ANDA 217155, held by Amneal. Tranexamic Acid.
As of Nov 15, 2026, ANDA 217155 (Tranexamic Acid), held by Amneal, was first approved by FDA on Oct 16, 2023, with 2 approved supplements and 0 published complete response letters.
Tranexamic acid in 0.7% sodium chloride injection is indicated in patients with hemophilia for short-term use (two to eight days) to reduce or prevent hemorrhage and reduce the need for replacement therapy during and following tooth extraction.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 16, 2023 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Tranexamic Acid1GM/100ML (10MG/ML) · solution;intravenous | Tranexamic Acid | Rx |
| Jun 9, 2025 | Supplement 3Labeling · Standard review | Approved | None posted |
| Mar 1, 2024 | Supplement 1Labeling · Standard review | Approved | None posted |
| Oct 16, 2023 | 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
