JUN 18, 2026 · REGULATORY LABEL UPDATE
FDA supplemental approval: Hydrocodone Bitartrate AND Acetaminophen (REMS)
U.S. Food and Drug Administration
FDA supplemental approval of a Risk Evaluation and Mitigation Strategy (REMS) for hydrocodone bitartrate and acetaminophen tablets across multiple dose strengths.
Reported
Approval date2026-06-18
Dose strengths approved2.5 mg, 5 mg, 7.5 mg, 10 mg hydrocodone bit…