FDA Drug Application (075135) for PACERONE by UPSHER SMITH

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Application Number075135
Product Number001
FormTABLET;ORAL
Dosage200MG
Product Market Status Prescription
Therapeutic Equivalence Evaluation Code AB Products meeting necessary bioequivalence requirements
Reference Drug
Drug NamePACERONE
Active IngredientAMIODARONE HYDROCHLORIDE



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