Application 208772

Type: NDA
Sponsor: ARIAD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ALUNBRIG	BRIGATINIB	TABLET;ORAL	30MG	Yes	No
002	ALUNBRIG	BRIGATINIB	TABLET;ORAL	90MG	Yes	No
003	ALUNBRIG	BRIGATINIB	TABLET;ORAL	180MG	Yes	Yes

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

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
N208772-001	ALUNBRIG	BRIGATINIB	30MG	TABLET / ORAL	RLD	2017-04-28
N208772-002	ALUNBRIG	BRIGATINIB	90MG	TABLET / ORAL	RLD, RS	2017-04-28
N208772-003	ALUNBRIG	BRIGATINIB	180MG	TABLET / ORAL	RLD	2017-10-02

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
N208772-001	9273077	2029-05-21	U-2837		2017-05-26
N208772-001	9012462	2031-04-28		Drug substance	2017-05-26
N208772-001	9611283	2034-04-10	U-2837		2017-05-26
N208772-001	10385078	2035-11-10	U-2837	Drug substance, Drug product	2019-09-10
N208772-002	9273077	2029-05-21	U-2837		2017-05-26
N208772-002	9012462	2031-04-28		Drug substance	2017-05-26
N208772-002	9611283	2034-04-10	U-2837		2017-05-26
N208772-002	10385078	2035-11-10	U-2837	Drug substance, Drug product	2019-09-10
N208772-003	9273077	2029-05-21	U-2837		2017-10-23
N208772-003	9012462	2031-04-28		Drug substance	2017-10-23
N208772-003	9611283	2034-04-10	U-2837		2017-10-23
N208772-003	10385078	2035-11-10	U-2837	Drug substance, Drug product	2019-09-10

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N208772-001	ODE-300	2027-05-22
N208772-002	ODE-300	2027-05-22
N208772-003	ODE-300	2027-05-22

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 4 · 126 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	N208772-001	ALUNBRIG	30MG	TABLET / ORAL	RLD	2017-04-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208772-002	ALUNBRIG	90MG	TABLET / ORAL	RLD, RS	2017-04-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208772-003	ALUNBRIG	180MG	TABLET / ORAL	RLD	2017-10-02	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N208772-001	ALUNBRIG	30MG	TABLET / ORAL	RLD	2017-04-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208772-002	ALUNBRIG	90MG	TABLET / ORAL	RLD, RS	2017-04-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208772-003	ALUNBRIG	180MG	TABLET / ORAL	RLD	2017-10-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208772-001	ALUNBRIG	30MG	TABLET / ORAL	RLD	2017-04-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208772-002	ALUNBRIG	90MG	TABLET / ORAL	RLD	2017-04-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208772-003	ALUNBRIG	180MG	TABLET / ORAL	RLD, RS	2017-10-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208772-001	ALUNBRIG	30MG	TABLET / ORAL	RLD	2017-04-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208772-002	ALUNBRIG	90MG	TABLET / ORAL	RLD	2017-04-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208772-003	ALUNBRIG	180MG	TABLET / ORAL	RLD, RS	2017-10-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208772-001	ALUNBRIG	30MG	TABLET / ORAL	RLD	2017-04-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208772-002	ALUNBRIG	90MG	TABLET / ORAL	RLD	2017-04-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208772-003	ALUNBRIG	180MG	TABLET / ORAL	RLD, RS	2017-10-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208772-001	ALUNBRIG	30MG	TABLET / ORAL	RLD	2017-04-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208772-002	ALUNBRIG	90MG	TABLET / ORAL	RLD	2017-04-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208772-003	ALUNBRIG	180MG	TABLET / ORAL	RLD, RS	2017-10-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208772-001	ALUNBRIG	30MG	TABLET / ORAL	RLD	2017-04-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208772-002	ALUNBRIG	90MG	TABLET / ORAL	RLD	2017-04-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208772-003	ALUNBRIG	180MG	TABLET / ORAL	RLD, RS	2017-10-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208772-001	ALUNBRIG	30MG	TABLET / ORAL	RLD	2017-04-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208772-002	ALUNBRIG	90MG	TABLET / ORAL	RLD	2017-04-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208772-003	ALUNBRIG	180MG	TABLET / ORAL	RLD, RS	2017-10-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208772-001	ALUNBRIG	30MG	TABLET / ORAL	RLD	2017-04-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208772-002	ALUNBRIG	90MG	TABLET / ORAL	RLD	2017-04-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208772-003	ALUNBRIG	180MG	TABLET / ORAL	RLD, RS	2017-10-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208772-001	ALUNBRIG	30MG	TABLET / ORAL	RLD	2017-04-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208772-002	ALUNBRIG	90MG	TABLET / ORAL	RLD	2017-04-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208772-003	ALUNBRIG	180MG	TABLET / ORAL	RLD, RS	2017-10-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N208772-001	ALUNBRIG	30MG	TABLET / ORAL	RLD	2017-04-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N208772-002	ALUNBRIG	90MG	TABLET / ORAL	RLD	2017-04-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N208772-003	ALUNBRIG	180MG	TABLET / ORAL	RLD, RS	2017-10-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208772-001	ALUNBRIG	30MG	TABLET / ORAL	RLD	2017-04-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208772-002	ALUNBRIG	90MG	TABLET / ORAL	RLD	2017-04-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208772-003	ALUNBRIG	180MG	TABLET / ORAL	RLD, RS	2017-10-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208772-001	ALUNBRIG	30MG	TABLET / ORAL	RLD	2017-04-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208772-002	ALUNBRIG	90MG	TABLET / ORAL	RLD	2017-04-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208772-003	ALUNBRIG	180MG	TABLET / ORAL	RLD, RS	2017-10-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208772-001	ALUNBRIG	30MG	TABLET / ORAL	RLD	2017-04-28	`1e350fbaab3a…`

