Application 210563

Type: NDA
Sponsor: PHARMACYCLICS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	IMBRUVICA	IBRUTINIB	TABLET;ORAL	140MG	Yes	No
002	IMBRUVICA	IBRUTINIB	TABLET;ORAL	280MG	Yes	No
003	IMBRUVICA	IBRUTINIB	TABLET;ORAL	420MG	Yes	No
004	IMBRUVICA	IBRUTINIB	TABLET;ORAL	560MG	Yes	Yes

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

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N210563-001	IMBRUVICA	IBRUTINIB	140MG	TABLET / ORAL	RLD	2018-02-16
N210563-002	IMBRUVICA	IBRUTINIB	280MG	TABLET / ORAL	RLD	2018-02-16
N210563-003	IMBRUVICA	IBRUTINIB	420MG	TABLET / ORAL	RLD, RS	2018-02-16
N210563-004	IMBRUVICA	IBRUTINIB	560MG	TABLET / ORAL	RLD	2018-02-16

Orange Book patents#

Current patent rows page 1 of 6 · 424 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N210563-001	7514444	2026-12-28		Drug substance, Drug product	2018-03-06
N210563-001	8476284	2026-12-28	U-1650		2018-03-06
N210563-001	8476284	2026-12-28	U-1946		2018-03-06
N210563-001	8476284	2026-12-28	U-2241		2018-03-06
N210563-001	8497277	2026-12-28	U-1491		2018-03-06
N210563-001	8497277	2026-12-28	U-1650		2018-03-06
N210563-001	8497277	2026-12-28	U-1946		2018-03-06
N210563-001	8497277	2026-12-28	U-2241		2018-03-06
N210563-001	8497277	2026-12-28	U-2242		2018-03-06
N210563-001	8497277	2026-12-28	U-3422		2018-03-06
N210563-001	8697711	2026-12-28		Drug substance, Drug product	2018-03-06
N210563-001	8703780	2026-12-28	U-1491		2018-03-06
N210563-001	8703780	2026-12-28	U-2242		2018-03-06
N210563-001	8735403	2026-12-28		Drug substance, Drug product	2018-03-06
N210563-001	8754091	2026-12-28		Drug product	2018-03-06
N210563-001	8952015	2026-12-28	U-1491		2018-03-06
N210563-001	8952015	2026-12-28	U-1650		2018-03-06
N210563-001	8952015	2026-12-28	U-1946		2018-03-06
N210563-001	8952015	2026-12-28	U-2241		2018-03-06
N210563-001	8952015	2026-12-28	U-2242		2018-03-06
N210563-001	8957079	2026-12-28		Drug substance, Drug product	2018-03-06
N210563-001	9181257	2026-12-28		Drug substance	2018-03-06
N210563-001	8563563	2027-04-26	U-1491		2018-03-06
N210563-001	8563563	2027-04-26	U-1650		2018-03-06
N210563-001	8563563	2027-04-26	U-1946		2018-03-06
N210563-001	8563563	2027-04-26	U-2241		2018-03-06
N210563-001	8563563	2027-04-26	U-2242		2018-03-06
N210563-001	7514444*PED	2027-06-28		Pediatric extension
N210563-001	8476284*PED	2027-06-28		Pediatric extension
N210563-001	8497277*PED	2027-06-28		Pediatric extension
N210563-001	8697711*PED	2027-06-28		Pediatric extension
N210563-001	8703780*PED	2027-06-28		Pediatric extension
N210563-001	8735403*PED	2027-06-28		Pediatric extension
N210563-001	8754091*PED	2027-06-28		Pediatric extension
N210563-001	8952015*PED	2027-06-28		Pediatric extension
N210563-001	8957079*PED	2027-06-28		Pediatric extension
N210563-001	9181257*PED	2027-06-28		Pediatric extension
N210563-001	8563563*PED	2027-10-26		Pediatric extension
