Azathioprine · Regulatory label update

FDA supplemental approval: Azathioprine (Labeling)

U.S. Food and Drug Administration · July 16, 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 US FDA supplemental approval record for a labeling change to azathioprine 50 mg tablets (generic, sponsor Rising Pharmaceuticals) approved on 16 July 2026. The record documents the regulatory action only and does not contain clinical trial data, efficacy evidence, or details of what labeling revisions were made.

What was studied

Regulatory label update. United States.

Key findings

Safety

This is a regulatory approval record and does not contain clinical trial results, safety data, or efficacy evidence. No comparative efficacy, adverse event rates, or clinical outcomes are reported.

Who this may help

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

Plain-language summary

FDA supplemental approval for azathioprine labeling change; regulatory action without clinical trial data or efficacy claims.

Study design

As stated by the source record.

SettingUnited States

Reported figures

Quoted from the source exactly as published.

Approval date2026-07-16

Submission typeSupplemental—Labeling

Drug strength50 mg

Caveats

This is a regulatory approval record and does not contain clinical trial results, safety data, or efficacy evidence.
The specific labeling changes made in this supplement are not detailed in this record.
No comparative efficacy, adverse event rates, or clinical outcomes are reported.
The record does not indicate the reason for the labeling supplement or what clinical or safety information prompted it.

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 applicable.

Directness

insufficient

Record does not report clinical outcomes or direct evidence.

Consistency

insufficient

Single regulatory action; no comparative or replicated data presented.

Risk of bias

insufficient

Regulatory submission; bias assessment not applicable to labeling action.

Sample adequacy

insufficient

No clinical sample reported in this regulatory 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 ANDA075568. This is a regulatory action record, not a clinical study. Brand name: AZATHIOPRINE. Active ingredient: AZATHIOPRINE. Sponsor: RISING. Submission type: SUPPL (supplement). Submission class: Labeling. Approval status date: 2026-07-16. Products: AZATHIOPRINE, TABLET, ORAL, AZATHIOPRINE 50MG.

Follow from this

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

RisingAzathioprine