Application 215256

Type: NDA
Sponsor: NOVO NORDISK INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	WEGOVY	SEMAGLUTIDE	INJECTABLE;INJECTION	0.25MG	No	No
002	WEGOVY	SEMAGLUTIDE	INJECTABLE;INJECTION	0.5MG	No	No
003	WEGOVY	SEMAGLUTIDE	INJECTABLE;INJECTION	1MG	No	No
004	WEGOVY	SEMAGLUTIDE	INJECTABLE;INJECTION	1.7MG	No	No
005	WEGOVY	SEMAGLUTIDE	INJECTABLE;INJECTION	2.4MG	No	No
006	WEGOVY HD	SEMAGLUTIDE	SOLUTION;SUBCUTANEOUS	7.2MG/0.75ML (7.2MG/0.75ML)	Yes	Yes

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

Orange Book products#

Current product rows page 1 of 1 · 12 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N215256-001	WEGOVY	SEMAGLUTIDE	0.25MG/0.5ML (0.25MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-06-04
N215256-002	WEGOVY	SEMAGLUTIDE	0.5MG/0.5ML (0.5MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-06-04
N215256-003	WEGOVY	SEMAGLUTIDE	1MG/0.5ML (1MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-06-04
N215256-004	WEGOVY	SEMAGLUTIDE	1.7MG/0.75ML (1.7MG/0.75ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-06-04
N215256-005	WEGOVY	SEMAGLUTIDE	2.4MG/0.75ML (2.4MG/0.75ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-06-04
N215256-006	WEGOVY HD	SEMAGLUTIDE	7.2MG/0.75ML (7.2MG/0.75ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2026-03-19
N215256-007	WEGOVY	SEMAGLUTIDE	0.25MG/0.5ML (0.25MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2026-05-05
N215256-008	WEGOVY	SEMAGLUTIDE	0.5MG/0.5ML (0.5MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2026-05-05
N215256-009	WEGOVY	SEMAGLUTIDE	1MG/0.5ML (1MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2026-05-05
N215256-010	WEGOVY	SEMAGLUTIDE	1.7MG/0.75ML (1.7MG/0.75ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2026-05-05
N215256-011	WEGOVY	SEMAGLUTIDE	2.4MG/0.75ML (2.4MG/0.75ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2026-05-05
N215256-012	WEGOVY FLEXTOUCH	SEMAGLUTIDE	9.6MG/3ML (3.2MG/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2026-06-18

