Metformin Hydrochloride · Regulatory label update

FDA supplemental approval: Metformin Hydrochloride (Labeling)

U.S. Food and Drug Administration · July 30, 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 U.S. FDA supplemental approval action for metformin hydrochloride extended-release tablets (500 mg and 750 mg formulations) manufactured by Amneal Pharmaceuticals NY, based on application ANDA078596, approved 30 July 2026. The record documents a labeling update only and does not contain clinical trial results, efficacy data, or comparative evidence.

What was studied

Regulatory label update.

Key findings

Supplemental approval granted for metformin hydrochloride extended-release tablets, 500 mg and 750 mg strengths Approval date: 2026-07-30 Submission type: labeling supplement (SUPPL, class Labeling)

Safety

This record does not contain clinical trial results, efficacy data, safety data, or labeling content details

Who this may help

This regulatory record does not provide clinical evidence or prescribing information changes. Clinicians should consult the updated product labeling directly from the FDA or manufacturer for any changes to indications, dosing, contraindications, or safety information.

Plain-language summary

FDA supplemental approval for metformin hydrochloride labeling update; regulatory action without clinical trial data or efficacy claims.

Reported figures

Quoted from the source exactly as published.

Approval status date2026-07-30

Application numberANDA078596

Clinical bottom line

Caveats

This record does not contain clinical trial results, efficacy data, safety data, or labeling content details
The specific labeling changes are not described in this regulatory action record
No information on comparative efficacy, absolute risk reduction, or patient populations is provided
Record is from 2026; verification against current FDA and manufacturer information is recommended

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 applicable.

Directness

insufficient

Labeling action; does not report clinical outcomes or comparative data.

Consistency

insufficient

Single regulatory action; no comparative evidence provided.

Risk of bias

insufficient

Not a clinical study; risk of bias framework does not apply.

Sample adequacy

insufficient

No sample or population data in regulatory record.

Source abstract

Drugs@FDA record for application ANDA078596. This is a regulatory action record, not a clinical study. Brand name: METFORMIN HYDROCHLORIDE. Active ingredient: METFORMIN HYDROCHLORIDE. Sponsor: AMNEAL PHARMS NY. Submission type: SUPPL (supplement). Submission class: Labeling. Approval status date: 2026-07-30. Products: METFORMIN HYDROCHLORIDE, TABLET, EXTENDED RELEASE, ORAL, METFORMIN HYDROCHLORIDE 500MG; 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.

Amneal Pharms NYMetformin Hydrochloride