MAR 26, 2026 · REGULATORY LABEL UPDATE
FDA supplemental approval: Paroxetine (Manufacturing (CMC))
U.S. Food and Drug Administration
FDA supplemental approval of manufacturing changes for paroxetine extended-release tablets; regulatory action with no clinical trial data reported.
Reported
Approval status date2026-03-26
Product strengths approved12.5 mg, 25 mg, 37.5 mg