Metformin Hydrochloride · Regulatory label update

FDA supplemental approval: Metformin Hydrochloride (Labeling)

U.S. Food and Drug Administration · July 29, 2026

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AI Summary

This record documents FDA supplemental approval of labeling for metformin hydrochloride extended-release 500 mg tablets (ANDA 077124) sponsored by Sun Pharmaceutical Industries, effective 29 July 2026. The action pertains to labeling updates only and does not contain clinical trial results, efficacy data, or comparative safety information.

What was studied

Regulatory label update.

Key findings

Safety

This is a regulatory labeling action, not a clinical trial; no efficacy, safety, or comparative outcome data are reported.

Who this may help

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

Plain-language summary

FDA supplemental approval of metformin hydrochloride labeling; this is a regulatory action, not a clinical trial, and contains no efficacy or safety outcome data.

Reported figures

Quoted from the source exactly as published.

Approval date2026-07-29

Dose500 mg

Caveats

This is a regulatory labeling action, not a clinical trial; no efficacy, safety, or comparative outcome data are reported.
The specific labeling changes are not described in this record.
No study population, sample size, or clinical endpoints are provided.
This record does not support any inference about clinical effectiveness or comparative benefit.

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

Regulatory record; no study design applicable.

Directness

insufficient

Labeling action only; no clinical outcome data reported.

Consistency

insufficient

Single regulatory action; no comparative data.

Risk of bias

insufficient

Regulatory record does not contain trial methodology.

Sample adequacy

insufficient

No human subjects study; sample size not applicable.

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 ANDA077124. This is a regulatory action record, not a clinical study. Brand name: METFORMIN HYDROCHLORIDE. Active ingredient: METFORMIN HYDROCHLORIDE. Sponsor: SUN PHARM INDUSTRIES. Submission type: SUPPL (supplement). Submission class: Labeling. Approval status date: 2026-07-29. Products: METFORMIN HYDROCHLORIDE, TABLET, EXTENDED RELEASE, ORAL, METFORMIN HYDROCHLORIDE 500MG.

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

SUN Pharm IndustriesMetformin Hydrochloride