Trileptal

Treats partial-onset seizures. NDA 21285, held by Novartis. Oxcarbazepine.

As of Nov 14, 2026, NDA 21285 (Trileptal), held by Novartis, was first approved by FDA on May 25, 2001, with 26 approved supplements and 0 published complete response letters.

First approved: May 25, 2001
Review: Standard
Supplements approved: 26
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

TRILEPTAL is indicated for use as monotherapy or adjunctive therapy in the treatment of partial-onset seizures in adults and as monotherapy in the treatment of partial-onset seizures in pediatric patients aged 4 years and above, and as adjunctive therapy in pediatric patients aged 2 years and above with partial-onset seizures. TRILEPTAL is indicated for: Adults: Monotherapy or adjunctive therapy in the treatment of partial-onset seizures Pediatrics: - Monotherapy in the treatment of partial-onset seizures in children 4-16 years - Adjunctive therapy in the treatment of partial-onset seizures in children 2-16 years

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 27 submissions below


Oct 28, 2005	Supplement 8Efficacy (new indication or use) · Priority review	Approved	Letter Label
May 25, 2001	Original applicationNew dosage form · Standard review	Approved	Review Label Letter

Products

1 strengths and forms

Product	Active ingredient	Marketing
Trileptal300MG/5ML · suspension;oral	Oxcarbazepine	RxReference drug

All 27 submissions, including labeling and manufacturing supplements


Sep 23, 2025	Supplement 41Labeling · Standard review	Approved	Label Medication Guide Letter
Sep 4, 2024	Supplement 42Labeling · Standard review	Approved	Letter Label
Jan 4, 2019	Supplement 36Labeling · Standard review	Approved	Letter Label
Mar 22, 2018	Supplement 35Labeling · Standard review	Approved	Letter Label
Nov 17, 2017	Supplement 34Labeling · Standard review	Approved	Letter Letter Label
Mar 23, 2017	Supplement 31Labeling · Standard review	Approved	Label Letter
Jul 3, 2014	Supplement 27Labeling	Approved	Letter Label
Jun 6, 2014	Supplement 30Labeling · Standard review	Approved	Letter Label
May 8, 2014	Supplement 29Manufacturing · Standard review	Approved	None posted
Feb 28, 2014	Supplement 28Manufacturing · Standard review	Approved	None posted
Feb 8, 2013	Supplement 23Labeling · Standard review	Approved	Letter Label
Oct 30, 2011	Supplement 25REMS	Approved	Letter
Mar 3, 2011	Supplement 22Labeling · Standard review	Approved	Label Letter
Mar 3, 2011	Supplement 20Labeling · Standard review	Approved	Label Letter
Mar 3, 2011	Supplement 19Labeling · Standard review	Approved	Label Letter
Mar 3, 2011	Supplement 18Labeling · Standard review	Approved	Label Letter
Mar 3, 2011	Supplement 15Labeling · Standard review	Approved	Label Letter
Mar 3, 2011	Supplement 13Labeling · Standard review	Approved	Label Letter
Mar 3, 2011	Supplement 9Labeling · Standard review	Approved	Label Letter
Apr 23, 2009	Supplement 21Labeling	Approved	Label Letter
Aug 31, 2007	Supplement 14Labeling · Standard review	Approved	Letter
Oct 28, 2005	Supplement 8Efficacy (new indication or use) · Priority review	Approved	Letter Label
Mar 25, 2005	Supplement 7Labeling · Standard review	Approved	Letter Label
Sep 10, 2002	Supplement 3Manufacturing · Standard review	Approved	None posted
Apr 1, 2002	Supplement 2Labeling · Standard review	Approved	Letter
Jan 18, 2002	Supplement 1Manufacturing · Standard review	Approved	None posted
May 25, 2001	Original applicationNew dosage form · Standard review	Approved	Review Label Letter

Identifiers

Application: NDA 21285
Drugs@FDA: Overview at FDA
Company: Novartis Pharmaceuticals Corporation

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters