Tramadol Hydrochloride AND Acetaminophen · Regulatory label update

FDA supplemental approval: Tramadol Hydrochloride AND Acetaminophen (REMS)

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

Insufficient Information Why this matters to you Expert discussion

The material analysed did not support any firm read.

AI Summary

The FDA approved a supplemental ANDA for tramadol hydrochloride 37.5 mg and acetaminophen 325 mg tablets (Aurobindo Pharma) on 18 June 2026, with REMS (Risk Evaluation and Mitigation Strategy) requirements. This is a regulatory approval action and does not contain or evaluate clinical trial data.

What was studied

Regulatory label update. Patients eligible for tramadol–acetaminophen combination therapy (population characteristics not detailed in this regulatory record)..

Key findings

Supplemental ANDA approval granted for fixed-dose combination tablet containing tramadol hydrochloride 37.5 mg + acetaminophen 325 mg

Safety

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

Who this may help

This approval allows generic distribution of a fixed-dose tramadol–acetaminophen combination under REMS. Clinicians should consult the approved prescribing information and REMS program requirements before dispensing; this record does not evaluate efficacy or safety relative to other analgesics.

Plain-language summary

FDA supplemental approval of a fixed-dose tramadol–acetaminophen combination tablet with REMS requirements; this is a regulatory action, not a clinical efficacy study.

Study design

As stated by the source record.

PopulationPatients eligible for tramadol–acetaminophen combination therapy (population characteristics not detailed in this regulatory record).

Reported figures

Quoted from the source exactly as published.

Approval date2026-06-18

Tramadol hydrochloride dose37.5 mg

Acetaminophen dose325 mg

Clinical bottom line

Caveats

This record does not contain clinical trial results, efficacy data, or comparative safety analyses.
REMS requirements are noted but not detailed in this record.
No population demographics, inclusion criteria, or contraindications are specified.
Approval does not imply superiority over other pain management options; consult full prescribing information for indication and use.

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 approval record; no clinical study design present.

Directness

insufficient

Record does not report clinical trial outcomes or comparative efficacy data.

Consistency

insufficient

Single regulatory action; no comparative or pooled evidence reported.

Risk of bias

insufficient

Regulatory record does not disclose trial methodology or bias assessment.

Sample adequacy

insufficient

No clinical sample size or trial population data disclosed in this record.

Source abstract

Drugs@FDA record for application ANDA207152. This is a regulatory action record, not a clinical study. Brand name: TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN. Active ingredient: TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN. Sponsor: AUROBINDO PHARMA. Submission type: SUPPL (supplement). Submission class: REMS. Approval status date: 2026-06-18. Products: TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN, TABLET, ORAL, ACETAMINOPHEN 325MG + TRAMADOL HYDROCHLORIDE 37.5MG.

Follow from this

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

Aurobindo PharmaTramadol Hydrochloride AND Acetaminophen