ANDA 206594, held by Epic Pharma LLC. Tranexamic Acid.
As of Nov 15, 2026, ANDA 206594 (Tranexamic Acid), held by Epic Pharma LLC, was first approved by FDA on Sep 28, 2017, with 2 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 28, 2017 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Tranexamic Acid100MG/ML · injectable;injection | Tranexamic Acid | Discontinued |
| Nov 8, 2021 | Supplement 4Labeling · Standard review | Approved | None posted |
| May 14, 2018 | Supplement 1Labeling · Standard review | Approved | None posted |
| Sep 28, 2017 | 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
