← FDA Drug Approvals (Drugs@FDA)

SODIUM PHENYLBUTYRATE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: NAVINTA LLC · Approved 2026-02-17

Drug application

FDA Application #

ANDA220418

Application type

Abbreviated New Drug Application (Generic)

Brand name

SODIUM PHENYLBUTYRATE

Generic name

SODIUM PHENYLBUTYRATE

Active ingredients

SODIUM PHENYLBUTYRATE

Dosage form

TABLET

Route

ORAL

Marketing status

Prescription

Sponsor

NAVINTA LLC

Manufacturer

Zydus Pharmaceuticals USA Inc.

First approval

2026-02-17

Source

Authoritative

Drugs@FDA application overview

Machine

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