FDA Drug Application (021485) for STALEVO 125 by ORION PHARMA

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Application Number021485
Product Number006
FormTABLET;ORAL
Dosage31.25MG;200MG;125MG
Product Market Status Prescription
Therapeutic Equivalence Evaluation Code AB Products meeting necessary bioequivalence requirements
Reference Drug
Drug NameSTALEVO 125
Active IngredientCARBIDOPA; ENTACAPONE; LEVODOPA



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