Manages urea cycle disorders involving deficiencies of carbamylphosphate synthetase…. ANDA 216462, held by Glenmark Pharms Ltd. Sodium Phenylbutyrate.
As of Nov 15, 2026, ANDA 216462 (Sodium Phenylbutyrate), held by Glenmark Pharms Ltd, was first approved by FDA on Nov 1, 2022, with 0 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Sodium phenylbutyrate tablets are 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 |
|---|---|---|---|
| Nov 1, 2022 | 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
