FDA Drug Application (076642) for REPREXAIN by AMNEAL PHARMS NY

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Application Number076642
Product Number003
FormTABLET;ORAL
Dosage2.5MG;200MG
Product Market Status Prescription
Therapeutic Equivalence Evaluation Code AB Products meeting necessary bioequivalence requirements
Reference Drug
Drug NameREPREXAIN
Active IngredientHYDROCODONE BITARTRATE; IBUPROFEN



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