For hemophilia for short-term use (2 to 8 days). ANDA 212676, held by Milla Pharms. Tranexamic Acid.
As of Nov 15, 2026, ANDA 212676 (Tranexamic Acid), held by Milla Pharms, was first approved by FDA on Jul 17, 2019, 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 |
|---|---|---|---|
| Jul 17, 2019 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Tranexamic Acid100MG/ML · injectable;injection | Tranexamic Acid | Rx |
| Apr 1, 2024 | Supplement 2Labeling · Standard review | Approved | None posted |
| Nov 18, 2020 | Supplement 1Labeling · Standard review | Approved | None posted |
| Jul 17, 2019 | 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
