FDA Drug Application (019865) for BETAPACE by COVIS PHARMA SARL

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Application Number019865
Product Number001
FormTABLET;ORAL
Dosage80MG
Product Market Status Prescription
Therapeutic Equivalence Evaluation Code AB1 Products meeting necessary bioequivalence requirements
Reference Drug
Drug NameBETAPACE
Active IngredientSOTALOL HYDROCHLORIDE



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