Application 022341

Type: NDA
Sponsor: NOVO NORDISK INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	VICTOZA	LIRAGLUTIDE RECOMBINANT	SOLUTION;SUBCUTANEOUS	18MG/3ML (6MG/ML)	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
N022341-001	VICTOZA	LIRAGLUTIDE	18MG/3ML (6MG/ML)	SOLUTION / SUBCUTANEOUS	AP1	RLD, RS	2010-01-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N022341-001	AP1

Orange Book patents#

Current patent rows page 1 of 1 · 4 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N022341-001	8114833	2025-08-13		Drug substance, Drug product	2012-03-13
N022341-001	8114833*PED	2026-02-13		Pediatric extension
N022341-001	9968659	2037-01-09	U-2313		2018-06-12
N022341-001	9968659*PED	2037-07-09		Pediatric extension

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 · 41 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
2026-02-19 14:30 UTC	2026-02	N022341-001	VICTOZA	18MG/3ML (6MG/ML)	SOLUTION / SUBCUTANEOUS	AP1	RLD, RS	2010-01-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022341-001	VICTOZA	18MG/3ML (6MG/ML)	SOLUTION / SUBCUTANEOUS	AP1	RLD, RS	2010-01-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022341-001	VICTOZA	18MG/3ML (6MG/ML)	SOLUTION / SUBCUTANEOUS	AP	RLD, RS	2010-01-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022341-001	VICTOZA	18MG/3ML (6MG/ML)	SOLUTION / SUBCUTANEOUS	AP	RLD, RS	2010-01-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022341-001	VICTOZA	18MG/3ML (6MG/ML)	SOLUTION / SUBCUTANEOUS	AP	RLD, RS	2010-01-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022341-001	VICTOZA	18MG/3ML (6MG/ML)	SOLUTION / SUBCUTANEOUS	AP	RLD, RS	2010-01-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022341-001	VICTOZA	18MG/3ML (6MG/ML)	SOLUTION / SUBCUTANEOUS		RLD, RS	2010-01-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022341-001	VICTOZA	18MG/3ML (6MG/ML)	SOLUTION / SUBCUTANEOUS		RLD, RS	2010-01-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022341-001	VICTOZA	18MG/3ML (6MG/ML)	SOLUTION / SUBCUTANEOUS		RLD, RS	2010-01-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022341-001	VICTOZA	18MG/3ML (6MG/ML)	SOLUTION / SUBCUTANEOUS		RLD, RS	2010-01-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022341-001	VICTOZA	18MG/3ML (6MG/ML)	SOLUTION / SUBCUTANEOUS		RLD, RS	2010-01-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022341-001	VICTOZA	18MG/3ML (6MG/ML)	SOLUTION / SUBCUTANEOUS		RLD, RS	2010-01-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022341-001	VICTOZA	18MG/3ML (6MG/ML)	SOLUTION / SUBCUTANEOUS		RLD, RS	2010-01-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022341-001	VICTOZA	18MG/3ML (6MG/ML)	SOLUTION / SUBCUTANEOUS		RLD, RS	2010-01-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022341-001	VICTOZA	18MG/3ML (6MG/ML)	SOLUTION / SUBCUTANEOUS		RLD, RS	2010-01-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022341-001	VICTOZA	18MG/3ML (6MG/ML)	SOLUTION / SUBCUTANEOUS		RLD, RS	2010-01-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022341-001	VICTOZA	18MG/3ML (6MG/ML)	SOLUTION / SUBCUTANEOUS		RLD, RS	2010-01-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022341-001	VICTOZA	18MG/3ML (6MG/ML)	SOLUTION / SUBCUTANEOUS		RLD, RS	2010-01-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022341-001	VICTOZA	18MG/3ML (6MG/ML)	SOLUTION / SUBCUTANEOUS		RLD, RS	2010-01-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022341-001	VICTOZA	18MG/3ML (6MG/ML)	SOLUTION / SUBCUTANEOUS		RLD, RS	2010-01-25	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022341-001	VICTOZA	18MG/3ML (6MG/ML)	SOLUTION / SUBCUTANEOUS		RLD, RS	2010-01-25	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022341-001	VICTOZA	18MG/3ML (6MG/ML)	SOLUTION / SUBCUTANEOUS		RLD, RS	2010-01-25	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022341-001	VICTOZA	18MG/3ML (6MG/ML)	SOLUTION / SUBCUTANEOUS		RLD, RS	2010-01-25	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022341-001	VICTOZA	18MG/3ML (6MG/ML)	SOLUTION / SUBCUTANEOUS		RLD, RS	2010-01-25	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022341-001	VICTOZA	18MG/3ML (6MG/ML)	SOLUTION / SUBCUTANEOUS		RLD, RS	2010-01-25	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022341-001	VICTOZA	18MG/3ML (6MG/ML)	SOLUTION / SUBCUTANEOUS		RLD, RS	2010-01-25	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022341-001	VICTOZA	18MG/3ML (6MG/ML)	SOLUTION / SUBCUTANEOUS		RLD, RS	2010-01-25	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022341-001	VICTOZA	18MG/3ML (6MG/ML)	SOLUTION / SUBCUTANEOUS		RLD, RS	2010-01-25	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022341-001	VICTOZA	18MG/3ML (6MG/ML)	SOLUTION / SUBCUTANEOUS		RLD, RS	2010-01-25	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022341-001	VICTOZA	18MG/3ML (6MG/ML)	SOLUTION / SUBCUTANEOUS		RLD, RS	2010-01-25	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022341-001	VICTOZA	18MG/3ML (6MG/ML)	SOLUTION / SUBCUTANEOUS		RLD, RS	2010-01-25	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022341-001	VICTOZA	18MG/3ML (6MG/ML)	SOLUTION / SUBCUTANEOUS		RLD, RS	2010-01-25	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022341-001	VICTOZA	18MG/3ML (6MG/ML)	SOLUTION / SUBCUTANEOUS		RLD, RS	2010-01-25	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022341-001	VICTOZA	18MG/3ML (6MG/ML)	SOLUTION / SUBCUTANEOUS		RLD, RS	2010-01-25	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022341-001	VICTOZA	18MG/3ML (6MG/ML)	SOLUTION / SUBCUTANEOUS		RLD, RS	2010-01-25	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N022341-001	