ANDA 202819, held by Sigmapharm Labs LLC. Sodium Phenylbutyrate.
As of Nov 15, 2026, ANDA 202819 (Sodium Phenylbutyrate), held by Sigmapharm Labs LLC, was first approved by FDA on Mar 22, 2013, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 22, 2013 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Sodium Phenylbutyrate3GM/TEASPOONFUL ยท powder;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
