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 a regulatory record documenting FDA approval of a labeling supplement for metformin hydrochloride extended-release 500 mg tablets (ANDA090014, sponsor Torrent) effective 11 August 2026. The record does not contain clinical trial data, efficacy results, or comparative outcomes; it confirms only that a labeling change was approved.

What was studied

Regulatory label update.

Key findings

Safety

No clinical trial results, safety data, or comparative efficacy information are provided.

Who this may help

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

Plain-language summary

FDA supplemental approval for metformin hydrochloride labeling change; regulatory action with no clinical trial data reported.

Reported figures

Quoted from the source exactly as published.

Approval date2026-08-11

Dose strength500 mg

Caveats

This is a regulatory approval record, not a clinical trial or efficacy study.
The specific labeling changes are not detailed in this record; only approval of the supplement is documented.
No clinical trial results, safety data, or comparative efficacy information are provided.
The nature and extent of the labeling modification cannot be determined from this record.

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 supplement; no clinical outcomes reported.

Consistency

insufficient

No comparative or clinical data provided in record.

Risk of bias

insufficient

Regulatory action; no trial methodology or bias assessment.

Sample adequacy

insufficient

No clinical study or sample size reported.

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 ANDA090014. This is a regulatory action record, not a clinical study. Brand name: METFORMIN HYDROCHLORIDE. Active ingredient: METFORMIN HYDROCHLORIDE. Sponsor: TORRENT. Submission type: SUPPL (supplement). Submission class: Labeling. Approval status date: 2026-08-11. 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.

TorrentMetformin Hydrochloride