N210563-001	8008309	2027-11-13		Drug substance, Drug product	2018-03-06
N210563-001	8008309*PED	2028-05-13		Pediatric extension
N210563-001	10004746	2031-06-03	U-1684		2018-07-17
N210563-001	10004746	2031-06-03	U-1946		2018-07-17
N210563-001	10004746	2031-06-03	U-2241		2018-07-17
N210563-001	10004746	2031-06-03	U-2242		2018-07-17
N210563-001	10016435	2031-06-03	U-1650		2018-08-02
N210563-001	10478439	2031-06-03	U-1650		2019-12-10
N210563-001	10478439	2031-06-03	U-1684		2019-12-10
N210563-001	10478439	2031-06-03	U-1946		2019-12-10
N210563-001	10478439	2031-06-03	U-2241		2019-12-10
N210563-001	10478439	2031-06-03	U-2242		2019-12-10
N210563-001	10478439	2031-06-03	U-2665		2019-12-10
N210563-001	10478439	2031-06-03	U-3422		2019-12-10
N210563-001	10751342	2031-06-03	U-1491		2020-09-10
N210563-001	10751342	2031-06-03	U-1946		2020-09-10
N210563-001	10751342	2031-06-03	U-2943		2020-09-10
N210563-001	10751342	2031-06-03	U-2944		2020-09-10
N210563-001	11672803	2031-06-03	U-1684		2023-07-14
N210563-001	11672803	2031-06-03	U-1946		2023-07-14
N210563-001	11672803	2031-06-03	U-2241		2023-07-14
N210563-001	11672803	2031-06-03	U-2242		2023-07-14
N210563-001	8999999	2031-06-03	U-1491		2018-03-06
N210563-001	8999999	2031-06-03	U-1946		2018-03-06
N210563-001	8999999	2031-06-03	U-2241		2018-03-06
N210563-001	8999999	2031-06-03	U-2242		2018-03-06
N210563-001	9125889	2031-06-03	U-1650		2018-03-06
N210563-001	9801881	2031-06-03	U-1491		2018-03-06
N210563-001	9801881	2031-06-03	U-2242		2018-03-06
N210563-001	9801883	2031-06-03	U-2159		2018-03-06
N210563-001	9801883	2031-06-03	U-2243		2018-03-06
N210563-001	10004746*PED	2031-12-03		Pediatric extension
N210563-001	10016435*PED	2031-12-03		Pediatric extension
N210563-001	10478439*PED	2031-12-03		Pediatric extension
N210563-001	10751342*PED	2031-12-03		Pediatric extension
N210563-001	8999999*PED	2031-12-03		Pediatric extension
N210563-001	9125889*PED	2031-12-03		Pediatric extension
N210563-001	9801881*PED	2031-12-03		Pediatric extension
N210563-001	9801883*PED	2031-12-03		Pediatric extension
N210563-001	10106548	2033-06-03		Drug substance, Drug product	2018-10-26
N210563-001	10125140	2033-06-03		Drug substance, Drug product	2018-11-16
N210563-001	10752634	2033-06-03		Drug product	2020-09-10

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 16 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N210563-001	NPP	2025-08-24
N210563-001	PED	2026-02-24
N210563-001	ODE-405	2029-08-24
N210563-001	PED	2030-02-24
N210563-002	NPP	2025-08-24
N210563-002	PED	2026-02-24
N210563-002	ODE-405	2029-08-24
N210563-002	PED	2030-02-24
N210563-003	NPP	2025-08-24
N210563-003	PED	2026-02-24
N210563-003	ODE-405	2029-08-24
N210563-003	PED	2030-02-24
N210563-004	NPP	2025-08-24
N210563-004	PED	2026-02-24
N210563-004	ODE-405	2029-08-24
N210563-004	PED	2030-02-24

