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OLPRUVA

NDA · New Drug Application · Sponsor: ACER · Approved 2022-12-22

Drug application

FDA Application #

NDA214860

Application type

New Drug Application

Brand name

OLPRUVA

Generic name

Sodium Phenylbutyrate

Active ingredients

SODIUM PHENYLBUTYRATE

Dosage form

FOR SUSPENSION

Route

ORAL

Marketing status

Prescription

Sponsor

ACER

First approval

2022-12-22

Source

Authoritative

Drugs@FDA application overview

Machine

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