Application 211675

Type: NDA
Sponsor: ABBVIE INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	RINVOQ	UPADACITINIB	TABLET, EXTENDED RELEASE;ORAL	15MG	Yes	Yes
002	RINVOQ	UPADACITINIB	TABLET, EXTENDED RELEASE;ORAL	30MG	Yes	Yes
003	RINVOQ	UPADACITINIB	TABLET, EXTENDED RELEASE;ORAL	45MG	Yes	No

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N211675-001	RINVOQ	UPADACITINIB	15MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2019-08-16
N211675-002	RINVOQ	UPADACITINIB	30MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2022-01-14
N211675-003	RINVOQ	UPADACITINIB	45MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2022-03-16

Orange Book patents#

Current patent rows page 1 of 2 · 97 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N211675-001	8962629	2031-01-15	U-3255	Drug substance	2019-09-13
N211675-001	8962629	2031-01-15	U-3275	Drug substance	2019-09-13
N211675-001	8962629	2031-01-15	U-3341	Drug substance	2019-09-13
N211675-001	8962629	2031-01-15	U-3371	Drug substance	2019-09-13
N211675-001	8962629	2031-01-15	U-3624	Drug substance	2019-09-13
N211675-001	8962629	2031-01-15	U-3945	Drug substance	2019-09-13
N211675-001	8962629	2031-01-15	U-3946	Drug substance	2019-09-13
N211675-001	RE47221	2033-08-16		Drug substance	2019-09-13
N211675-001	10519164	2036-10-17		Drug product	2020-01-29
N211675-001	10597400	2036-10-17	U-3255		2020-04-17
N211675-001	10981923	2036-10-17		Drug substance	2021-05-18
N211675-001	10981924	2036-10-17		Drug product	2021-05-18
N211675-001	10995095	2036-10-17	U-3298		2022-02-10
N211675-001	11186584	2036-10-17		Drug substance	2021-12-17
N211675-001	11198697	2036-10-17		Drug product	2021-12-17
N211675-001	11365198	2036-10-17	U-3275		2022-07-20
N211675-001	11365198	2036-10-17	U-3946		2022-07-20
N211675-001	11512092	2036-10-17	U-3275		2022-12-16
N211675-001	11512092	2036-10-17	U-3371		2022-12-16
N211675-001	11512092	2036-10-17	U-3487		2022-12-16
N211675-001	11512092	2036-10-17	U-3946		2022-12-16
N211675-001	11524964	2036-10-17	U-3371		2023-01-12
N211675-001	11535624	2036-10-17	U-3255		2023-01-26
N211675-001	11535625	2036-10-17	U-3298		2023-01-26
N211675-001	11661425	2036-10-17		Drug substance, Drug product	2023-06-29
N211675-001	11680069	2036-10-17		Drug substance, Drug product	2023-07-20
N211675-001	11718627	2036-10-17		Drug substance, Drug product	2023-08-11
N211675-001	11767326	2036-10-17	U-3298		2023-10-23
N211675-001	11773105	2036-10-17		Drug substance, Drug product	2023-11-02
N211675-001	11773106	2036-10-17	U-3275		2023-11-02
N211675-001	11773106	2036-10-17	U-3371		2023-11-02
N211675-001	11773106	2036-10-17	U-3487		2023-11-02
N211675-001	11773106	2036-10-17	U-3946		2023-11-02
N211675-001	11780847	2036-10-17		Drug product	2023-11-08
N211675-001	11780848	2036-10-17	U-3371		2023-11-08
N211675-001	11787815	2036-10-17		Drug product	2023-11-08
N211675-001	11795175	2036-10-17	U-3255		2023-11-22
N211675-001	11976077	2036-10-17	U-3298		2024-06-05
N211675-001	11993605	2036-10-17	U-3275		2024-06-26
N211675-001	11993605	2036-10-17	U-3946		2024-06-26
N211675-001	11993606	2036-10-17	U-3487		2024-06-26
N211675-001	12077545	2036-10-17		Drug product	2024-09-27
N211675-001	12103933	2036-10-17		Drug product	2024-10-31
N211675-001	12110297	2036-10-17		Drug product	2024-11-05
N211675-001	12110298	2036-10-17		Drug substance, Drug product	2024-11-05
N211675-001	12365689	2036-10-17	U-3945		2025-08-20
N211675-001	12570664	2036-10-17	U-4454		2026-04-08
N211675-001	9951080	2036-10-17		Drug substance, Drug product	2019-09-13
N211675-001	9963459	2036-10-17		Drug product	2019-09-13
N211675-001	11564922	2038-03-09	U-3624		2023-06-15
N211675-001	11564922	2038-03-09	U-4303		2023-06-15
N211675-001	11607411	2038-03-09	U-3341		2023-04-18
N211675-001	11607411	2038-03-09	U-4302		2023-04-18
N211675-002	8962629	2031-01-15	U-3341	Drug substance	2022-02-10
N211675-002	8962629	2031-01-15	U-3624	Drug substance	2022-02-10
N211675-002	RE47221	2033-08-16		Drug substance	2022-02-10
N211675-002	10344036	2036-10-17		Drug product	2022-02-10
N211675-002	10550126	2036-10-17	U-3298		2022-02-10
N211675-002	10730883	2036-10-17		Drug product	2022-02-10
N211675-002	10981923	2036-10-17		Drug substance	2022-02-10
N211675-002	10981924	2036-10-17		Drug product	2022-02-10
N211675-002	11186584	2036-10-17		Drug substance	2022-02-10
N211675-002	11198697	2036-10-17		Drug product	2022-02-10
N211675-002	11535626	2036-10-17	U-3298		2023-01-26
N211675-002	11661425	2036-10-17		Drug substance, Drug product	2023-06-29
N211675-002	11680069	2036-10-17		Drug substance, Drug product	2023-07-20
N211675-002	11718627	2036-10-17		Drug substance, Drug product	2023-08-11
N211675-002	11767326	2036-10-17	U-3298		2023-10-23
N211675-002	11773105	2036-10-17		Drug substance, Drug product	2023-11-02
N211675-002	12077545	2036-10-17		Drug product	2024-09-27
N211675-002	12091415	2036-10-17		Drug product	2024-10-16
N211675-002	12110298	2036-10-17		Drug substance, Drug product	2024-11-05
N211675-002	12116373	2036-10-17		Drug product	2024-11-05
N211675-002	9951080	2036-10-17		Drug substance, Drug product	2022-02-10
N211675-002	11564922	2038-03-09	U-3624		2023-08-11
N211675-002	11564922	2038-03-09	U-4303		2023-08-11
N211675-002	11607411	2038-03-09	U-3341		2023-08-11
N211675-002	11607411	2038-03-09	U-4302		2023-08-11
N211675-003	8962629	2031-01-15	U-3341	Drug substance	2022-04-14
N211675-003	8962629	2031-01-15	U-3624	Drug substance	2022-04-14

