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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 209620


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NDA 209620 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 209620
Tradename:AZELASTINE HYDROCHLORIDE
Applicant:Alembic
Ingredient:azelastine hydrochloride
Patents:0
Pharmacology for NDA: 209620
Mechanism of ActionHistamine 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 Limited 46708-506 46708-506-06 1 BOTTLE in 1 CARTON (46708-506-06) / 6 mL in 1 BOTTLE
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:RXDosage:SOLUTION/DROPS;OPHTHALMICStrength0.05%
Approval Date:Mar 20, 2019TE:ATRLD:No

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2025, www.DrugPatentWatch.com.
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