Treats cyclic heavy menstrual bleeding in females of reproductive potential. ANDA 203256, held by Ani Pharms. Tranexamic Acid.
As of Nov 15, 2026, ANDA 203256 (Tranexamic Acid), held by Ani Pharms, was first approved by FDA on Jul 25, 2016, with 1 approved supplement 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 |
|---|---|---|---|
| Jul 25, 2016 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Tranexamic Acid650MG · tablet;oral | Tranexamic Acid | Rx |
| Oct 15, 2021 | Supplement 1Labeling · Standard review | Approved | None posted |
| Jul 25, 2016 | 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
