APPLICATION
ANDA203918
TYPE
ANDA
ORIGINAL APPROVAL
2016-06-15
LATEST ACTION
2016-06-15
ROUTE
ORAL
DOSAGE FORM
POWDER
MARKETING STATUS
Prescription
Products
SODIUM PHENYLBUTYRATEPrescription
SODIUM PHENYLBUTYRATE 3GM/TEASPOONFUL · POWDER · ORAL
Approval history
2016-06-15UNKNOWN · OriginalAP
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
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