Acetaminophen · Regulatory label update

FDA supplemental approval: Hydrocodone Bitartrate AND Acetaminophen (REMS)

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

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AI Summary

The FDA approved a supplemental Risk Evaluation and Mitigation Strategy (REMS) application for hydrocodone bitartrate and acetaminophen fixed-dose combinations (5 mg, 7.5 mg, and 10 mg hydrocodone with 300 mg acetaminophen per tablet) on 18 June 2026. This is a regulatory action establishing risk management requirements and does not report clinical trial data, efficacy, or safety outcomes.

What was studied

Regulatory label update. Intervention: Hydrocodone bitartrate and acetaminophen fixed-dose tablet combinations: 5 mg/300 mg, 7.5 mg/300 mg, and 10 mg/300 mg oral tablets.

Key findings

Supplemental REMS approval for three fixed-dose formulations: 5 mg/300 mg, 7.5 mg/300 mg, and 10 mg/300 mg tablets Approval date: 18 June 2026 Sponsor: Alvogen

Safety

This record is a regulatory approval action and does not contain clinical trial results, efficacy data, or safety outcome measures. No information provided on the rationale for REMS requirements, specific risk mitigation elements, or postmarket safety surveillance findings.

Who this may help

The source did not state who this applies to in practice.

Plain-language summary

FDA supplemental REMS approval for hydrocodone bitartrate and acetaminophen fixed-dose combinations; establishes risk mitigation requirements but does not report clinical efficacy or safety trial outcomes.

Study design

As stated by the source record.

InterventionHydrocodone bitartrate and acetaminophen fixed-dose tablet combinations: 5 mg/300 mg, 7.5 mg/300 mg, and 10 mg/300 mg oral tablets

Reported figures

Quoted from the source exactly as published.

Approval status date2026-06-18

Application numberANDA208540

Hydrocodone bitartrate dose (formulation 1)5 mg

Hydrocodone bitartrate dose (formulation 2)7.5 mg

Hydrocodone bitartrate dose (formulation 3)10 mg

Acetaminophen dose (all formulations)300 mg

Caveats

This record is a regulatory approval action and does not contain clinical trial results, efficacy data, or safety outcome measures.
No information provided on the rationale for REMS requirements, specific risk mitigation elements, or postmarket safety surveillance findings.
Record does not specify indication(s) for use or intended patient population.
No comparative data with other formulations or comparators reported.

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 trial design present.

Directness

insufficient

Record does not address clinical endpoints or patient outcomes.

Consistency

insufficient

Single regulatory action; no comparative data or replicated findings.

Risk of bias

insufficient

Not applicable to regulatory approval record.

Sample adequacy

insufficient

No clinical population or sample size data in this regulatory filing.

Source abstract

Drugs@FDA record for application ANDA208540. This is a regulatory action record, not a clinical study. Brand name: HYDROCODONE BITARTRATE AND ACETAMINOPHEN. Active ingredient: ACETAMINOPHEN. Sponsor: ALVOGEN. Submission type: SUPPL (supplement). Submission class: REMS. Approval status date: 2026-06-18. Products: HYDROCODONE BITARTRATE AND ACETAMINOPHEN, TABLET, ORAL, ACETAMINOPHEN 300MG + HYDROCODONE BITARTRATE 10MG; HYDROCODONE BITARTRATE AND ACETAMINOPHEN, TABLET, ORAL, ACETAMINOPHEN 300MG + HYDROCODONE BITARTRATE 5MG; HYDROCODONE BITARTRATE AND ACETAMINOPHEN, TABLET, ORAL, ACETAMINOPHEN 300MG + HYDROCODONE BITARTRATE 7.5MG.

Follow from this

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

AlvogenAcetaminophen