Orange Book patents#

Current patent rows page 1 of 2 · 110 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N215256-001	8536122	2026-03-20		Drug substance, Drug product	2021-06-30
N215256-001	8129343	2031-12-05		Drug substance, Drug product	2021-06-30
N215256-001	9764003	2033-06-21	U-3161		2021-06-30
N215256-001	10888605	2038-08-24	U-3162	Drug product	2021-06-30
N215256-001	11752198	2038-08-24	U-3162	Drug product	2023-10-10
N215256-001	12214017	2038-08-24	U-3162	Drug product	2025-03-06
N215256-001	11478533	2040-05-13	U-3861		2025-09-03
N215256-001	11318191	2041-02-17	U-3162	Drug product	2022-06-29
N215256-002	8536122	2026-03-20		Drug substance, Drug product	2021-06-30
N215256-002	8129343	2031-12-05		Drug substance, Drug product	2021-06-30
N215256-002	9764003	2033-06-21	U-3161		2021-06-30
N215256-002	10888605	2038-08-24	U-3162	Drug product	2021-06-30
N215256-002	11752198	2038-08-24	U-3162	Drug product	2023-10-10
N215256-002	12214017	2038-08-24	U-3162	Drug product	2025-03-06
N215256-002	11478533	2040-05-13	U-3861		2025-09-03
N215256-002	11318191	2041-02-17	U-3162	Drug product	2022-06-29
N215256-003	8536122	2026-03-20		Drug substance, Drug product	2021-06-30
N215256-003	8129343	2031-12-05		Drug substance, Drug product	2021-06-30
N215256-003	9764003	2033-06-21	U-3161		2021-06-30
N215256-003	10888605	2038-08-24	U-3162	Drug product	2021-06-30
N215256-003	11752198	2038-08-24	U-3162	Drug product	2023-10-10
N215256-003	12214017	2038-08-24	U-3162	Drug product	2025-03-06
N215256-003	11478533	2040-05-13	U-3861		2025-09-03
N215256-003	11318191	2041-02-17	U-3162	Drug product	2022-06-29
N215256-004	8536122	2026-03-20		Drug substance, Drug product	2021-06-30
N215256-004	8129343	2031-12-05		Drug substance, Drug product	2021-06-30
N215256-004	9764003	2033-06-21	U-3161		2021-06-30
N215256-004	10888605	2038-08-24	U-3162	Drug product	2021-06-30
N215256-004	11752198	2038-08-24	U-3162	Drug product	2023-10-10
N215256-004	12214017	2038-08-24	U-3162	Drug product	2025-03-06
N215256-004	11478533	2040-05-13	U-3861		2025-09-03
N215256-004	11318191	2041-02-17	U-3162	Drug product	2022-06-29
N215256-005	8536122	2026-03-20		Drug substance, Drug product	2021-06-30
N215256-005	8129343	2031-12-05		Drug substance, Drug product	2021-06-30
N215256-005	9764003	2033-06-21	U-3161		2021-06-30
N215256-005	10888605	2038-08-24	U-3162	Drug product	2021-06-30
N215256-005	11752198	2038-08-24	U-3162	Drug product	2023-10-10
N215256-005	12214017	2038-08-24	U-3162	Drug product	2025-03-06
N215256-005	12029779	2038-10-10	U-3162		2024-07-09
N215256-005	12551536	2038-10-10	U-4418		2026-03-02
N215256-005	11478533	2040-05-13	U-3861		2025-09-03
N215256-005	11318191	2041-02-17	U-3162	Drug product	2022-06-29
N215256-006	8129343	2031-12-05		Drug substance, Drug product	2026-03-31
N215256-006	9764003	2033-06-21	U-4418		2026-03-31
N215256-006	10888605	2038-08-24	U-4418	Drug product	2026-03-31
N215256-006	11752198	2038-08-24	U-4418	Drug product	2026-03-31
N215256-006	12214017	2038-08-24	U-4418	Drug product	2026-03-31
N215256-006	12029779	2038-10-10	U-4418		2026-03-31
N215256-006	12551536	2038-10-10	U-4418		2026-03-31
N215256-006	11318191	2041-02-17	U-4418	Drug product	2026-03-31
N215256-007	8129343	2031-12-05		Drug substance, Drug product	2026-06-23
N215256-007	9764003	2033-06-21	U-3161		2026-06-23
N215256-007	12569543	2037-04-28	U-4443		2026-06-23
N215256-007	10888605	2038-08-24	U-3162	Drug product	2026-06-23
N215256-007	11752198	2038-08-24	U-3162	Drug product	2026-06-23
N215256-007	12214017	2038-08-24	U-3162	Drug product	2026-06-23
N215256-007	12029779	2038-10-10	U-3162		2026-06-23
N215256-007	12551536	2038-10-10	U-4418		2026-06-23
N215256-007	11478533	2040-05-13	U-3861		2026-06-23
N215256-007	11318191	2041-02-17	U-3162	Drug product	2026-06-23
N215256-007	11318191	2041-02-17	U-4443	Drug product	2026-06-23
N215256-007	11318191	2041-02-17	U-4560	Drug product	2026-06-23
N215256-008	8129343	2031-12-05		Drug substance, Drug product	2026-06-23
N215256-008	9764003	2033-06-21	U-3161		2026-06-23
N215256-008	12569543	2037-04-28	U-4443		2026-06-23
N215256-008	10888605	2038-08-24	U-3162	Drug product	2026-06-23
N215256-008	11752198	2038-08-24	U-3162	Drug product	2026-06-23
N215256-008	12214017	2038-08-24	U-3162	Drug product	2026-06-23
N215256-008	12029779	2038-10-10	U-3162		2026-06-23
N215256-008	12551536	2038-10-10	U-4418		2026-06-23
N215256-008	11478533	2040-05-13	U-3861		2026-06-23
N215256-008	11318191	2041-02-17	U-3162	Drug product	2026-06-23
N215256-008	11318191	2041-02-17	U-4443	Drug product	2026-06-23
N215256-008	11318191	2041-02-17	U-4560	Drug product	2026-06-23
N215256-009	8129343	2031-12-05		Drug substance, Drug product	2026-06-23
N215256-009	9764003	2033-06-21	U-3161		2026-06-23
N215256-009	12569543	2037-04-28	U-4443		2026-06-23
N215256-009	10888605	2038-08-24	U-3162	Drug product	2026-06-23
N215256-009	11752198	2038-08-24	U-3162	Drug product	2026-06-23
N215256-009	12214017	2038-08-24	U-3162	Drug product	2026-06-23

