Trileptal

Treats partial-onset seizures. NDA 21014, held by Novartis. Oxcarbazepine.

As of Nov 13, 2026, NDA 21014 (Trileptal), held by Novartis, was first approved by FDA on Jan 14, 2000, with 34 approved supplements and 0 published complete response letters.

First approved: Jan 14, 2000
Review: Standard
Supplements approved: 34
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 35 submissions below

Date	Submission	Status	Documents
Oct 28, 2005	Supplement 13Efficacy (new indication or use) · Priority review	Approved	Letter Label Pediatric Medical Review Pediatric Clinical Pharmacology Review
Aug 7, 2003	Supplement 3Efficacy (new indication or use) · Standard review	Approved	Review Letter Label
Jan 14, 2000	Original applicationNew molecular entity · Standard review	Approved	Review Letter Label

Products

3 strengths and forms

Product	Active ingredient	Marketing
Trileptal150MG · tablet;oral	Oxcarbazepine	RxReference drug
Trileptal300MG · tablet;oral	Oxcarbazepine	RxReference drug
Trileptal600MG · tablet;oral	Oxcarbazepine	RxReference drug

All 35 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Sep 23, 2025	Supplement 49Labeling · Standard review	Approved	Label Medication Guide Letter
Sep 4, 2024	Supplement 50Labeling · Standard review	Approved	Letter Label
Jan 4, 2019	Supplement 43Labeling · Standard review	Approved	Letter Label
Mar 22, 2018	Supplement 42Labeling · Standard review	Approved	Letter Label
Nov 17, 2017	Supplement 41Labeling · Standard review	Approved	Letter Label
Mar 23, 2017	Supplement 36Labeling · Standard review	Approved	Label Letter
Jun 17, 2016	Supplement 39Manufacturing · Standard review	Approved	None posted
May 6, 2016	Supplement 40Manufacturing · Standard review	Approved	None posted
Apr 14, 2015	Supplement 38Manufacturing · Standard review	Approved	None posted
Jul 3, 2014	Supplement 33Labeling · Standard review	Approved	Letter Label
Jun 6, 2014	Supplement 35Labeling · Standard review	Approved	Letter Label
May 8, 2014	Supplement 34Manufacturing · Standard review	Approved	None posted
Feb 8, 2013	Supplement 29Labeling · Standard review	Approved	Letter Label
Oct 30, 2011	Supplement 31REMS	Approved	Letter
Mar 3, 2011	Supplement 28Labeling · Standard review	Approved	Label Letter
Mar 3, 2011	Supplement 27Labeling · Standard review	Approved	Label Letter
Mar 3, 2011	Supplement 25Labeling · Standard review	Approved	Label Letter
Mar 3, 2011	Supplement 24Labeling · Standard review	Approved	Label Letter
Mar 3, 2011	Supplement 22Labeling · Standard review	Approved	Label Letter
Mar 3, 2011	Supplement 19Labeling · Standard review	Approved	Label Letter
Mar 3, 2011	Supplement 15Labeling · Standard review	Approved	Label Letter
Apr 23, 2009	Supplement 26Labeling	Approved	Label Letter
Aug 31, 2007	Supplement 21Labeling · Standard review	Approved	Letter
Jan 9, 2007	Supplement 20Manufacturing	Approved	None posted
Nov 9, 2005	Supplement 14Manufacturing · Standard review	Approved	Letter
Oct 28, 2005	Supplement 13Efficacy (new indication or use) · Priority review	Approved	Letter Label Pediatric Medical Review Pediatric Clinical Pharmacology Review
Mar 25, 2005	Supplement 12Labeling · Standard review	Approved	Letter Label
Aug 7, 2003	Supplement 3Efficacy (new indication or use) · Standard review	Approved	Review Letter Label
Mar 27, 2003	Supplement 7Manufacturing · Standard review	Approved	Letter
May 1, 2002	Supplement 5Manufacturing · Standard review	Approved	None posted
Apr 1, 2002	Supplement 6Labeling · Standard review	Approved	Letter
Nov 14, 2001	Supplement 4Manufacturing · Standard review	Approved	None posted
Aug 29, 2000	Supplement 2Manufacturing · Standard review	Approved	None posted
Jun 2, 2000	Supplement 1Manufacturing · Standard review	Approved	None posted
Jan 14, 2000	Original applicationNew molecular entity · Standard review	Approved	Review Letter Label

Identifiers

Application: NDA 21014
Drugs@FDA: Overview at FDA
Company: Novartis Pharmaceuticals Corporation

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