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 an FDA regulatory record documenting approval of a supplemental labeling application for metformin hydrochloride tablets (generic, ANDA) by Mylan, effective 11 August 2026. The record confirms the regulatory action but does not disclose the specific labeling changes made, the clinical or safety rationale, or any trial results.

What was studied

Regulatory label update.

Key findings

Supplemental labeling approval granted for metformin hydrochloride tablets in three strengths: 500 mg, 850 mg, and 1 g oral tablets

Safety

This record does not contain clinical trial results, efficacy data, or safety outcomes.

Who this may help

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

Plain-language summary

FDA supplemental approval of labeling changes for an established generic metformin hydrochloride formulation; regulatory action without new clinical trial data.

Reported figures

Quoted from the source exactly as published.

Approval status date2026-08-11

Application numberANDA075973

Caveats

This record does not contain clinical trial results, efficacy data, or safety outcomes.
The specific labeling changes approved are not disclosed in this regulatory record.
No information on the clinical or regulatory rationale for the labeling supplement is provided.
As a generic ANDA supplement, this does not represent new clinical evidence or comparative benefit assessment.

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

Record does not disclose labeling changes or clinical rationale.

Consistency

insufficient

No comparative data or outcome data reported.

Risk of bias

insufficient

Not a clinical study; bias assessment not applicable.

Sample adequacy

insufficient

No patient cohort or sample reported.

Source abstract

Drugs@FDA record for application ANDA075973. This is a regulatory action record, not a clinical study. Brand name: METFORMIN HYDROCHLORIDE. Active ingredient: METFORMIN HYDROCHLORIDE. Sponsor: MYLAN. Submission type: SUPPL (supplement). Submission class: Labeling. Approval status date: 2026-08-11. Products: METFORMIN HYDROCHLORIDE, TABLET, ORAL, METFORMIN HYDROCHLORIDE 1GM; METFORMIN HYDROCHLORIDE, TABLET, ORAL, METFORMIN HYDROCHLORIDE 500MG; METFORMIN HYDROCHLORIDE, TABLET, ORAL, METFORMIN HYDROCHLORIDE 850MG.

Follow from this

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

Metformin HydrochlorideMylan