FDA Drug Application (021303) for ADDERALL XR 25 by SHIRE

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Application Number021303
Product Number004
FormCAPSULE, EXTENDED RELEASE;ORAL
Dosage6.25MG;6.25MG;6.25MG;6.25MG
Product Market Status Prescription
Therapeutic Equivalence Evaluation Code AB Products meeting necessary bioequivalence requirements
Reference Drug
Drug NameADDERALL XR 25
Active IngredientAMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE



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