FDA Drug Application (019111) for TUSSIONEX PENNKINETIC by UCB INC

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Application Number019111
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 NameTUSSIONEX PENNKINETIC
Active IngredientCHLORPHENIRAMINE POLISTIREX; HYDROCODONE POLISTIREX



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