FDA Drug Application (022402) for CODEINE SULFATE by ROXANE

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Application Number022402
Product Number001
FormTABLET;ORAL
Dosage15MG
Product Market Status Prescription
Therapeutic Equivalence Evaluation Code AB Products meeting necessary bioequivalence requirements
Reference Drug
Drug NameCODEINE SULFATE
Active IngredientCODEINE SULFATE



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