FDA Drug Application (021513) for ENABLEX by APIL

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Application Number021513
Product Number001
FormTABLET, EXTENDED RELEASE;ORAL
DosageEQ 7.5MG BASE
Product Market Status Prescription
Therapeutic Equivalence Evaluation Code AB Products meeting necessary bioequivalence requirements
Reference Drug
Drug NameENABLEX
Active IngredientDARIFENACIN HYDROBROMIDE



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