Application 203341

Type: NDA
Sponsor: PF PRISM CV

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	BOSULIF	BOSUTINIB MONOHYDRATE	TABLET;ORAL	EQ 100MG BASE	Yes	Yes
002	BOSULIF	BOSUTINIB MONOHYDRATE	TABLET;ORAL	EQ 500MG BASE	Yes	No
003	BOSULIF	BOSUTINIB MONOHYDRATE	TABLET;ORAL	EQ 400MG BASE	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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	TE codes	RLD / RS	Approval date
N203341-001	BOSULIF	BOSUTINIB MONOHYDRATE	EQ 100MG BASE	TABLET / ORAL	AB	RLD, RS	2012-09-04
N203341-002	BOSULIF	BOSUTINIB MONOHYDRATE	EQ 500MG BASE	TABLET / ORAL	AB	RLD	2012-09-04
N203341-003	BOSULIF	BOSUTINIB MONOHYDRATE	EQ 400MG BASE	TABLET / ORAL	AB	RLD	2017-10-27

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
N203341-001	AB
N203341-002	AB
N203341-003	AB

Orange Book patents#

Current patent rows page 1 of 1 · 33 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N203341-001	7417148	2025-12-11	U-1283		2012-09-25
N203341-001	7417148	2025-12-11	U-3707		2012-09-25
N203341-001	7417148	2025-12-11	U-3708		2012-09-25
N203341-001	7919625	2025-12-11		Drug product	2012-09-25
N203341-001	7417148*PED	2026-06-11		Pediatric extension
N203341-001	7919625*PED	2026-06-11		Pediatric extension
N203341-001	7767678	2026-11-23		Drug substance, Drug product	2012-09-25
N203341-001	7767678*PED	2027-05-23		Pediatric extension
N203341-001	11103497	2034-02-28	U-3216		2021-09-29
N203341-001	11103497	2034-02-28	U-3217		2021-09-29
N203341-001	11103497*PED	2034-08-28		Pediatric extension
N203341-002	7417148	2025-12-11	U-1283
N203341-002	7417148	2025-12-11	U-3707
N203341-002	7417148	2025-12-11	U-3708
N203341-002	7919625	2025-12-11		Drug product
N203341-002	7417148*PED	2026-06-11		Pediatric extension
N203341-002	7919625*PED	2026-06-11		Pediatric extension
N203341-002	7767678	2026-11-23		Drug substance, Drug product
N203341-002	7767678*PED	2027-05-23		Pediatric extension
N203341-002	11103497	2034-02-28	U-3216		2021-09-29
N203341-002	11103497	2034-02-28	U-3217		2021-09-29
N203341-002	11103497*PED	2034-08-28		Pediatric extension
N203341-003	7417148	2025-12-11	U-1283		2017-11-15
N203341-003	7417148	2025-12-11	U-3707		2017-11-15
N203341-003	7417148	2025-12-11	U-3708		2017-11-15
N203341-003	7919625	2025-12-11		Drug product	2017-11-15
N203341-003	7417148*PED	2026-06-11		Pediatric extension
N203341-003	7919625*PED	2026-06-11		Pediatric extension
N203341-003	7767678	2026-11-23		Drug substance, Drug product	2017-11-15
N203341-003	7767678*PED	2027-05-23		Pediatric extension
N203341-003	11103497	2034-02-28	U-3216		2021-09-29
N203341-003	11103497	2034-02-28	U-3217		2021-09-29
N203341-003	11103497*PED	2034-08-28		Pediatric extension

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N203341-001	I-923	2026-09-26
N203341-001	PED	2027-03-26
N203341-001	ODE-444	2030-09-26
N203341-001	PED	2031-03-26
N203341-002	I-923	2026-09-26
N203341-002	PED	2027-03-26
N203341-002	ODE-444	2030-09-26
N203341-002	PED	2031-03-26
N203341-003	I-923	2026-09-26
N203341-003	PED	2027-03-26
N203341-003	ODE-444	2030-09-26
N203341-003	PED	2031-03-26

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.

