Metformin Hydrochloride · Regulatory label update

FDA supplemental approval: Metformin Hydrochloride (Labeling)

U.S. Food and Drug Administration · July 14, 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 action by the FDA approving a labeling supplement for metformin hydrochloride extended-release 500 mg tablets (ANDA 076450, Actavis Elizabeth, approved 14 July 2026). The record documents an administrative approval and does not contain clinical trial results, efficacy data, or safety findings.

What was studied

Regulatory label update.

Key findings

Safety

This record does not contain clinical trial results, efficacy endpoints, or comparative safety data No information on indication, contraindication, or adverse event updates

Who this may help

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

Plain-language summary

FDA supplemental approval for labeling of metformin hydrochloride extended-release tablet; a regulatory action that does not contain clinical trial data or efficacy evidence.

Reported figures

Quoted from the source exactly as published.

Approval date2026-07-14

Application numberANDA076450

Dose approved500 mg extended-release tablet

Caveats

This record does not contain clinical trial results, efficacy endpoints, or comparative safety data
Labeling submission type; the specific labeling changes are not detailed in this record
No information on indication, contraindication, or adverse event updates
Generic ANDA approval; does not establish new clinical evidence

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 action record; no study design present

Directness

insufficient

Labeling action; does not report clinical outcomes or direct evidence

Consistency

insufficient

Single regulatory action; no comparison data provided

Risk of bias

insufficient

Not applicable to regulatory labeling submission

Sample adequacy

insufficient

No sample or study population 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 ANDA076450. This is a regulatory action record, not a clinical study. Brand name: METFORMIN HYDROCHLORIDE. Active ingredient: METFORMIN HYDROCHLORIDE. Sponsor: ACTAVIS ELIZABETH. Submission type: SUPPL (supplement). Submission class: Labeling. Approval status date: 2026-07-14. 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.

Actavis ElizabethMetformin Hydrochloride