ANDA 90910, held by Alvogen. Sodium Phenylbutyrate.
As of Nov 15, 2026, ANDA 90910 (Sodium Phenylbutyrate), held by Alvogen, was first approved by FDA on Nov 18, 2011, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 18, 2011 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Sodium Phenylbutyrate500MG ยท tablet;oral | Sodium Phenylbutyrate | Discontinued |
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
