Details for New Drug Application (NDA): 210092

NDA 210092 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 210092

Tradename:	AZELASTINE HYDROCHLORIDE
Applicant:	Gland Pharma Ltd
Ingredient:	azelastine hydrochloride
Patents:	0

Pharmacology for NDA: 210092

Mechanism of Action

Histamine H1 Receptor Antagonists

Suppliers and Packaging for NDA: 210092

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
AZELASTINE HYDROCHLORIDE	azelastine hydrochloride	SOLUTION/DROPS;OPHTHALMIC	210092	ANDA	Gland Pharma Limited	68083-287	68083-287-01	1 BOTTLE, PLASTIC in 1 BOX (68083-287-01) / 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:	Feb 25, 2020	TE:	AT	RLD:	No

Complete Access Available with Subscription