Composition
- Active ingredients
- SODIUM PHENYLBUTYRATE 6GM/PACKET
Strengths and forms
The FDA lists each strength of a product separately; these pages share one label.
- SODIUM PHENYLBUTYRATE 1GM/PACKET · For suspensionNDA214860-008 · Prescription
- SODIUM PHENYLBUTYRATE 6.67GM/PACKET · For suspensionNDA214860-006 · Prescription
- SODIUM PHENYLBUTYRATE 5GM/PACKET · For suspensionNDA214860-004 · Prescription
- SODIUM PHENYLBUTYRATE 3GM/PACKET · For suspensionNDA214860-002 · Prescription
- SODIUM PHENYLBUTYRATE 0.5GM/PACKET · For suspensionNDA214860-007 · Prescription
- SODIUM PHENYLBUTYRATE 6GM/PACKET · For suspensionThis page
- SODIUM PHENYLBUTYRATE 4GM/PACKET · For suspensionNDA214860-003 · Prescription
- SODIUM PHENYLBUTYRATE 2GM/PACKET · For suspensionNDA214860-001 · Prescription
Official product information
Drugs@FDA lists the approved labels, letters and reviews for application NDA214860.
At a glance
- Brand name
- Olpruva
- Active substance
- sodium phenylbutyrate
- Route
- Oral
- Dosage form
- For suspension
- Applicant
- Acer
- Status
- Prescription
- FDA approval
- 22 Dec 2022
- Application
- NDA214860-005