Application Nr Approved Date Route Status External Links
ANDA205880 None Intravenous None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Sodium Phenylacetate And Sodium Benzoate Injection 10% / 10% Is A Nitrogen Binding Agent Indicated As Adjunctive Therapy For The Treatment Of Acute Hyperammonemia And Associated Encephalopathy In Patients With Deficiencies In Enzymes Of The Urea Cycle. (1) Sodium Phenylacetate And Sodium Benzoate Injection 10% / 10% Is Indicated As Adjunctive Therapy In Pediatric And Adult Patients For The Treatment Of Acute Hyperammonemia And Associated Encephalopathy In Patients With Deficiencies In Enzymes Of The Urea Cycle. During Acute Hyperammonemic Episodes, Arginine Supplementation, Caloric Supplementation, Dietary Protein Restriction, Hemodialysis, And Other Ammonia Lowering Therapies Should Be Considered [ See Warnings And Precautions (5) ].

All Formulated Excipients (0 Total)

None

Active Ingredients ( 2 Total)

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