Product history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N203341-001	BOSULIF	EQ 100MG BASE	TABLET / ORAL	AB	RLD, RS	2012-09-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203341-002	BOSULIF	EQ 500MG BASE	TABLET / ORAL	AB	RLD	2012-09-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203341-003	BOSULIF	EQ 400MG BASE	TABLET / ORAL	AB	RLD	2017-10-27	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N203341-001	BOSULIF	EQ 100MG BASE	TABLET / ORAL	AB	RLD, RS	2012-09-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203341-002	BOSULIF	EQ 500MG BASE	TABLET / ORAL	AB	RLD	2012-09-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203341-003	BOSULIF	EQ 400MG BASE	TABLET / ORAL	AB	RLD	2017-10-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N203341-001	BOSULIF	EQ 100MG BASE	TABLET / ORAL	AB	RLD, RS	2012-09-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203341-002	BOSULIF	EQ 500MG BASE	TABLET / ORAL	AB	RLD	2012-09-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203341-003	BOSULIF	EQ 400MG BASE	TABLET / ORAL		RLD	2017-10-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203341-001	BOSULIF	EQ 100MG BASE	TABLET / ORAL	AB	RLD, RS	2012-09-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203341-002	BOSULIF	EQ 500MG BASE	TABLET / ORAL	AB	RLD	2012-09-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203341-003	BOSULIF	EQ 400MG BASE	TABLET / ORAL		RLD	2017-10-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N203341-001	BOSULIF	EQ 100MG BASE	TABLET / ORAL	AB	RLD, RS	2012-09-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203341-002	BOSULIF	EQ 500MG BASE	TABLET / ORAL	AB	RLD	2012-09-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203341-003	BOSULIF	EQ 400MG BASE	TABLET / ORAL		RLD	2017-10-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203341-001	BOSULIF	EQ 100MG BASE	TABLET / ORAL		RLD, RS	2012-09-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203341-002	BOSULIF	EQ 500MG BASE	TABLET / ORAL		RLD	2012-09-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203341-003	BOSULIF	EQ 400MG BASE	TABLET / ORAL		RLD	2017-10-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203341-001	BOSULIF	EQ 100MG BASE	TABLET / ORAL		RLD, RS	2012-09-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203341-002	BOSULIF	EQ 500MG BASE	TABLET / ORAL		RLD	2012-09-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203341-003	BOSULIF	EQ 400MG BASE	TABLET / ORAL		RLD	2017-10-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203341-001	BOSULIF	EQ 100MG BASE	TABLET / ORAL		RLD, RS	2012-09-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203341-002	BOSULIF	EQ 500MG BASE	TABLET / ORAL		RLD	2012-09-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203341-003	BOSULIF	EQ 400MG BASE	TABLET / ORAL		RLD	2017-10-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203341-001	BOSULIF	EQ 100MG BASE	TABLET / ORAL		RLD, RS	2012-09-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203341-002	BOSULIF	EQ 500MG BASE	TABLET / ORAL		RLD	2012-09-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203341-003	BOSULIF	EQ 400MG BASE	TABLET / ORAL		RLD	2017-10-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203341-001	BOSULIF	EQ 100MG BASE	TABLET / ORAL		RLD, RS	2012-09-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203341-002	BOSULIF	EQ 500MG BASE	TABLET / ORAL		RLD	2012-09-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203341-003	BOSULIF	EQ 400MG BASE	TABLET / ORAL		RLD	2017-10-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N203341-001	BOSULIF	EQ 100MG BASE	TABLET / ORAL		RLD, RS	2012-09-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N203341-002	BOSULIF	EQ 500MG BASE	TABLET / ORAL		RLD	2012-09-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N203341-003	BOSULIF	EQ 400MG BASE	TABLET / ORAL		RLD	2017-10-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N203341-001	BOSULIF	EQ 100MG BASE	TABLET / ORAL		RLD, RS	2012-09-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N203341-002	BOSULIF	EQ 500MG BASE	TABLET / ORAL		RLD	2012-09-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N203341-003	BOSULIF	EQ 400MG BASE	TABLET / ORAL		RLD	2017-10-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N203341-001	BOSULIF	EQ 100MG BASE	TABLET / ORAL		RLD, RS	2012-09-04	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N203341-002	BOSULIF	EQ 500MG BASE	TABLET / ORAL		RLD	2012-09-04	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N203341-003	BOSULIF	EQ 400MG BASE	TABLET / ORAL		RLD	2017-10-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N203341-001	BOSULIF	EQ 100MG BASE	TABLET / ORAL		RLD, RS	2012-09-04	`301d65b070ca…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	N203341-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203341-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203341-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N203341-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203341-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203341-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N203341-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203341-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203341-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203341-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N203341-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203341-002	AB	1	`6a471c1ec25d…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N203341-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N203341-002	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N203341-003	AB	1	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 29 · 1,134 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N203341-001	7417148	2025-12-11	U-1283		2012-09-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203341-001	7417148	2025-12-11	U-3708		2012-09-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203341-001	7417148	2025-12-11	U-3707		2012-09-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203341-001	7919625	2025-12-11		Drug product	2012-09-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203341-001	7417148*PED	2026-06-11		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203341-001	7919625*PED	2026-06-11		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203341-001	7767678	2026-11-23		Drug substance, Drug product	2012-09-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203341-001	7767678*PED	2027-05-23		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203341-001	11103497	2034-02-28	U-3216		2021-09-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203341-001	11103497	2034-02-28	U-3217		2021-09-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203341-001	