Piroxicam · Regulatory label update

FDA supplemental approval: Piroxicam (Labeling)

U.S. Food and Drug Administration · June 25, 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 action record documenting FDA approval of a supplemental labeling change for piroxicam (10 mg and 20 mg capsules) under ANDA 206136 by Strides Pharma, effective 25 June 2026. The record does not contain clinical trial results, efficacy data, or comparative evidence; it only confirms the labeling submission class and approval status.

What was studied

Regulatory label update.

Key findings

Safety

This record does not contain clinical trial results, efficacy data, safety outcomes, or comparative effectiveness evidence. No efficacy, safety profile, or clinical use information is provided by this regulatory action alone.

Who this may help

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

Plain-language summary

FDA supplemental approval for piroxicam labeling changes; does not contain clinical trial data or efficacy evidence.

Reported figures

Quoted from the source exactly as published.

Approval status date2026-06-25

Application numberANDA206136

Strengths approved10 mg and 20 mg capsules

Caveats

This record does not contain clinical trial results, efficacy data, safety outcomes, or comparative effectiveness evidence.
The specific labeling changes approved are not detailed in this record.
No efficacy, safety profile, or clinical use information is provided by this regulatory action 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 record; no study design applies.

Directness

insufficient

Labeling action only; no clinical outcome data reported.

Consistency

insufficient

Single regulatory action; no comparative evidence presented.

Risk of bias

insufficient

Regulatory record does not report trial methodology or bias assessment.

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 ANDA206136. This is a regulatory action record, not a clinical study. Brand name: PIROXICAM. Active ingredient: PIROXICAM. Sponsor: STRIDES PHARMA. Submission type: SUPPL (supplement). Submission class: Labeling. Approval status date: 2026-06-25. Products: PIROXICAM, CAPSULE, ORAL, PIROXICAM 10MG; PIROXICAM, CAPSULE, ORAL, PIROXICAM 20MG.

Follow from this

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

Strides PharmaPiroxicam