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

This is an FDA supplemental approval of labeling changes for metformin hydrochloride tablets (500 mg, 850 mg, and 1 g formulations) by LAURUS, approved 11 August 2026. The record documents a regulatory action only and does not contain clinical trial results, efficacy data, or safety assessments.

What was studied

Regulatory label update.

Key findings

Safety

No clinical trial results, efficacy data, safety assessments, or comparative evidence are provided in this record.

Who this may help

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

Plain-language summary

FDA supplemental approval of labeling changes for metformin hydrochloride; regulatory action does not report clinical trial outcomes or efficacy data.

Reported figures

Quoted from the source exactly as published.

Approval date2026-08-11

Application numberANDA209882

Submission classLabeling

Caveats

This is a regulatory approval record for a labeling supplement, not a clinical study or trial.
No clinical trial results, efficacy data, safety assessments, or comparative evidence are provided in this record.
The specific labeling changes approved are not detailed in this regulatory action record.
No information on trial methodology, patient population, endpoints, or outcomes is available.

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 with a design.

Directness

insufficient

Regulatory record does not report clinical outcomes or direct efficacy evidence.

Consistency

insufficient

No comparative data or consistency assessment provided in this record.

Risk of bias

insufficient

Regulatory approval record does not assess risk of bias in clinical studies.

Sample adequacy

insufficient

No sample size or clinical trial data reported in this regulatory action.

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 ANDA209882. This is a regulatory action record, not a clinical study. Brand name: METFORMIN HYDROCHLORIDE. Active ingredient: METFORMIN HYDROCHLORIDE. Sponsor: LAURUS. Submission type: SUPPL (supplement). Submission class: Labeling. Approval status date: 2026-08-11. Products: METFORMIN HYDROCHLORIDE, TABLET, ORAL, METFORMIN HYDROCHLORIDE 850MG; METFORMIN HYDROCHLORIDE, TABLET, ORAL, METFORMIN HYDROCHLORIDE 1GM; METFORMIN HYDROCHLORIDE, TABLET, 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.

LaurusMetformin Hydrochloride