NDC 70069-091

Azelastine Hydrochloride 0.5 mg per 1 mL solution/ drops

On the label: Somerset Therapeutics, LLC.

India: 1

Where it's made

FactoryWhereRoleLast FDA inspection
Somerset Therapeutics Private LimitedBengaluru, IndiaMakes it, tests it, packages it and labels it Serious problems, FDA actionFeb 21, 2025 · 10 inspections, 4 with FDA action

Product details

Generic drug
Azelastine: every company that makes it
Form
solution/ drops, ophthalmic
Strength
0.5 mg per 1 mL
Approval
ANDA ANDA207411
On the market since
Apr 8, 2019
Package NDCs
70069-091-01
Official label
DailyMed (National Library of Medicine), updated Sep 26, 2025

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