JUL 29, 2026 · REGULATORY LABEL UPDATE
FDA supplemental approval: Tacrolimus (Labeling)
U.S. Food and Drug Administration
FDA supplemental approval of tacrolimus labeling by Alkem Labs; this is a regulatory action record without clinical trial data and does not support efficacy or comparative clinical claims.
Reported
Approval date2026-07-29
Strengths approved0.5 mg, 1 mg, 5 mg (oral capsules)