US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|
| SODIUM PHENYLBUTYRATE | 500MG | tablet · oral | PH HEALTH | Prescription | 15 Apr 2016 |
| SODIUM PHENYLBUTYRATE | 3GM/TEASPOONFUL | powder · oral | PH HEALTH | Prescription | 15 Jun 2016 |
| PHEBURANE | 84GM/BOT | pellets · oral | MEDUNIK | Prescription | 17 Jun 2022 |
| SODIUM PHENYLBUTYRATE | 500MG | tablet · oral | GLENMARK PHARMS LTD | Prescription | 1 Nov 2022 |
| OLPRUVA | 2GM/PACKET; 3GM/PACKET; 4GM/PACKET; 5GM/PACKET; 6GM/PACKET; 6.67GM/PACKET; 0.5GM/PACKET; 1GM/PACKET | for suspension · oral | ACER | Prescription | 22 Dec 2022 |
| SODIUM PHENYLBUTYRATE | 500MG | tablet · oral | NAVINTA LLC | Prescription | 17 Feb 2026 |
| BUPHENYL | 3GM/TEASPOONFUL | powder · oral | HORIZON THERAP US | Discontinued | 30 Apr 1996 |
| BUPHENYL | 500MG | tablet · oral | HORIZON THERAP US | Discontinued | 13 May 1996 |
| SODIUM PHENYLBUTYRATE | 500MG | tablet · oral | ALVOGEN | Discontinued | 18 Nov 2011 |
| SODIUM PHENYLBUTYRATE | 3GM/TEASPOONFUL | powder · oral | SIGMAPHARM LABS LLC | Discontinued | 22 Mar 2013 |
EMA European Union — centrally authorised medicines
Ammonaps Immedica Pharma AB · Authorised · authorised 7 Dec 1999 · ATC A16AX03
Therapeutic indication (EMA)
Ammonaps is indicated as adjunctive therapy in the chronic management of urea cycle disorders, involving deficiencies of carbamylphosphate synthetase, ornithine transcarbamylase orargininosuccinate synthetase. It is indicated in all patients with neonatal-onset presentation (complete enzyme deficiencies, presenting within the first 28 days of life). It is also indicated in patients with late-onset disease(partial enzyme deficiencies, presenting after the first month of life) who have a history of hyperammonaemic encephalopathy.
Pheburane Eurocept International B. V. · Authorised · authorised 30 Jul 2013 · ATC A16AX03
Therapeutic indication (EMA)
Treatment of chronic management of urea-cycle disorders.
Canada Canada — marketed products (Health Canada)
| Brand | DIN | Strength | Form · route | Company |
|---|
| PHEBURANE | 02436663 | 483 MG / G | GRANULES · ORAL | MEDUNIK CANADA |
Prices — United States and England
| Source | Product as listed | Price | Unit / pack | Date |
|---|
| NHS Drug Tariff | Sodium phenylbutyrate 500mg tablets | £493.00 | 250 tablet | 1 Oct 2026 |
NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.
Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.