FDA Drug Application (021485) for STALEVO 50 by ORION PHARMA

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Application Number021485
Product Number001
FormTABLET;ORAL
Dosage12.5MG;200MG;50MG
Product Market Status Prescription
Therapeutic Equivalence Evaluation Code AB Products meeting necessary bioequivalence requirements
Reference Drug
Drug NameSTALEVO 50
Active IngredientCARBIDOPA; ENTACAPONE; LEVODOPA

Active IngredientCount
List of drugs with Active Ingredient CARBIDOPA16
List of drugs with Active Ingredient ENTACAPONE9
List of drugs with Active Ingredient LEVODOPA17


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