Capecitabine · Regulatory label update

FDA supplemental approval: Capecitabine (Labeling)

U.S. Food and Drug Administration · July 1, 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 approval record for a supplemental labeling change to capecitabine (generic, oral tablets in 150 mg and 500 mg strengths) by the FDA on 1 July 2026. The record documents the administrative approval action only and contains no 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 data, or safety findings. No comparative efficacy or safety data are reported.

Who this may help

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

Plain-language summary

FDA supplemental approval for capecitabine labeling changes; does not report clinical trial outcomes or efficacy data.

Reported figures

Quoted from the source exactly as published.

Approval date2026-07-01

Application numberANDA210203

SponsorHETERO LABS LTD V

Formulations approvedCapecitabine 150 mg tablet oral; Capecitabine 500 mg tablet oral

Caveats

This record does not contain clinical trial results, efficacy data, or safety findings.
The nature and scope of the labeling change are not specified in this regulatory record.
No comparative efficacy or safety data are reported.
This is an ANDA (abbreviated new drug application) supplemental submission; the record does not indicate whether this represents a new indication, dosage revision, or other labeling modification.

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 record does not address clinical outcomes or interventions.

Consistency

insufficient

Single regulatory action; no comparative data reported.

Risk of bias

insufficient

Not applicable to regulatory approval record.

Sample adequacy

insufficient

No clinical trial population 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 ANDA210203. This is a regulatory action record, not a clinical study. Brand name: CAPECITABINE. Active ingredient: CAPECITABINE. Sponsor: HETERO LABS LTD V. Submission type: SUPPL (supplement). Submission class: Labeling. Approval status date: 2026-07-01. Products: CAPECITABINE, TABLET, ORAL, CAPECITABINE 150MG; CAPECITABINE, TABLET, ORAL, CAPECITABINE 500MG.

Follow from this

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

Hetero Labs LTD VCapecitabine