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 14 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N211675-001	I-919	2026-05-18
N211675-001	I-946	2027-04-26
N211675-001	NPP	2027-04-26
N211675-001	I-966	2028-04-28
N211675-001	ODE-481	2031-04-26
N211675-001	ODE-538	2032-04-28
N211675-002	I-919	2026-05-18
N211675-002	I-946	2027-04-26
N211675-002	NPP	2027-04-26
N211675-002	ODE-481	2031-04-26
N211675-003	I-919	2026-05-18
N211675-003	I-946	2027-04-26
N211675-003	NPP	2027-04-26
N211675-003	ODE-481	2031-04-26

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 3 · 102 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	N211675-001	RINVOQ	15MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2019-08-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211675-002	RINVOQ	30MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2022-01-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211675-003	RINVOQ	45MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2022-03-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211675-001	RINVOQ	15MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2019-08-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211675-002	RINVOQ	30MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2022-01-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211675-003	RINVOQ	45MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2022-03-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N211675-001	RINVOQ	15MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2019-08-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211675-002	RINVOQ	30MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2022-01-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211675-003	RINVOQ	45MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2022-03-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211675-001	RINVOQ	15MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2019-08-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211675-002	RINVOQ	30MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2022-01-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211675-003	RINVOQ	45MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2022-03-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211675-001	RINVOQ	15MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2019-08-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211675-002	RINVOQ	30MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2022-01-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211675-003	RINVOQ	45MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2022-03-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211675-001	RINVOQ	15MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2019-08-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211675-002	RINVOQ	30MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2022-01-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211675-003	RINVOQ	45MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2022-03-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211675-001	RINVOQ	15MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2019-08-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211675-002	RINVOQ	30MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2022-01-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211675-003	RINVOQ	45MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2022-03-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N211675-001	RINVOQ	15MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2019-08-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N211675-002	RINVOQ	30MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2022-01-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N211675-003	RINVOQ	45MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2022-03-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N211675-001	RINVOQ	15MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2019-08-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N211675-002	RINVOQ	30MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2022-01-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N211675-003	RINVOQ	45MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2022-03-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N211675-001	RINVOQ	15MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2019-08-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N211675-002	RINVOQ	30MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2022-01-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N211675-003	RINVOQ	45MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2022-03-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N211675-001	RINVOQ	15MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2019-08-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N211675-002	RINVOQ	30MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2022-01-14	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N211675-003	RINVOQ	45MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2022-03-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N211675-001	RINVOQ	15MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2019-08-16	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N211675-002	RINVOQ	30MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2022-01-14	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N211675-003	RINVOQ	45MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2022-03-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N211675-001	RINVOQ	15MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2019-08-16	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N211675-002	RINVOQ	30MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2022-01-14	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N211675-003	RINVOQ	45MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2022-03-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N211675-001	RINVOQ	15MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2019-08-16	`8072bd15b7f6…`

