Tramadol Hydrochloride · Regulatory label update

FDA supplemental approval: Tramadol Hydrochloride (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 an FDA supplemental approval dated 18 June 2026 for a REMS (Risk Evaluation and Mitigation Strategy) program for tramadol hydrochloride 50 mg tablets, submitted by Senores Pharms as an abbreviated new drug application (ANDA). The record documents regulatory action only and does not contain clinical trial results, efficacy data, or safety outcomes.

What was studied

Regulatory label update.

Key findings

Safety

This record does not contain clinical trial results, efficacy endpoints, or safety data. No information on the rationale for the REMS supplement or safety signals driving the approval is given.

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 tramadol hydrochloride; describes a regulatory action, not a clinical trial or efficacy evidence.

Reported figures

Quoted from the source exactly as published.

Approval date2026-06-18

Dose50 mg

Caveats

This record does not contain clinical trial results, efficacy endpoints, or safety data.
No comparator, control arm, or comparative effectiveness information is provided.
The specific requirements or changes to the REMS program are not detailed in this regulatory record.
No information on the rationale for the REMS supplement or safety signals driving the approval is given.

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 record; no clinical study design reported.

Directness

insufficient

Record documents REMS approval; does not report clinical outcomes or efficacy data.

Consistency

insufficient

Single regulatory action; consistency with other trials not addressed.

Risk of bias

insufficient

Not applicable to regulatory record; no clinical trial bias assessment possible.

Sample adequacy

insufficient

No study population or sample size; regulatory document only.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Drugs@FDA record for application ANDA090404. This is a regulatory action record, not a clinical study. Brand name: TRAMADOL HYDROCHLORIDE. Active ingredient: TRAMADOL HYDROCHLORIDE. Sponsor: SENORES PHARMS. Submission type: SUPPL (supplement). Submission class: REMS. Approval status date: 2026-06-18. Products: TRAMADOL HYDROCHLORIDE, TABLET, ORAL, TRAMADOL HYDROCHLORIDE 50MG.

Follow from this

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

Tramadol HydrochlorideSenores Pharms