Treats cyclic heavy menstrual bleeding in females of reproductive potential. ANDA 221213, held by Zydus Lifesciences. Tranexamic Acid.
As of Nov 15, 2026, ANDA 221213 (Tranexamic Acid), held by Zydus Lifesciences, was first approved by FDA on Oct 27, 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 |
|---|---|---|---|
| Oct 27, 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
