ANDA 210541, held by Zydus Pharms USA Inc. Canagliflozin.
As of Nov 15, 2026, ANDA 210541 (Canagliflozin), held by Zydus Pharms USA Inc, was not approved, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 13, 2023 | Original application | Tentative approval |
| Canagliflozin100MG · tablet;oral | Canagliflozin | None (tentative approval) |
| Canagliflozin300MG · tablet;oral | Canagliflozin | 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
