Application 218347

Type: NDA
Sponsor: ABBVIE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	RINVOQ LQ	UPADACITINIB	SOLUTION;ORAL	1MG/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
N218347-001	RINVOQ LQ	UPADACITINIB	1MG/ML	SOLUTION / ORAL		RLD, RS	2024-04-26

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N218347-001	8962629	2031-01-15	U-3945	Drug substance	2024-05-23
N218347-001	8962629	2031-01-15	U-3946	Drug substance	2024-05-23
N218347-001	RE47221	2033-08-16		Drug substance	2024-06-12
N218347-001	10981923	2036-10-17		Drug substance	2024-05-23
N218347-001	11186584	2036-10-17		Drug substance	2024-05-23
N218347-001	11661425	2036-10-17		Drug substance	2024-05-23
N218347-001	11680069	2036-10-17		Drug substance	2024-05-23
N218347-001	11718627	2036-10-17		Drug substance	2024-05-23
N218347-001	11773105	2036-10-17		Drug substance	2024-05-23
N218347-001	12110298	2036-10-17		Drug substance	2024-11-05
N218347-001	12365689	2036-10-17	U-3945		2025-08-20
N218347-001	9951080	2036-10-17		Drug substance	2024-05-23

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 2 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N218347-001	NP	2027-04-26
N218347-001	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.

