ANDA 210386, held by Aurobindo Pharma Ltd. Canagliflozin.
As of Nov 15, 2026, ANDA 210386 (Canagliflozin), held by Aurobindo Pharma Ltd, was first approved by FDA on Apr 20, 2026, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 20, 2026 | Original application | Approved | None posted |
| Canagliflozin100MG · tablet;oral | Canagliflozin | Discontinued |
| Canagliflozin300MG · tablet;oral | Canagliflozin | Discontinued |
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
