ANDA 202755, held by Chartwell Rx. Tranexamic Acid.
As of Nov 15, 2026, ANDA 202755 (Tranexamic Acid), held by Chartwell Rx, was first approved by FDA on Feb 25, 2016, with 3 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 25, 2016 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Tranexamic Acid100MG/ML · injectable;injection | Tranexamic Acid | Discontinued |
| Apr 14, 2021 | Supplement 4Labeling · Standard review | Approved | None posted |
| Nov 18, 2020 | Supplement 3Labeling · Standard review | Approved | None posted |
| Sep 12, 2018 | Supplement 1Manufacturing | Approved | None posted |
| Feb 25, 2016 | 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
