Metformin Hydrochloride · Regulatory label update

FDA supplemental approval: Metformin Hydrochloride (Labeling)

U.S. Food and Drug Administration · July 22, 2026

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AI Summary

This is a U.S. FDA supplemental approval action for a labeling update to metformin hydrochloride extended-release 500 mg tablet (ANDA 076249, sponsor IMPAX LABS), approved 22 July 2026. The record documents the regulatory decision and product specifications but does not contain clinical trial results, efficacy data, or safety evidence.

What was studied

Regulatory label update.

Key findings

Supplemental approval granted for metformin hydrochloride extended-release tablet 500 mg labeling

Safety

This record is a regulatory approval notice and does not contain clinical trial results, efficacy outcomes, safety data, or comparative evidence.

Who this may help

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

Plain-language summary

FDA supplemental approval for labeling of metformin hydrochloride extended-release tablet; does not report clinical trial data or comparative efficacy.

Reported figures

Quoted from the source exactly as published.

Approval date2026-07-22

Dose strength500 mg

Application numberANDA076249

Caveats

This record is a regulatory approval notice and does not contain clinical trial results, efficacy outcomes, safety data, or comparative evidence.
The specific labeling changes approved are not detailed in this record.
No patient population, sample size, or clinical endpoints are reported.

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

Labeling supplement does not address clinical outcomes or direct patient benefit.

Consistency

insufficient

Single approval action; no comparative or consistency data reported.

Risk of bias

insufficient

Regulatory action record; risk of bias assessment not applicable.

Sample adequacy

insufficient

No clinical study sample; approval is administrative labeling change only.

Source abstract

Drugs@FDA record for application ANDA076249. This is a regulatory action record, not a clinical study. Brand name: METFORMIN HYDROCHLORIDE. Active ingredient: METFORMIN HYDROCHLORIDE. Sponsor: IMPAX LABS. Submission type: SUPPL (supplement). Submission class: Labeling. Approval status date: 2026-07-22. Products: METFORMIN HYDROCHLORIDE, TABLET, EXTENDED RELEASE, ORAL, METFORMIN HYDROCHLORIDE 500MG.

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

Metformin HydrochlorideImpax Labs