ANDA 210449, held by Apotex. Canagliflozin.
As of Nov 15, 2026, ANDA 210449 (Canagliflozin), held by Apotex, was first approved by FDA on Apr 14, 2026, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 14, 2026 | Original application | Approved |
| Canagliflozin100MG · tablet;oral | Canagliflozin | Rx |
| Canagliflozin300MG · tablet;oral | Canagliflozin | 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
