Celecoxib · Regulatory label update

FDA supplemental approval: Celecoxib (Labeling)

U.S. Food and Drug Administration · July 17, 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 for labeling changes to celecoxib capsules (50 mg, 100 mg, 200 mg, and 400 mg oral formulations) approved on 17 July 2026. The record documents regulatory action only and does not contain clinical trial results, efficacy data, or safety outcomes.

What was studied

Regulatory label update.

Key findings

Safety

This record does not contain clinical trial results, efficacy data, or comparative safety information.

Who this may help

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

Plain-language summary

FDA supplemental approval for labeling of celecoxib; this is a regulatory action record, not a clinical study, and does not report efficacy or safety trial outcomes.

Caveats

This record does not contain clinical trial results, efficacy data, or comparative safety information.
The specific labeling changes approved are not detailed in this record.
No study design, sample size, endpoints, or statistical analyses are reported.
This approval applies only to ALEMBIC's ANDA submission ANDA204519; generalizability to other manufacturers or formulations unknown.

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

This is a regulatory record, not a clinical study; design category does not apply.

Directness

insufficient

Regulatory approval record contains no clinical trial data or direct efficacy/safety evidence.

Consistency

insufficient

No comparative or trial data provided in this approval record.

Risk of bias

insufficient

Regulatory records do not report study methodology or bias assessment.

Sample adequacy

insufficient

This is a labeling approval; no participant data or sample size reported.

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 ANDA204519. This is a regulatory action record, not a clinical study. Brand name: CELECOXIB. Active ingredient: CELECOXIB. Sponsor: ALEMBIC. Submission type: SUPPL (supplement). Submission class: Labeling. Approval status date: 2026-07-17. Products: CELECOXIB, CAPSULE, ORAL, CELECOXIB 200MG; CELECOXIB, CAPSULE, ORAL, CELECOXIB 50MG; CELECOXIB, CAPSULE, ORAL, CELECOXIB 400MG; CELECOXIB, CAPSULE, ORAL, CELECOXIB 100MG.

Follow from this

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

CelecoxibAlembic