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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 091444

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NDA 091444 describes AZELASTINE HYDROCHLORIDE, which is a drug marketed by Alembic, Apotex, Epic Pharma Llc, Gland, Sandoz, Somerset Theraps Llc, Sun Pharm, Alkem Labs Ltd, Amneal, Apotex Inc, Aurobindo Pharma Ltd, Bionpharma, Hikma, Padagis Israel, Padagis Us, Sciegen Pharms Inc, Zydus Pharms, Aurobindo Pharma, and Teva Pharms Usa Inc, and is included in thirty NDAs. It is available from seventeen suppliers. Additional details are available on the AZELASTINE HYDROCHLORIDE profile page.

The generic ingredient in AZELASTINE HYDROCHLORIDE is azelastine hydrochloride; fluticasone propionate. There are twelve drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the azelastine hydrochloride; fluticasone propionate profile page.

Summary for 091444

Tradename:	AZELASTINE HYDROCHLORIDE
Applicant:	Hikma
Ingredient:	azelastine hydrochloride
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SPRAY, METERED;NASAL			Strength	0.137MG/SPRAY
Approval Date:	Oct 24, 2014	TE:		RLD:	No

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