Treats cyclic heavy menstrual bleeding in females of reproductive potential. ANDA 218729, held by Appco. Tranexamic Acid.
As of Nov 15, 2026, ANDA 218729 (Tranexamic Acid), held by Appco, was first approved by FDA on Jun 11, 2025, with 0 approved supplements and 0 published complete response letters.
Tranexamic acid tablets are indicated for the treatment of cyclic heavy menstrual bleeding in females of reproductive potential.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 11, 2025 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Tranexamic Acid650MG · tablet;oral | 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
