FDA Drug Application (091444) for AZELASTINE HYDROCHLORIDE by ROXANE

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Application Number091444
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

Active IngredientCount
List of drugs with Active Ingredient AZELASTINE HYDROCHLORIDE5


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