JUL 13, 2026 · REGULATORY LABEL UPDATE
FDA supplemental approval: Lithium Carbonate (Labeling)
U.S. Food and Drug Administration
FDA supplemental approval for labeling changes to an established lithium carbonate product; no clinical trial data or efficacy comparisons are provided in this regulatory record.
Reported
Approval status date2026-07-13
Product strengthLITHIUM CARBONATE 300MG
Dosage formTABLET, EXTENDED RELEASE, ORAL