NDA 217062, held by Auson Pharm.
As of Nov 13, 2026, NDA 217062, held by Auson Pharm, was not approved, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 20, 2025 | Original applicationNew dosage form ยท Standard review | Tentative approval |
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