Application 021014

Type: NDA
Sponsor: NOVARTIS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TRILEPTAL	OXCARBAZEPINE	TABLET;ORAL	150MG	Yes	No
002	TRILEPTAL	OXCARBAZEPINE	TABLET;ORAL	300MG	Yes	No
003	TRILEPTAL	OXCARBAZEPINE	TABLET;ORAL	600MG	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N021014-001	TRILEPTAL	OXCARBAZEPINE	150MG	TABLET / ORAL	AB	RLD	2000-01-14
N021014-002	TRILEPTAL	OXCARBAZEPINE	300MG	TABLET / ORAL	AB	RLD	2000-01-14
N021014-003	TRILEPTAL	OXCARBAZEPINE	600MG	TABLET / ORAL	AB	RLD, RS	2000-01-14

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
N021014-001	AB
N021014-002	AB
N021014-003	AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 4 · 132 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	N021014-001	TRILEPTAL	150MG	TABLET / ORAL	AB	RLD	2000-01-14	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N021014-002	TRILEPTAL	300MG	TABLET / ORAL	AB	RLD	2000-01-14	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N021014-003	TRILEPTAL	600MG	TABLET / ORAL	AB	RLD, RS	2000-01-14	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N021014-001	TRILEPTAL	150MG	TABLET / ORAL	AB	RLD	2000-01-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021014-002	TRILEPTAL	300MG	TABLET / ORAL	AB	RLD	2000-01-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021014-003	TRILEPTAL	600MG	TABLET / ORAL	AB	RLD, RS	2000-01-14	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021014-001	TRILEPTAL	150MG	TABLET / ORAL	AB	RLD	2000-01-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021014-002	TRILEPTAL	300MG	TABLET / ORAL	AB	RLD	2000-01-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021014-003	TRILEPTAL	600MG	TABLET / ORAL	AB	RLD, RS	2000-01-14	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021014-001	TRILEPTAL	150MG	TABLET / ORAL	AB	RLD	2000-01-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021014-002	TRILEPTAL	300MG	TABLET / ORAL	AB	RLD	2000-01-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021014-003	TRILEPTAL	600MG	TABLET / ORAL	AB	RLD, RS	2000-01-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021014-001	TRILEPTAL	150MG	TABLET / ORAL	AB	RLD	2000-01-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021014-002	TRILEPTAL	300MG	TABLET / ORAL	AB	RLD	2000-01-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021014-003	TRILEPTAL	600MG	TABLET / ORAL	AB	RLD, RS	2000-01-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021014-001	TRILEPTAL	150MG	TABLET / ORAL	AB	RLD	2000-01-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021014-002	TRILEPTAL	300MG	TABLET / ORAL	AB	RLD	2000-01-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021014-003	TRILEPTAL	600MG	TABLET / ORAL	AB	RLD, RS	2000-01-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021014-001	TRILEPTAL	150MG	TABLET / ORAL	AB	RLD	2000-01-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021014-002	TRILEPTAL	300MG	TABLET / ORAL	AB	RLD	2000-01-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021014-003	TRILEPTAL	600MG	TABLET / ORAL	AB	RLD, RS	2000-01-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021014-001	TRILEPTAL	150MG	TABLET / ORAL	AB	RLD	2000-01-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021014-002	TRILEPTAL	300MG	TABLET / ORAL	AB	RLD	2000-01-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021014-003	TRILEPTAL	600MG	TABLET / ORAL	AB	RLD, RS	2000-01-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021014-001	TRILEPTAL	150MG	TABLET / ORAL	AB	RLD	2000-01-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021014-002	TRILEPTAL	300MG	TABLET / ORAL	AB	RLD	2000-01-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021014-003	TRILEPTAL	600MG	TABLET / ORAL	AB	RLD, RS	2000-01-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021014-001	TRILEPTAL	150MG	TABLET / ORAL	AB	RLD	2000-01-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021014-002	TRILEPTAL	300MG	TABLET / ORAL	AB	RLD	2000-01-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021014-003	TRILEPTAL	600MG	TABLET / ORAL	AB	RLD, RS	2000-01-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021014-001	TRILEPTAL	150MG	TABLET / ORAL	AB	RLD	2000-01-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021014-002	TRILEPTAL	300MG	TABLET / ORAL	AB	RLD	2000-01-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021014-003	