Observed Orange Book patent history#

Patent history page 1 of 51 · 2,016 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	N211675-001	8962629	2031-01-15	U-3371	Drug substance	2019-09-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211675-001	8962629	2031-01-15	U-3624	Drug substance	2019-09-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211675-001	8962629	2031-01-15	U-3946	Drug substance	2019-09-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211675-001	8962629	2031-01-15	U-3945	Drug substance	2019-09-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211675-001	8962629	2031-01-15	U-3275	Drug substance	2019-09-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211675-001	8962629	2031-01-15	U-3255	Drug substance	2019-09-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211675-001	8962629	2031-01-15	U-3341	Drug substance	2019-09-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211675-001	RE47221	2033-08-16		Drug substance	2019-09-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211675-001	10519164	2036-10-17		Drug product	2020-01-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211675-001	10597400	2036-10-17	U-3255		2020-04-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211675-001	10981923	2036-10-17		Drug substance	2021-05-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211675-001	10981924	2036-10-17		Drug product	2021-05-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211675-001	10995095	2036-10-17	U-3298		2022-02-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211675-001	11186584	2036-10-17		Drug substance	2021-12-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211675-001	11198697	2036-10-17		Drug product	2021-12-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211675-001	11365198	2036-10-17	U-3946		2022-07-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211675-001	11365198	2036-10-17	U-3275		2022-07-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211675-001	11512092	2036-10-17	U-3946		2022-12-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211675-001	11512092	2036-10-17	U-3275		2022-12-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211675-001	11512092	2036-10-17	U-3487		2022-12-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211675-001	11512092	2036-10-17	U-3371		2022-12-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211675-001	11524964	2036-10-17	U-3371		2023-01-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211675-001	11535624	2036-10-17	U-3255		2023-01-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211675-001	11535625	2036-10-17	U-3298		2023-01-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211675-001	11661425	2036-10-17		Drug substance, Drug product	2023-06-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211675-001	11680069	2036-10-17		Drug substance, Drug product	2023-07-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211675-001	11718627	2036-10-17		Drug substance, Drug product	2023-08-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211675-001	11767326	2036-10-17	U-3298		2023-10-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211675-001	11773105	2036-10-17		Drug substance, Drug product	2023-11-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211675-001	11773106	2036-10-17	U-3946		2023-11-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211675-001	11773106	2036-10-17	U-3275		2023-11-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211675-001	11773106	2036-10-17	U-3487		2023-11-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211675-001	11773106	2036-10-17	U-3371		2023-11-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211675-001	11780847	2036-10-17		Drug product	2023-11-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211675-001	11780848	2036-10-17	U-3371		2023-11-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211675-001	11787815	2036-10-17		Drug product	2023-11-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211675-001	11795175	2036-10-17	U-3255		2023-11-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211675-001	11976077	2036-10-17	U-3298		2024-06-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211675-001	11993605	2036-10-17	U-3275		2024-06-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211675-001	11993605	2036-10-17	U-3946		2024-06-26	`011fe1cb6892…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 12 · 466 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	N211675-001	I-919	2026-05-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211675-001	I-946	2027-04-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211675-001	NPP	2027-04-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211675-001	I-966	2028-04-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211675-001	ODE-481	2031-04-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211675-002	I-919	2026-05-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211675-002	I-946	2027-04-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211675-002	NPP	2027-04-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211675-002	ODE-481	2031-04-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211675-003	I-919	2026-05-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211675-003	I-946	2027-04-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211675-003	NPP	2027-04-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211675-003	ODE-481	2031-04-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211675-001	I-883	2025-01-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211675-001	I-886	2025-03-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211675-001	I-888	2025-04-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211675-001	I-919	2026-05-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211675-001	I-946	2027-04-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211675-001	NPP	2027-04-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211675-001	I-966	2028-04-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211675-001	ODE-481	2031-04-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211675-002	I-883	2025-01-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211675-002	I-886	2025-03-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211675-002	I-919	2026-05-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211675-002	I-946	2027-04-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211675-002	NPP	2027-04-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211675-002	ODE-481	2031-04-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211675-003	I-886	2025-03-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211675-003	I-919	2026-05-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211675-003	I-946	2027-04-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211675-003	NPP	2027-04-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211675-003	ODE-481	2031-04-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N211675-001	I-883	2025-01-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211675-001	I-886	2025-03-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211675-001	I-888	2025-04-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211675-001	I-919	2026-05-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211675-001	I-946	2027-04-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211675-001	NPP	2027-04-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211675-001	I-966	2028-04-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211675-001	ODE-481	2031-04-26	`6a471c1ec25d…`