Observed Orange Book patent history#

Patent history page 1 of 13 · 501 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	N208772-001	9273077	2029-05-21	U-2837		2017-05-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208772-001	9012462	2031-04-28		Drug substance	2017-05-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208772-001	9611283	2034-04-10	U-2837		2017-05-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208772-001	10385078	2035-11-10	U-2837	Drug substance, Drug product	2019-09-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208772-002	9273077	2029-05-21	U-2837		2017-05-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208772-002	9012462	2031-04-28		Drug substance	2017-05-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208772-002	9611283	2034-04-10	U-2837		2017-05-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208772-002	10385078	2035-11-10	U-2837	Drug substance, Drug product	2019-09-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208772-003	9273077	2029-05-21	U-2837		2017-10-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208772-003	9012462	2031-04-28		Drug substance	2017-10-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208772-003	9611283	2034-04-10	U-2837		2017-10-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208772-003	10385078	2035-11-10	U-2837	Drug substance, Drug product	2019-09-10	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N208772-001	9273077	2029-05-21	U-2837		2017-05-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208772-001	9012462	2031-04-28		Drug substance	2017-05-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208772-001	9611283	2034-04-10	U-2837		2017-05-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208772-001	10385078	2035-11-10	U-2837	Drug substance, Drug product	2019-09-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208772-002	9273077	2029-05-21	U-2837		2017-05-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208772-002	9012462	2031-04-28		Drug substance	2017-05-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208772-002	9611283	2034-04-10	U-2837		2017-05-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208772-002	10385078	2035-11-10	U-2837	Drug substance, Drug product	2019-09-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208772-003	9273077	2029-05-21	U-2837		2017-10-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208772-003	9012462	2031-04-28		Drug substance	2017-10-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208772-003	9611283	2034-04-10	U-2837		2017-10-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208772-003	10385078	2035-11-10	U-2837	Drug substance, Drug product	2019-09-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208772-001	9273077	2029-05-21	U-2837		2017-05-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208772-001	9012462	2031-04-28		Drug substance	2017-05-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208772-001	9611283	2034-04-10	U-2837		2017-05-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208772-001	10385078	2035-11-10	U-2837	Drug substance, Drug product	2019-09-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208772-002	9273077	2029-05-21	U-2837		2017-05-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208772-002	9012462	2031-04-28		Drug substance	2017-05-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208772-002	9611283	2034-04-10	U-2837		2017-05-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208772-002	10385078	2035-11-10	U-2837	Drug substance, Drug product	2019-09-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208772-003	9273077	2029-05-21	U-2837		2017-10-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208772-003	9012462	2031-04-28		Drug substance	2017-10-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208772-003	9611283	2034-04-10	U-2837		2017-10-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208772-003	10385078	2035-11-10	U-2837	Drug substance, Drug product	2019-09-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208772-001	9273077	2029-05-21	U-2837		2017-05-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208772-001	9012462	2031-04-28		Drug substance	2017-05-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208772-001	9611283	2034-04-10	U-2837		2017-05-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208772-001	10385078	2035-11-10	U-2837	Drug substance, Drug product	2019-09-10	`6a471c1ec25d…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 9 · 327 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	N208772-001	ODE-300	2027-05-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208772-002	ODE-300	2027-05-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208772-003	ODE-300	2027-05-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N208772-001	ODE-300	2027-05-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208772-002	ODE-300	2027-05-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208772-003	ODE-300	2027-05-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208772-001	ODE-300	2027-05-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208772-002	ODE-300	2027-05-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208772-003	ODE-300	2027-05-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208772-001	ODE-300	2027-05-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208772-002	ODE-300	2027-05-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208772-003	ODE-300	2027-05-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208772-001	ODE-300	2027-05-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208772-002	ODE-300	2027-05-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208772-003	ODE-300	2027-05-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208772-001	ODE-300	2027-05-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208772-002	ODE-300	2027-05-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208772-003	ODE-300	2027-05-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208772-001	ODE-142	2024-04-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208772-001	ODE-300	2027-05-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208772-002	ODE-142	2024-04-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208772-002	ODE-300	2027-05-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208772-003	ODE-142	2024-04-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208772-003	ODE-300	2027-05-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208772-001	ODE-142	2024-04-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208772-001	ODE-300	2027-05-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208772-002	ODE-142	2024-04-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208772-002	ODE-300	2027-05-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208772-003	ODE-142	2024-04-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208772-003	ODE-300	2027-05-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208772-001	ODE-142	2024-04-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208772-001	ODE-300	2027-05-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208772-002	ODE-142	2024-04-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208772-002	ODE-300	2027-05-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208772-003	ODE-142	2024-04-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208772-003	ODE-300	2027-05-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208772-001	ODE-142	2024-04-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208772-001	ODE-300	2027-05-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208772-002	ODE-142	2024-04-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208772-002	ODE-300	2027-05-22	`d8e5a09893c0…`