TRILEPTAL	600MG	TABLET / ORAL	AB	RLD, RS	2000-01-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021014-001	TRILEPTAL	150MG	TABLET / ORAL	AB	RLD	2000-01-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021014-002	TRILEPTAL	300MG	TABLET / ORAL	AB	RLD	2000-01-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021014-003	TRILEPTAL	600MG	TABLET / ORAL	AB	RLD, RS	2000-01-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021014-001	TRILEPTAL	150MG	TABLET / ORAL	AB	RLD	2000-01-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021014-002	TRILEPTAL	300MG	TABLET / ORAL	AB	RLD	2000-01-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021014-003	TRILEPTAL	600MG	TABLET / ORAL	AB	RLD, RS	2000-01-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021014-001	TRILEPTAL	150MG	TABLET / ORAL	AB	RLD	2000-01-14	`79d66fd596c7…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 132 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	N021014-001	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N021014-002	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N021014-003	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N021014-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021014-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021014-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021014-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021014-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021014-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021014-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021014-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021014-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021014-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021014-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021014-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021014-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021014-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021014-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021014-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021014-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021014-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021014-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021014-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021014-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021014-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021014-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021014-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021014-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021014-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021014-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021014-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021014-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021014-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021014-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021014-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021014-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021014-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021014-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021014-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021014-001	AB	1	`79d66fd596c7…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 4 of 4 · 68 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Oxcarbazepine	OXCARBAZEPINE	XLCare Pharmaceuticals Inc.	9f5d17e4-ca68-48e2-9e87-d3ab1c59aa93	2024-07-16	Warnings, Adverse reactions	Name fallback generic name: OXCARBAZEPINE
OXCARBAZEPINE	OXCARBAZEPINE	Bryant Ranch Prepack	78f196d4-110e-45b1-813a-725f52c1a4eb	2024-04-04	Warnings, Adverse reactions	Name fallback generic name: OXCARBAZEPINE
OXCARBAZEPINE	OXCARBAZEPINE	Bryant Ranch Prepack	d3c7a3b8-b9a2-4a5f-98b3-0ed02eca3433	2024-04-02	Warnings, Adverse reactions	Name fallback generic name: OXCARBAZEPINE
OXCARBAZEPINE	OXCARBAZEPINE	Bryant Ranch Prepack	255f64ba-7667-48e6-8599-3b598bf6f4e9	2024-01-12	Warnings, Adverse reactions	Name fallback generic name: OXCARBAZEPINE
OXCARBAZEPINE	OXCARBAZEPINE	Breckenridge Pharmaceutical, Inc.	682a1210-b26e-426e-8ffe-d25d91bdd608	2024-01-09	Warnings, Adverse reactions	Name fallback generic name: OXCARBAZEPINE
