Application 205552

Type: NDA
Sponsor: PHARMACYCLICS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	IMBRUVICA	IBRUTINIB	CAPSULE;ORAL	140MG	Yes	Yes
002	IMBRUVICA	IBRUTINIB	CAPSULE;ORAL	70MG	Yes	No

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N205552-001	IMBRUVICA	IBRUTINIB	140MG	CAPSULE / ORAL		RLD, RS	2013-11-13
N205552-002	IMBRUVICA	IBRUTINIB	70MG	CAPSULE / ORAL		RLD	2017-12-20

Orange Book patents#

Current patent rows page 1 of 3 · 196 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N205552-001	7514444	2026-12-28		Drug substance, Drug product	2013-12-12
N205552-001	8476284	2026-12-28	U-1650		2013-12-12
N205552-001	8476284	2026-12-28	U-1946		2013-12-12
N205552-001	8497277	2026-12-28	U-1491		2013-12-12
N205552-001	8497277	2026-12-28	U-1650		2013-12-12
N205552-001	8497277	2026-12-28	U-1946		2013-12-12
N205552-001	8497277	2026-12-28	U-2241		2013-12-12
N205552-001	8497277	2026-12-28	U-2242		2013-12-12
N205552-001	8497277	2026-12-28	U-3422		2013-12-12
N205552-001	8697711	2026-12-28		Drug substance, Drug product	2014-05-13
N205552-001	8703780	2026-12-28	U-1491		2014-05-13
N205552-001	8735403	2026-12-28		Drug substance, Drug product	2014-06-18
N205552-001	8754091	2026-12-28		Drug product	2014-07-01
N205552-001	8952015	2026-12-28	U-1491		2017-09-01
N205552-001	8952015	2026-12-28	U-1650		2017-09-01
N205552-001	8952015	2026-12-28	U-1946		2017-09-01
N205552-001	8957079	2026-12-28		Drug substance, Drug product	2015-03-16
N205552-001	9181257	2026-12-28		Drug substance, Drug product	2015-12-08
N205552-001	8563563	2027-04-26	U-1491		2018-01-19
N205552-001	8563563	2027-04-26	U-1650		2018-01-19
N205552-001	8563563	2027-04-26	U-1946		2018-01-19
N205552-001	8563563	2027-04-26	U-2219		2018-01-19
N205552-001	7514444*PED	2027-06-28		Pediatric extension
N205552-001	8476284*PED	2027-06-28		Pediatric extension
N205552-001	8497277*PED	2027-06-28		Pediatric extension
N205552-001	8697711*PED	2027-06-28		Pediatric extension
N205552-001	8703780*PED	2027-06-28		Pediatric extension
N205552-001	8735403*PED	2027-06-28		Pediatric extension
N205552-001	8754091*PED	2027-06-28		Pediatric extension
N205552-001	8952015*PED	2027-06-28		Pediatric extension
N205552-001	8957079*PED	2027-06-28		Pediatric extension
N205552-001	9181257*PED	2027-06-28		Pediatric extension
N205552-001	8563563*PED	2027-10-26		Pediatric extension
N205552-001	8008309	2027-11-13		Drug substance, Drug product	2013-12-12
N205552-001	8008309*PED	2028-05-13		Pediatric extension
N205552-001	10004746	2031-06-03	U-1684		2018-07-16
N205552-001	10004746	2031-06-03	U-1946		2018-07-16
N205552-001	10004746	2031-06-03	U-2241		2018-07-16
N205552-001	10004746	2031-06-03	U-2242		2018-07-16
N205552-001	10016435	2031-06-03	U-1650		2018-08-03
N205552-001	10478439	2031-06-03	U-1650		2019-12-10
N205552-001	10478439	2031-06-03	U-1684		2019-12-10
N205552-001	10478439	2031-06-03	U-1946		2019-12-10
N205552-001	10478439	2031-06-03	U-2241		2019-12-10
N205552-001	10478439	2031-06-03	U-2242		2019-12-10
N205552-001	10478439	2031-06-03	U-2665		2019-12-10
N205552-001	10478439	2031-06-03	U-3422		2019-12-10
N205552-001	10751342	2031-06-03	U-1491		2020-09-10
N205552-001	10751342	2031-06-03	U-1946		2020-09-10
N205552-001	10751342	2031-06-03	U-2943		2020-09-10
N205552-001	10751342	2031-06-03	U-2944		2020-09-10
N205552-001	11672803	2031-06-03	U-1684		2023-07-14
N205552-001	11672803	2031-06-03	U-1946		2023-07-14
N205552-001	11672803	2031-06-03	U-2241		2023-07-14
N205552-001	11672803	2031-06-03	U-2242		2023-07-14
N205552-001	8999999	2031-06-03	U-1683		2015-04-28
N205552-001	8999999	2031-06-03	U-1684		2015-04-28
N205552-001	9125889	2031-06-03	U-1745		2015-09-25
N205552-001	9801881	2031-06-03	U-1491		2017-11-06
N205552-001	9801883	2031-06-03	U-2159		2017-11-06
N205552-001	10004746*PED	2031-12-03		Pediatric extension
N205552-001	10016435*PED	2031-12-03		Pediatric extension
N205552-001	10478439*PED	2031-12-03		Pediatric extension
N205552-001	10751342*PED	2031-12-03		Pediatric extension
N205552-001	8999999*PED	2031-12-03		Pediatric extension
N205552-001	9125889*PED	2031-12-03		Pediatric extension
N205552-001	9801881*PED	2031-12-03		Pediatric extension
N205552-001	9801883*PED	2031-12-03		Pediatric extension
