Application 206030

Type: NDA
Sponsor: LUNDBECK PHARMS LLC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CARNEXIV	CARBAMAZEPINE	SOLUTION;INTRAVENOUS	200MG/20ML (10MG/ML)	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
N206030-001	CARNEXIV	CARBAMAZEPINE	200MG/20ML (10MG/ML)	SOLUTION / INTRAVENOUS		RLD	2016-10-07

Orange Book patents#

Current patent rows page 1 of 1 · 9 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N206030-001	9629797	2028-11-10	U-2004		2017-05-10
N206030-001	9629797	2028-11-10	U-2005		2017-05-10
N206030-001	9629797	2028-11-10	U-2006		2017-05-10
N206030-001	9770407	2028-11-10		Drug product	2017-10-04
N206030-001	7635773	2029-03-13		Drug product	2016-10-18
N206030-001	8410077	2029-03-13		Drug product	2016-10-18
N206030-001	9750822	2029-03-13		Drug product	2017-10-27
N206030-001	9493582	2033-02-27		Drug product	2016-12-08
N206030-001	11529357	2040-01-31		Drug product	2023-01-17

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 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N206030-001	CARNEXIV	200MG/20ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD	2016-10-07	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N206030-001	CARNEXIV	200MG/20ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD	2016-10-07	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N206030-001	CARNEXIV	200MG/20ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD	2016-10-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206030-001	CARNEXIV	200MG/20ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD	2016-10-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N206030-001	CARNEXIV	200MG/20ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD	2016-10-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206030-001	CARNEXIV	200MG/20ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD	2016-10-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206030-001	CARNEXIV	200MG/20ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD	2016-10-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206030-001	CARNEXIV	200MG/20ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD	2016-10-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N206030-001	CARNEXIV	200MG/20ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD	2016-10-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N206030-001	CARNEXIV	200MG/20ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD	2016-10-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N206030-001	CARNEXIV	200MG/20ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD	2016-10-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N206030-001	CARNEXIV	200MG/20ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD	2016-10-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N206030-001	CARNEXIV	200MG/20ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD	2016-10-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N206030-001	CARNEXIV	200MG/20ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD	2016-10-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N206030-001	CARNEXIV	200MG/20ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD	2016-10-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N206030-001	CARNEXIV	200MG/20ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD	2016-10-07	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N206030-001	CARNEXIV	200MG/20ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD	2016-10-07	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N206030-001	CARNEXIV	200MG/20ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD	2016-10-07	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N206030-001	CARNEXIV	200MG/20ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD	2016-10-07	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N206030-001	CARNEXIV	200MG/20ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD	2016-10-07	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N206030-001	CARNEXIV	200MG/20ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD	2016-10-07	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N206030-001	CARNEXIV	200MG/20ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD	2016-10-07	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N206030-001	CARNEXIV	200MG/20ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD	2016-10-07	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N206030-001	CARNEXIV	200MG/20ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD	2016-10-07	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N206030-001	CARNEXIV	200MG/20ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD	2016-10-07	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N206030-001	CARNEXIV	200MG/20ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD	2016-10-07	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N206030-001	CARNEXIV	200MG/20ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD	2016-10-07	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N206030-001	CARNEXIV	200MG/20ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD	2016-10-07	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N206030-001	CARNEXIV	200MG/20ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD	2016-10-07	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N206030-001	CARNEXIV	200MG/20ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD	2016-10-07	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N206030-001	CARNEXIV	200MG/20ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD	2016-10-07	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N206030-001	CARNEXIV	200MG/20ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD	2016-10-07	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N206030-001	CARNEXIV	200MG/20ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD	2016-10-07	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N206030-001	CARNEXIV	200MG/20ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD	2016-10-07	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N206030-001	CARNEXIV	200MG/20ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD	2016-10-07	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N206030-001	CARNEXIV	200MG/20ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD	2016-10-07	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N206030-001	CARNEXIV	200MG/20ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD	2016-10-07	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N206030-001	CARNEXIV	200MG/20ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD	2016-10-07	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N206030-001	CARNEXIV	200MG/20ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD	2016-10-07	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N206030-001	CARNEXIV	200MG/20ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD	2016-10-07	`f41ea6bd6efb…`

