Application 021986

Type: NDA
Sponsor: BRISTOL MYERS SQUIBB

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SPRYCEL	DASATINIB	TABLET;ORAL	20MG	Yes	No
002	SPRYCEL	DASATINIB	TABLET;ORAL	50MG	Yes	No
003	SPRYCEL	DASATINIB	TABLET;ORAL	70MG	Yes	No
004	SPRYCEL	DASATINIB	TABLET;ORAL	100MG	Yes	Yes
005	SPRYCEL	DASATINIB	TABLET;ORAL	80MG	Yes	No
006	SPRYCEL	DASATINIB	TABLET;ORAL	140MG	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N021986-001	SPRYCEL	DASATINIB	20MG	TABLET / ORAL	AB	RLD	2006-06-28
N021986-002	SPRYCEL	DASATINIB	50MG	TABLET / ORAL	AB	RLD	2006-06-28
N021986-003	SPRYCEL	DASATINIB	70MG	TABLET / ORAL	AB	RLD	2006-06-28
N021986-004	SPRYCEL	DASATINIB	100MG	TABLET / ORAL	AB	RLD, RS	2008-05-30
N021986-005	SPRYCEL	DASATINIB	80MG	TABLET / ORAL	AB	RLD	2010-10-28
N021986-006	SPRYCEL	DASATINIB	140MG	TABLET / ORAL	AB	RLD	2010-10-28

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 6 matching rows.

Application-product, TE code table
Application-product	TE code
N021986-001	AB
N021986-002	AB
N021986-003	AB
N021986-004	AB
N021986-005	AB
N021986-006	AB

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Coverage / status
N021986-001	7491725	2026-03-28	Drug substance, Drug product
N021986-001	7491725*PED	2026-09-28	Pediatric extension
N021986-002	7491725	2026-03-28	Drug substance, Drug product
N021986-002	7491725*PED	2026-09-28	Pediatric extension
N021986-003	7491725	2026-03-28	Drug substance, Drug product
N021986-003	7491725*PED	2026-09-28	Pediatric extension
N021986-004	7491725	2026-03-28	Drug substance, Drug product
N021986-004	7491725*PED	2026-09-28	Pediatric extension
N021986-005	7491725	2026-03-28	Drug substance, Drug product
N021986-005	7491725*PED	2026-09-28	Pediatric extension
N021986-006	7491725	2026-03-28	Drug substance, Drug product
N021986-006	7491725*PED	2026-09-28	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
N021986-001	ODE-225	2025-12-21
N021986-001	PED	2026-06-21
N021986-002	ODE-225	2025-12-21
N021986-002	PED	2026-06-21
N021986-003	ODE-225	2025-12-21
N021986-003	PED	2026-06-21
N021986-004	ODE-225	2025-12-21
N021986-004	PED	2026-06-21
N021986-005	ODE-225	2025-12-21
N021986-005	PED	2026-06-21
N021986-006	ODE-225	2025-12-21
N021986-006	PED	2026-06-21

