FDA Drug Application (079108) for DEXMETHYLPHENIDATE HYDROCHLORIDE by IMPAX LABS INC

Back to FDA Applications sponsored by IMPAX LABS INC

Application Number079108
Product Number001
FormCAPSULE, EXTENDED RELEASE;ORAL
Dosage5MG
Product Market Status Prescription
Therapeutic Equivalence Evaluation Code AB Products meeting necessary bioequivalence requirements
Reference Drug
Drug NameDEXMETHYLPHENIDATE HYDROCHLORIDE
Active IngredientDEXMETHYLPHENIDATE HYDROCHLORIDE

Active IngredientCount
List of drugs with Active Ingredient DEXMETHYLPHENIDATE HYDROCHLORIDE3


Back to FDA Applications sponsored by IMPAX LABS INC