Hydrocodone Bitartrate AND 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

This is an FDA supplemental approval (REMS) record for fixed-dose combinations of hydrocodone bitartrate and acetaminophen in tablet form, approved on 18 June 2026 by the FDA. The record confirms regulatory authorization but does not contain clinical trial results, efficacy data, or comparative benefit information. Clinicians and researchers should consult the approved REMS labeling and risk mitigation requirements for prescribing and dispensing information.

What was studied

Regulatory label update.

Key findings

Supplemental REMS approval granted for hydrocodone bitartrate and acetaminophen combination tablets Three strengths approved: 5 mg, 7.5 mg, and 10 mg hydrocodone bitartrate each combined with 325 mg acetaminophen

Safety

This record contains no clinical trial results, efficacy data, or safety outcome comparisons. No pharmacokinetic, pharmacodynamic, or adverse event data are reported.

Who this may help

This is a regulatory authorization record and does not evaluate clinical efficacy, safety, or comparative benefit. Prescribers should review the FDA-approved REMS requirements and product labeling before dispensing.

Plain-language summary

FDA supplemental REMS approval for hydrocodone bitartrate and acetaminophen combination tablets; regulatory classification only, with no clinical trial data or efficacy comparison.

Reported figures

Quoted from the source exactly as published.

Approval status date2026-06-18

Submission classREMS

Strength 1 (hydrocodone bitartrate)5 mg

Strength 2 (hydrocodone bitartrate)7.5 mg

Strength 3 (hydrocodone bitartrate)10 mg

Fixed acetaminophen dose (all strengths)325 mg

Clinical bottom line

Caveats

This record contains no clinical trial results, efficacy data, or safety outcome comparisons.
No information on patient populations, indications, or clinical trial methodology is provided.
REMS requirements and risk mitigation details are not detailed in this regulatory record.
No pharmacokinetic, pharmacodynamic, or adverse event data are 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 study design present.

Directness

insufficient

Record does not address clinical outcomes or patient populations.

Consistency

insufficient

Single regulatory action; no comparative or longitudinal data.

Risk of bias

insufficient

Regulatory record; bias assessment not applicable.

Sample adequacy

insufficient

No clinical sample or trial population described.

Source abstract

Drugs@FDA record for application ANDA210211. This is a regulatory action record, not a clinical study. Brand name: HYDROCODONE BITARTRATE AND ACETAMINOPHEN. Active ingredient: HYDROCODONE BITARTRATE AND ACETAMINOPHEN. Sponsor: WES PHARMA INC. Submission type: SUPPL (supplement). Submission class: REMS. Approval status date: 2026-06-18. Products: HYDROCODONE BITARTRATE AND ACETAMINOPHEN, TABLET, ORAL, ACETAMINOPHEN 325MG + HYDROCODONE BITARTRATE 10MG; HYDROCODONE BITARTRATE AND ACETAMINOPHEN, TABLET, ORAL, ACETAMINOPHEN 325MG + HYDROCODONE BITARTRATE 5MG; HYDROCODONE BITARTRATE AND ACETAMINOPHEN, TABLET, ORAL, ACETAMINOPHEN 325MG + 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.

WES PharmaHydrocodone Bitartrate AND Acetaminophen