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 · 168 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N210563-001	IMBRUVICA	140MG	TABLET / ORAL	RLD	2018-02-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210563-002	IMBRUVICA	280MG	TABLET / ORAL	RLD	2018-02-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210563-003	IMBRUVICA	420MG	TABLET / ORAL	RLD, RS	2018-02-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210563-004	IMBRUVICA	560MG	TABLET / ORAL	RLD	2018-02-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N210563-001	IMBRUVICA	140MG	TABLET / ORAL	RLD	2018-02-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210563-002	IMBRUVICA	280MG	TABLET / ORAL	RLD	2018-02-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210563-003	IMBRUVICA	420MG	TABLET / ORAL	RLD, RS	2018-02-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210563-004	IMBRUVICA	560MG	TABLET / ORAL	RLD	2018-02-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210563-001	IMBRUVICA	140MG	TABLET / ORAL	RLD	2018-02-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210563-002	IMBRUVICA	280MG	TABLET / ORAL	RLD	2018-02-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210563-003	IMBRUVICA	420MG	TABLET / ORAL	RLD, RS	2018-02-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210563-004	IMBRUVICA	560MG	TABLET / ORAL	RLD	2018-02-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N210563-001	IMBRUVICA	140MG	TABLET / ORAL	RLD	2018-02-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N210563-002	IMBRUVICA	280MG	TABLET / ORAL	RLD	2018-02-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N210563-003	IMBRUVICA	420MG	TABLET / ORAL	RLD, RS	2018-02-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N210563-004	IMBRUVICA	560MG	TABLET / ORAL	RLD	2018-02-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210563-001	IMBRUVICA	140MG	TABLET / ORAL	RLD	2018-02-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210563-002	IMBRUVICA	280MG	TABLET / ORAL	RLD	2018-02-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210563-003	IMBRUVICA	420MG	TABLET / ORAL	RLD, RS	2018-02-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210563-004	IMBRUVICA	560MG	TABLET / ORAL	RLD	2018-02-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210563-001	IMBRUVICA	140MG	TABLET / ORAL	RLD	2018-02-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210563-002	IMBRUVICA	280MG	TABLET / ORAL	RLD	2018-02-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210563-003	IMBRUVICA	420MG	TABLET / ORAL	RLD, RS	2018-02-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210563-004	IMBRUVICA	560MG	TABLET / ORAL	RLD	2018-02-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210563-001	IMBRUVICA	140MG	TABLET / ORAL	RLD	2018-02-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210563-002	IMBRUVICA	280MG	TABLET / ORAL	RLD	2018-02-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210563-003	IMBRUVICA	420MG	TABLET / ORAL	RLD, RS	2018-02-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210563-004	IMBRUVICA	560MG	TABLET / ORAL	RLD	2018-02-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N210563-001	IMBRUVICA	140MG	TABLET / ORAL	RLD	2018-02-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N210563-002	IMBRUVICA	280MG	TABLET / ORAL	RLD	2018-02-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N210563-003	IMBRUVICA	420MG	TABLET / ORAL	RLD, RS	2018-02-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N210563-004	IMBRUVICA	560MG	TABLET / ORAL	RLD	2018-02-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210563-001	IMBRUVICA	140MG	TABLET / ORAL	RLD	2018-02-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210563-002	IMBRUVICA	280MG	TABLET / ORAL	RLD	2018-02-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210563-003	IMBRUVICA	420MG	TABLET / ORAL	RLD, RS	2018-02-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210563-004	IMBRUVICA	560MG	TABLET / ORAL	RLD	2018-02-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N210563-001	IMBRUVICA	140MG	TABLET / ORAL	RLD	2018-02-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N210563-002	IMBRUVICA	280MG	TABLET / ORAL	RLD	2018-02-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N210563-003	IMBRUVICA	420MG	TABLET / ORAL	RLD, RS	2018-02-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N210563-004	IMBRUVICA	560MG	TABLET / ORAL	RLD	2018-02-16	`d8e5a09893c0…`

