FDA Tentative Approval: AZELASTINE HYDROCHLORIDE — Original Application (Aurohealth LLC)

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Summary

FDA issued tentative approval for Aurohealth LLC's azelastine hydrochloride nasal spray (ANDA 216561), a generic product intended for allergic rhinitis, subject…

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Diseases / indications

• Allergic Rhinitis

Drugs mentioned

• Azelastine hydrochloride nasal spray (AZELASTINE HYDROCHLORIDE)

Snippet

ORIG TA for AZELASTINE HYDROCHLORIDE (AZELASTINE HYDROCHLORIDE)