← FDA DRUG APPROVALS

FDA NDA · NDA021014

TRILEPTAL

oxcarbazepine

Sponsor: NOVARTIS

APPLICATION
NDA021014
TYPE
NDA
ORIGINAL APPROVAL
2000-01-14
LATEST ACTION
2025-09-23
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

TRILEPTAL · ReferencePrescription
OXCARBAZEPINE 300MG · TABLET · ORAL
TRILEPTAL · ReferencePrescription
OXCARBAZEPINE 600MG · TABLET · ORAL
TRILEPTAL · ReferencePrescription
OXCARBAZEPINE 150MG · TABLET · ORAL

Approval history

2025-09-23Labeling · Supplement 49 · standard — Letter ↗AP
2024-09-04Labeling · Supplement 50 · standard — Letter ↗AP
2019-01-04Labeling · Supplement 43 · standard — Label ↗AP
2018-03-22Labeling · Supplement 42 · standard — Label ↗AP
2017-11-17Labeling · Supplement 41 · standard — Label ↗AP
2017-03-23Labeling · Supplement 36 · standard — Letter ↗AP
2016-06-17Manufacturing (CMC) · Supplement 39 · standardAP
2016-05-06Manufacturing (CMC) · Supplement 40 · standardAP
2015-04-14Manufacturing (CMC) · Supplement 38 · standardAP
2014-07-03Labeling · Supplement 33 · standard — Letter ↗AP
2014-06-06Labeling · Supplement 35 · standard — Letter ↗AP
2014-05-08Manufacturing (CMC) · Supplement 34 · standardAP
2013-02-08Labeling · Supplement 29 · standard — Label ↗AP
2011-10-30REMS · Supplement 31 — Letter ↗AP
2011-03-03Labeling · Supplement 27 · standard — Letter ↗AP
2011-03-03Labeling · Supplement 19 · standard — Letter ↗AP
2011-03-03Labeling · Supplement 25 · standard — Letter ↗AP
2011-03-03Labeling · Supplement 15 · standard — Letter ↗AP
2011-03-03Labeling · Supplement 28 · standard — Letter ↗AP
2011-03-03Labeling · Supplement 24 · standard — Label ↗AP
2011-03-03Labeling · Supplement 22 · standard — Letter ↗AP
2009-04-23Labeling · Supplement 26 · 901 required — Letter ↗AP
2007-08-31Labeling · Supplement 21 · standard — Letter ↗AP
2007-01-09Manufacturing (CMC) · Supplement 20AP
2005-11-09Manufacturing (CMC) · Supplement 14 · standard — Letter ↗AP
2005-10-28Efficacy · Supplement 13 · priority — Pediatric Medical Review ↗AP
2005-03-25Labeling · Supplement 12 · standard — Letter ↗AP
2003-08-07Efficacy · Supplement 3 · standard — Review ↗AP
2003-03-27Manufacturing (CMC) · Supplement 7 · standard — Letter ↗AP
2002-05-01Manufacturing (CMC) · Supplement 5 · standardAP
2002-04-01Labeling · Supplement 6 · standard — Letter ↗AP
2001-11-14Manufacturing (CMC) · Supplement 4 · standardAP
2000-08-29Manufacturing (CMC) · Supplement 2 · standardAP
2000-06-02Manufacturing (CMC) · Supplement 1 · standardAP
2000-01-14Type 1 - New Molecular Entity · Original · standard — Review ↗AP
—Manufacturing (CMC) · Supplement 51 · standard — Letter ↗AP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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