Meperidine Hydrochloride · Regulatory label update

FDA supplemental approval: Meperidine Hydrochloride (REMS)

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

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AI Summary

The FDA approved a supplemental REMS (Risk Evaluation and Mitigation Strategy) application for meperidine hydrochloride 100 mg tablets on 18 June 2026. This is a regulatory action record documenting approval of risk management requirements; it does not contain clinical trial results, efficacy data, or safety outcomes.

What was studied

Regulatory label update.

Key findings

REMS supplement approved for meperidine hydrochloride 100 mg oral tablet formulation (ANDA088640) on 2026-06-18

Safety

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

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 meperidine hydrochloride; this is a regulatory action record without clinical trial data.

Reported figures

Quoted from the source exactly as published.

Approval status date2026-06-18

Dose100 mg

Caveats

This record does not contain clinical trial results, efficacy data, or safety outcomes.
The record does not specify the content, requirements, or rationale for the REMS approval.
No comparative data, sample size, or endpoint results are provided.
No information on affected patient populations or indication for use is stated in this record.

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; not a clinical study.

Directness

insufficient

Record documents regulatory action only; no clinical outcomes reported.

Consistency

insufficient

Single regulatory record; no comparative data or replication.

Risk of bias

insufficient

Not applicable to regulatory approval documentation.

Sample adequacy

insufficient

No sample or clinical population described in this record.

Source abstract

Drugs@FDA record for application ANDA088640. This is a regulatory action record, not a clinical study. Brand name: MEPERIDINE HYDROCHLORIDE. Active ingredient: MEPERIDINE HYDROCHLORIDE. Sponsor: BARR. Submission type: SUPPL (supplement). Submission class: REMS. Approval status date: 2026-06-18. Products: MEPERIDINE HYDROCHLORIDE, TABLET, ORAL, MEPERIDINE HYDROCHLORIDE 100MG.

Follow from this

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

Meperidine HydrochlorideBarr