Meperidine Hydrochloride · Regulatory label update

FDA supplemental approval: Meperidine 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

The FDA approved a supplemental application (REMS) for meperidine hydrochloride tablets (50 mg and 100 mg oral formulations) sponsored by Sun Pharmaceutical Industries. This is a regulatory action establishing or modifying risk mitigation requirements; it does not contain clinical trial data, efficacy findings, or safety outcome comparisons.

What was studied

Regulatory label update.

Key findings

Supplemental REMS approval for meperidine hydrochloride 50 mg and 100 mg tablets Approval date: 18 June 2026 Sponsor: Sun Pharmaceutical Industries Inc.

Safety

This record does not contain clinical trial results, efficacy data, or safety outcome comparisons. Sponsor: Sun Pharmaceutical Industries Inc.

Who this may help

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

Plain-language summary

FDA supplemental approval for a Risk Evaluation and Mitigation Strategy (REMS) governing meperidine hydrochloride tablets; this is a regulatory action, not a clinical trial, and does not report efficacy or safety outcomes.

Reported figures

Quoted from the source exactly as published.

Approval date2026-06-18

Dose strengths approved50 mg, 100 mg

Caveats

This record does not contain clinical trial results, efficacy data, or safety outcome comparisons.
The specific content of the REMS (e.g., prescriber training, patient counselling requirements) is not described in this administrative record.
No information on patient population, indication, or comparative benefit is provided.
Approval status does not indicate new clinical evidence or changes in the clinical profile of meperidine.

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; design classification not applicable.

Directness

insufficient

Record does not report clinical outcomes or comparative efficacy data.

Consistency

insufficient

Single regulatory action; no comparative data or replication reported.

Risk of bias

insufficient

Regulatory approval record; bias assessment framework does not apply.

Sample adequacy

insufficient

No patient population or sample size; regulatory administrative record only.

Source abstract

Drugs@FDA record for application ANDA040446. This is a regulatory action record, not a clinical study. Brand name: MEPERIDINE HYDROCHLORIDE. Active ingredient: MEPERIDINE HYDROCHLORIDE. Sponsor: SUN PHARM INDS INC. Submission type: SUPPL (supplement). Submission class: REMS. Approval status date: 2026-06-18. Products: MEPERIDINE HYDROCHLORIDE, TABLET, ORAL, MEPERIDINE HYDROCHLORIDE 50MG; 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 HydrochlorideSUN Pharm Inds