JUN 18, 2026 · REGULATORY LABEL UPDATE
FDA supplemental approval: Hydrocodone Bitartrate AND Acetaminophen (REMS)
U.S. Food and Drug Administration
FDA supplemental REMS approval for hydrocodone bitartrate and acetaminophen combination tablets; regulatory classification only, with no clinical trial data or efficacy comparison.
Reported
Approval status date2026-06-18
Submission classREMS
Strength 1 (hydrocodone bitartrat…5 mg