FDA Drug Application (077954) for AZELASTINE HYDROCHLORIDE by APOTEX INC

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Application Number077954
Product Number001
FormSPRAY, METERED;NASAL
DosageEQ 0.125MG BASE/SPRAY
Product Market Status Prescription
Therapeutic Equivalence Evaluation Code AB Products meeting necessary bioequivalence requirements
Reference Drug
Drug NameAZELASTINE HYDROCHLORIDE
Active IngredientAZELASTINE HYDROCHLORIDE



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