Home Applications 215256 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 42 .
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 TE codes 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 · 115 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 · 14 matching rows.
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 · 184 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 2026-08-18 06:07:40 2026-07 N215256-001 WEGOVY 0.25MG/0.5ML (0.25MG/0.5ML) SOLUTION / SUBCUTANEOUS RLD, RS 2021-06-04 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215256-002 WEGOVY 0.5MG/0.5ML (0.5MG/0.5ML) SOLUTION / SUBCUTANEOUS RLD, RS 2021-06-04 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215256-003 WEGOVY 1MG/0.5ML (1MG/0.5ML) SOLUTION / SUBCUTANEOUS RLD, RS 2021-06-04 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215256-004 WEGOVY 1.7MG/0.75ML (1.7MG/0.75ML) SOLUTION / SUBCUTANEOUS RLD, RS 2021-06-04 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215256-005 WEGOVY 2.4MG/0.75ML (2.4MG/0.75ML) SOLUTION / SUBCUTANEOUS RLD, RS 2021-06-04 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215256-006 WEGOVY HD 7.2MG/0.75ML (7.2MG/0.75ML) SOLUTION / SUBCUTANEOUS RLD, RS 2026-03-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215256-007 WEGOVY 0.25MG/0.5ML (0.25MG/0.5ML) SOLUTION / SUBCUTANEOUS RLD, RS 2026-05-05 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215256-008 WEGOVY 0.5MG/0.5ML (0.5MG/0.5ML) SOLUTION / SUBCUTANEOUS RLD, RS 2026-05-05 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215256-009 WEGOVY 1MG/0.5ML (1MG/0.5ML) SOLUTION / SUBCUTANEOUS RLD, RS 2026-05-05 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215256-010 WEGOVY 1.7MG/0.75ML (1.7MG/0.75ML) SOLUTION / SUBCUTANEOUS RLD, RS 2026-05-05 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215256-011 WEGOVY 2.4MG/0.75ML (2.4MG/0.75ML) SOLUTION / SUBCUTANEOUS RLD, RS 2026-05-05 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215256-012 WEGOVY FLEXTOUCH 9.6MG/3ML (3.2MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2026-06-18 caaa826d4ba7…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…
Observed Orange Book patent history# Patent history page 1 of 29 · 1,137 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-18 06:07:40 2026-07 N215256-001 8536122 2026-03-20 Drug substance, Drug product 2021-06-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215256-001 8129343 2031-12-05 Drug substance, Drug product 2021-06-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215256-001 9764003 2033-06-21 U-3161 2021-06-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215256-001 10888605 2038-08-24 U-3162 Drug product 2021-06-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215256-001 11752198 2038-08-24 U-3162 Drug product 2023-10-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215256-001 12214017 2038-08-24 U-3162 Drug product 2025-03-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215256-001 11478533 2040-05-13 U-3861 2025-09-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215256-001 11318191 2041-02-17 U-3162 Drug product 2022-06-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215256-002 8536122 2026-03-20 Drug substance, Drug product 2021-06-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215256-002 8129343 2031-12-05 Drug substance, Drug product 2021-06-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215256-002 9764003 2033-06-21 U-3161 2021-06-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215256-002 10888605 2038-08-24 U-3162 Drug product 2021-06-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215256-002 11752198 2038-08-24 U-3162 Drug product 2023-10-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215256-002 12214017 2038-08-24 U-3162 Drug product 2025-03-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215256-002 11478533 2040-05-13 U-3861 2025-09-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215256-002 11318191 2041-02-17 U-3162 Drug product 2022-06-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215256-003 8536122 2026-03-20 Drug substance, Drug product 2021-06-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215256-003 8129343 2031-12-05 Drug substance, Drug product 2021-06-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215256-003 9764003 2033-06-21 U-3161 2021-06-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215256-003 10888605 2038-08-24 U-3162 Drug product 2021-06-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215256-003 11752198 2038-08-24 U-3162 Drug product 2023-10-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215256-003 12214017 2038-08-24 U-3162 Drug product 2025-03-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215256-003 11478533 2040-05-13 U-3861 2025-09-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215256-003 11318191 2041-02-17 U-3162 Drug product 2022-06-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215256-004 8536122 2026-03-20 Drug substance, Drug product 2021-06-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215256-004 8129343 2031-12-05 Drug substance, Drug product 2021-06-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215256-004 9764003 2033-06-21 U-3161 2021-06-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215256-004 10888605 2038-08-24 U-3162 Drug product 2021-06-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215256-004 11752198 2038-08-24 U-3162 Drug product 2023-10-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215256-004 12214017 2038-08-24 U-3162 Drug product 2025-03-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215256-004 11478533 2040-05-13 U-3861 2025-09-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215256-004 11318191 2041-02-17 U-3162 Drug product 2022-06-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215256-005 8536122 2026-03-20 Drug substance, Drug product 2021-06-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215256-005 8129343 2031-12-05 Drug substance, Drug product 2021-06-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215256-005 9764003 2033-06-21 U-3161 2021-06-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215256-005 10888605 2038-08-24 U-3162 Drug product 2021-06-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215256-005 11752198 2038-08-24 U-3162 Drug product 2023-10-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215256-005 12214017 2038-08-24 U-3162 Drug product 2025-03-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215256-005 12029779 2038-10-10 U-3162 2024-07-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215256-005 12551536 2038-10-10 U-4418 2026-03-02 caaa826d4ba7…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 11 · 415 observed states.
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