Application 021285

Type: NDA
Sponsor: NOVARTIS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TRILEPTAL	OXCARBAZEPINE	SUSPENSION;ORAL	300MG/5ML	Yes	Yes

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N021285-001	TRILEPTAL	OXCARBAZEPINE	300MG/5ML	SUSPENSION / ORAL	AB	RLD, RS	2001-05-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N021285-001	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 2 · 44 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	N021285-001	TRILEPTAL	300MG/5ML	SUSPENSION / ORAL	AB	RLD, RS	2001-05-25	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N021285-001	TRILEPTAL	300MG/5ML	SUSPENSION / ORAL	AB	RLD, RS	2001-05-25	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021285-001	TRILEPTAL	300MG/5ML	SUSPENSION / ORAL	AB	RLD, RS	2001-05-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021285-001	TRILEPTAL	300MG/5ML	SUSPENSION / ORAL	AB	RLD, RS	2001-05-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021285-001	TRILEPTAL	300MG/5ML	SUSPENSION / ORAL	AB	RLD, RS	2001-05-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021285-001	TRILEPTAL	300MG/5ML	SUSPENSION / ORAL	AB	RLD, RS	2001-05-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021285-001	TRILEPTAL	300MG/5ML	SUSPENSION / ORAL	AB	RLD, RS	2001-05-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021285-001	TRILEPTAL	300MG/5ML	SUSPENSION / ORAL	AB	RLD, RS	2001-05-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021285-001	TRILEPTAL	300MG/5ML	SUSPENSION / ORAL	AB	RLD, RS	2001-05-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021285-001	TRILEPTAL	300MG/5ML	SUSPENSION / ORAL	AB	RLD, RS	2001-05-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021285-001	TRILEPTAL	300MG/5ML	SUSPENSION / ORAL	AB	RLD, RS	2001-05-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021285-001	TRILEPTAL	300MG/5ML	SUSPENSION / ORAL	AB	RLD, RS	2001-05-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021285-001	TRILEPTAL	300MG/5ML	SUSPENSION / ORAL	AB	RLD, RS	2001-05-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021285-001	TRILEPTAL	300MG/5ML	SUSPENSION / ORAL	AB	RLD, RS	2001-05-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021285-001	TRILEPTAL	300MG/5ML	SUSPENSION / ORAL	AB	RLD, RS	2001-05-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021285-001	TRILEPTAL	300MG/5ML	SUSPENSION / ORAL	AB	RLD, RS	2001-05-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021285-001	TRILEPTAL	300MG/5ML	SUSPENSION / ORAL	AB	RLD, RS	2001-05-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021285-001	TRILEPTAL	300MG/5ML	SUSPENSION / ORAL	AB	RLD, RS	2001-05-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021285-001	TRILEPTAL	300MG/5ML	SUSPENSION / ORAL	AB	RLD, RS	2001-05-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021285-001	TRILEPTAL	300MG/5ML	SUSPENSION / ORAL	AB	RLD, RS	2001-05-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021285-001	TRILEPTAL	300MG/5ML	SUSPENSION / ORAL	AB	RLD, RS	2001-05-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021285-001	TRILEPTAL	300MG/5ML	SUSPENSION / ORAL	AB	RLD, RS	2001-05-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021285-001	TRILEPTAL	300MG/5ML	SUSPENSION / ORAL	AB	RLD, RS	2001-05-25	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021285-001	TRILEPTAL	300MG/5ML	SUSPENSION / ORAL	AB	RLD, RS	2001-05-25	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021285-001	TRILEPTAL	300MG/5ML	SUSPENSION / ORAL	AB	RLD, RS	2001-05-25	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021285-001	TRILEPTAL	300MG/5ML	SUSPENSION / ORAL	AB	RLD, RS	2001-05-25	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021285-001	TRILEPTAL	300MG/5ML	SUSPENSION / ORAL	AB	RLD, RS	2001-05-25	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021285-001	TRILEPTAL	300MG/5ML	SUSPENSION / ORAL	AB	RLD, RS	2001-05-25	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021285-001	TRILEPTAL	300MG/5ML	SUSPENSION / ORAL	AB	RLD, RS	2001-05-25	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021285-001	TRILEPTAL	300MG/5ML	SUSPENSION / ORAL	AB	RLD, RS	2001-05-25	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021285-001	TRILEPTAL	300MG/5ML	SUSPENSION / ORAL	AB	RLD, RS	2001-05-25	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021285-001	TRILEPTAL	300MG/5ML	SUSPENSION / ORAL	AB	RLD, RS	2001-05-25	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021285-001	TRILEPTAL	300MG/5ML	SUSPENSION / ORAL	AB	RLD, RS	2001-05-25	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021285-001	TRILEPTAL	300MG/5ML	SUSPENSION / ORAL	AB	RLD, RS	2001-05-25	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021285-001	TRILEPTAL	300MG/5ML	SUSPENSION / ORAL	AB	RLD, RS	2001-05-25	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021285-001	TRILEPTAL	300MG/5ML	SUSPENSION / ORAL	AB	RLD, RS	2001-05-25	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021285-001	TRILEPTAL	300MG/5ML	SUSPENSION / ORAL	AB	RLD, RS	2001-05-25	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021285-001	TRILEPTAL	300MG/5ML	SUSPENSION / ORAL	AB	RLD, RS	2001-05-25	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021285-001	TRILEPTAL	300MG/5ML	SUSPENSION / ORAL	AB	RLD, RS	2001-05-25	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021285-001	TRILEPTAL	300MG/5ML	SUSPENSION / ORAL	AB	RLD, RS	2001-05-25	`3a93d1ddd44b…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 44 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	N021285-001	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N021285-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021285-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021285-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021285-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021285-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021285-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021285-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021285-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021285-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021285-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021285-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021285-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021285-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021285-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021285-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021285-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021285-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021285-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021285-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021285-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021285-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021285-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021285-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021285-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021285-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021285-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021285-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021285-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021285-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021285-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021285-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021285-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021285-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021285-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021285-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021285-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021285-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021285-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021285-001	AB	1	`3a93d1ddd44b…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N021285-001	8119148	2020-12-19	U-724	Drug product	2012-03-08	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021285-001	8119148*PED	2021-06-19		Pediatric extension		`74a2ff9319b5…`
2021-12-28 21:50 UTC	2021-12	N021285-001	8119148*PED	2021-06-19		Pediatric extension		`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021285-001	8119148*PED	2021-06-19		Pediatric extension		`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021285-001	8119148*PED	2021-06-19		Pediatric extension		`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021285-001	8119148	2020-12-19	U-724	Drug product	2012-03-08	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021285-001	8119148*PED	2021-06-19		Pediatric extension		`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021285-001	8119148	2020-12-19	U-724	Drug product	2012-03-08	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021285-001	8119148*PED	2021-06-19		Pediatric extension		`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021285-001	8119148	2020-12-19	U-724	Drug product	2012-03-08	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021285-001	8119148*PED	2021-06-19		Pediatric extension		`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021285-001	8119148	2020-12-19	U-724	Drug product	2012-03-08	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021285-001	8119148*PED	2021-06-19		Pediatric extension		`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021285-001	8119148	2020-12-19	U-724	Drug product	2012-03-08	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021285-001	8119148*PED	2021-06-19		Pediatric extension		`ea99ee380514…`