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 12 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N215256-001	I-935	2027-03-08
N215256-001	I-973	2028-08-15
N215256-002	I-935	2027-03-08
N215256-002	I-973	2028-08-15
N215256-003	I-935	2027-03-08
N215256-003	I-973	2028-08-15
N215256-004	D-190	2026-07-21
N215256-004	I-935	2027-03-08
N215256-004	I-973	2028-08-15
N215256-005	I-935	2027-03-08
N215256-005	I-973	2028-08-15
N215256-006	NS	2029-03-19

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 5 · 172 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N215256-001	WEGOVY	0.25MG/0.5ML (0.25MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-06-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215256-002	WEGOVY	0.5MG/0.5ML (0.5MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-06-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215256-003	WEGOVY	1MG/0.5ML (1MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-06-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215256-004	WEGOVY	1.7MG/0.75ML (1.7MG/0.75ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-06-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215256-005	WEGOVY	2.4MG/0.75ML (2.4MG/0.75ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-06-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215256-001	WEGOVY	0.25MG/0.5ML (0.25MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-06-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215256-002	WEGOVY	0.5MG/0.5ML (0.5MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-06-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215256-003	WEGOVY	1MG/0.5ML (1MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-06-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215256-004	WEGOVY	1.7MG/0.75ML (1.7MG/0.75ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-06-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215256-005	WEGOVY	2.4MG/0.75ML (2.4MG/0.75ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-06-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N215256-001	WEGOVY	0.25MG/0.5ML (0.25MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-06-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215256-002	WEGOVY	0.5MG/0.5ML (0.5MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-06-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215256-003	WEGOVY	1MG/0.5ML (1MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-06-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215256-004	WEGOVY	1.7MG/0.75ML (1.7MG/0.75ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-06-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215256-005	WEGOVY	2.4MG/0.75ML (2.4MG/0.75ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-06-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215256-001	WEGOVY	0.25MG/0.5ML (0.25MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-06-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215256-002	WEGOVY	0.5MG/0.5ML (0.5MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-06-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215256-003	WEGOVY	1MG/0.5ML (1MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-06-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215256-004	WEGOVY	1.7MG/0.75ML (1.7MG/0.75ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-06-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215256-005	WEGOVY	2.4MG/0.75ML (2.4MG/0.75ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-06-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215256-001	WEGOVY	0.25MG/0.5ML (0.25MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-06-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215256-002	WEGOVY	0.5MG/0.5ML (0.5MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-06-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215256-003	WEGOVY	1MG/0.5ML (1MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-06-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215256-004	WEGOVY	1.7MG/0.75ML (1.7MG/0.75ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-06-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215256-005	WEGOVY	2.4MG/0.75ML (2.4MG/0.75ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-06-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215256-001	WEGOVY	0.25MG/0.5ML (0.25MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-06-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215256-002	WEGOVY	0.5MG/0.5ML (0.5MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-06-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215256-003	WEGOVY	1MG/0.5ML (1MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-06-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215256-004	WEGOVY	1.7MG/0.75ML (1.7MG/0.75ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-06-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215256-005	WEGOVY	2.4MG/0.75ML (2.4MG/0.75ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-06-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215256-001	WEGOVY	0.25MG/0.5ML (0.25MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-06-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215256-002	WEGOVY	0.5MG/0.5ML (0.5MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-06-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215256-003	WEGOVY	1MG/0.5ML (1MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-06-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215256-004	WEGOVY	1.7MG/0.75ML (1.7MG/0.75ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-06-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215256-005	WEGOVY	2.4MG/0.75ML (2.4MG/0.75ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-06-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215256-001	WEGOVY	0.25MG/0.5ML (0.25MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-06-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215256-002	WEGOVY	0.5MG/0.5ML (0.5MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-06-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215256-003	WEGOVY	1MG/0.5ML (1MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-06-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215256-004	WEGOVY	1.7MG/0.75ML (1.7MG/0.75ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-06-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215256-005	WEGOVY	2.4MG/0.75ML (2.4MG/0.75ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-06-04	`5bbf6a4d5a75…`