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
Rinvoq	UPADACITINIB	AbbVie Inc.	2966aec7-2ef0-923c-d8ff-fe1a957bf095	2026-06-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 211675 application number: NDA211675 ndc (product): 0074-2306 ndc (product): 0074-2310 ndc (product): 0074-1043

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 20 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0074-1043	Rinvoq	Upadacitinib	AbbVie Inc.	NDA	Current
0074-1043	Rinvoq	Upadacitinib	AbbVie Inc.	NDA	Current
0074-1043	Rinvoq	Upadacitinib	AbbVie Inc.	NDA	Current
0074-1043	Rinvoq	Upadacitinib	AbbVie Inc.	NDA	Current
0074-2306	Rinvoq	Upadacitinib	AbbVie Inc.	NDA	Current
0074-2306	Rinvoq	Upadacitinib	AbbVie Inc.	NDA	Current
0074-2306	Rinvoq	Upadacitinib	AbbVie Inc.	NDA	Current
0074-2306	Rinvoq	Upadacitinib	AbbVie Inc.	NDA	Current
0074-2306	Rinvoq	Upadacitinib	AbbVie Inc.	NDA	Current
0074-2306	Rinvoq	Upadacitinib	AbbVie Inc.	NDA	Current
0074-2306	Rinvoq	Upadacitinib	AbbVie Inc.	NDA	Current
0074-2306	Rinvoq	Upadacitinib	AbbVie Inc.	NDA	Current
0074-2306	Rinvoq	Upadacitinib	AbbVie Inc.	NDA	Current
0074-2306	Rinvoq	Upadacitinib	AbbVie Inc.	NDA	Current
0074-2306	Rinvoq	Upadacitinib	AbbVie Inc.	NDA	Current
0074-2310	Rinvoq	Upadacitinib	AbbVie Inc.	NDA	Current
0074-2310	Rinvoq	Upadacitinib	AbbVie Inc.	NDA	Current
0074-2310	Rinvoq	Upadacitinib	AbbVie Inc.	NDA	Current
0074-2310	Rinvoq	Upadacitinib	AbbVie Inc.	NDA	Current
0074-2310	Rinvoq	Upadacitinib	AbbVie Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
83758	SUPPL	2025-10-15
83749	SUPPL	2025-10-14
83745	SUPPL	2025-10-14
83274	SUPPL	2025-09-03
83273	SUPPL	2025-09-03
82122	SUPPL	2025-05-01
82037	SUPPL	2025-04-29
82036	SUPPL	2025-04-29
81769	SUPPL	2025-03-28
81749	SUPPL	2025-03-27
78995	SUPPL	2024-07-08
78297	SUPPL	2024-04-29
78296	SUPPL	2024-04-29
78287	SUPPL	2024-04-29
78286	SUPPL	2024-04-29
76577	SUPPL	2023-11-15
76569	SUPPL	2023-11-15
74315	SUPPL	2023-08-03
74625	SUPPL	2023-06-26
74610	SUPPL	2023-06-23
74312	SUPPL	2023-05-18
73985	SUPPL	2023-04-13
73982	SUPPL	2023-04-12
72474	SUPPL	2022-10-26
72472	SUPPL	2022-10-26
72451	SUPPL	2022-10-24
70954	SUPPL	2022-05-03
70886	SUPPL	2022-05-02
70566	SUPPL	2022-03-21
70565	SUPPL	2022-03-21
70546	SUPPL	2022-03-17
69918	SUPPL	2022-01-19
69917	SUPPL	2022-01-19
69898	SUPPL	2022-01-18
69594	SUPPL	2021-12-16
69593	SUPPL	2021-12-16
69571	SUPPL	2021-12-15
69569	SUPPL	2021-12-15
69568	SUPPL	2021-12-15
69484	SUPPL	2021-12-07
69483	SUPPL	2021-12-07
69480	SUPPL	2021-12-06
63949	SUPPL	2020-07-17
63885	SUPPL	2020-07-13
63884	SUPPL	2020-07-13
59982	ORIG	2019-09-12
59741	ORIG	2019-08-19
59735	ORIG	2019-08-16
59734	ORIG	2019-08-16