Active substances
Phenylacetate + Sodium benzoate
- SFDA 1
- US FDA 7
SFDA Saudi Arabia — SFDA human drug list
| Trade name | Strength | Form · route | Pack | Public price | Type | Company | Status |
|---|---|---|---|---|---|---|---|
| SODIUM PHENYLACETATE AND SODIUM BENZOATE INJECTION | 10,10 %,% | Injection · Intravenous use | 1 Vial | SAR 11070.70 | Generic · Prescription | Navinta LLC | Valid |
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| SODIUM PHENYLACETATE AND SODIUM BENZOATE | 10%;10% (5GM/50ML;5GM/50ML) | solution · intravenous | AILEX PHARMS LLC | Prescription | 24 Feb 2016 |
| SODIUM PHENYLACETATE AND SODIUM BENZOATE | 10%;10% (5GM/50ML;5GM/50ML) | solution · intravenous | NAVINTA LLC | Prescription | 4 Aug 2016 |
| SODIUM PHENYLACETATE AND SODIUM BENZOATE | 10%;10% (5GM/50ML;5GM/50ML) | solution · intravenous | MAIA PHARMS INC | Prescription | 8 May 2017 |
| SODIUM PHENYLACETATE AND SODIUM BENZOATE | 10%;10% (2GM/20ML;2GM/20ML) | solution · intravenous | MAIA PHARMS INC | Prescription | 10 Jun 2021 |
| SODIUM PHENYLACETATE AND SODIUM BENZOATE | 10%;10% (2GM/20ML; 2GM/20ML) | solution · intravenous | NAVINTA LLC | Prescription | 14 Jul 2023 |
| UCEPHAN | 100MG/ML;100MG/ML | solution · oral | B BRAUN | Discontinued | 23 Dec 1987 |
| AMMONUL | 10%;10% (5GM/50ML;5GM/50ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | solution · intravenous | BAUSCH | Discontinued | 17 Feb 2005 |
Components
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.