Observed Orange Book patent history#

Patent history page 1 of 403 · 16,117 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	N210563-001	7514444	2026-12-28		Drug substance, Drug product	2018-03-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210563-001	8476284	2026-12-28	U-1946		2018-03-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210563-001	8476284	2026-12-28	U-1650		2018-03-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210563-001	8476284	2026-12-28	U-2241		2018-03-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210563-001	8497277	2026-12-28	U-2242		2018-03-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210563-001	8497277	2026-12-28	U-1650		2018-03-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210563-001	8497277	2026-12-28	U-2241		2018-03-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210563-001	8497277	2026-12-28	U-1946		2018-03-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210563-001	8497277	2026-12-28	U-3422		2018-03-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210563-001	8497277	2026-12-28	U-1491		2018-03-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210563-001	8697711	2026-12-28		Drug substance, Drug product	2018-03-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210563-001	8703780	2026-12-28	U-1491		2018-03-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210563-001	8703780	2026-12-28	U-2242		2018-03-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210563-001	8735403	2026-12-28		Drug substance, Drug product	2018-03-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210563-001	8754091	2026-12-28		Drug product	2018-03-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210563-001	8952015	2026-12-28	U-1491		2018-03-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210563-001	8952015	2026-12-28	U-2241		2018-03-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210563-001	8952015	2026-12-28	U-2242		2018-03-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210563-001	8952015	2026-12-28	U-1650		2018-03-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210563-001	8952015	2026-12-28	U-1946		2018-03-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210563-001	8957079	2026-12-28		Drug substance, Drug product	2018-03-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210563-001	9181257	2026-12-28		Drug substance	2018-03-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210563-001	8563563	2027-04-26	U-1650		2018-03-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210563-001	8563563	2027-04-26	U-1946		2018-03-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210563-001	8563563	2027-04-26	U-2242		2018-03-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210563-001	8563563	2027-04-26	U-2241		2018-03-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210563-001	8563563	2027-04-26	U-1491		2018-03-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210563-001	7514444*PED	2027-06-28		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210563-001	8476284*PED	2027-06-28		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210563-001	8497277*PED	2027-06-28		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210563-001	8697711*PED	2027-06-28		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210563-001	8703780*PED	2027-06-28		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210563-001	8735403*PED	2027-06-28		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210563-001	8754091*PED	2027-06-28		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210563-001	8952015*PED	2027-06-28		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210563-001	8957079*PED	2027-06-28		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210563-001	9181257*PED	2027-06-28		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210563-001	8563563*PED	2027-10-26		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210563-001	8008309	2027-11-13		Drug substance, Drug product	2018-03-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210563-001	8008309*PED	2028-05-13		Pediatric extension		`caaa826d4ba7…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 17 · 668 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	N210563-001	NPP	2025-08-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210563-001	PED	2026-02-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210563-001	ODE-405	2029-08-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210563-001	PED	2030-02-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210563-002	NPP	2025-08-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210563-002	PED	2026-02-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210563-002	ODE-405	2029-08-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210563-002	PED	2030-02-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210563-003	NPP	2025-08-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210563-003	PED	2026-02-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210563-003	ODE-405	2029-08-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210563-003	PED	2030-02-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210563-004	NPP	2025-08-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210563-004	PED	2026-02-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210563-004	ODE-405	2029-08-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210563-004	PED	2030-02-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N210563-001	NPP	2025-08-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210563-001	PED	2026-02-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210563-001	ODE-405	2029-08-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210563-001	PED	2030-02-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210563-002	NPP	2025-08-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210563-002	PED	2026-02-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210563-002	ODE-405	2029-08-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210563-002	PED	2030-02-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210563-003	NPP	2025-08-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210563-003	PED	2026-02-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210563-003	ODE-405	2029-08-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210563-003	PED	2030-02-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210563-004	NPP	2025-08-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210563-004	PED	2026-02-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210563-004	ODE-405	2029-08-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210563-004	PED	2030-02-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210563-001	M-14	2025-08-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210563-001	NPP	2025-08-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210563-001	PED	2026-02-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210563-001	ODE-405	2029-08-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210563-001	PED	2030-02-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210563-002	M-14	2025-08-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210563-002	NPP	2025-08-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210563-002	PED	2026-02-24	`31067a03dcf5…`