11103497*PED	2034-08-28		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203341-002	7417148	2025-12-11	U-1283			`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203341-002	7417148	2025-12-11	U-3707			`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203341-002	7417148	2025-12-11	U-3708			`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203341-002	7919625	2025-12-11		Drug product		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203341-002	7417148*PED	2026-06-11		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203341-002	7919625*PED	2026-06-11		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203341-002	7767678	2026-11-23		Drug substance, Drug product		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203341-002	7767678*PED	2027-05-23		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203341-002	11103497	2034-02-28	U-3216		2021-09-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203341-002	11103497	2034-02-28	U-3217		2021-09-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203341-002	11103497*PED	2034-08-28		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203341-003	7417148	2025-12-11	U-1283		2017-11-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203341-003	7417148	2025-12-11	U-3708		2017-11-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203341-003	7417148	2025-12-11	U-3707		2017-11-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203341-003	7919625	2025-12-11		Drug product	2017-11-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203341-003	7417148*PED	2026-06-11		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203341-003	7919625*PED	2026-06-11		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203341-003	7767678	2026-11-23		Drug substance, Drug product	2017-11-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203341-003	7767678*PED	2027-05-23		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203341-003	11103497	2034-02-28	U-3216		2021-09-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203341-003	11103497	2034-02-28	U-3217		2021-09-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203341-003	11103497*PED	2034-08-28		Pediatric extension		`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N203341-001	7417148	2025-12-11	U-1283		2012-09-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203341-001	7417148	2025-12-11	U-3708		2012-09-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203341-001	7417148	2025-12-11	U-3707		2012-09-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203341-001	7919625	2025-12-11		Drug product	2012-09-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203341-001	7417148*PED	2026-06-11		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203341-001	7919625*PED	2026-06-11		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203341-001	7767678	2026-11-23		Drug substance, Drug product	2012-09-25	`caaa826d4ba7…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 12 · 453 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-09-14 22:38:34	2026-08	N203341-001	I-923	2026-09-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203341-001	PED	2027-03-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203341-001	ODE-444	2030-09-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203341-001	PED	2031-03-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203341-002	I-923	2026-09-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203341-002	PED	2027-03-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203341-002	ODE-444	2030-09-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203341-002	PED	2031-03-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203341-003	I-923	2026-09-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203341-003	PED	2027-03-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203341-003	ODE-444	2030-09-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203341-003	PED	2031-03-26	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N203341-001	I-923	2026-09-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203341-001	PED	2027-03-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203341-001	ODE-444	2030-09-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203341-001	PED	2031-03-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203341-002	I-923	2026-09-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203341-002	PED	2027-03-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203341-002	ODE-444	2030-09-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203341-002	PED	2031-03-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203341-003	I-923	2026-09-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203341-003	PED	2027-03-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203341-003	ODE-444	2030-09-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203341-003	PED	2031-03-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N203341-001	I-923	2026-09-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203341-001	PED	2027-03-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203341-001	ODE-444	2030-09-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203341-001	PED	2031-03-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203341-002	I-923	2026-09-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203341-002	PED	2027-03-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203341-002	ODE-444	2030-09-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203341-002	PED	2031-03-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203341-003	I-923	2026-09-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203341-003	PED	2027-03-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203341-003	ODE-444	2030-09-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203341-003	PED	2031-03-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203341-001	ODE-163	2024-12-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203341-001	PED	2025-06-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203341-001	I-923	2026-09-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203341-001	PED	2027-03-26	`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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
BOSULIF	BOSUTINIB	U.S. Pharmaceuticals	d5929f91-6496-4c0e-97e8-0bd524e15763	2026-05-28	Warnings, Adverse reactions	Exact identifier application applno (NDA): 203341 application number: NDA203341 ndc (product): 63539-193 ndc (product): 63539-117
BOSULIF	BOSUTINIB	Pfizer Laboratories Div Pfizer Inc	adc84ad5-a04d-4fee-9ba8-91f7abd928e3	2026-03-10	Warnings, Adverse reactions	Exact identifier application applno (NDA): 203341 application number: NDA203341 ndc (product): 0069-0136 ndc (product): 0069-0193 ndc (product): 0069-0135

