ANDA 202286, held by Apotex. Tranexamic Acid.
As of Nov 15, 2026, ANDA 202286 (Tranexamic Acid), held by Apotex, was first approved by FDA on Jan 27, 2014, with 1 approved supplement and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 27, 2014 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Tranexamic Acid650MG · tablet;oral | Tranexamic Acid | Discontinued |
| Dec 23, 2021 | Supplement 5Labeling · Standard review | Approved | None posted |
| Jan 27, 2014 | Original application | Approved |
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
