Application 215309

Type: NDA
Sponsor: INCYTE CORP

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	OPZELURA	RUXOLITINIB	CREAM;TOPICAL	1%	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
N215309-001	OPZELURA	RUXOLITINIB PHOSPHATE	EQ 1.5% BASE	CREAM / TOPICAL		RLD, RS	2021-09-21

Orange Book patents#

Current patent rows page 1 of 1 · 39 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N215309-001	10639310	2026-12-12	U-3229		2021-10-20
N215309-001	9079912	2026-12-12	U-3229		2021-10-20
N215309-001	9079912	2026-12-12	U-3404		2021-10-20
N215309-001	9974790	2026-12-12	U-3229		2021-10-20
N215309-001	9974790	2026-12-12	U-3404		2021-10-20
N215309-001	10639310*PED	2027-06-12		Pediatric extension
N215309-001	9079912*PED	2027-06-12		Pediatric extension
N215309-001	9974790*PED	2027-06-12		Pediatric extension
N215309-001	7598257	2027-12-24		Drug substance, Drug product	2021-10-20
N215309-001	8415362	2027-12-24		Drug substance, Drug product	2021-10-20
N215309-001	10610530	2028-06-12	U-3229		2021-10-20
N215309-001	10610530	2028-06-12	U-3404		2021-10-20
N215309-001	8722693	2028-06-12		Drug substance, Drug product	2021-10-20
N215309-001	8822481	2028-06-12	U-3229		2021-10-20
N215309-001	8822481	2028-06-12	U-3404		2021-10-20
N215309-001	7598257*PED	2028-06-24		Pediatric extension
N215309-001	8415362*PED	2028-06-24		Pediatric extension
N215309-001	10610530*PED	2028-12-12		Pediatric extension
N215309-001	8722693*PED	2028-12-12		Pediatric extension
N215309-001	8822481*PED	2028-12-12		Pediatric extension
N215309-001	10758543	2031-05-20		Drug product	2021-10-20
N215309-001	10869870	2031-05-20	U-3229		2021-10-20
N215309-001	10869870	2031-05-20	U-3404		2021-10-20
N215309-001	11219624	2031-05-20	U-3229	Drug product	2022-02-08
N215309-001	11571425	2031-05-20		Drug product	2023-02-28
N215309-001	11590136	2031-05-20	U-3229		2023-03-28
N215309-001	11590136	2031-05-20	U-3404		2023-03-28
N215309-001	12226419	2031-05-20		Drug product	2025-03-17
N215309-001	12544381	2031-05-20		Drug product	2026-03-03
N215309-001	12564593	2031-05-20		Drug product	2026-03-24
N215309-001	10758543*PED	2031-11-20		Pediatric extension
N215309-001	10869870*PED	2031-11-20		Pediatric extension
N215309-001	11219624*PED	2031-11-20		Pediatric extension
N215309-001	11590138	2040-06-10	U-3551		2023-03-28
N215309-001	12233067	2040-07-28	U-4151		2025-03-17
N215309-001	11510923	2040-09-04	U-3505		2022-12-16
N215309-001	11590137	2040-09-04	U-3505		2023-03-28
N215309-001	12589096	2040-09-04	U-3505		2026-04-27
N215309-001	11602536	2041-05-05	U-3550		2023-03-28

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N215309-001	I-896	2025-07-18
N215309-001	PED	2026-01-18
N215309-001	NPP	2028-09-18