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
Alunbrig	BRIGATINIB	Takeda Pharmaceuticals America, Inc.	0fe9ff20-d402-41f3-bc1e-7002ea7007db	2026-01-12	Warnings, Adverse reactions	Exact identifier application applno (NDA): 208772 application number: NDA208772 ndc (product): 63020-113 ndc (product): 63020-090 ndc (product): 63020-198 ndc (product): 63020-180

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 33 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
63020-090	Alunbrig	brigatinib	Takeda Pharmaceuticals America, Inc.	NDA	Current
63020-090	Alunbrig	brigatinib	Takeda Pharmaceuticals America, Inc.	NDA	Current
63020-090	Alunbrig	brigatinib	Takeda Pharmaceuticals America, Inc.	NDA	Current
63020-090	Alunbrig	brigatinib	Millennium Pharmaceuticals, Inc.	NDA	Current
63020-090	Alunbrig	brigatinib	Millennium Pharmaceuticals, Inc.	NDA	Current
63020-090	Alunbrig	brigatinib	Millennium Pharmaceuticals, Inc.	NDA	Current
63020-090	Alunbrig	brigatinib	Millennium Pharmaceuticals, Inc.	NDA	Current
63020-090	Alunbrig	brigatinib	Takeda Pharmaceuticals America, Inc.	NDA	Current
63020-113	Alunbrig	brigatinib	Takeda Pharmaceuticals America, Inc.	NDA	Current
63020-113	Alunbrig	brigatinib	Takeda Pharmaceuticals America, Inc.	NDA	Current
63020-113	Alunbrig	brigatinib	Takeda Pharmaceuticals America, Inc.	NDA	Current
63020-113	Alunbrig	brigatinib	Millennium Pharmaceuticals, Inc.	NDA	Current
63020-113	Alunbrig	brigatinib	Millennium Pharmaceuticals, Inc.	NDA	Current
63020-113	Alunbrig	brigatinib	Millennium Pharmaceuticals, Inc.	NDA	Current
63020-113	Alunbrig	brigatinib	Millennium Pharmaceuticals, Inc.	NDA	Current
63020-113	Alunbrig	brigatinib	Takeda Pharmaceuticals America, Inc.	NDA	Current
63020-180	Alunbrig	brigatinib	Takeda Pharmaceuticals America, Inc.	NDA	Current
63020-180	Alunbrig	brigatinib	Takeda Pharmaceuticals America, Inc.	NDA	Current
63020-180	Alunbrig	brigatinib	Takeda Pharmaceuticals America, Inc.	NDA	Current
63020-180	Alunbrig	brigatinib	Millennium Pharmaceuticals, Inc.	NDA	Current
63020-180	Alunbrig	brigatinib	Millennium Pharmaceuticals, Inc.	NDA	Current
63020-180	Alunbrig	brigatinib	Millennium Pharmaceuticals, Inc.	NDA	Current
63020-180	Alunbrig	brigatinib	Millennium Pharmaceuticals, Inc.	NDA	Current
63020-180	Alunbrig	brigatinib	Takeda Pharmaceuticals America, Inc.	NDA	Current
63020-198	Alunbrig	brigatinib	Takeda Pharmaceuticals America, Inc.	NDA	Current
63020-198	Alunbrig	brigatinib	Takeda Pharmaceuticals America, Inc.	NDA	Current
63020-198	Alunbrig	brigatinib	Takeda Pharmaceuticals America, Inc.	NDA	Current
63020-198	Alunbrig	brigatinib	Millennium Pharmaceuticals, Inc.	NDA	Current
63020-198	Alunbrig	brigatinib	Millennium Pharmaceuticals, Inc.	NDA	Current
63020-198	Alunbrig	brigatinib	Millennium Pharmaceuticals, Inc.	NDA	Current
63020-198	Alunbrig	brigatinib	Millennium Pharmaceuticals, Inc.	NDA	Current
63020-198	Alunbrig	brigatinib	Takeda Pharmaceuticals America, Inc.	NDA	Current
76189-113	Alunbrig	Brigatinib	ARIAD Pharmaceuticals Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
70387	SUPPL	2022-03-03
70313	SUPPL	2022-03-01
68808	SUPPL	2021-09-29
68793	SUPPL	2021-09-28
63321	SUPPL	2020-05-28
63288	SUPPL	2020-05-22
57089	SUPPL	2018-12-31
57008	SUPPL	2018-12-26
48573	ORIG	2017-05-30
48165	ORIG	2017-04-28
48164	ORIG	2017-04-28