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
Imbruvica	IBRUTINIB	Pharmacyclics LLC	0dfd0279-ff17-4ea9-89be-9803c71bab44	2025-10-21	Warnings, Adverse reactions	Exact identifier application applno (NDA): 210563 application number: NDA210563 ndc (product): 57962-280 ndc (product): 57962-420 ndc (product): 57962-014

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 64 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
57962-014	Imbruvica	Ibrutinib	Pharmacyclics LLC	NDA	Current
57962-014	Imbruvica	Ibrutinib	Pharmacyclics LLC	NDA	Current
57962-014	Imbruvica	Ibrutinib	Pharmacyclics LLC	NDA	Current
57962-014	Imbruvica	Ibrutinib	Pharmacyclics LLC	NDA	Current
57962-014	Imbruvica	Ibrutinib	Pharmacyclics LLC	NDA	Current
57962-014	Imbruvica	Ibrutinib	Pharmacyclics LLC	NDA	Current
57962-014	Imbruvica	Ibrutinib	Pharmacyclics LLC	NDA	Current
57962-014	Imbruvica	Ibrutinib	Pharmacyclics LLC	NDA	Current
57962-014	Imbruvica	Ibrutinib	Pharmacyclics LLC	NDA	Current
57962-014	Imbruvica	Ibrutinib	Pharmacyclics LLC	NDA	Current
57962-014	Imbruvica	Ibrutinib	Pharmacyclics LLC	NDA	Current
57962-014	Imbruvica	Ibrutinib	Pharmacyclics LLC	NDA	Current
57962-014	Imbruvica	Ibrutinib	Pharmacyclics LLC	NDA	Current
57962-014	Imbruvica	Ibrutinib	Pharmacyclics LLC	NDA	Current
57962-014	Imbruvica	Ibrutinib	Pharmacyclics LLC	NDA	Current
57962-014	Imbruvica	Ibrutinib	Pharmacyclics LLC	NDA	Current
57962-280	Imbruvica	Ibrutinib	Pharmacyclics LLC	NDA	Current
57962-280	Imbruvica	Ibrutinib	Pharmacyclics LLC	NDA	Current
57962-280	Imbruvica	Ibrutinib	Pharmacyclics LLC	NDA	Current
57962-280	Imbruvica	Ibrutinib	Pharmacyclics LLC	NDA	Current
57962-280	Imbruvica	Ibrutinib	Pharmacyclics LLC	NDA	Current
57962-280	Imbruvica	Ibrutinib	Pharmacyclics LLC	NDA	Current
57962-280	Imbruvica	Ibrutinib	Pharmacyclics LLC	NDA	Current
57962-280	Imbruvica	Ibrutinib	Pharmacyclics LLC	NDA	Current
57962-280	Imbruvica	Ibrutinib	Pharmacyclics LLC	NDA	Current
57962-280	Imbruvica	Ibrutinib	Pharmacyclics LLC	NDA	Current
57962-280	Imbruvica	Ibrutinib	Pharmacyclics LLC	NDA	Current
57962-280	Imbruvica	Ibrutinib	Pharmacyclics LLC	NDA	Current
57962-280	Imbruvica	Ibrutinib	Pharmacyclics LLC	NDA	Current
57962-280	Imbruvica	Ibrutinib	Pharmacyclics LLC	NDA	Current
57962-280	Imbruvica	Ibrutinib	Pharmacyclics LLC	NDA	Current
57962-280	Imbruvica	Ibrutinib	Pharmacyclics LLC	NDA	Current
57962-420	Imbruvica	Ibrutinib	Pharmacyclics LLC	NDA	Current
57962-420	Imbruvica	Ibrutinib	Pharmacyclics LLC	NDA	Current
57962-420	Imbruvica	Ibrutinib	Pharmacyclics LLC	NDA	Current