Observed Orange Book patent history#

Patent history page 1 of 10 · 369 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N206030-001	9629797	2028-11-10	U-2004		2017-05-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206030-001	9629797	2028-11-10	U-2005		2017-05-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206030-001	9629797	2028-11-10	U-2006		2017-05-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206030-001	9770407	2028-11-10		Drug product	2017-10-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206030-001	7635773	2029-03-13		Drug product	2016-10-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206030-001	8410077	2029-03-13		Drug product	2016-10-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206030-001	9750822	2029-03-13		Drug product	2017-10-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206030-001	9493582	2033-02-27		Drug product	2016-12-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206030-001	11529357	2040-01-31		Drug product	2023-01-17	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N206030-001	9629797	2028-11-10	U-2004		2017-05-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206030-001	9629797	2028-11-10	U-2005		2017-05-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206030-001	9629797	2028-11-10	U-2006		2017-05-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206030-001	9770407	2028-11-10		Drug product	2017-10-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206030-001	7635773	2029-03-13		Drug product	2016-10-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206030-001	8410077	2029-03-13		Drug product	2016-10-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206030-001	9750822	2029-03-13		Drug product	2017-10-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206030-001	9493582	2033-02-27		Drug product	2016-12-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206030-001	11529357	2040-01-31		Drug product	2023-01-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N206030-001	9629797	2028-11-10	U-2004		2017-05-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206030-001	9629797	2028-11-10	U-2005		2017-05-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206030-001	9629797	2028-11-10	U-2006		2017-05-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206030-001	9770407	2028-11-10		Drug product	2017-10-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206030-001	7635773	2029-03-13		Drug product	2016-10-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206030-001	8410077	2029-03-13		Drug product	2016-10-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206030-001	9750822	2029-03-13		Drug product	2017-10-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206030-001	9493582	2033-02-27		Drug product	2016-12-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206030-001	11529357	2040-01-31		Drug product	2023-01-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206030-001	9629797	2028-11-10	U-2004		2017-05-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206030-001	9629797	2028-11-10	U-2005		2017-05-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206030-001	9629797	2028-11-10	U-2006		2017-05-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206030-001	9770407	2028-11-10		Drug product	2017-10-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206030-001	7635773	2029-03-13		Drug product	2016-10-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206030-001	8410077	2029-03-13		Drug product	2016-10-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206030-001	9750822	2029-03-13		Drug product	2017-10-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206030-001	9493582	2033-02-27		Drug product	2016-12-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206030-001	11529357	2040-01-31		Drug product	2023-01-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N206030-001	9629797	2028-11-10	U-2004		2017-05-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N206030-001	9629797	2028-11-10	U-2005		2017-05-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N206030-001	9629797	2028-11-10	U-2006		2017-05-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N206030-001	9770407	2028-11-10		Drug product	2017-10-04	`6a471c1ec25d…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N206030-001	ODE-124	2023-10-07	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N206030-001	ODE-124	2023-10-07	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N206030-001	ODE-124	2023-10-07	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N206030-001	ODE-124	2023-10-07	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N206030-001	ODE-124	2023-10-07	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N206030-001	ODE-124	2023-10-07	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N206030-001	ODE-124	2023-10-07	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N206030-001	ODE-124	2023-10-07	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N206030-001	ODE-124	2023-10-07	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N206030-001	ODE-124	2023-10-07	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N206030-001	ODE-124	2023-10-07	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N206030-001	ODE-124	2023-10-07	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N206030-001	ODE-124	2023-10-07	`ea99ee380514…`
2023-12-20 04:57 UTC	2023-12	N206030-001	ODE-124	2023-10-07	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N206030-001	ODE-124	2023-10-07	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N206030-001	ODE-124	2023-10-07	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N206030-001	ODE-124	2023-10-07	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N206030-001	ODE-124	2023-10-07	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N206030-001	ODE-124	2023-10-07	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N206030-001	ODE-124	2023-10-07	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N206030-001	ODE-124	2023-10-07	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N206030-001	ODE-124	2023-10-07	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N206030-001	ODE-124	2023-10-07	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N206030-001	ODE-124	2023-10-07	`cb3db0bc1861…`

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 5 of 5 · 81 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CARBAMAZEPINE	CARBAMAZEPINE	Aphena Pharma Solutions - Tennessee, LLC	c1fc31ef-6b2e-4de4-a185-ec44e94e7b40	2016-06-02	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CARBAMAZEPINE

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 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
67386-621	CARNEXIV	Carbamazepine	Lundbeck Pharmaceuticals LLC	NDA	Current
67386-621	CARNEXIV	Carbamazepine	Lundbeck Pharmaceuticals LLC	NDA	Current
67386-621	CARNEXIV	Carbamazepine	Lundbeck Pharmaceuticals LLC	NDA	Current
67386-621	CARNEXIV	Carbamazepine	Lundbeck Pharmaceuticals LLC	NDA	Current
67386-621	CARNEXIV	Carbamazepine	Lundbeck Pharmaceuticals LLC	NDA	Current
67386-621	CARNEXIV	Carbamazepine	Lundbeck Pharmaceuticals LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
61267	SUPPL	2019-12-13
61264	SUPPL	2019-12-13
50467	ORIG	2017-11-21
45609	ORIG	2016-10-12
45521	ORIG	2016-10-12