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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 078621

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NDA 078621 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 078621

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

Pharmacology for NDA: 078621

Mechanism of Action	Histamine H1 Receptor Antagonists

Suppliers and Packaging for NDA: 078621

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
AZELASTINE HYDROCHLORIDE	azelastine hydrochloride	SOLUTION/DROPS;OPHTHALMIC	078621	ANDA	Apotex Corp.	60505-0578	60505-0578-4	1 BOTTLE, PLASTIC in 1 CARTON (60505-0578-4) / 6 mL in 1 BOTTLE, PLASTIC

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION/DROPS;OPHTHALMIC			Strength	0.05%
Approval Date:	Aug 3, 2009	TE:	AT	RLD:	No

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