FDA Drug Application (075618) for BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE by HIKMA INTL PHARMS

Back to FDA Applications sponsored by HIKMA INTL PHARMS

Application Number075618
Product Number001
FormCAPSULE;ORAL
Dosage325MG;50MG;40MG;30MG
Product Market Status Prescription
Therapeutic Equivalence Evaluation Code AB Products meeting necessary bioequivalence requirements
Reference Drug
Drug NameBUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE
Active IngredientACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE

Active IngredientCount
List of drugs with Active Ingredient ACETAMINOPHEN107
List of drugs with Active Ingredient BUTALBITAL30
List of drugs with Active Ingredient CAFFEINE44
List of drugs with Active Ingredient CODEINE PHOSPHATE51


Back to FDA Applications sponsored by HIKMA INTL PHARMS