Acetaminophen · Regulatory label update

FDA supplemental approval: Oxycodone AND Acetaminophen (REMS)

U.S. Food and Drug Administration · June 18, 2026

Regulatory Update Why this matters to you Expert discussion

An action by a regulator. Authoritative on labelling and availability.

AI Summary

This is a regulatory approval record documenting FDA supplemental approval of an oxycodone and acetaminophen tablet formulation (5 mg oxycodone + 325 mg acetaminophen) as an ANDA under a REMS requirement, dated 18 June 2026. The record does not contain clinical trial data, efficacy endpoints, or safety results; it is a regulatory action only.

What was studied

Regulatory label update. Intervention: Oxycodone hydrochloride 5 mg + acetaminophen 325 mg, tablet, oral.

Key findings

FDA approved supplemental ANDA 207574 for oxycodone hydrochloride 5 mg + acetaminophen 325 mg tablet formulation on 2026-06-18 Submission class REMS indicates Risk Evaluation and Mitigation Strategy requirement imposed

Safety

This is a regulatory action record and does not contain clinical trial results, efficacy data, or safety endpoints

Who this may help

This record confirms regulatory approval of an oxycodone–acetaminophen combination but does not provide clinical evidence of efficacy, safety, or comparative benefit. Clinicians should consult the approved label, prescribing information, and product-specific REMS requirements before use.

Plain-language summary

FDA supplemental approval action for an existing opioid–acetaminophen combination product; regulatory record documenting REMS requirement but not clinical efficacy or safety trial data.

Study design

As stated by the source record.

InterventionOxycodone hydrochloride 5 mg + acetaminophen 325 mg, tablet, oral

Reported figures

Quoted from the source exactly as published.

Oxycodone dose5 mg

Acetaminophen dose325 mg

Approval date2026-06-18

Clinical bottom line

Caveats

This is a regulatory action record and does not contain clinical trial results, efficacy data, or safety endpoints
No population characteristics, sample size, or study duration are reported
The REMS requirement is noted but specific elements and restrictions are not detailed in this record
Comparative or absolute benefit data are absent; approval status alone does not imply superiority over alternatives

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

insufficient

Regulatory action record; no clinical study design reported.

Directness

insufficient

Record documents approval action, not clinical outcome measurement.

Consistency

insufficient

Single regulatory decision; no comparative data or replication reported.

Risk of bias

insufficient

Regulatory record does not assess or report trial-level bias.

Sample adequacy

insufficient

No sample size or patient population data in this regulatory record.

Source abstract

Drugs@FDA record for application ANDA207574. This is a regulatory action record, not a clinical study. Brand name: OXYCODONE AND ACETAMINOPHEN. Active ingredient: ACETAMINOPHEN. Sponsor: SANALUZ. Submission type: SUPPL (supplement). Submission class: REMS. Approval status date: 2026-06-18. Products: OXYCODONE AND ACETAMINOPHEN, TABLET, ORAL, ACETAMINOPHEN 325MG + OXYCODONE HYDROCHLORIDE 5MG.

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

AcetaminophenSanaluz