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Last Updated: January 24, 2026

Generic Companies with Tentative Approvals for: azelastine hydrochloride

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azelastine hydrochloride Generic Filers with Tentative Approvals

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

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Glossary

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Applicant	Generic Name	NDA	Strength	Dosage Form
Aurobindo Pharma	azelastine hydrochloride	216561	0.2055MG/SPRAY	SPRAY, METERED;NASAL
>Applicant	>Generic Name	>NDA	>Strength	>Dosage Form

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