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 supplemental FDA approval of labeling changes for Ajanta Pharma's metformin hydrochloride extended-release tablets (500 mg and 1 g formulations), approved on 2026-08-11. The record documents a regulatory action only and does not include clinical trial results, efficacy data, or comparative evidence.

What was studied

Regulatory label update.

Key findings

Safety

This is a regulatory record and does not report clinical trial outcomes, efficacy data, or safety results. The record does not specify whether changes are safety-related, administrative, or manufacturing-related.

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 existing metformin hydrochloride extended-release product; no clinical trial data or efficacy evidence is reported.

Caveats

This is a regulatory record and does not report clinical trial outcomes, efficacy data, or safety results.
The specific labeling changes made are not detailed in this record.
No comparative or clinical evidence is presented; approval does not imply new efficacy claims.
The record does not specify whether changes are safety-related, administrative, or manufacturing-related.

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 only; no study design applicable.

Directness

insufficient

Labeling action does not report clinical outcomes or comparisons.

Consistency

insufficient

Single regulatory action; consistency cannot be assessed.

Risk of bias

insufficient

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

Sample adequacy

insufficient

No sample size reported; regulatory approval action only.

What is missing. This record has no key findings, reported figures. That is a gap in the analysis, not a judgement about the study.

Source abstract

Drugs@FDA record for application ANDA213651. This is a regulatory action record, not a clinical study. Brand name: METFORMIN HYDROCHLORIDE. Active ingredient: METFORMIN HYDROCHLORIDE. Sponsor: AJANTA PHARMA LTD. Submission type: SUPPL (supplement). Submission class: Labeling. Approval status date: 2026-08-11. Products: METFORMIN HYDROCHLORIDE, TABLET, EXTENDED RELEASE, ORAL, METFORMIN HYDROCHLORIDE 500MG; METFORMIN HYDROCHLORIDE, TABLET, EXTENDED RELEASE, ORAL, METFORMIN HYDROCHLORIDE 1GM.

Follow from this

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

Metformin HydrochlorideAjanta Pharma