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Oxcarbazepine · Regulatory label update
U.S. Food and Drug Administration · July 13, 2026
An action by a regulator. Authoritative on labelling and availability.
This is a supplemental FDA approval for a labeling change to Kanchan Healthcare's generic oxcarbazepine oral suspension (300 mg/5 mL), effective 13 July 2026. The record is purely regulatory and contains no clinical trial results, efficacy data, safety outcomes, or comparative evidence.
Regulatory label update.
This is a supplemental FDA approval for a labeling change to Kanchan Healthcare's generic oxcarbazepine oral suspension (300 mg/5 mL), effective 13 July 2026. The record is purely regulatory and contains no clinical trial results, efficacy data, safety outcomes, or comparative evidence.
This record does not contain clinical trial results, efficacy data, safety outcomes, or comparative evidence.
The source did not state who this applies to in practice.
FDA supplemental approval for labeling change to an established generic oxcarbazepine suspension; regulatory action without clinical trial 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 ANDA217782. This is a regulatory action record, not a clinical study. Brand name: OXCARBAZEPINE. Active ingredient: OXCARBAZEPINE. Sponsor: KANCHAN HLTHCARE. Submission type: SUPPL (supplement). Submission class: Labeling. Approval status date: 2026-07-13. Products: OXCARBAZEPINE, SUSPENSION, ORAL, OXCARBAZEPINE 300MG/5ML.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.