N205552-001	10106548	2033-06-03		Drug substance, Drug product	2018-10-26
N205552-001	10125140	2033-06-03		Drug substance, Drug product	2018-11-16
N205552-001	10294231	2033-06-03		Drug product	2019-05-23
N205552-001	10294232	2033-06-03		Drug product	2019-05-23
N205552-001	10752634	2033-06-03		Drug product	2020-09-10
N205552-001	10961251	2033-06-03		Drug product	2021-04-16
N205552-001	9713617	2033-06-03		Drug product	2017-08-28
N205552-001	9725455	2033-06-03		Drug substance	2017-08-28
N205552-001	9540382	2033-08-18	U-1650		2017-01-30
N205552-001	9540382	2033-08-18	U-1684		2017-01-30
N205552-001	9540382	2033-08-18	U-1946		2017-01-30
N205552-001	9296753	2033-10-30		Drug substance, Drug product	2016-04-18

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 8 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N205552-001	NPP	2025-08-24
N205552-001	PED	2026-02-24
N205552-001	ODE-405	2029-08-24
N205552-001	PED	2030-02-24
N205552-002	NPP	2025-08-24
N205552-002	PED	2026-02-24
N205552-002	ODE-405	2029-08-24
N205552-002	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 3 · 84 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	N205552-001	IMBRUVICA	140MG	CAPSULE / ORAL	RLD, RS	2013-11-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205552-002	IMBRUVICA	70MG	CAPSULE / ORAL	RLD	2017-12-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N205552-001	IMBRUVICA	140MG	CAPSULE / ORAL	RLD, RS	2013-11-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205552-002	IMBRUVICA	70MG	CAPSULE / ORAL	RLD	2017-12-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205552-001	IMBRUVICA	140MG	CAPSULE / ORAL	RLD, RS	2013-11-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205552-002	IMBRUVICA	70MG	CAPSULE / ORAL	RLD	2017-12-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N205552-001	IMBRUVICA	140MG	CAPSULE / ORAL	RLD, RS	2013-11-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205552-002	IMBRUVICA	70MG	CAPSULE / ORAL	RLD	2017-12-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205552-001	IMBRUVICA	140MG	CAPSULE / ORAL	RLD, RS	2013-11-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205552-002	IMBRUVICA	70MG	CAPSULE / ORAL	RLD	2017-12-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205552-001	IMBRUVICA	140MG	CAPSULE / ORAL	RLD, RS	2013-11-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205552-002	IMBRUVICA	70MG	CAPSULE / ORAL	RLD	2017-12-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205552-001	IMBRUVICA	140MG	CAPSULE / ORAL	RLD, RS	2013-11-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205552-002	IMBRUVICA	70MG	CAPSULE / ORAL	RLD	2017-12-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205552-001	IMBRUVICA	140MG	CAPSULE / ORAL	RLD, RS	2013-11-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205552-002	IMBRUVICA	70MG	CAPSULE / ORAL	RLD	2017-12-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205552-001	IMBRUVICA	140MG	CAPSULE / ORAL	RLD, RS	2013-11-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205552-002	IMBRUVICA	70MG	CAPSULE / ORAL	RLD	2017-12-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N205552-001	IMBRUVICA	140MG	CAPSULE / ORAL	RLD, RS	2013-11-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N205552-002	IMBRUVICA	70MG	CAPSULE / ORAL	RLD	2017-12-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N205552-001	IMBRUVICA	140MG	CAPSULE / ORAL	RLD, RS	2013-11-13	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N205552-002	IMBRUVICA	70MG	CAPSULE / ORAL	RLD	2017-12-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N205552-001	IMBRUVICA	140MG	CAPSULE / ORAL	RLD, RS	2013-11-13	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N205552-002	IMBRUVICA	70MG	CAPSULE / ORAL	RLD	2017-12-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N205552-001	IMBRUVICA	140MG	CAPSULE / ORAL	RLD, RS	2013-11-13	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N205552-002	IMBRUVICA	70MG	CAPSULE / ORAL	RLD	2017-12-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N205552-001	IMBRUVICA	140MG	CAPSULE / ORAL	RLD, RS	2013-11-13	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N205552-002	IMBRUVICA	70MG	CAPSULE / ORAL	RLD	2017-12-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N205552-001	