Tacrolimus · Regulatory label update

FDA supplemental approval: Tacrolimus (Labeling)

U.S. Food and Drug Administration · July 29, 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 supplemental approval of tacrolimus labeling (oral capsules in 0.5 mg, 1 mg, and 5 mg strengths) submitted by Alkem Labs Ltd, approved on 29 July 2026. The record documents a regulatory action only and contains no clinical trial results, efficacy data, or comparative evidence.

What was studied

Regulatory label update.

Key findings

Supplemental approval of labeling for tacrolimus capsules in three strengths: 0.5 mg, 1 mg, and 5 mg

Safety

This record does not contain clinical trial results, efficacy data, or safety findings. The nature of the labeling change (e.g., new indication, safety update, or manufacturing change) is not specified.

Who this may help

This record confirms FDA labeling approval for tacrolimus oral capsules but provides no clinical efficacy, safety, or comparative data. Readers should consult the approved label and underlying NDA/ANDA records for clinical information.

Plain-language summary

FDA supplemental approval of tacrolimus labeling by Alkem Labs; this is a regulatory action record without clinical trial data and does not support efficacy or comparative clinical claims.

Reported figures

Quoted from the source exactly as published.

Approval date2026-07-29

Strengths approved0.5 mg, 1 mg, 5 mg (oral capsules)

Clinical bottom line

Caveats

This record does not contain clinical trial results, efficacy data, or safety findings.
The nature of the labeling change (e.g., new indication, safety update, or manufacturing change) is not specified.
No comparator or control group data is present.
No patient population, dosing regimen details, or clinical outcomes are reported in this regulatory record.

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

Labeling approval does not report clinical outcomes or patient data.

Consistency

insufficient

No comparative data or replication reported in this record.

Risk of bias

insufficient

Not applicable to a labeling approval record.

Sample adequacy

insufficient

No patient sample or clinical trial data in this record.

Source abstract

Drugs@FDA record for application ANDA203740. This is a regulatory action record, not a clinical study. Brand name: TACROLIMUS. Active ingredient: TACROLIMUS. Sponsor: ALKEM LABS LTD. Submission type: SUPPL (supplement). Submission class: Labeling. Approval status date: 2026-07-29. Products: TACROLIMUS, CAPSULE, ORAL, TACROLIMUS EQ 1MG BASE; TACROLIMUS, CAPSULE, ORAL, TACROLIMUS EQ 5MG BASE; TACROLIMUS, CAPSULE, ORAL, TACROLIMUS EQ 0.5MG BASE.

Follow from this

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

TacrolimusAlkem Labs