VICTOZA	18MG/3ML (6MG/ML)	SOLUTION / SUBCUTANEOUS		RLD, RS	2010-01-25	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022341-001	VICTOZA	18MG/3ML (6MG/ML)	SOLUTION / SUBCUTANEOUS		RLD, RS	2010-01-25	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N022341-001	VICTOZA	18MG/3ML (6MG/ML)	SOLUTION / SUBCUTANEOUS		RLD, RS	2010-01-25	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N022341-001	VICTOZA	18MG/3ML (6MG/ML)	SOLUTION / SUBCUTANEOUS		RLD, RS	2010-01-25	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N022341-001	VICTOZA	18MG/3ML (6MG/ML)	SOLUTION / SUBCUTANEOUS		RLD, RS	2010-01-25	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N022341-001	AP1	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022341-001	AP1	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022341-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022341-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022341-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022341-001	AP	1	`03ed91905a0d…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N022341-001	AP1	1	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 12 · 460 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N022341-001	8114833	2025-08-13		Drug substance, Drug product	2012-03-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022341-001	8114833*PED	2026-02-13		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022341-001	9968659	2037-01-09	U-2313		2018-06-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022341-001	9968659*PED	2037-07-09		Pediatric extension		`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022341-001	8114833	2025-08-13		Drug substance, Drug product	2012-03-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022341-001	8114833*PED	2026-02-13		Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022341-001	9968659	2037-01-09	U-2313		2018-06-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022341-001	9968659*PED	2037-07-09		Pediatric extension		`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022341-001	8114833	2025-08-13		Drug substance, Drug product	2012-03-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022341-001	8114833*PED	2026-02-13		Pediatric extension		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022341-001	9968659	2037-01-09	U-2313		2018-06-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022341-001	9968659*PED	2037-07-09		Pediatric extension		`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022341-001	8114833	2025-08-13		Drug substance, Drug product	2012-03-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022341-001	8114833*PED	2026-02-13		Pediatric extension		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022341-001	9265893	2032-09-23		Drug product	2016-03-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022341-001	9265893*PED	2033-03-23		Pediatric extension		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022341-001	9968659	2037-01-09	U-2313		2018-06-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022341-001	9968659*PED	2037-07-09		Pediatric extension		`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022341-001	8114833	2025-08-13		Drug substance, Drug product	2012-03-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022341-001	8114833*PED	2026-02-13		Pediatric extension		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022341-001	9265893	2032-09-23		Drug product	2016-03-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022341-001	9265893*PED	2033-03-23		Pediatric extension		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022341-001	9968659	2037-01-09	U-2313		2018-06-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022341-001	9968659*PED	2037-07-09		Pediatric extension		`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022341-001	7762994	2024-05-23		Drug product	2019-03-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022341-001	7762994*PED	2024-11-23		Pediatric extension		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022341-001	8114833	2025-08-13		Drug substance, Drug product	2012-03-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022341-001	8114833*PED	2026-02-13		Pediatric extension		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022341-001	9265893	2032-09-23		Drug product	2016-03-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022341-001	9265893*PED	2033-03-23		Pediatric extension		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022341-001	9968659	2037-01-09	U-2313		2018-06-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022341-001	9968659*PED	2037-07-09		Pediatric extension		`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022341-001	7762994	2024-05-23		Drug product	2019-03-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022341-001	7762994*PED	2024-11-23		Pediatric extension		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022341-001	8114833	2025-08-13		Drug substance, Drug product	2012-03-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022341-001	8114833*PED	2026-02-13		Pediatric extension		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022341-001	9265893	2032-09-23		Drug product	2016-03-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022341-001	9265893*PED	2033-03-23		Pediatric extension		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022341-001	9968659	2037-01-09	U-2313		2018-06-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022341-001	9968659*PED	2037-07-09		Pediatric extension		`2680178bc6a6…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 46 observed states.

