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 (ANDA204603) for an oxycodone hydrochloride oral solution formulation (100 mg/5 mL) under a REMS requirement on 18 June 2026. This is a regulatory action record that confirms manufacturing and labelling compliance but does not contain clinical trial results, efficacy data, or safety outcomes.

What was studied

Regulatory label update.

Key findings

Supplemental ANDA approval for oxycodone hydrochloride oral solution 100 mg/5 mL by Novel Labs Inc. Approval granted with REMS (Risk Evaluation and Mitigation Strategy) designation Approval date: 2026-06-18

Safety

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

Who this may help

This regulatory approval confirms that the oxycodone hydrochloride oral solution meets FDA standards for pharmaceutical manufacture and safety labelling. However, the record does not provide clinical trial data, efficacy comparisons, or new safety findings; it is an administrative approval action only.

Plain-language summary

FDA supplemental approval of an oxycodone hydrochloride oral solution formulation under a REMS (Risk Evaluation and Mitigation Strategy) designation; establishes regulatory status but does not report clinical trial outcomes or efficacy data.

Reported figures

Quoted from the source exactly as published.

Formulation strength100 mg/5 mL

Approval date2026-06-18

Clinical bottom line

Caveats

This record does not contain clinical trial results, efficacy data, or safety outcomes.
No comparative data with other formulations or opioid preparations is reported.
REMS designation indicates the product carries restrictions on distribution and use, but specific REMS requirements are not detailed in this record.
No patient population or sample size data; this is an approval action, not a study.

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 action record, not a clinical trial or study.

Directness

insufficient

Record does not report clinical outcomes or comparative efficacy data.

Consistency

insufficient

No efficacy or safety data presented for comparison with other sources.

Risk of bias

insufficient

Regulatory action record; bias assessment not applicable to approval action.

Sample adequacy

insufficient

No clinical trial population or sample size data reported in this record.

Source abstract

Drugs@FDA record for application ANDA204603. This is a regulatory action record, not a clinical study. Brand name: OXYCODONE HYDROCHLORIDE. Active ingredient: OXYCODONE HYDROCHLORIDE. Sponsor: NOVEL LABS INC. 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 HydrochlorideNovel Labs