FDA Drug Application (021802) for FOCALIN XR by NOVARTIS

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Application Number021802
Product Number001
FormCAPSULE, EXTENDED RELEASE;ORAL
Dosage5MG
Product Market Status Prescription
Therapeutic Equivalence Evaluation Code AB Products meeting necessary bioequivalence requirements
Reference Drug
Drug NameFOCALIN XR
Active IngredientDEXMETHYLPHENIDATE HYDROCHLORIDE



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