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

This is a regulatory approval record documenting FDA acceptance of a supplemental application (ANDA206914) for oxycodone hydrochloride oral solution 5 mg/5 mL under Risk Evaluation and Mitigation Strategy (REMS) requirements. The record does not contain clinical trial results, efficacy data, or safety outcomes; it reflects only the regulatory action taken on 18 June 2026.

What was studied

Regulatory label update.

Key findings

Supplemental REMS approval granted for oxycodone hydrochloride oral solution 5 mg/5 mL formulation

Safety

No clinical trial data, efficacy endpoints, safety outcomes, or comparative effectiveness data are presented.

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 framework; describes regulatory status, not clinical efficacy or safety data.

Reported figures

Quoted from the source exactly as published.

Approval status date2026-06-18

Product strength5 mg/5 mL

Caveats

This is a regulatory approval record, not a clinical study or trial report.
No clinical trial data, efficacy endpoints, safety outcomes, or comparative effectiveness data are presented.
No information on patient population, dosing regimen, indication, or REMS requirements is provided in this record.
Approval does not imply new clinical evidence; supplement may relate to manufacturing, labelling, or compliance changes.

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 present.

Directness

insufficient

Approval action does not report clinical outcomes or endpoints.

Consistency

insufficient

Single regulatory action; no comparative or replication data provided.

Risk of bias

insufficient

Regulatory record; methodological quality assessment not applicable.

Sample adequacy

insufficient

No clinical population or sample size reported in this record.

Source abstract

Drugs@FDA record for application ANDA206914. This is a regulatory action record, not a clinical study. Brand name: OXYCODONE HYDROCHLORIDE. Active ingredient: OXYCODONE HYDROCHLORIDE. Sponsor: PHARM ASSOC. 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 HydrochloridePharm Assoc