57962-420	Imbruvica	Ibrutinib	Pharmacyclics LLC	NDA	Current
57962-420	Imbruvica	Ibrutinib	Pharmacyclics LLC	NDA	Current
57962-420	Imbruvica	Ibrutinib	Pharmacyclics LLC	NDA	Current
57962-420	Imbruvica	Ibrutinib	Pharmacyclics LLC	NDA	Current
57962-420	Imbruvica	Ibrutinib	Pharmacyclics LLC	NDA	Current
57962-420	Imbruvica	Ibrutinib	Pharmacyclics LLC	NDA	Current
57962-420	Imbruvica	Ibrutinib	Pharmacyclics LLC	NDA	Current
57962-420	Imbruvica	Ibrutinib	Pharmacyclics LLC	NDA	Current
57962-420	Imbruvica	Ibrutinib	Pharmacyclics LLC	NDA	Current
57962-420	Imbruvica	Ibrutinib	Pharmacyclics LLC	NDA	Current
57962-420	Imbruvica	Ibrutinib	Pharmacyclics LLC	NDA	Current
57962-420	Imbruvica	Ibrutinib	Pharmacyclics LLC	NDA	Current
57962-420	Imbruvica	Ibrutinib	Pharmacyclics LLC	NDA	Current
57962-560	Imbruvica	Ibrutinib	Pharmacyclics LLC	NDA	Current
57962-560	Imbruvica	Ibrutinib	Pharmacyclics LLC	NDA	Current
57962-560	Imbruvica	Ibrutinib	Pharmacyclics LLC	NDA	Current
57962-560	Imbruvica	Ibrutinib	Pharmacyclics LLC	NDA	Current
57962-560	Imbruvica	Ibrutinib	Pharmacyclics LLC	NDA	Current
57962-560	Imbruvica	Ibrutinib	Pharmacyclics LLC	NDA	Current
57962-560	Imbruvica	Ibrutinib	Pharmacyclics LLC	NDA	Current
57962-560	Imbruvica	Ibrutinib	Pharmacyclics LLC	NDA	Current
57962-560	Imbruvica	Ibrutinib	Pharmacyclics LLC	NDA	Current
57962-560	Imbruvica	Ibrutinib	Pharmacyclics LLC	NDA	Current
57962-560	Imbruvica	Ibrutinib	Pharmacyclics LLC	NDA	Current
57962-560	Imbruvica	Ibrutinib	Pharmacyclics LLC	NDA	Current
57962-560	Imbruvica	Ibrutinib	Pharmacyclics LLC	NDA	Current
57962-560	Imbruvica	Ibrutinib	Pharmacyclics LLC	NDA	Current
57962-560	Imbruvica	Ibrutinib	Pharmacyclics LLC	NDA	Current
57962-560	Imbruvica	Ibrutinib	Pharmacyclics LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
83994	SUPPL	2025-10-31
83881	SUPPL	2025-10-23
80731	SUPPL	2024-12-26
80727	SUPPL	2024-12-26
78463	SUPPL	2024-05-14
74334	SUPPL	2023-05-22
74321	SUPPL	2023-05-19
71967	SUPPL	2022-08-30
71893	SUPPL	2022-08-25
71071	SUPPL	2022-05-16
71070	SUPPL	2022-05-16
65749	SUPPL	2020-12-28
65722	SUPPL	2020-12-28
65688	SUPPL	2020-12-22
65678	SUPPL	2020-12-22
64259	SUPPL	2020-08-11
64243	SUPPL	2020-08-10
62627	SUPPL	2020-04-22
62623	SUPPL	2020-04-21
61037	SUPPL	2019-11-22
61027	SUPPL	2019-11-22
59631	SUPPL	2019-08-08
59348	SUPPL	2019-07-16
57573	SUPPL	2019-02-13
57373	SUPPL	2019-01-29
56108	ORIG	2018-10-26
56107	ORIG	2018-10-26
55349	SUPPL	2018-08-28
55345	SUPPL	2018-08-28
54222	ORIG	2018-05-17
52698	ORIG	2018-02-23
52679	ORIG	2018-02-21