Observed Orange Book patent history#

Patent history page 1 of 26 · 1,022 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	N215256-001	8536122	2026-03-20		Drug substance, Drug product	2021-06-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215256-001	8129343	2031-12-05		Drug substance, Drug product	2021-06-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215256-001	9764003	2033-06-21	U-3161		2021-06-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215256-001	10888605	2038-08-24	U-3162	Drug product	2021-06-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215256-001	11752198	2038-08-24	U-3162	Drug product	2023-10-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215256-001	12214017	2038-08-24	U-3162	Drug product	2025-03-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215256-001	11478533	2040-05-13	U-3861		2025-09-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215256-001	11318191	2041-02-17	U-3162	Drug product	2022-06-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215256-002	8536122	2026-03-20		Drug substance, Drug product	2021-06-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215256-002	8129343	2031-12-05		Drug substance, Drug product	2021-06-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215256-002	9764003	2033-06-21	U-3161		2021-06-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215256-002	10888605	2038-08-24	U-3162	Drug product	2021-06-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215256-002	11752198	2038-08-24	U-3162	Drug product	2023-10-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215256-002	12214017	2038-08-24	U-3162	Drug product	2025-03-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215256-002	11478533	2040-05-13	U-3861		2025-09-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215256-002	11318191	2041-02-17	U-3162	Drug product	2022-06-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215256-003	8536122	2026-03-20		Drug substance, Drug product	2021-06-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215256-003	8129343	2031-12-05		Drug substance, Drug product	2021-06-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215256-003	9764003	2033-06-21	U-3161		2021-06-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215256-003	10888605	2038-08-24	U-3162	Drug product	2021-06-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215256-003	11752198	2038-08-24	U-3162	Drug product	2023-10-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215256-003	12214017	2038-08-24	U-3162	Drug product	2025-03-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215256-003	11478533	2040-05-13	U-3861		2025-09-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215256-003	11318191	2041-02-17	U-3162	Drug product	2022-06-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215256-004	8536122	2026-03-20		Drug substance, Drug product	2021-06-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215256-004	8129343	2031-12-05		Drug substance, Drug product	2021-06-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215256-004	9764003	2033-06-21	U-3161		2021-06-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215256-004	10888605	2038-08-24	U-3162	Drug product	2021-06-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215256-004	11752198	2038-08-24	U-3162	Drug product	2023-10-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215256-004	12214017	2038-08-24	U-3162	Drug product	2025-03-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215256-004	11478533	2040-05-13	U-3861		2025-09-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215256-004	11318191	2041-02-17	U-3162	Drug product	2022-06-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215256-005	8536122	2026-03-20		Drug substance, Drug product	2021-06-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215256-005	8129343	2031-12-05		Drug substance, Drug product	2021-06-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215256-005	9764003	2033-06-21	U-3161		2021-06-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215256-005	10888605	2038-08-24	U-3162	Drug product	2021-06-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215256-005	11752198	2038-08-24	U-3162	Drug product	2023-10-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215256-005	12214017	2038-08-24	U-3162	Drug product	2025-03-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215256-005	12029779	2038-10-10	U-3162		2024-07-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215256-005	11478533	2040-05-13	U-3861		2025-09-03	`011fe1cb6892…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 11 · 401 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N215256-001	I-935	2027-03-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215256-001	I-973	2028-08-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215256-002	I-935	2027-03-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215256-002	I-973	2028-08-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215256-003	I-935	2027-03-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215256-003	I-973	2028-08-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215256-004	D-190	2026-07-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215256-004	I-935	2027-03-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215256-004	I-973	2028-08-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215256-005	I-935	2027-03-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215256-005	I-973	2028-08-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215256-001	NPP	2025-12-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215256-001	I-935	2027-03-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215256-001	I-973	2028-08-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215256-002	NPP	2025-12-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215256-002	I-935	2027-03-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215256-002	I-973	2028-08-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215256-003	NPP	2025-12-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215256-003	I-935	2027-03-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215256-003	I-973	2028-08-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215256-004	NPP	2025-12-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215256-004	D-190	2026-07-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215256-004	I-935	2027-03-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215256-004	I-973	2028-08-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215256-005	NPP	2025-12-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215256-005	I-935	2027-03-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215256-005	I-973	2028-08-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N215256-001	NPP	2025-12-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215256-001	I-935	2027-03-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215256-002	NPP	2025-12-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215256-002	I-935	2027-03-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215256-003	NPP	2025-12-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215256-003	I-935	2027-03-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215256-004	NPP	2025-12-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215256-004	D-190	2026-07-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215256-004	I-935	2027-03-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215256-005	NPP	2025-12-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215256-005	I-935	2027-03-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215256-001	NPP	2025-12-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215256-001	I-935	2027-03-08	`fd3edfee7708…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
WEGOVY	SEMAGLUTIDE	A-S Medication Solutions	f5e548d0-cc79-4c34-a3f5-e20a5b8b6564	2024-04-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 215256 application number: NDA215256 ndc (product): 50090-5824