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
2026-08-18 06:07:40	2026-07	N215309-001	OPZELURA	EQ 1.5% BASE	CREAM / TOPICAL	RLD, RS	2021-09-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N215309-001	OPZELURA	EQ 1.5% BASE	CREAM / TOPICAL	RLD, RS	2021-09-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215309-001	OPZELURA	EQ 1.5% BASE	CREAM / TOPICAL	RLD, RS	2021-09-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N215309-001	OPZELURA	EQ 1.5% BASE	CREAM / TOPICAL	RLD, RS	2021-09-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215309-001	OPZELURA	EQ 1.5% BASE	CREAM / TOPICAL	RLD, RS	2021-09-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215309-001	OPZELURA	EQ 1.5% BASE	CREAM / TOPICAL	RLD, RS	2021-09-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215309-001	OPZELURA	EQ 1.5% BASE	CREAM / TOPICAL	RLD, RS	2021-09-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215309-001	OPZELURA	EQ 1.5% BASE	CREAM / TOPICAL	RLD, RS	2021-09-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215309-001	OPZELURA	EQ 1.5% BASE	CREAM / TOPICAL	RLD, RS	2021-09-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215309-001	OPZELURA	EQ 1.5% BASE	CREAM / TOPICAL	RLD, RS	2021-09-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N215309-001	OPZELURA	EQ 1.5% BASE	CREAM / TOPICAL	RLD, RS	2021-09-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N215309-001	OPZELURA	EQ 1.5% BASE	CREAM / TOPICAL	RLD, RS	2021-09-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N215309-001	OPZELURA	EQ 1.5% BASE	CREAM / TOPICAL	RLD, RS	2021-09-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N215309-001	OPZELURA	EQ 1.5% BASE	CREAM / TOPICAL	RLD, RS	2021-09-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N215309-001	OPZELURA	EQ 1.5% BASE	CREAM / TOPICAL	RLD, RS	2021-09-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N215309-001	OPZELURA	EQ 1.5% BASE	CREAM / TOPICAL	RLD, RS	2021-09-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N215309-001	OPZELURA	EQ 1.5% BASE	CREAM / TOPICAL	RLD, RS	2021-09-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N215309-001	OPZELURA	EQ 1.5% BASE	CREAM / TOPICAL	RLD, RS	2021-09-21	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N215309-001	OPZELURA	EQ 1.5% BASE	CREAM / TOPICAL	RLD, RS	2021-09-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N215309-001	OPZELURA	EQ 1.5% BASE	CREAM / TOPICAL	RLD, RS	2021-09-21	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N215309-001	OPZELURA	EQ 1.5% BASE	CREAM / TOPICAL	RLD, RS	2021-09-21	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N215309-001	OPZELURA	EQ 1.5% BASE	CREAM / TOPICAL	RLD, RS	2021-09-21	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N215309-001	OPZELURA	EQ 1.5% BASE	CREAM / TOPICAL	RLD, RS	2021-09-21	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N215309-001	OPZELURA	EQ 1.5% BASE	CREAM / TOPICAL	RLD, RS	2021-09-21	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N215309-001	OPZELURA	EQ 1.5% BASE	CREAM / TOPICAL	RLD, RS	2021-09-21	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N215309-001	OPZELURA	EQ 1.5% BASE	CREAM / TOPICAL	RLD, RS	2021-09-21	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N215309-001	OPZELURA	EQ 1.5% BASE	CREAM / TOPICAL	RLD, RS	2021-09-21	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N215309-001	OPZELURA	EQ 1.5% BASE	CREAM / TOPICAL	RLD, RS	2021-09-21	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N215309-001	OPZELURA	EQ 1.5% BASE	CREAM / TOPICAL	RLD, RS	2021-09-21	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N215309-001	OPZELURA	EQ 1.5% BASE	CREAM / TOPICAL	RLD, RS	2021-09-21	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N215309-001	OPZELURA	EQ 1.5% BASE	CREAM / TOPICAL	RLD, RS	2021-09-21	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N215309-001	OPZELURA	EQ 1.5% BASE	CREAM / TOPICAL	RLD, RS	2021-09-21	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N215309-001	OPZELURA	EQ 1.5% BASE	CREAM / TOPICAL	RLD, RS	2021-09-21	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N215309-001	OPZELURA	EQ 1.5% BASE	CREAM / TOPICAL	RLD, RS	2021-09-21	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 25 · 972 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	N215309-001	10639310	2026-12-12	U-3229		2021-10-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215309-001	9079912	2026-12-12	U-3404		2021-10-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215309-001	9079912	2026-12-12	U-3229		2021-10-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215309-001	9974790	2026-12-12	U-3404		2021-10-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215309-001	9974790	2026-12-12	U-3229		2021-10-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215309-001	10639310*PED	2027-06-12		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215309-001	9079912*PED	2027-06-12		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215309-001	9974790*PED	2027-06-12		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215309-001	7598257	2027-12-24		Drug substance, Drug product	2021-10-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215309-001	8415362	2027-12-24		Drug substance, Drug product	2021-10-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215309-001	10610530	2028-06-12	U-3404		2021-10-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215309-001	10610530	2028-06-12	U-3229		2021-10-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215309-001	8722693	2028-06-12		Drug substance, Drug product	2021-10-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215309-001	8822481	2028-06-12	U-3404		2021-10-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215309-001	8822481	2028-06-12	U-3229		2021-10-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215309-001	7598257*PED	2028-06-24		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215309-001	8415362*PED	2028-06-24		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215309-001	10610530*PED	2028-12-12		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215309-001	8722693*PED	2028-12-12		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215309-001	8822481*PED	