Metformin Hydrochloride · Regulatory label update

FDA supplemental approval: Metformin Hydrochloride (Labeling)

U.S. Food and Drug Administration · August 11, 2026

Regulatory Update Why this matters to you Expert discussion

An action by a regulator. Authoritative on labelling and availability.

AI Summary

The FDA issued a supplemental approval for a labeling change to metformin hydrochloride extended-release 500 mg tablets (ANDA076873, Sandoz) on 11 August 2026. This is a regulatory action record that documents approval of a labeling modification and does not contain clinical trial results, efficacy data, or safety comparisons.

What was studied

Regulatory label update.

Key findings

Safety

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

Who this may help

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

Plain-language summary

FDA supplemental approval for metformin hydrochloride labeling change; records a regulatory action, not clinical trial evidence.

Reported figures

Quoted from the source exactly as published.

Approval date2026-08-11

Strength500 mg

Caveats

This regulatory record does not contain clinical trial results, safety data, or efficacy comparisons.
The specific labeling change(s) approved are not detailed in this record.
No information on mechanism, indication, dosing recommendations, or contraindications changes is provided.

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 record, not a clinical study.

Directness

insufficient

Labeling action does not report clinical outcomes or efficacy data.

Consistency

insufficient

No comparative or replication data provided in regulatory record.

Risk of bias

insufficient

Not applicable to regulatory labeling approval record.

Sample adequacy

insufficient

No study population or sample size reported.

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 ANDA076873. This is a regulatory action record, not a clinical study. Brand name: METFORMIN HYDROCHLORIDE. Active ingredient: METFORMIN HYDROCHLORIDE. Sponsor: SANDOZ. Submission type: SUPPL (supplement). Submission class: Labeling. Approval status date: 2026-08-11. Products: METFORMIN HYDROCHLORIDE, TABLET, EXTENDED RELEASE, ORAL, METFORMIN HYDROCHLORIDE 500MG.

Follow from this

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

SandozMetformin Hydrochloride