Details for New Drug Application (NDA): 216576

NDA 216576 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 216576

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

Pharmacology for NDA: 216576

Mechanism of Action

Histamine H1 Receptor Antagonists

Suppliers and Packaging for NDA: 216576

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
AZELASTINE HYDROCHLORIDE	azelastine hydrochloride	SPRAY, METERED;NASAL	216576	ANDA	Amneal Pharmaceuticals NY LLC	69238-2147	69238-2147-3	200 CARTON in 1 BOTTLE (69238-2147-3) / 1 SPRAY, METERED in 1 CARTON

Profile for product number 001

Active Rx/OTC/Discontinued:	OTC	Dosage:	SPRAY, METERED;NASAL			Strength	0.2055MG/SPRAY
Approval Date:	Jun 5, 2024	TE:		RLD:	No

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