APR 28, 2026 · REGULATORY LABEL UPDATE
FDA supplemental approval: Tranexamic Acid (Labeling)
U.S. Food and Drug Administration
This is an FDA supplemental approval action for labeling of an existing drug; it does not report clinical trial outcomes or comparative efficacy data.
Reported
Approval date2026-04-28
Application numberANDA205035
Drug strength100 mg/mL