Treats cyclic heavy menstrual bleeding in females of reproductive potential. ANDA 219702, held by Pharmazone. Tranexamic Acid.
As of Nov 15, 2026, ANDA 219702 (Tranexamic Acid), held by Pharmazone, was first approved by FDA on Jan 26, 2026, 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 |
|---|---|---|---|
| Jan 26, 2026 | 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
