FDA Approval Activities for this Drug…

Astelin (azelastine hydrochloride) Nasal Spray, Wallace NDA 20-114/S-005 5/30/00 6/6/00 Astelin Indications: Treatment of the symptoms of seasonal allergic sneezing, and nasal pruritus in adults and children 5 years and older (NOTE: Previously approved for 12 years and older). Astelin (azelastine hydrochloride) Nasal Spray, Wallace NDA 20-114/S-006 OPTIVAR (azelastine hydrochloride ophthalmic solution), 0.05%, ASTA Medica, NDA 21-127 5/22/00 5/23/00 5/23/00 2/15/02 Optivar Indications: Treatment of itching of the eye, associated with allergic conjunctivitis. AZELASTINE HYDROCHLORIDE Solution/Drops; Ophthalmic 0.05% OPTIVAR MEDPOINTE HLC 020114 AZELASTINE HYDROCHLORIDE Spray, Metered; Nasal 0.125MG BASE/SPRAY ASTELIN MEDPOINTE HLC OPTIVAR (azelastine hydrochloride ophthalmic solution), MedPointe, Labeling Revision

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