IMBRUVICA	140MG	CAPSULE / ORAL	RLD, RS	2013-11-13	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N205552-002	IMBRUVICA	70MG	CAPSULE / ORAL	RLD	2017-12-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N205552-001	IMBRUVICA	140MG	CAPSULE / ORAL	RLD, RS	2013-11-13	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N205552-002	IMBRUVICA	70MG	CAPSULE / ORAL	RLD	2017-12-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N205552-001	IMBRUVICA	140MG	CAPSULE / ORAL	RLD, RS	2013-11-13	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N205552-002	IMBRUVICA	70MG	CAPSULE / ORAL	RLD	2017-12-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N205552-001	IMBRUVICA	140MG	CAPSULE / ORAL	RLD, RS	2013-11-13	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N205552-002	IMBRUVICA	70MG	CAPSULE / ORAL	RLD	2017-12-20	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N205552-001	IMBRUVICA	140MG	CAPSULE / ORAL	RLD, RS	2013-11-13	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N205552-002	IMBRUVICA	70MG	CAPSULE / ORAL	RLD	2017-12-20	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N205552-001	IMBRUVICA	140MG	CAPSULE / ORAL	RLD, RS	2013-11-13	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N205552-002	IMBRUVICA	70MG	CAPSULE / ORAL	RLD	2017-12-20	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N205552-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N205552-002	AB	1	`87673890dc5c…`

Observed Orange Book patent history#

Patent history page 1 of 192 · 7,659 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	N205552-001	7514444	2026-12-28		Drug substance, Drug product	2013-12-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205552-001	8476284	2026-12-28	U-1650		2013-12-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205552-001	8476284	2026-12-28	U-1946		2013-12-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205552-001	8497277	2026-12-28	U-1491		2013-12-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205552-001	8497277	2026-12-28	U-1946		2013-12-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205552-001	8497277	2026-12-28	U-2242		2013-12-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205552-001	8497277	2026-12-28	U-2241		2013-12-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205552-001	8497277	2026-12-28	U-3422		2013-12-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205552-001	8497277	2026-12-28	U-1650		2013-12-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205552-001	8697711	2026-12-28		Drug substance, Drug product	2014-05-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205552-001	8703780	2026-12-28	U-1491		2014-05-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205552-001	8735403	2026-12-28		Drug substance, Drug product	2014-06-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205552-001	8754091	2026-12-28		Drug product	2014-07-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205552-001	8952015	2026-12-28	U-1650		2017-09-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205552-001	8952015	2026-12-28	U-1491		2017-09-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205552-001	8952015	2026-12-28	U-1946		2017-09-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205552-001	8957079	2026-12-28		Drug substance, Drug product	2015-03-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205552-001	9181257	2026-12-28		Drug substance, Drug product	2015-12-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205552-001	8563563	2027-04-26	U-1946		2018-01-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205552-001	8563563	2027-04-26	U-2219		2018-01-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205552-001	8563563	2027-04-26	U-1650		2018-01-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205552-001	8563563	2027-04-26	U-1491		2018-01-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205552-001	7514444*PED	2027-06-28		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205552-001	8476284*PED	2027-06-28		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205552-001	8497277*PED	2027-06-28		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205552-001	8697711*PED	2027-06-28		