OXCARBAZEPINE

Major Pharmaceuticals🇺🇸 United States

FDA Page

Effective Date: Jun 15, 2026
Approval ID: b1d54def-057d-4608-bc8f-1d967ac3ec91
Products: 3 registered
Version: 5

Regulatory Information

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Status

Approved

Full Title

These highlights do not include all the information needed to use OXCARBAZEPINE TABLETS safely and effectively. See full prescribing information for OXCARBAZEPINE TABLETS. Oxcarbazepine film-coated tablets, for oral use Initial U.S. Approval: 2000

Quick Stats

Total Products3

Labelers2

Label Sections21

Regulatory Agency

🇺🇸

U.S. Food and Drug Administration

United States

Data Sources & Disclaimer: Approval information is sourced from official FDA databases. This content is for informational purposes only and does not constitute medical or regulatory advice. Always refer to official FDA websites for the most current information.