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	N022341-001	NPP	2022-06-17	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022341-001	PED	2022-12-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022341-001	NPP	2022-06-17	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022341-001	PED	2022-12-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022341-001	NPP	2022-06-17	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022341-001	PED	2022-12-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022341-001	M-176	2019-04-22	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022341-001	I-750	2020-08-25	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022341-001	NPP	2022-06-17	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022341-001	PED	2022-12-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022341-001	NPP	2022-06-17	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N022341-001	PED	2022-12-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022341-001	NPP	2022-06-17	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022341-001	PED	2022-12-17	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022341-001	NPP	2022-06-17	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022341-001	PED	2022-12-17	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022341-001	NPP	2022-06-17	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N022341-001	PED	2022-12-17	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022341-001	I-750	2020-08-25	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N022341-001	NPP	2022-06-17	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N022341-001	PED	2022-12-17	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022341-001	I-750	2020-08-25	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N022341-001	NPP	2022-06-17	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N022341-001	PED	2022-12-17	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022341-001	M-176	2019-04-22	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022341-001	I-750	2020-08-25	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022341-001	NPP	2022-06-17	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022341-001	PED	2022-12-17	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022341-001	M-176	2019-04-22	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N022341-001	I-750	2020-08-25	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N022341-001	NPP	2022-06-17	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N022341-001	PED	2022-12-17	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022341-001	M-176	2019-04-22	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N022341-001	I-750	2020-08-25	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N022341-001	NPP	2022-06-17	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N022341-001	PED	2022-12-17	`ea99ee380514…`
2023-01-26 05:58 UTC	2023-01	N022341-001	NPP	2022-06-17	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N022341-001	PED	2022-12-17	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022341-001	NPP	2022-06-17	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022341-001	PED	2022-12-17	`3a93d1ddd44b…`

