ANDA 218599, held by Gland. Tranexamic Acid.
As of Nov 15, 2026, ANDA 218599 (Tranexamic Acid), held by Gland, was first approved by FDA on Apr 16, 2024, with 0 approved supplements and 0 published complete response letters.
Tranexamic Acid in 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 |
|---|---|---|---|
| Apr 16, 2024 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Tranexamic Acid1GM/100ML (10MG/ML) · solution;intravenous | Tranexamic Acid | Rx |
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
