Oxcarbazepine · Regulatory label update

FDA supplemental approval: Oxcarbazepine (Labeling)

U.S. Food and Drug Administration · September 2, 2026

Regulatory Update Why this matters to you Expert discussion

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

AI Summary

This is a U.S. FDA supplemental approval action for oxcarbazepine 300 mg/5 mL oral suspension, granted to SUN PHARM INDS LTD on 2 September 2026. The record documents a labeling supplement under ANDA 078734 and contains no clinical trial results, efficacy data, or safety comparisons.

What was studied

Regulatory label update.

Key findings

FDA approval date: 2 September 2026 Product: oxcarbazepine 300 mg/5 mL oral suspension Submission type: labeling supplement (SUPPL)

Safety

This is a regulatory action record, not a clinical study; no trial outcomes, efficacy claims, or safety data are reported. No comparative efficacy or safety data against other formulations or competitors is provided.

Who this may help

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

Plain-language summary

FDA supplemental approval for oxcarbazepine oral suspension labeling; does not report clinical trial outcomes or comparative efficacy data.

Reported figures

Quoted from the source exactly as published.

Approval status date2026-09-02

Strength/concentration300 mg/5 mL

Caveats

This is a regulatory action record, not a clinical study; no trial outcomes, efficacy claims, or safety data are reported.
The specific labeling changes are not detailed in this record.
No comparative efficacy or safety data against other formulations or competitors is provided.
The record does not indicate what clinical or safety evidence supported the labeling supplement.

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 action record; no clinical study design present.

Directness

insufficient

Labeling action; no direct clinical outcome data reported.

Consistency

insufficient

Single regulatory action; no comparative or replication data.

Risk of bias

insufficient

Regulatory approval record; bias assessment not applicable.

Sample adequacy

insufficient

No clinical sample or trial population described.

Source abstract

Drugs@FDA record for application ANDA078734. This is a regulatory action record, not a clinical study. Brand name: OXCARBAZEPINE. Active ingredient: OXCARBAZEPINE. Sponsor: SUN PHARM INDS LTD. Submission type: SUPPL (supplement). Submission class: Labeling. Approval status date: 2026-09-02. Products: OXCARBAZEPINE, SUSPENSION, ORAL, OXCARBAZEPINE 300MG/5ML.

Follow from this

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

SUN Pharm IndsOxcarbazepine