You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: December 30, 2025

Details for New Drug Application (NDA): 203660

✉ Email this page to a colleague

« Back to Dashboard

NDA 203660 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 203660

Tradename:	AZELASTINE HYDROCHLORIDE
Applicant:	Epic Pharma Llc
Ingredient:	azelastine hydrochloride
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SOLUTION/DROPS;OPHTHALMIC			Strength	0.05%
Approval Date:	Nov 8, 2016	TE:		RLD:	No

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.