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 16 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0169-4501	WEGOVY	semaglutide	Novo Nordisk	NDA	Current
0169-4501	WEGOVY	semaglutide	Novo Nordisk	NDA	Current
0169-4501	WEGOVY	semaglutide	Novo Nordisk	NDA	Current
0169-4505	WEGOVY	semaglutide	Novo Nordisk	NDA	Current
0169-4505	WEGOVY	semaglutide	Novo Nordisk	NDA	Current
0169-4505	WEGOVY	semaglutide	Novo Nordisk	NDA	Current
0169-4517	WEGOVY	semaglutide	Novo Nordisk	NDA	Current
0169-4517	WEGOVY	semaglutide	Novo Nordisk	NDA	Current
0169-4517	WEGOVY	semaglutide	Novo Nordisk	NDA	Current
0169-4524	WEGOVY	semaglutide	Novo Nordisk	NDA	Current
0169-4524	WEGOVY	semaglutide	Novo Nordisk	NDA	Current
0169-4524	WEGOVY	semaglutide	Novo Nordisk	NDA	Current
0169-4525	WEGOVY	semaglutide	Novo Nordisk	NDA	Current
0169-4525	WEGOVY	semaglutide	Novo Nordisk	NDA	Current
0169-4525	WEGOVY	semaglutide	Novo Nordisk	NDA	Current
50090-5824	WEGOVY	semaglutide	A-S Medication Solutions	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
85892	SUPPL	2026-05-12
85515	SUPPL	2026-03-24
85499	SUPPL	2026-03-24
85452	SUPPL	2026-03-23
85190	SUPPL	2026-03-02
85178	SUPPL	2026-02-27
84885	SUPPL	2026-01-30
84943	SUPPL	2026-01-29
84296	SUPPL	2025-11-25
84279	SUPPL	2025-11-24
83779	SUPPL	2025-10-15
83774	SUPPL	2025-10-15
83118	SUPPL	2025-08-18
83106	SUPPL	2025-08-15
80472	SUPPL	2024-12-03
80452	SUPPL	2024-11-29
80167	SUPPL	2024-11-05
80134	SUPPL	2024-11-05
80129	SUPPL	2024-11-05
77775	SUPPL	2024-03-11
77770	SUPPL	2024-03-08
74874	SUPPL	2023-07-24
74868	SUPPL	2023-07-24
73508	SUPPL	2023-02-16
73507	SUPPL	2023-02-15
73054	SUPPL	2022-12-27
73037	SUPPL	2022-12-27
73036	SUPPL	2022-12-27
71941	SUPPL	2022-08-29
69772	ORIG	2021-12-27
67729	ORIG	2021-06-07
67725	ORIG	2021-06-07
67724	ORIG	2021-06-07