FDA Drug Application (078127) for ONDANSETRON HYDROCHLORIDE by APOTEX

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Application Number078127
Product Number001
FormSOLUTION;ORAL
DosageEQ 4MG BASE/5ML
Product Market Status Prescription
Therapeutic Equivalence Evaluation Code AA Products in conventional dosage forms not presenting bioequivalence problems
Reference Drug
Drug NameONDANSETRON HYDROCHLORIDE
Active IngredientONDANSETRON HYDROCHLORIDE



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