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 (ANDA206456) on 18 June 2026 for oxycodone hydrochloride oral solution (5 mg/5 mL) from sponsor Pharmobedient under a Risk Evaluation and Mitigation Strategy (REMS) requirement. This record documents a regulatory action only and does not contain clinical trial results, efficacy data, or safety comparisons.

What was studied

Regulatory label update.

Key findings

Supplemental approval granted for oxycodone hydrochloride oral solution 5 mg/5 mL formulation on 2026-06-18 REMS classification applied to this product approval

Safety

This record contains no clinical trial results, efficacy outcomes, safety data, or comparative evidence. This is an administrative approval action, not a measure of clinical benefit or safety profile.

Who this may help

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

Plain-language summary

FDA supplemental approval action for oxycodone hydrochloride oral solution under REMS requirements; this is a regulatory classification change, not a clinical efficacy finding.

Reported figures

Quoted from the source exactly as published.

Application numberANDA206456

Approval date2026-06-18

Dose and formulationOXYCODONE HYDROCHLORIDE 5MG/5ML, SOLUTION, ORAL

Caveats

This record contains no clinical trial results, efficacy outcomes, safety data, or comparative evidence.
The REMS designation indicates Risk Evaluation and Mitigation Strategy requirements but does not specify what those requirements are in this record.
No information is provided on the clinical rationale, evidence base, or conditions of approval beyond the regulatory classification.
This is an administrative approval action, not a measure of clinical benefit or safety profile.

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.

Directness

insufficient

Record does not report clinical trial outcomes or efficacy data.

Consistency

insufficient

No comparative or confirmatory data presented in this approval record.

Risk of bias

insufficient

Regulatory approval does not address or report on trial bias assessment.

Sample adequacy

insufficient

This is an administrative record with no human subjects data.

Source abstract

Drugs@FDA record for application ANDA206456. This is a regulatory action record, not a clinical study. Brand name: OXYCODONE HYDROCHLORIDE. Active ingredient: OXYCODONE HYDROCHLORIDE. Sponsor: PHARMOBEDIENT. Submission type: SUPPL (supplement). Submission class: REMS. Approval status date: 2026-06-18. Products: OXYCODONE HYDROCHLORIDE, SOLUTION, ORAL, OXYCODONE HYDROCHLORIDE 5MG/5ML.

Follow from this

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

Oxycodone HydrochloridePharmobedient