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205552-001	8703780*PED	2027-06-28		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205552-001	8735403*PED	2027-06-28		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205552-001	8754091*PED	2027-06-28		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205552-001	8952015*PED	2027-06-28		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205552-001	8957079*PED	2027-06-28		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205552-001	9181257*PED	2027-06-28		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205552-001	8563563*PED	2027-10-26		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205552-001	8008309	2027-11-13		Drug substance, Drug product	2013-12-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205552-001	8008309*PED	2028-05-13		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205552-001	10004746	2031-06-03	U-2242		2018-07-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205552-001	10004746	2031-06-03	U-2241		2018-07-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205552-001	10004746	2031-06-03	U-1946		2018-07-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205552-001	10004746	2031-06-03	U-1684		2018-07-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205552-001	10016435	2031-06-03	U-1650		2018-08-03	`caaa826d4ba7…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 13 · 503 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	N205552-001	NPP	2025-08-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205552-001	PED	2026-02-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205552-001	ODE-405	2029-08-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205552-001	PED	2030-02-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205552-002	NPP	2025-08-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205552-002	PED	2026-02-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205552-002	ODE-405	2029-08-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205552-002	PED	2030-02-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N205552-001	NPP	2025-08-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205552-001	PED	2026-02-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205552-001	ODE-405	2029-08-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205552-001	PED	2030-02-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205552-002	NPP	2025-08-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205552-002	PED	2026-02-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205552-002	ODE-405	2029-08-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205552-002	PED	2030-02-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205552-001	ODE-152	2024-08-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205552-001	PED	2025-02-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205552-001	M-14	2025-08-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205552-001	NPP	2025-08-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205552-001	PED	2026-02-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205552-001	ODE-405	2029-08-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205552-001	PED	2030-02-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205552-002	M-14	2025-08-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205552-002	NPP	2025-08-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205552-002	PED	2026-02-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205552-002	ODE-405	2029-08-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205552-002	PED	2030-02-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N205552-001	ODE-152	2024-08-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205552-001	PED	2025-02-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205552-001	M-14	2025-08-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205552-001	NPP	2025-08-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205552-001	PED	2026-02-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205552-001	ODE-405	2029-08-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205552-001	PED	2030-02-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205552-002	M-14	2025-08-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205552-002	NPP	2025-08-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205552-002	PED	2026-02-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205552-002	ODE-405	2029-08-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205552-002	PED	2030-02-24	`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
