FDA Drug Application (091671) for HYDROCODONE POLISTIREX AND CHLORPHENIRAMNE POLISTIREX by NEOS THERAP INC

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Application Number091671
Product Number001
FormSUSPENSION, EXTENDED RELEASE;ORAL
DosageEQ 8MG MALEATE/5ML;EQ 10MG BITARTRATE/5ML
Product Market Status Prescription
Therapeutic Equivalence Evaluation Code AB Products meeting necessary bioequivalence requirements
Reference Drug
Drug NameHYDROCODONE POLISTIREX AND CHLORPHENIRAMNE POLISTIREX
Active IngredientCHLORPHENIRAMINE POLISTIREX; HYDROCODONE POLISTIREX



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