE HYDROCHLORIDE ALLERGY profile page.

The generic ingredient in AZELASTINE HYDROCHLORIDE ALLERGY is azelastine hydrochloride. There are twelve drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the azelastine hydrochloride profile page.
Summary for 216561
Tradename:AZELASTINE HYDROCHLORIDE ALLERGY
Applicant:Aurobindo Pharma
Ingredient:azelastine hydrochloride
Patents:0
Pharmacology for NDA: 216561
Mechanism of ActionHistamine H1 Receptor Antagonists
Suppliers and Packaging for NDA: 216561
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AZELASTINE HYDROCHLORIDE ALLERGY azelastine hydrochloride SPRAY, METERED;NASAL 216561 ANDA Aurohealth LLC 58602-020 58602-020-07 1 BOTTLE, SPRAY in 1 CARTON (58602-020-07) / 200 SPRAY, METERED in 1 BOTTLE, SPRAY
AZELASTINE HYDROCHLORIDE ALLERGY azelastine hydrochloride SPRAY, METERED;NASAL 216561 ANDA Aurohealth LLC 58602-020 58602-020-51 1 BOTTLE, SPRAY in 1 CARTON (58602-020-51) / 60 SPRAY, METERED in 1 BOTTLE, SPRAY

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:SPRAY, METERED;NASALStrength0.2055MG/SPRAY
Approval Date:Jan 27, 2025TE:RLD:No

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2025, www.DrugPatentWatch.com.
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