NDA 209203, held by Ironwood Pharms Inc. Allopurinol; Lesinurad.
As of Nov 13, 2026, NDA 209203 (Duzallo), held by Ironwood Pharms Inc, was first approved by FDA on Aug 18, 2017, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 18, 2017 | Original applicationNew combination · Standard review | Approved |
| Duzallo200MG;200MG · tablet;oral | Allopurinol; Lesinurad | DiscontinuedReference drug |
| Duzallo300MG;200MG · tablet;oral | Allopurinol; Lesinurad | DiscontinuedReference drug |
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
