Manages urea cycle disorders involving deficiencies of carbamylphosphate synthetase…. ANDA 204395, held by Ph Health. Sodium Phenylbutyrate.
As of Nov 15, 2026, ANDA 204395 (Sodium Phenylbutyrate), held by Ph Health, was first approved by FDA on Apr 15, 2016, with 0 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Sodium Phenylbutyrate Tablets is indicated as adjunctive therapy in the chronic management of patients with urea cycle disorders involving deficiencies of carbamylphosphate synthetase (CPS), ornithine transcarbamylase (OTC), or argininosuccinic acid synthetase (AS). It is indicated in all patients with neonatal-onset deficiency (complete enzymatic deficiency, presenting within the first 28 days of life). It is also indicated in patients with late-onset disease (partial enzymatic deficiency, presenting after the first month of life) who have a history of hyperammonemic encephalopathy.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 15, 2016 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Sodium Phenylbutyrate500MG · tablet;oral | Sodium Phenylbutyrate | Rx |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
