FDA Drug Application (021860) for SARAFEM by APIL

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Application Number021860
Product Number001
FormTABLET;ORAL
DosageEQ 10MG BASE
Product Market Status Prescription
Therapeutic Equivalence Evaluation Code AB1 Products meeting necessary bioequivalence requirements
Reference Drug
Drug NameSARAFEM
Active IngredientFLUOXETINE HYDROCHLORIDE



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