Oxcarbazepine · Regulatory label update

FDA supplemental approval: Oxcarbazepine (Labeling)

U.S. Food and Drug Administration · May 28, 2026

Regulatory Update Why this matters to you Expert discussion

An action by a regulator. Authoritative on labelling and availability.

AI Summary

The FDA granted a supplemental approval (labeling change) for oxcarbazepine tablet formulations (150 mg, 300 mg, 600 mg) from Zydus on 28 May 2026 under ANDA 211747. This is a regulatory action document that records the approval of labeling modifications and does not contain clinical trial results, efficacy data, or safety findings.

What was studied

Regulatory label update.

Key findings

Supplemental approval granted for oxcarbazepine tablets in three strengths: 150 mg, 300 mg, and 600 mg oral tablets

Safety

This record does not contain clinical trial results, efficacy data, safety studies, or comparative effectiveness information. No dosing, indication, contraindication, or adverse event information is provided.

Who this may help

The source did not state who this applies to in practice.

Plain-language summary

FDA supplemental approval of oxcarbazepine labeling; this is a regulatory action, not a clinical evidence report, and does not contain trial outcomes or efficacy data.

Reported figures

Quoted from the source exactly as published.

Approval date2026-05-28

ANDA number211747

Submission classLabeling

Caveats

This record does not contain clinical trial results, efficacy data, safety studies, or comparative effectiveness information.
The specific nature of the labeling change (what was added, changed, or clarified) is not detailed in this regulatory record.
No dosing, indication, contraindication, or adverse event information is provided.
The record does not indicate whether this approval reflects new clinical evidence or is a routine administrative or manufacturing change.

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 study design applicable.

Directness

insufficient

Labeling action; clinical evidence not reported.

Consistency

insufficient

No comparative or trial data provided in record.

Risk of bias

insufficient

Not a clinical trial; bias assessment not applicable.

Sample adequacy

insufficient

No patient data reported in regulatory record.

Source abstract

Drugs@FDA record for application ANDA211747. This is a regulatory action record, not a clinical study. Brand name: OXCARBAZEPINE. Active ingredient: OXCARBAZEPINE. Sponsor: ZYDUS. Submission type: SUPPL (supplement). Submission class: Labeling. Approval status date: 2026-05-28. Products: OXCARBAZEPINE, TABLET, ORAL, OXCARBAZEPINE 600MG; OXCARBAZEPINE, TABLET, ORAL, OXCARBAZEPINE 150MG; OXCARBAZEPINE, TABLET, ORAL, OXCARBAZEPINE 300MG.

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

OxcarbazepineZydus