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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 210092


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NDA 210092 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 210092
Tradename:AZELASTINE HYDROCHLORIDE
Applicant:Gland
Ingredient:azelastine hydrochloride
Patents:0
Pharmacology for NDA: 210092
Mechanism of ActionHistamine 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
AZELASTINE HYDROCHLORIDE azelastine hydrochloride SOLUTION/DROPS;OPHTHALMIC 210092 ANDA Fosun Pharma USA Inc 72266-141 72266-141-01 1 BOTTLE, PLASTIC in 1 CARTON (72266-141-01) / 6 mL in 1 BOTTLE, PLASTIC

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION/DROPS;OPHTHALMICStrength0.05%
Approval Date:Feb 25, 2020TE:ATRLD:No

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Preferred Citation:

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