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 record documenting a labeling change for metformin hydrochloride (ANDA 075972) sponsored by Chartwell, approved 11 August 2026. The record does not contain clinical trial data, efficacy results, or safety findings; it records only the regulatory action and affected product strengths (625 mg, 750 mg, 850 mg, 1 g tablets).

What was studied

Regulatory label update.

Key findings

Safety

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

Who this may help

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

Plain-language summary

This is an FDA supplemental approval action for metformin hydrochloride labeling; it documents a regulatory decision, not clinical trial evidence.

Reported figures

Quoted from the source exactly as published.

Approval date2026-08-11

Product strengths approved625 mg, 750 mg, 850 mg, 1 gram tablets

Caveats

This record does not contain clinical trial results, efficacy data, or safety analyses.
The specific content of the labeling change is not described in this record.
No comparative benefit or risk information is provided.
This is an approval of a labeling supplement only; it does not indicate new clinical evidence or indications.

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

No clinical trial data or outcomes are reported in this record.

Consistency

insufficient

No comparative efficacy or safety data are provided.

Risk of bias

insufficient

Not applicable to a regulatory labeling submission.

Sample adequacy

insufficient

No clinical study sample is reported in this record.

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 ANDA075972. This is a regulatory action record, not a clinical study. Brand name: METFORMIN HYDROCHLORIDE. Active ingredient: METFORMIN HYDROCHLORIDE. Sponsor: CHARTWELL. Submission type: SUPPL (supplement). Submission class: Labeling. Approval status date: 2026-08-11. Products: METFORMIN HYDROCHLORIDE, TABLET, ORAL, METFORMIN HYDROCHLORIDE 750MG; METFORMIN HYDROCHLORIDE, TABLET, ORAL, METFORMIN HYDROCHLORIDE 850MG; METFORMIN HYDROCHLORIDE, TABLET, ORAL, METFORMIN HYDROCHLORIDE 625MG; METFORMIN HYDROCHLORIDE, TABLET, ORAL, METFORMIN HYDROCHLORIDE 1GM.

Follow from this

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

Metformin HydrochlorideChartwell