Details for New Drug Application (NDA): 209620

NDA 209620 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 209620

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

Pharmacology for NDA: 209620

Mechanism of Action

Histamine H1 Receptor Antagonists

Suppliers and Packaging for NDA: 209620

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
AZELASTINE HYDROCHLORIDE	azelastine hydrochloride	SOLUTION/DROPS;OPHTHALMIC	209620	ANDA	Alembic Pharmaceuticals Inc.	62332-506	62332-506-06	1 BOTTLE in 1 CARTON (62332-506-06) / 6 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION/DROPS;OPHTHALMIC			Strength	0.05%
Approval Date:	Mar 20, 2019	TE:	AT	RLD:	No

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