FDA Drug Application (065331) for EPIRUBICIN HYDROCHLORIDE by IMPAX LABS INC

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Application Number065331
Product Number001
FormINJECTABLE;INJECTION
Dosage50MG/25ML (2MG/ML)
Product Market Status Prescription
Therapeutic Equivalence Evaluation Code AP Injectable aqueous solutions and, in certain instances, intravenous non-aqueous solutions
Reference Drug
Drug NameEPIRUBICIN HYDROCHLORIDE
Active IngredientEPIRUBICIN HYDROCHLORIDE



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