MAY 5, 2026 · REGULATORY LABEL UPDATE
FDA supplemental approval: Leucovorin Calcium (Labeling)
U.S. Food and Drug Administration
FDA supplemental approval for labeling changes to leucovorin calcium tablets; regulatory action confirming revised labeling without new clinical efficacy data.
Reported
Approval date2026-05-05
Product strengths5 mg, 10 mg, 15 mg, 25 mg base equivalent