NDA 220758, held by Ridhisidhi, Pllc. Empagliflozin.
As of Nov 13, 2026, NDA 220758 (Empagliflozin), held by Ridhisidhi, Pllc, was not approved, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 17, 2026 | Original applicationNew dosage form ยท Standard review | Tentative approval |
| Product | Active ingredient | Marketing |
|---|---|---|
| Empagliflozinsolution | Empagliflozin | None (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
