FDA Drug Application (085055) for TYLENOL W/ CODEINE NO. 4 by JANSSEN PHARMS

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Application Number085055
Product Number004
FormTABLET;ORAL
Dosage300MG;60MG
Product Market Status Prescription
Therapeutic Equivalence Evaluation Code AA Products in conventional dosage forms not presenting bioequivalence problems
Reference Drug
Drug NameTYLENOL W/ CODEINE NO. 4
Active IngredientACETAMINOPHEN; CODEINE PHOSPHATE



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