FDA Drug Application (203839) for HYDROCODONE BITARTRATE AND PSEUDOEPHEDRINE HYDROCHLORIDE by TRIS PHARMA INC

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Application Number203839
Product Number001
FormSOLUTION;ORAL
Dosage5MG/5ML;60MG/5ML
Product Market Status Prescription
Therapeutic Equivalence Evaluation Code AA Products in conventional dosage forms not presenting bioequivalence problems
Reference Drug
Drug NameHYDROCODONE BITARTRATE AND PSEUDOEPHEDRINE HYDROCHLORIDE
Active IngredientHYDROCODONE BITARTRATE; PSEUDOEPHEDRINE HYDROCHLORIDE



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