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Naproxen · Regulatory label update
U.S. Food and Drug Administration · June 30, 2026
An action by a regulator. Authoritative on labelling and availability.
This is an FDA supplemental approval record for a labeling change to naproxen oral suspension (25 mg/mL) by Hetero Labs Ltd III, approved on 30 June 2026. The record does not contain clinical trial data, efficacy outcomes, or safety analyses; it documents only the regulatory action itself.
Regulatory label update.
This is an FDA supplemental approval record for a labeling change to naproxen oral suspension (25 mg/mL) by Hetero Labs Ltd III, approved on 30 June 2026. The record does not contain clinical trial data, efficacy outcomes, or safety analyses; it documents only the regulatory action itself.
This record does not contain clinical trial results, efficacy data, safety data, or comparative evidence. Approval status does not imply efficacy, safety superiority, or clinical benefit; it confirms administrative regulatory action only.
The source did not state who this applies to in practice.
FDA supplemental approval for naproxen labeling changes; does not report clinical trial outcomes or comparative efficacy data.
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.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Drugs@FDA record for application ANDA215776. This is a regulatory action record, not a clinical study. Brand name: NAPROXEN. Active ingredient: NAPROXEN. Sponsor: HETERO LABS LTD III. Submission type: SUPPL (supplement). Submission class: Labeling. Approval status date: 2026-06-30. Products: NAPROXEN, SUSPENSION, ORAL, NAPROXEN 25MG/ML.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.