ANDA 218242, held by Fresenius Kabi USA. Tranexamic Acid.
As of Nov 15, 2026, ANDA 218242 (Tranexamic Acid), held by Fresenius Kabi USA, was first approved by FDA on Aug 15, 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 |
|---|---|---|---|
| Aug 15, 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
