FDA Drug Application (204658) for HYDROCODONE BITARTRATE AND PSEUDOEPHEDRINE HYDROCHLORIDE by PADDOCK LLC

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Application Number204658
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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