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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 091444

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NDA 091444 describes AZELASTINE HYDROCHLORIDE, which is a drug marketed by Alembic, Apotex Inc, Epic Pharma Llc, Gland Pharma Ltd, Sandoz, Somerset Theraps Llc, Sun Pharm, Alkem Labs Ltd, Amneal, Aurobindo Pharma Ltd, Bionpharma, Hikma, Padagis Israel, Sciegen Pharms Inc, Upsher Smith Labs, Zydus Pharms, and Apotex, and is included in twenty-eight NDAs. It is available from nineteen 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. Five 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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