Oxycodone Hydrochloride · Regulatory label update

FDA supplemental approval: Oxycodone Hydrochloride (REMS)

U.S. Food and Drug Administration · June 18, 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 for oxycodone hydrochloride oral solution (100 mg/5 mL) under REMS on 18 June 2026. This is a regulatory action document that confirms approval status and formulation details but does not contain clinical trial results, efficacy data, or comparative safety information.

What was studied

Regulatory label update.

Key findings

Supplemental ANDA approval granted for oxycodone hydrochloride oral solution, 100 mg/5 mL formulation Approval classified as REMS (Risk Evaluation and Mitigation Strategy) submission Sponsor: VISTAPHARM LLC; approval date 18 June 2026

Safety

Record does not contain clinical trial results, efficacy endpoints, or safety data Sponsor: VISTAPHARM LLC; approval date 18 June 2026

Who this may help

This approval permits marketing of the specified oxycodone hydrochloride formulation under REMS controls. Clinicians should consult full REMS requirements and prescribing information; this record does not establish efficacy, safety profile, or comparative positioning versus existing opioid products.

Plain-language summary

FDA supplemental approval of oxycodone hydrochloride oral solution under REMS framework; regulatory action, not efficacy evidence.

Reported figures

Quoted from the source exactly as published.

FormulationOXYCODONE HYDROCHLORIDE, SOLUTION, ORAL, 100MG/5ML

Application numberANDA202537

Approval date2026-06-18

Clinical bottom line

Caveats

Record does not contain clinical trial results, efficacy endpoints, or safety data
No information on patient population, dosing rationale, or comparative benefit
REMS designation indicates risk mitigation requirements, but specific REMS components are not detailed in this record
Approval is supplemental; underlying NDA data and previous approvals not included here

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 clinical study design reported.

Directness

insufficient

Record documents approval action only; no clinical outcomes reported.

Consistency

insufficient

No comparative data or outcome measures provided in record.

Risk of bias

insufficient

Regulatory approval record does not include trial methodology or bias assessment.

Sample adequacy

insufficient

No sample size or patient data reported in regulatory action.

Source abstract

Drugs@FDA record for application ANDA202537. This is a regulatory action record, not a clinical study. Brand name: OXYCODONE HYDROCHLORIDE. Active ingredient: OXYCODONE HYDROCHLORIDE. Sponsor: VISTAPHARM LLC. Submission type: SUPPL (supplement). Submission class: REMS. Approval status date: 2026-06-18. Products: OXYCODONE HYDROCHLORIDE, SOLUTION, ORAL, OXYCODONE HYDROCHLORIDE 100MG/5ML.

Follow from this

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

Oxycodone HydrochlorideVistapharm