For hemophilia for short-term use (2 to 8 days). ANDA 209860, held by Apotex. Tranexamic Acid.
As of Nov 15, 2026, ANDA 209860 (Tranexamic Acid), held by Apotex, was first approved by FDA on Jan 14, 2020, with 2 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, 2020 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Tranexamic Acid100MG/ML · injectable;injection | Tranexamic Acid | Rx |
| Nov 9, 2021 | Supplement 1Labeling · Standard review | Approved | None posted |
| Nov 9, 2021 | Supplement 2Labeling · Standard review | Approved | None posted |
| Jan 14, 2020 | Original application | Approved | None posted |
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
