FDA Drug Application (087003) for ROXICET by ROXANE

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Application Number087003
Product Number001
FormTABLET;ORAL
Dosage325MG;5MG
Product Market Status Prescription
Therapeutic Equivalence Evaluation Code AA Products in conventional dosage forms not presenting bioequivalence problems
Reference Drug
Drug NameROXICET
Active IngredientACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

Active IngredientCount
List of drugs with Active Ingredient ACETAMINOPHEN107
List of drugs with Active Ingredient OXYCODONE HYDROCHLORIDE27


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