FDA Drug Application (085762) for DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE by MYLAN

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Application Number085762
Product Number001
FormTABLET;ORAL
Dosage0.025MG;2.5MG
Product Market Status Prescription
Therapeutic Equivalence Evaluation Code AA Products in conventional dosage forms not presenting bioequivalence problems
Reference Drug
Drug NameDIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE
Active IngredientATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE



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