← FDA DRUG APPROVALS

FDA NDA · NDA214860

OLPRUVA

Sponsor: ACER

APPLICATION
NDA214860
TYPE
NDA
ORIGINAL APPROVAL
2022-12-22
LATEST ACTION
2025-10-10
ROUTE
ORAL
DOSAGE FORM
FOR SUSPENSION
MARKETING STATUS
Prescription

Products

OLPRUVA · ReferencePrescription
SODIUM PHENYLBUTYRATE 1GM/PACKET · FOR SUSPENSION · ORAL
OLPRUVA · ReferencePrescription
SODIUM PHENYLBUTYRATE 6.67GM/PACKET · FOR SUSPENSION · ORAL
OLPRUVA · ReferencePrescription
SODIUM PHENYLBUTYRATE 5GM/PACKET · FOR SUSPENSION · ORAL
OLPRUVA · ReferencePrescription
SODIUM PHENYLBUTYRATE 3GM/PACKET · FOR SUSPENSION · ORAL
OLPRUVA · ReferencePrescription
SODIUM PHENYLBUTYRATE 0.5GM/PACKET · FOR SUSPENSION · ORAL
OLPRUVA · ReferencePrescription
SODIUM PHENYLBUTYRATE 6GM/PACKET · FOR SUSPENSION · ORAL
OLPRUVA · ReferencePrescription
SODIUM PHENYLBUTYRATE 4GM/PACKET · FOR SUSPENSION · ORAL
OLPRUVA · ReferencePrescription
SODIUM PHENYLBUTYRATE 2GM/PACKET · FOR SUSPENSION · ORAL

Approval history

2025-10-10Efficacy · Supplement 7 · standard — Label ↗AP
2022-12-22Type 5 - New Formulation or New Manufacturer · Original · standard — Letter ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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