APPLICATION
NDA216513
TYPE
NDA
ORIGINAL APPROVAL
2022-06-17
LATEST ACTION
2026-07-16
ROUTE
ORAL
DOSAGE FORM
PELLETS
MARKETING STATUS
Prescription
Products
PHEBURANE · ReferencePrescription
SODIUM PHENYLBUTYRATE 84GM/BOT · PELLETS · ORAL
Approval history
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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