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 1 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Liraglutide	LIRAGLUTIDE	Teva Pharmaceuticals USA, Inc.	14bf9812-14ee-46ce-93b1-686e4906cbbc	2026-01-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 022341 application number: NDA022341
Victoza	LIRAGLUTIDE	Novo Nordisk	5a9ef4ea-c76a-4d34-a604-27c5b505f5a4	2025-10-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 022341 application number: NDA022341 ndc (product): 0169-4060
Liraglutide	LIRAGLUTIDE	A-S Medication Solutions	0ba917f7-b974-4364-a745-7494ecae3e73	2025-01-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 022341 application number: NDA022341
Victoza	LIRAGLUTIDE	A-S Medication Solutions	1d18f106-0584-4fee-97ab-32771a64b809	2023-02-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 022341 application number: NDA022341 ndc (product): 50090-2853
Victoza	LIRAGLUTIDE	A-S Medication Solutions	35e613e3-7aae-4152-b827-99d1ee7841be	2023-02-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 022341 application number: NDA022341 ndc (product): 50090-4503

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
0169-4060	Victoza	liraglutide	Novo Nordisk	NDA	Current
0169-4060	Victoza	liraglutide	Novo Nordisk	NDA	Current
0169-4060	Victoza	liraglutide	Novo Nordisk	NDA	Current
0169-4060	Victoza	liraglutide	Novo Nordisk	NDA	Current
0169-4060	Victoza	liraglutide	Novo Nordisk	NDA	Current
0169-4060	Victoza	liraglutide	Novo Nordisk	NDA	Current
0169-4060	Victoza	liraglutide	Novo Nordisk	NDA	Current
50090-2853	Victoza	liraglutide	A-S Medication Solutions	NDA	Current
50090-4503	Victoza	liraglutide	A-S Medication Solutions	NDA	Current
50090-4503	Victoza	liraglutide	A-S Medication Solutions	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
83787	SUPPL	2025-10-15
83786	SUPPL	2025-10-15
83771	SUPPL	2025-10-15
82371	SUPPL	2025-05-30
81252	SUPPL	2025-02-21
81237	SUPPL	2025-02-13
80065	SUPPL	2024-11-01
80064	SUPPL	2024-11-01
74710	SUPPL	2023-07-07
74703	SUPPL	2023-07-06
71328	SUPPL	2022-06-15
71327	SUPPL	2022-06-15
71280	SUPPL	2022-06-13
71279	SUPPL	2022-06-13
65317	SUPPL	2020-11-25
65316	SUPPL	2020-11-25
65307	SUPPL	2020-11-25
64220	SUPPL	2020-08-06
64212	SUPPL	2020-08-06
64211	SUPPL	2020-08-06
64010	SUPPL	2020-07-22
59152	SUPPL	2019-06-21
59151	SUPPL	2019-06-21
59110	SUPPL	2019-06-18
49554	SUPPL	2017-08-28
49547	SUPPL	2017-08-28
49108	SUPPL	2017-07-28
48151	SUPPL	2017-04-27
48119	SUPPL	2017-04-26
45358	SUPPL	2016-09-22
17275	SUPPL	2016-04-27
7270	SUPPL	2016-04-26
29625	SUPPL	2015-07-08
17274	SUPPL	2015-03-26
7269	SUPPL	2015-03-11
38603	SUPPL	2015-03-03
7268	SUPPL	2015-02-27
29624	SUPPL	2014-08-01
38602	SUPPL	2013-06-18
7267	SUPPL	2013-06-14
29623	SUPPL	2013-04-18
17273	SUPPL	2013-04-17
29622	SUPPL	2012-12-19
17272	SUPPL	2012-12-18
38601	SUPPL	2012-04-09
38600	SUPPL	2012-04-09
29621	SUPPL	2012-04-09
17271	SUPPL	2012-04-09
7266	SUPPL	2012-04-09
7265	SUPPL	2012-04-09
29620	SUPPL	2011-05-24
38599	SUPPL	2011-05-23
38598	SUPPL	2010-12-26
42495	ORIG	2010-04-06
29619	ORIG	2010-01-26
17270	ORIG	2010-01-26
64949	ORIG	1900-01-01
63984	ORIG	1900-01-01
63983	ORIG	1900-01-01
63982	ORIG	1900-01-01
63120	SUPPL	1900-01-01
63119	SUPPL	1900-01-01