Methotrexate · Regulatory label update

FDA supplemental approval: Methotrexate (Labeling)

U.S. Food and Drug Administration · May 27, 2026

Regulatory Update Why this matters to you Expert discussion

An action by a regulator. Authoritative on labelling and availability.

AI Summary

The FDA approved a supplemental application (labeling change) for methotrexate sodium tablets on 27 May 2026. This record documents a regulatory action only and contains no clinical trial data, efficacy evidence, or safety results.

What was studied

Regulatory label update.

Key findings

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

This is an FDA supplemental approval for labeling changes to methotrexate; it documents a regulatory action, not clinical evidence of efficacy or safety.

Reported figures

Quoted from the source exactly as published.

Approval date2026-05-27

Application numberANDA213343

Product strengthMETHOTREXATE SODIUM EQ 2.5MG BASE

Caveats

This record does not contain clinical trial results, efficacy data, or safety outcomes.
The specific labeling changes approved are not described in this excerpt.
No comparator or comparative effectiveness data are reported.
The basis for approval and scope of labeling revision cannot be determined from this record alone.

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 clinical study design present.

Directness

insufficient

Record does not report clinical trial outcomes or direct evidence.

Consistency

insufficient

No comparative data or consistency assessment provided.

Risk of bias

insufficient

Not applicable to regulatory labeling submission record.

Sample adequacy

insufficient

No study population or sample size reported in this record.

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 ANDA213343. This is a regulatory action record, not a clinical study. Brand name: METHOTREXATE. Active ingredient: METHOTREXATE. Sponsor: ACCORD HLTHCARE. Submission type: SUPPL (supplement). Submission class: Labeling. Approval status date: 2026-05-27. Products: METHOTREXATE SODIUM, TABLET, ORAL, METHOTREXATE SODIUM EQ 2.5MG BASE.

Follow from this

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

MethotrexateAccord Hlthcare