FDA Drug Application (089718) for BUTALBITAL, ACETAMINOPHEN AND CAFFEINE by HIKMA PHARMS LLC

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Application Number089718
Product Number001
FormTABLET;ORAL
Dosage325MG;50MG;40MG
Product Market Status Prescription
Therapeutic Equivalence Evaluation Code AA Products in conventional dosage forms not presenting bioequivalence problems
Reference Drug
Drug NameBUTALBITAL, ACETAMINOPHEN AND CAFFEINE
Active IngredientACETAMINOPHEN; BUTALBITAL; CAFFEINE



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