FDA Drug Application (021748) for GLUMETZA by SANTARUS INC

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Application Number021748
Product Number001
FormTABLET, EXTENDED RELEASE;ORAL
Dosage500MG
Product Market Status Prescription
Therapeutic Equivalence Evaluation Code AB3 Products meeting necessary bioequivalence requirements
Reference Drug
Drug NameGLUMETZA
Active IngredientMETFORMIN HYDROCHLORIDE



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