FDA NDA · NDA020573

BUPHENYL

sodium phenylbutyrate

Sponsor: HORIZON THERAP US

APPLICATION

NDA020573

TYPE

NDA

ORIGINAL APPROVAL

1996-04-30

LATEST ACTION

2022-07-29

ROUTE

ORAL

DOSAGE FORM

POWDER

MARKETING STATUS

Discontinued

Products

BUPHENYL · ReferenceDiscontinued

SODIUM PHENYLBUTYRATE 3GM/TEASPOONFUL · POWDER · ORAL

2022-07-29Labeling · Supplement 22 · standard — Letter ↗AP

2013-08-05Manufacturing (CMC) · Supplement 19 · priorityAP

2009-03-31Labeling · Supplement 15 · standard — Label ↗AP

1998-10-09Labeling · Supplement 2 · standardAP

1996-11-07Manufacturing (CMC) · Supplement 1 · priorityAP

1996-04-30Type 1 - New Molecular Entity · Original · priority — Review ↗AP

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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