Hydrocodone Bitartrate AND Acetaminophen · Regulatory label update

FDA supplemental approval: Hydrocodone Bitartrate 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 action record documenting FDA approval of a supplemental REMS submission for hydrocodone bitartrate-acetaminophen combination tablets on 18 June 2026. The record confirms authorization of the REMS requirement but contains no clinical trial results, efficacy data, or comparative evidence.

What was studied

Regulatory label update.

Key findings

FDA approved supplemental REMS application (ANDA207709) for hydrocodone bitartrate-acetaminophen on 2026-06-18 Three tablet strengths approved: 5 mg/300 mg, 7.5 mg/300 mg, and 10 mg/300 mg

Safety

This record does not contain clinical trial results, efficacy outcomes, or safety data.

Who this may help

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

Plain-language summary

FDA supplemental approval of a Risk Evaluation and Mitigation Strategy (REMS) for an existing hydrocodone-acetaminophen combination; confirms regulatory authorization but does not report clinical trial outcomes.

Reported figures

Quoted from the source exactly as published.

Approval date2026-06-18

Submission classREMS

Caveats

This record does not contain clinical trial results, efficacy outcomes, or safety data.
REMS approval reflects regulatory requirement but does not establish clinical superiority or comparative benefit.
No dosing recommendations, patient populations, or therapeutic indications are reported in this record.
No data on prior approvals, modifications to existing REMS, or rationale for the supplemental submission are provided.

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

This is a regulatory action, not a clinical study.

Directness

insufficient

Regulatory record does not report clinical outcomes or efficacy data.

Consistency

insufficient

No comparative or replication data provided in this approval record.

Risk of bias

insufficient

Risk of bias assessment does not apply to regulatory approval documents.

Sample adequacy

insufficient

No clinical trial sample size data reported in this record.

Source abstract

Drugs@FDA record for application ANDA207709. This is a regulatory action record, not a clinical study. Brand name: HYDROCODONE BITARTRATE AND ACETAMINOPHEN. Active ingredient: HYDROCODONE BITARTRATE AND ACETAMINOPHEN. Sponsor: AUROLIFE PHARMA LLC. 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.

Hydrocodone Bitartrate AND AcetaminophenAurolife Pharma