Imbruvica	IBRUTINIB	Pharmacyclics LLC	0dfd0279-ff17-4ea9-89be-9803c71bab44	2025-10-21	Warnings, Adverse reactions	Exact identifier application applno (NDA): 205552 application number: NDA205552 ndc (product): 57962-070 ndc (product): 57962-140 ndc (product): 57962-007

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 34 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
57962-007	Imbruvica	Ibrutinib	Pharmacyclics LLC	NDA	Current
57962-007	Imbruvica	Ibrutinib	Pharmacyclics LLC	NDA	Current
57962-070	Imbruvica	Ibrutinib	Pharmacyclics LLC	NDA	Current
57962-070	Imbruvica	Ibrutinib	Pharmacyclics LLC	NDA	Current
57962-070	Imbruvica	Ibrutinib	Pharmacyclics LLC	NDA	Current
57962-070	Imbruvica	Ibrutinib	Pharmacyclics LLC	NDA	Current
57962-070	Imbruvica	Ibrutinib	Pharmacyclics LLC	NDA	Current
57962-070	Imbruvica	Ibrutinib	Pharmacyclics LLC	NDA	Current
57962-070	Imbruvica	Ibrutinib	Pharmacyclics LLC	NDA	Current
57962-070	Imbruvica	Ibrutinib	Pharmacyclics LLC	NDA	Current
57962-070	Imbruvica	Ibrutinib	Pharmacyclics LLC	NDA	Current
57962-070	Imbruvica	Ibrutinib	Pharmacyclics LLC	NDA	Current
57962-070	Imbruvica	Ibrutinib	Pharmacyclics LLC	NDA	Current
57962-070	Imbruvica	Ibrutinib	Pharmacyclics LLC	NDA	Current
57962-070	Imbruvica	Ibrutinib	Pharmacyclics LLC	NDA	Current
57962-070	Imbruvica	Ibrutinib	Pharmacyclics LLC	NDA	Current
57962-070	Imbruvica	Ibrutinib	Pharmacyclics LLC	NDA	Current
57962-070	Imbruvica	Ibrutinib	Pharmacyclics LLC	NDA	Current
57962-140	Imbruvica	Ibrutinib	Pharmacyclics LLC	NDA	Current
57962-140	Imbruvica	Ibrutinib	Pharmacyclics LLC	NDA	Current
57962-140	Imbruvica	Ibrutinib	Pharmacyclics LLC	NDA	Current
57962-140	Imbruvica	Ibrutinib	Pharmacyclics LLC	NDA	Current
57962-140	Imbruvica	Ibrutinib	Pharmacyclics LLC	NDA	Current
57962-140	Imbruvica	Ibrutinib	Pharmacyclics LLC	NDA	Current
57962-140	Imbruvica	Ibrutinib	Pharmacyclics LLC	NDA	Current
57962-140	Imbruvica	Ibrutinib	Pharmacyclics LLC	NDA	Current
57962-140	Imbruvica	Ibrutinib	Pharmacyclics LLC	NDA	Current
57962-140	Imbruvica	Ibrutinib	Pharmacyclics LLC	NDA	Current
57962-140	Imbruvica	Ibrutinib	Pharmacyclics LLC	NDA	Current
57962-140	Imbruvica	Ibrutinib	Pharmacyclics LLC	NDA	Current
57962-140	Imbruvica	Ibrutinib	Pharmacyclics LLC	NDA	Current
57962-140	Imbruvica	Ibrutinib	Pharmacyclics LLC	NDA	Current
57962-140	Imbruvica	Ibrutinib	Pharmacyclics LLC	NDA	Current
57962-140	Imbruvica	Ibrutinib	Pharmacyclics LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
83880	SUPPL	2025-10-23
83869	SUPPL	2025-10-22
80730	SUPPL	2024-12-26
80726	SUPPL	2024-12-26
78462	SUPPL	2024-05-14
78449	SUPPL	2024-05-10
78448	SUPPL	2024-05-10
78447	SUPPL	2024-05-10
74333	SUPPL	2023-05-22
74320	SUPPL	2023-05-19
71966	SUPPL	2022-08-30
71892	SUPPL	2022-08-25
71056	SUPPL	2022-05-12
71051	SUPPL	2022-05-12
69651	SUPPL	2021-12-20
65750	SUPPL	2020-12-28
65721	SUPPL	2020-12-28
65689	SUPPL	2020-12-22
65677	SUPPL	2020-12-22
64258	SUPPL	2020-08-11
64242	SUPPL	2020-08-10
62626	SUPPL	2020-04-22
62621	SUPPL	2020-04-21
62201	SUPPL	2020-03-19
61036	SUPPL	2019-11-22
61028	SUPPL	2019-11-22
59630	SUPPL	2019-08-08
59347	SUPPL	2019-07-16
57572	SUPPL	2019-02-13
57372	SUPPL	2019-01-29
55348	SUPPL	2018-08-28
55341	SUPPL	2018-08-28
55340	SUPPL	2018-08-28
55338	SUPPL	2018-08-28
54290	SUPPL	2018-05-22
50905	SUPPL	2017-12-27
50854	SUPPL	2017-12-26
50617	SUPPL	2017-12-06
43491	ORIG	2017-12-06
49244	SUPPL	2017-08-04
49200	SUPPL	2017-08-02
47884	SUPPL	2017-04-07
46946	SUPPL	2017-01-24
19657	SUPPL	2016-07-18
32687	SUPPL	2016-06-29
40481	SUPPL	2016-05-09
40480	SUPPL	2016-05-09
10465	SUPPL	2016-05-09
40479	SUPPL	2016-03-08
32686	SUPPL	2016-03-08
45441	ORIG	2015-04-13
45440	ORIG	2015-04-13
40478	SUPPL	2015-01-29
32685	SUPPL	2015-01-29
40477	SUPPL	2014-07-29
10464	SUPPL	2014-07-29
45439	ORIG	2014-02-14
45438	ORIG	2014-02-12
44921	ORIG	2013-11-25
40475	ORIG	2013-11-15
10462	ORIG	2013-11-15