Oxcarbazepine	OXCARBAZEPINE	Precision Dose, Inc.	636fc847-b3d2-4255-a959-d75499fdb198	2023-11-20	Warnings, Adverse reactions	Name fallback generic name: OXCARBAZEPINE
Oxcarbazepine	OXCARBAZEPINE	Proficient Rx LP	95867dcd-fd0e-4570-987b-d35939f7d7d1	2022-11-01	Warnings, Adverse reactions	Name fallback generic name: OXCARBAZEPINE
Oxcarbazepine	OXCARBAZEPINE	Kanchan Healthcare Inc	7be73d22-f87b-4459-a91c-37c1e34db230		Warnings, Adverse reactions	Name fallback generic name: OXCARBAZEPINE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 29 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0078-0337	Trileptal	oxcarbazepine	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0337	Trileptal	oxcarbazepine	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0337	Trileptal	oxcarbazepine	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0337	Trileptal	oxcarbazepine	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0337	Trileptal	oxcarbazepine	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0337	Trileptal	oxcarbazepine	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0337	Trileptal	oxcarbazepine	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0456	Trileptal	oxcarbazepine	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0456	Trileptal	oxcarbazepine	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0456	Trileptal	oxcarbazepine	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0456	Trileptal	oxcarbazepine	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0456	Trileptal	oxcarbazepine	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0456	Trileptal	oxcarbazepine	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0456	Trileptal	oxcarbazepine	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0457	Trileptal	oxcarbazepine	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0457	Trileptal	oxcarbazepine	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0457	Trileptal	oxcarbazepine	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0457	Trileptal	oxcarbazepine	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0457	Trileptal	oxcarbazepine	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0457	Trileptal	oxcarbazepine	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0457	Trileptal	oxcarbazepine	Novartis Pharmaceuticals Corporation	NDA	Current
55289-007	Trileptal	oxcarbazepine	PD-Rx Pharmaceuticals, Inc.	NDA	Current
55289-007	Trileptal	oxcarbazepine	PD-Rx Pharmaceuticals, Inc.	NDA	Current
55289-007	Trileptal	oxcarbazepine	PD-Rx Pharmaceuticals, Inc.	NDA	Current
55289-007	Trileptal	oxcarbazepine	PD-Rx Pharmaceuticals, Inc.	NDA	Current
70518-1300	Trileptal	oxcarbazepine	REMEDYREPACK INC.	NDA	Current
70518-1300	Trileptal	oxcarbazepine	REMEDYREPACK INC.	NDA	Current
70518-1349	Trileptal	oxcarbazepine	REMEDYREPACK INC.	NDA	Current
70518-1349	Trileptal	oxcarbazepine	REMEDYREPACK INC.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
83527	SUPPL	2025-09-26
83526	SUPPL	2025-09-26
83435	SUPPL	2025-09-25
81207	SUPPL	2025-02-11
81206	SUPPL	2025-02-11
79543	SUPPL	2024-09-05
79541	SUPPL	2024-09-05
57415	SUPPL	2019-02-04
57136	SUPPL	2019-01-08
53501	SUPPL	2018-03-28
53242	SUPPL	2018-03-23
53236	SUPPL	2018-03-23
50489	SUPPL	2017-11-27
50460	SUPPL	2017-11-20
47726	SUPPL	2017-03-28
47668	SUPPL	2017-03-24
35890	SUPPL	2014-07-08
4044	SUPPL	2014-07-08
14165	SUPPL	2014-06-10
4045	SUPPL	2014-06-10
35889	SUPPL	2013-02-12
4043	SUPPL	2013-02-12
26490	SUPPL	2011-11-14
35888	SUPPL	2011-03-21
35887	SUPPL	2011-03-21
35885	SUPPL	2011-03-21
35884	SUPPL	2011-03-21
35883	SUPPL	2011-03-21
14164	SUPPL	2011-03-21
14163	SUPPL	2011-03-21
26489	SUPPL	2011-03-08
26487	SUPPL	2011-03-08
26486	SUPPL	2011-03-08
4042	SUPPL	2011-03-08
4041	SUPPL	2011-03-08
4040	SUPPL	2011-03-08
4038	SUPPL	2011-03-08
35886	SUPPL	2009-05-12
26488	SUPPL	2009-05-04
4039	SUPPL	2007-09-06
24144	ORIG	2007-03-16
41877	SUPPL	2006-05-31
26485	SUPPL	2005-11-18
26484	SUPPL	2005-11-01
14162	SUPPL	2005-10-28
14161	SUPPL	2005-03-30
4037	SUPPL	2005-03-30
35882	SUPPL	2003-08-15
4034	SUPPL	2003-08-15
4036	SUPPL	2003-04-15
4035	SUPPL	2002-04-01
41876	ORIG	2002-02-28
35881	ORIG	1999-01-10
26483	ORIG	1999-01-10
52101	SUPPL	1900-01-01
52099	SUPPL	1900-01-01
52096	SUPPL	1900-01-01
52094	SUPPL	1900-01-01