For hemophilia for short-term use (2 to 8 days). ANDA 205035, held by Eugia Pharma. Tranexamic Acid.
As of Nov 15, 2026, ANDA 205035 (Tranexamic Acid), held by Eugia Pharma, was first approved by FDA on Jan 14, 2016, with 4 approved supplements and 0 published complete response letters.
Tranexamic acid injection is indicated in patients with hemophilia for short-term use (2 to 8 days) to reduce or prevent hemorrhage and reduce the need for replacement therapy during and following tooth extraction.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 14, 2016 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Tranexamic Acid100MG/ML · injectable;injection | Tranexamic Acid | Rx |
| Apr 28, 2026 | Supplement 12Labeling · Standard review | Approved | None posted |
| Apr 6, 2021 | Supplement 4Labeling · Standard review | Approved | None posted |
| Dec 10, 2020 | Supplement 3Labeling · Standard review | Approved | None posted |
| May 14, 2018 | Supplement 1Labeling · Standard review | Approved | None posted |
| Jan 14, 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