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 28 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0069-0135	BOSULIF	Bosutinib monohydrate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0135	BOSULIF	Bosutinib monohydrate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0135	BOSULIF	Bosutinib monohydrate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0135	BOSULIF	Bosutinib monohydrate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0135	BOSULIF	Bosutinib monohydrate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0135	BOSULIF	Bosutinib monohydrate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0135	BOSULIF	Bosutinib monohydrate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0135	BOSULIF	Bosutinib monohydrate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0136	BOSULIF	Bosutinib monohydrate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0136	BOSULIF	Bosutinib monohydrate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0136	BOSULIF	Bosutinib monohydrate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0136	BOSULIF	Bosutinib monohydrate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0136	BOSULIF	Bosutinib monohydrate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0136	BOSULIF	Bosutinib monohydrate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0136	BOSULIF	Bosutinib monohydrate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0136	BOSULIF	Bosutinib monohydrate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0193	BOSULIF	Bosutinib monohydrate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0193	BOSULIF	Bosutinib monohydrate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0193	BOSULIF	Bosutinib monohydrate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0193	BOSULIF	Bosutinib monohydrate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0193	BOSULIF	Bosutinib monohydrate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0193	BOSULIF	Bosutinib monohydrate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0193	BOSULIF	Bosutinib monohydrate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0193	BOSULIF	Bosutinib monohydrate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
63539-117	BOSULIF	Bosutinib	U.S. Pharmaceuticals	NDA	Current
63539-117	BOSULIF	Bosutinib monohydrate	U.S. Pharmaceuticals	NDA	Current
63539-117	BOSULIF	Bosutinib monohydrate	U.S. Pharmaceuticals	NDA	Current
63539-193	BOSULIF	Bosutinib	U.S. Pharmaceuticals	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
85286	SUPPL	2026-03-06
85262	SUPPL	2026-03-04
80522	SUPPL	2024-12-05
80496	SUPPL	2024-12-04
75572	SUPPL	2023-09-27
75570	SUPPL	2023-09-26
74044	SUPPL	2023-04-24
74036	SUPPL	2023-04-21
67511	SUPPL	2021-05-17
67489	SUPPL	2021-05-14
63616	SUPPL	2020-06-18
63613	SUPPL	2020-06-18
60530	SUPPL	2019-10-10
60517	SUPPL	2019-10-10
59724	SUPPL	2019-08-15
59705	SUPPL	2019-08-15
56079	SUPPL	2018-10-23
56045	SUPPL	2018-10-19
54001	SUPPL	2018-05-03
50884	SUPPL	2017-12-27
50777	SUPPL	2017-12-19
48050	SUPPL	2017-04-18
48049	SUPPL	2017-04-18
48040	SUPPL	2017-04-14
48039	SUPPL	2017-04-14
45907	SUPPL	2016-11-18
45909	SUPPL	2016-11-17
32414	SUPPL	2016-04-06
19460	SUPPL	2016-04-05
19459	SUPPL	2015-10-06
10199	SUPPL	2015-09-24
40289	SUPPL	2015-01-05
32413	SUPPL	2014-11-28
32412	SUPPL	2013-10-01
40288	SUPPL	2013-09-30
24432	ORIG	2012-09-13
22921	ORIG	2012-09-13
10198	ORIG	2012-09-06
19458	ORIG	2012-09-04