FDA Drug Application (202214) for HYDROCODONE BITARTRATE AND ACETAMINOPHEN by TRIS PHARMA INC

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Application Number202214
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 NameHYDROCODONE BITARTRATE AND ACETAMINOPHEN
Active IngredientACETAMINOPHEN; HYDROCODONE BITARTRATE



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