NDA 22554, held by Salix Pharms. Rifaximin.
As of Nov 14, 2026, NDA 22554 (Xifaxan), held by Salix Pharms, was first approved by FDA on Mar 24, 2010, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 24, 2010 | Original applicationTYPE 6 · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Xifaxan550MG · tablet;oral | Rifaximin | RxReference 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
