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 1 of 5 · 81 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Carbamazepine	CARBAMAZEPINE	Apotex Corp.	e91f9de3-3fdd-0a6b-71ce-53a2cc142816	2026-09-10	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CARBAMAZEPINE
CARBAMAZEPINE	CARBAMAZEPINE	REMEDYREPACK INC.	5f9535b1-ff6a-41b3-bbb2-efcf8fbacf4c	2026-08-28	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CARBAMAZEPINE
carbamazepine	CARBAMAZEPINE	Northstar Rx LLC	c91a5a1b-5481-445b-86e8-f10109ac3937	2026-08-26	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CARBAMAZEPINE
CARBAMAZEPINE	CARBAMAZEPINE	Apotex Corp.	bf0d012f-da14-8ce3-d74f-56172cddebc5	2026-08-26	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CARBAMAZEPINE
Carbamazepine	CARBAMAZEPINE	American Health Packaging	87b87b57-021a-4cb2-9edd-6efa732c208f	2026-08-25	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CARBAMAZEPINE
Carbamazepine	CARBAMAZEPINE	Ascend Laboratories, LLC	f0a254c5-bd33-4b14-b9f0-830b3438f5c6	2026-08-20	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CARBAMAZEPINE
Tegretol	CARBAMAZEPINE	Novartis Pharmaceuticals Corporation	8d409411-aa9f-4f3a-a52c-fbcb0c3ec053	2026-08-20	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CARBAMAZEPINE
Carbatrol	CARBAMAZEPINE	Takeda Pharmaceuticals America, Inc.	bc03e499-5bac-4293-bff4-6864153a624d	2026-08-17	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CARBAMAZEPINE
Carbamazepine	CARBAMAZEPINE	Unichem Pharmaceuticals (USA), Inc.	50ba2042-fc67-4266-a773-a30f07649a5a	2026-08-17	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CARBAMAZEPINE
Carbamazepine	CARBAMAZEPINE	Umedica Laboratories USA Inc.	48080efd-1781-4585-83f8-c43957ac63b3	2026-08-12	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CARBAMAZEPINE
Carbamazepine	CARBAMAZEPINE	Umedica Laboratories USA Inc.	f3465f71-8931-43b6-baea-eac7046a4400	2026-08-12	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CARBAMAZEPINE
CARBAMAZEPINE	CARBAMAZEPINE	Alembic Pharmaceuticals Inc.	87d343a8-84d5-4cdd-b0a0-629311b51f11	2026-08-12	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CARBAMAZEPINE
CARBAMAZEPINE	CARBAMAZEPINE	REMEDYREPACK INC.	52cf3ba9-0a7c-4809-830e-af93d1532726	2026-08-04	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CARBAMAZEPINE
carbamazepine	CARBAMAZEPINE	Zydus Lifesciences Limited	d10e5f83-56db-4bc9-8c51-150a2e3e20ea	2026-08-04	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CARBAMAZEPINE
carbamazepine	CARBAMAZEPINE	Zydus Pharmaceuticals (USA) Inc.	c5e4a25a-0137-4327-96f5-15735891ad5c	2026-08-04	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CARBAMAZEPINE
Carbamazepine	CARBAMAZEPINE	Torrent Pharmaceuticals Limited	7c4860c1-daba-4e0f-97fd-d30cbc8603a2	2026-08-03	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CARBAMAZEPINE
CARBAMAZEPINE	CARBAMAZEPINE	Torrent Pharmaceuticals Limited	97e6e175-75e8-437b-b457-ddb1ae4e857d	2026-07-31	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CARBAMAZEPINE
Carbamazepine	CARBAMAZEPINE	REMEDYREPACK INC.	9f3d91cd-a959-4e07-a51b-8a4e9ba9ece2	2026-07-29	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CARBAMAZEPINE
CARBAMAZEPINE	CARBAMAZEPINE	American Health Packaging	7108d630-89bc-4815-b6fb-a1f4676c496e	2026-07-24	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CARBAMAZEPINE
Carbamazepine	CARBAMAZEPINE	REMEDYREPACK INC.	9471b7fb-29d3-4009-9d0f-f20c27351db5	2026-07-23	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