2028-12-12		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215309-001	10758543	2031-05-20		Drug product	2021-10-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215309-001	10869870	2031-05-20	U-3404		2021-10-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215309-001	10869870	2031-05-20	U-3229		2021-10-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215309-001	11219624	2031-05-20	U-3229	Drug product	2022-02-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215309-001	11571425	2031-05-20		Drug product	2023-02-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215309-001	11590136	2031-05-20	U-3229		2023-03-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215309-001	11590136	2031-05-20	U-3404		2023-03-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215309-001	12226419	2031-05-20		Drug product	2025-03-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215309-001	12544381	2031-05-20		Drug product	2026-03-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215309-001	12564593	2031-05-20		Drug product	2026-03-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215309-001	10758543*PED	2031-11-20		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215309-001	10869870*PED	2031-11-20		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215309-001	11219624*PED	2031-11-20		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215309-001	11590138	2040-06-10	U-3551		2023-03-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215309-001	12233067	2040-07-28	U-4151		2025-03-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215309-001	11510923	2040-09-04	U-3505		2022-12-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215309-001	11590137	2040-09-04	U-3505		2023-03-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215309-001	12589096	2040-09-04	U-3505		2026-04-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215309-001	11602536	2041-05-05	U-3550		2023-03-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N215309-001	10639310	2026-12-12	U-3229		2021-10-20	`011fe1cb6892…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 3 · 110 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-08-18 06:07:40	2026-07	N215309-001	I-896	2025-07-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215309-001	PED	2026-01-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215309-001	NPP	2028-09-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N215309-001	I-896	2025-07-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215309-001	PED	2026-01-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215309-001	NPP	2028-09-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215309-001	NP	2024-09-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215309-001	PED	2025-03-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215309-001	I-896	2025-07-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215309-001	PED	2026-01-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215309-001	NPP	2028-09-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N215309-001	NP	2024-09-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215309-001	PED	2025-03-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215309-001	I-896	2025-07-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215309-001	PED	2026-01-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215309-001	NP	2024-09-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215309-001	PED	2025-03-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215309-001	I-896	2025-07-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215309-001	PED	2026-01-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215309-001	NP	2024-09-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215309-001	PED	2025-03-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215309-001	I-896	2025-07-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215309-001	PED	2026-01-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215309-001	NP	2024-09-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215309-001	PED	2025-03-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215309-001	I-896	2025-07-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215309-001	PED	2026-01-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215309-001	NP	2024-09-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215309-001	PED	2025-03-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215309-001	I-896	2025-07-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215309-001	PED	2026-01-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215309-001	NP	2024-09-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215309-001	PED	2025-03-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215309-001	I-896	2025-07-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215309-001	PED	2026-01-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215309-001	NP	2024-09-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215309-001	PED	2025-03-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215309-001	I-896	2025-07-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215309-001	PED	2026-01-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N215309-001	NP	2024-09-21	`d06236e962d9…`

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
OPZELURA	RUXOLITINIB	Incyte Corporation	24da5509-6631-4795-9d42-273faecd08e7	2026-06-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 215309 application number: NDA215309 ndc (product): 50881-007

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50881-007	OPZELURA	ruxolitinib	Incyte Corporation	NDA	Current
50881-007	OPZELURA	ruxolitinib	Incyte Corporation	NDA	Current
50881-007	OPZELURA	ruxolitinib	Incyte Corporation	NDA	Current
50881-007	OPZELURA	ruxolitinib	Incyte Corporation	NDA	Current
50881-007	OPZELURA	ruxolitinib	Incyte Corporation	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
85858	SUPPL	2026-05-11
83398	SUPPL	2025-09-19
83397	SUPPL	2025-09-19
83395	SUPPL	2025-09-19
73759	SUPPL	2023-03-14
73741	SUPPL	2023-03-14
71593	SUPPL	2022-07-19
71592	SUPPL	2022-07-19
71589	SUPPL	2022-07-19
71552	ORIG	2022-07-14
71520	ORIG	2022-07-06
68716	ORIG	2021-09-22