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	N218347-001	RINVOQ LQ	1MG/ML	SOLUTION / ORAL	RLD, RS	2024-04-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218347-001	RINVOQ LQ	1MG/ML	SOLUTION / ORAL	RLD, RS	2024-04-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N218347-001	RINVOQ LQ	1MG/ML	SOLUTION / ORAL	RLD, RS	2024-04-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N218347-001	RINVOQ LQ	1MG/ML	SOLUTION / ORAL	RLD, RS	2024-04-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N218347-001	RINVOQ LQ	1MG/ML	SOLUTION / ORAL	RLD, RS	2024-04-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N218347-001	RINVOQ LQ	1MG/ML	SOLUTION / ORAL	RLD, RS	2024-04-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N218347-001	RINVOQ LQ	1MG/ML	SOLUTION / ORAL	RLD, RS	2024-04-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N218347-001	RINVOQ LQ	1MG/ML	SOLUTION / ORAL	RLD, RS	2024-04-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N218347-001	RINVOQ LQ	1MG/ML	SOLUTION / ORAL	RLD, RS	2024-04-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N218347-001	RINVOQ LQ	1MG/ML	SOLUTION / ORAL	RLD, RS	2024-04-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N218347-001	RINVOQ LQ	1MG/ML	SOLUTION / ORAL	RLD, RS	2024-04-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N218347-001	RINVOQ LQ	1MG/ML	SOLUTION / ORAL	RLD, RS	2024-04-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N218347-001	RINVOQ LQ	1MG/ML	SOLUTION / ORAL	RLD, RS	2024-04-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N218347-001	RINVOQ LQ	1MG/ML	SOLUTION / ORAL	RLD, RS	2024-04-26	`8072bd15b7f6…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N218347-001	RINVOQ LQ	1MG/ML	SOLUTION / ORAL	RLD, RS	2024-04-26	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 4 · 143 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	N218347-001	8962629	2031-01-15	U-3946	Drug substance	2024-05-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N218347-001	8962629	2031-01-15	U-3945	Drug substance	2024-05-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N218347-001	RE47221	2033-08-16		Drug substance	2024-06-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N218347-001	10981923	2036-10-17		Drug substance	2024-05-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N218347-001	11186584	2036-10-17		Drug substance	2024-05-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N218347-001	11661425	2036-10-17		Drug substance	2024-05-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N218347-001	11680069	2036-10-17		Drug substance	2024-05-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N218347-001	11718627	2036-10-17		Drug substance	2024-05-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N218347-001	11773105	2036-10-17		Drug substance	2024-05-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N218347-001	12110298	2036-10-17		Drug substance	2024-11-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N218347-001	12365689	2036-10-17	U-3945		2025-08-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N218347-001	9951080	2036-10-17		Drug substance	2024-05-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218347-001	8962629	2031-01-15	U-3946	Drug substance	2024-05-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218347-001	8962629	2031-01-15	U-3945	Drug substance	2024-05-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218347-001	RE47221	2033-08-16		Drug substance	2024-06-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218347-001	10981923	2036-10-17		Drug substance	2024-05-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218347-001	11186584	2036-10-17		Drug substance	2024-05-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218347-001	11661425	2036-10-17		Drug substance	2024-05-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218347-001	11680069	2036-10-17		Drug substance	2024-05-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218347-001	11718627	2036-10-17		Drug substance	2024-05-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218347-001	11773105	2036-10-17		Drug substance	2024-05-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218347-001	12110298	2036-10-17		Drug substance	2024-11-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218347-001	12365689	2036-10-17	U-3945		2025-08-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218347-001	9951080	2036-10-17		Drug substance	2024-05-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N218347-001	8962629	2031-01-15	U-3946	Drug substance	2024-05-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N218347-001	8962629	2031-01-15	U-3945	Drug substance	2024-05-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N218347-001	RE47221	2033-08-16		Drug substance	2024-06-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N218347-001	10981923	2036-10-17		Drug substance	2024-05-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N218347-001	11186584	2036-10-17		Drug substance	2024-05-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N218347-001	11661425	2036-10-17		Drug substance	2024-05-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N218347-001	11680069	2036-10-17		Drug substance	2024-05-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N218347-001	11718627	2036-10-17		Drug substance	2024-05-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N218347-001	11773105	2036-10-17		Drug substance	2024-05-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N218347-001	12110298	2036-10-17		Drug substance	2024-11-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N218347-001	9951080	2036-10-17		Drug substance	2024-05-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N218347-001	8962629	2031-01-15	U-3946	Drug substance	2024-05-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N218347-001	8962629	2031-01-15	U-3945	Drug substance	2024-05-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N218347-001	RE47221	2033-08-16		Drug substance	2024-06-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N218347-001	10981923	2036-10-17		Drug substance	2024-05-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N218347-001	11186584	2036-10-17		Drug substance	2024-05-23	`fd3edfee7708…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N218347-001	NP	2027-04-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N218347-001	ODE-481	2031-04-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218347-001	NP	2027-04-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218347-001	ODE-481	2031-04-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N218347-001	NP	2027-04-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N218347-001	ODE-481	2031-04-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N218347-001	NP	2027-04-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N218347-001	ODE-481	2031-04-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N218347-001	NP	2027-04-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N218347-001	ODE-481	2031-04-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N218347-001	NCE	2024-08-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N218347-001	NP	2027-04-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N218347-001	ODE-481	2031-04-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N218347-001	NCE	2024-08-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N218347-001	NP	2027-04-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N218347-001	ODE-481	2031-04-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N218347-001	NCE	2024-08-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N218347-001	NP	2027-04-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N218347-001	ODE-481	2031-04-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N218347-001	NCE	2024-08-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N218347-001	NP	2027-04-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N218347-001	ODE-481	2031-04-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N218347-001	NCE	2024-08-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N218347-001	NP	2027-04-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N218347-001	ODE-481	2031-04-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N218347-001	NCE	2024-08-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N218347-001	NP	2027-04-26	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N218347-001	ODE-481	2031-04-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N218347-001	NCE	2024-08-16	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N218347-001	NP	2027-04-26	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N218347-001	ODE-481	2031-04-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N218347-001	NCE	2024-08-16	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N218347-001	NP	2027-04-26	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N218347-001	ODE-481	2031-04-26	`1e350fbaab3a…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N218347-001	NP	2027-04-26	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N218347-001	ODE-481	2031-04-26	`a50c72e98297…`

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): 218347 application number: NDA218347

Documents#

Document, Submission type, Date table
Document	Submission type	Date
85995	SUPPL	2026-05-21
85990	SUPPL	2026-05-21
83759	SUPPL	2025-10-15
83748	SUPPL	2025-10-14
83747	SUPPL	2025-10-14
81951	ORIG	2025-04-11
81770	SUPPL	2025-03-28
81752	SUPPL	2025-03-27
81751	SUPPL	2025-03-27
78299	ORIG	2024-04-29
78289	ORIG	2024-04-29