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 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0078-0357	Trileptal	oxcarbazepine	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0357	Trileptal	oxcarbazepine	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0357	Trileptal	oxcarbazepine	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0357	Trileptal	oxcarbazepine	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0357	Trileptal	oxcarbazepine	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0357	Trileptal	oxcarbazepine	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0357	Trileptal	oxcarbazepine	Novartis Pharmaceuticals Corporation	NDA	Current
0781-6270	Oxcarbazepine	oxcarbazepine	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-6270	Oxcarbazepine	oxcarbazepine	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-6270	Oxcarbazepine	oxcarbazepine	Sandoz Inc	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
83529	SUPPL	2025-09-26
83528	SUPPL	2025-09-26
83436	SUPPL	2025-09-25
79544	SUPPL	2024-09-05
79542	SUPPL	2024-09-05
57416	SUPPL	2019-02-04
57137	SUPPL	2019-01-08
53500	SUPPL	2018-03-28
53247	SUPPL	2018-03-23
53246	SUPPL	2018-03-23
50491	SUPPL	2017-11-27
50490	SUPPL	2017-11-27
50461	SUPPL	2017-11-20
47727	SUPPL	2017-03-28
47667	SUPPL	2017-03-24
14885	SUPPL	2014-07-08
4916	SUPPL	2014-07-08
36582	SUPPL	2014-06-10
4917	SUPPL	2014-06-10
36581	SUPPL	2013-02-12
27376	SUPPL	2013-02-12
4915	SUPPL	2011-11-14
36580	SUPPL	2011-03-21
36579	SUPPL	2011-03-21
36578	SUPPL	2011-03-21
14884	SUPPL	2011-03-21
14882	SUPPL	2011-03-21
14881	SUPPL	2011-03-21
14880	SUPPL	2011-03-21
27375	SUPPL	2011-03-08
27374	SUPPL	2011-03-08
27373	SUPPL	2011-03-08
27372	SUPPL	2011-03-08
4913	SUPPL	2011-03-08
4912	SUPPL	2011-03-08
4910	SUPPL	2011-03-08
14883	SUPPL	2009-05-12
4914	SUPPL	2009-05-04
4911	SUPPL	2007-09-06
44609	ORIG	2007-03-16
4909	SUPPL	2005-11-01
36577	SUPPL	2005-10-28
36576	SUPPL	2005-03-30
27371	SUPPL	2005-03-30
42081	ORIG	2002-04-30
4908	SUPPL	2002-04-01
27370	ORIG	2001-05-29
14879	ORIG	2001-05-29