FDA Drug Application (021121) for CONCERTA by JANSSEN PHARMS

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Application Number021121
Product Number001
FormTABLET, EXTENDED RELEASE;ORAL
Dosage18MG
Product Market Status Prescription
Therapeutic Equivalence Evaluation Code AB Products meeting necessary bioequivalence requirements
Reference Drug
Drug NameCONCERTA
Active IngredientMETHYLPHENIDATE HYDROCHLORIDE



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