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Oxycodone Hydrochloride · Regulatory label update
U.S. Food and Drug Administration · June 18, 2026
An action by a regulator. Authoritative on labelling and availability.
The FDA issued a supplemental approval (REMS supplement) on 18 June 2026 for an oxycodone hydrochloride oral solution (100 mg/5 mL) manufactured by ANI Pharma. This is a regulatory action documenting approval of a Risk Evaluation and Mitigation Strategy (REMS) submission; it does not report clinical trial outcomes, comparative efficacy, or safety data.
Regulatory label update. Intervention: Oxycodone hydrochloride oral solution 100 mg/5 mL.
Supplemental approval granted for oxycodone hydrochloride oral solution 100 mg/5 mL Approval date: 18 June 2026 Submission classification: REMS (Risk Evaluation and Mitigation Strategy)
This regulatory record does not contain clinical trial results, efficacy data, safety outcomes, or comparative effectiveness information. REMS approval indicates risk mitigation requirements are in place but does not evaluate clinical benefit or harm.
The source did not state who this applies to in practice.
FDA supplemental approval of an opioid formulation under REMS requirements; this is a regulatory action, not a clinical evidence evaluation.
As stated by the source record.
Quoted from the source exactly as published.
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.
Drugs@FDA record for application ANDA203447. This is a regulatory action record, not a clinical study. Brand name: OXYCODONE HYDROCHLORIDE. Active ingredient: OXYCODONE HYDROCHLORIDE. Sponsor: ANI PHARMS. Submission type: SUPPL (supplement). Submission class: REMS. Approval status date: 2026-06-18. Products: OXYCODONE HYDROCHLORIDE, SOLUTION, ORAL, OXYCODONE HYDROCHLORIDE 100MG/5ML.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.