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 granted on 2026-07-15 for metformin hydrochloride extended-release 750 mg tablets (Zydus LifeSciences, ANDA077078). The record documents regulatory classification and approval status only and does not contain clinical trial results, efficacy data, or safety findings.

What was studied

Regulatory label update.

Key findings

Safety

This record contains no clinical trial results, efficacy data, or safety findings. No adverse event, pharmacokinetic, or outcome data are reported.

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 efficacy or safety data.

Reported figures

Quoted from the source exactly as published.

Approval status date2026-07-15

Product strength750 mg

Caveats

This record contains no clinical trial results, efficacy data, or safety findings.
The specific labeling changes made are not detailed in this record.
No comparative or control data are presented.
No adverse event, pharmacokinetic, or outcome data are reported.

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 record does not report clinical trial outcomes or comparative data.

Consistency

insufficient

No clinical efficacy or safety data presented in this record.

Risk of bias

insufficient

Not applicable; this is a regulatory submission classification, not a study.

Sample adequacy

insufficient

No sample size or clinical population data 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 ANDA077078. 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 750MG.

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