FDA Drug Application (202819) for SODIUM PHENYLBUTYRATE by SIGMAPHARM LABS LLC

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Application Number202819
Product Number001
FormPOWDER;ORAL
Dosage3GM/TEASPOONFUL
Product Market Status Prescription
Therapeutic Equivalence Evaluation Code AB Products meeting necessary bioequivalence requirements
Reference Drug
Drug NameSODIUM PHENYLBUTYRATE
Active IngredientSODIUM PHENYLBUTYRATE



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