APPLICATION
NDA020572
TYPE
NDA
ORIGINAL APPROVAL
1996-05-13
LATEST ACTION
2022-07-29
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
BUPHENYL · ReferenceDiscontinued
SODIUM PHENYLBUTYRATE 500MG · TABLET · ORAL
Approval history
2015-10-06Manufacturing (CMC) · Supplement 21 · priorityAP
2013-08-02Manufacturing (CMC) · Supplement 20 · priorityAP
1998-10-09Labeling · Supplement 2 · standardAP
1996-11-07Manufacturing (CMC) · Supplement 1 · priorityAP
1996-05-13Type 3 - New Dosage Form · Original · priorityAP
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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