FDA Drug Application (021123) for ULTRACET by JANSSEN PHARMS

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Application Number021123
Product Number001
FormTABLET;ORAL
Dosage325MG;37.5MG
Product Market Status Prescription
Therapeutic Equivalence Evaluation Code AB Products meeting necessary bioequivalence requirements
Reference Drug
Drug NameULTRACET
Active IngredientACETAMINOPHEN; TRAMADOL HYDROCHLORIDE



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