FDA Drug Application (079165) for ROPINIROLE HYDROCHLORIDE by APOTEX

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Application Number079165
Product Number001
FormTABLET;ORAL
DosageEQ 0.25MG BASE
Product Market Status Prescription
Therapeutic Equivalence Evaluation Code AB Products meeting necessary bioequivalence requirements
Reference Drug
Drug NameROPINIROLE HYDROCHLORIDE
Active IngredientROPINIROLE HYDROCHLORIDE



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