Metformin Hydrochloride · Regulatory label update

FDA supplemental approval: Metformin Hydrochloride (Labeling)

U.S. Food and Drug Administration · July 15, 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 action for a labeling change to metformin hydrochloride extended-release tablets (500 mg) from Zydus Lifesciences, approved on 15 July 2026. The record documents the regulatory decision only and contains no clinical trial results, efficacy data, or safety outcomes.

What was studied

Regulatory label update.

Key findings

Safety

This record does not contain clinical trial results, efficacy data, safety outcomes, or comparative evidence.

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 evidence of efficacy or safety.

Reported figures

Quoted from the source exactly as published.

Approval date2026-07-15

Drug strength500 mg

Dosage formtablet, extended release, oral

Caveats

This record does not contain clinical trial results, efficacy data, safety outcomes, or comparative evidence.
The nature of the labeling change is not specified in this record.
No information on the rationale, scope, or clinical implications of the approval is provided.
This is an administrative approval document, not a source for evaluating clinical practice or patient outcomes.

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

Regulatory labeling approval does not contain clinical trial data.

Consistency

insufficient

No comparative or outcome data provided in this record.

Risk of bias

insufficient

Risk of bias assessment not applicable to regulatory approval documentation.

Sample adequacy

insufficient

No study population or sample size 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 ANDA077060. This is a regulatory action record, not a clinical study. Brand name: METFORMIN HYDROCHLORIDE. Active ingredient: METFORMIN HYDROCHLORIDE. Sponsor: ZYDUS LIFESCIENCES. Submission type: SUPPL (supplement). Submission class: Labeling. Approval status date: 2026-07-15. 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.

Zydus LifesciencesMetformin Hydrochloride