NDA 21948, held by Pfizer. Anidulafungin.
As of Nov 14, 2026, NDA 21948 (Eraxis), held by Pfizer, was first approved by FDA on Feb 17, 2006, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 17, 2006 | Original applicationTYPE 6 · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Eraxis50MG · injectable; injection | Anidulafungin | 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