Treats cyclic heavy menstrual bleeding in females of reproductive potential. ANDA 205133, held by Aurobindo Pharma USA. Tranexamic Acid.
As of Nov 14, 2026, ANDA 205133 (Tranexamic Acid), held by Aurobindo Pharma USA, was first approved by FDA on Sep 21, 2015, 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 |
|---|---|---|---|
| Sep 21, 2015 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Tranexamic Acid650MG · tablet;oral | Tranexamic Acid | Rx |
| Aug 20, 2025 | Supplement 3Labeling · Standard review | Approved | None posted |
| Sep 21, 2015 | 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
