MAR 31, 2026 · REGULATORY LABEL UPDATE
FDA supplemental approval: Methylene Blue (Manufacturing (CMC))
U.S. Food and Drug Administration
FDA supplemental approval for manufacturing changes to methylene blue intravenous solutions; confirms compliance with Chemistry, Manufacturing, and Controls standards but does not report clinical efficacy or safety data.
Reported
Approval date2026-03-31
Application numberANDA215636
Submission typeSupplement (Manufacturing CMC)