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 a labeling change for metformin hydrochloride tablets (500 mg, 850 mg, and 1 gram formulations) by Glenmark Pharmaceuticals, approved on 11 August 2026. The record is a regulatory action and does not contain clinical trial data, efficacy results, or comparative benefit information.

What was studied

Regulatory label update.

Key findings

Supplemental approval granted for labeling of metformin hydrochloride tablets in three strengths: 500 mg, 850 mg, and 1 gram

Safety

No safety or efficacy outcome measures are reported

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; this is a regulatory action, not a clinical trial, and does not report efficacy or comparative benefit data.

Reported figures

Quoted from the source exactly as published.

Approval status date2026-08-11

Product strengths approved500 mg, 850 mg, 1 gram

Caveats

This record does not contain clinical trial results, efficacy data, or comparative benefit analysis
Specific labeling changes are not detailed in the provided text
No safety or efficacy outcome measures are reported
This is a supplemental approval for an already-approved drug; the nature of the labeling revision is not specified

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 record, not a clinical study.

Directness

insufficient

Record does not describe clinical trial outcomes or direct evidence.

Consistency

insufficient

No comparative data or evidence synthesis provided in record.

Risk of bias

insufficient

Regulatory approval record; does not assess trial methodology or bias.

Sample adequacy

insufficient

No clinical trial population or sample size described.

Source abstract

Drugs@FDA record for application ANDA078170. This is a regulatory action record, not a clinical study. Brand name: METFORMIN HYDROCHLORIDE. Active ingredient: METFORMIN HYDROCHLORIDE. Sponsor: GLENMARK PHARMS LTD. Submission type: SUPPL (supplement). Submission class: Labeling. Approval status date: 2026-08-11. Products: METFORMIN HYDROCHLORIDE, TABLET, ORAL, METFORMIN HYDROCHLORIDE 1GM; METFORMIN HYDROCHLORIDE, TABLET, ORAL, METFORMIN HYDROCHLORIDE 500MG; METFORMIN HYDROCHLORIDE, TABLET, ORAL, METFORMIN HYDROCHLORIDE 850MG.

Follow from this

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

Metformin HydrochlorideGlenmark Pharms