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 7 · 246 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
2026-02-19 14:30 UTC	2026-02	N021986-001	SPRYCEL	20MG	TABLET / ORAL	AB	RLD	2006-06-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021986-002	SPRYCEL	50MG	TABLET / ORAL	AB	RLD	2006-06-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021986-003	SPRYCEL	70MG	TABLET / ORAL	AB	RLD	2006-06-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021986-004	SPRYCEL	100MG	TABLET / ORAL	AB	RLD, RS	2008-05-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021986-005	SPRYCEL	80MG	TABLET / ORAL	AB	RLD	2010-10-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021986-006	SPRYCEL	140MG	TABLET / ORAL	AB	RLD	2010-10-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021986-001	SPRYCEL	20MG	TABLET / ORAL	AB	RLD	2006-06-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021986-002	SPRYCEL	50MG	TABLET / ORAL	AB	RLD	2006-06-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021986-003	SPRYCEL	70MG	TABLET / ORAL	AB	RLD	2006-06-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021986-004	SPRYCEL	100MG	TABLET / ORAL	AB	RLD, RS	2008-05-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021986-005	SPRYCEL	80MG	TABLET / ORAL	AB	RLD	2010-10-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021986-006	SPRYCEL	140MG	TABLET / ORAL	AB	RLD	2010-10-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021986-001	SPRYCEL	20MG	TABLET / ORAL	AB	RLD	2006-06-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021986-002	SPRYCEL	50MG	TABLET / ORAL	AB	RLD	2006-06-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021986-003	SPRYCEL	70MG	TABLET / ORAL	AB	RLD	2006-06-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021986-004	SPRYCEL	100MG	TABLET / ORAL	AB	RLD, RS	2008-05-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021986-005	SPRYCEL	80MG	TABLET / ORAL	AB	RLD	2010-10-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021986-006	SPRYCEL	140MG	TABLET / ORAL	AB	RLD	2010-10-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021986-001	SPRYCEL	20MG	TABLET / ORAL	AB	RLD	2006-06-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021986-002	SPRYCEL	50MG	TABLET / ORAL	AB	RLD	2006-06-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021986-003	SPRYCEL	70MG	TABLET / ORAL	AB	RLD	2006-06-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021986-004	SPRYCEL	100MG	TABLET / ORAL	AB	RLD, RS	2008-05-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021986-005	SPRYCEL	80MG	TABLET / ORAL	AB	RLD	2010-10-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021986-006	SPRYCEL	140MG	TABLET / ORAL	AB	RLD	2010-10-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021986-001	SPRYCEL	20MG	TABLET / ORAL	AB	RLD	2006-06-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021986-002	SPRYCEL	50MG	TABLET / ORAL	AB	RLD	2006-06-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021986-003	SPRYCEL	70MG	TABLET / ORAL	AB	RLD	2006-06-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021986-004	SPRYCEL	100MG	TABLET / ORAL	AB	RLD, RS	2008-05-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021986-005	SPRYCEL	80MG	TABLET / ORAL	AB	RLD	2010-10-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021986-006	SPRYCEL	140MG	TABLET / ORAL	AB	RLD	2010-10-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021986-001	SPRYCEL	20MG	TABLET / ORAL	AB	RLD	2006-06-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021986-002	SPRYCEL	50MG	TABLET / ORAL	AB	RLD	2006-06-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021986-003	SPRYCEL	70MG	TABLET / ORAL	AB	RLD	2006-06-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021986-004	SPRYCEL	100MG	TABLET / ORAL	AB	RLD, RS	2008-05-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021986-005	SPRYCEL	80MG	TABLET / ORAL	AB	RLD	2010-10-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021986-006	SPRYCEL	140MG	TABLET / ORAL	AB	RLD	2010-10-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021986-001	SPRYCEL	20MG	TABLET / ORAL	AB	RLD	2006-06-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021986-002	SPRYCEL	50MG	TABLET / ORAL	AB	RLD	2006-06-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021986-003	SPRYCEL	70MG	TABLET / ORAL	AB	RLD	2006-06-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021986-004	SPRYCEL	100MG	TABLET / ORAL	AB	RLD, RS	2008-05-30	`2680178bc6a6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 74 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N021986-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021986-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021986-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021986-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021986-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021986-006	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021986-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021986-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021986-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021986-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021986-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021986-006	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021986-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021986-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021986-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021986-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021986-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021986-006	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021986-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021986-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021986-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021986-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021986-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021986-006	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021986-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021986-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021986-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021986-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021986-005	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021986-006	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021986-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021986-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021986-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021986-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021986-005	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021986-006	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021986-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021986-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021986-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021986-004	AB	1	`2680178bc6a6…`

Observed Orange Book patent history#

Patent history page 1 of 32 · 1,248 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N021986-001	7491725	2026-03-28	Drug substance, Drug product		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021986-001	7491725*PED	2026-09-28	Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021986-002	7491725	2026-03-28	Drug substance, Drug product		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021986-002	7491725*PED	2026-09-28	Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021986-003	7491725	2026-03-28	Drug substance, Drug product		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021986-003	7491725*PED	2026-09-28	Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021986-004	7491725	2026-03-28	Drug substance, Drug product		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021986-004	7491725*PED	2026-09-28	Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021986-005	7491725	2026-03-28	Drug substance, Drug product		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021986-005	7491725*PED	2026-09-28	Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021986-006	7491725	2026-03-28	Drug substance, Drug product		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021986-006	7491725*PED	2026-09-28	Pediatric extension		`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021986-001	8680103	2025-02-04	Drug product	2014-04-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021986-001	8680103*PED	2025-08-04	Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021986-001	7491725	2026-03-28	Drug substance, Drug product		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021986-001	7491725*PED	2026-09-28	Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021986-002	8680103	2025-02-04	Drug product	2014-04-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021986-002	8680103*PED	2025-08-04	Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021986-002	7491725	2026-03-28	Drug substance, Drug product		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021986-002	7491725*PED	2026-09-28	Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021986-003	8680103	2025-02-04	Drug product	2014-04-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021986-003	8680103*PED	2025-08-04	Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021986-003	7491725	2026-03-28	Drug substance, Drug product		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021986-003	7491725*PED	2026-09-28	Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021986-004	8680103	2025-02-04	Drug product	2014-04-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021986-004	8680103*PED	2025-08-04	Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021986-004	7491725	2026-03-28	Drug substance, Drug product		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021986-004	7491725*PED	2026-09-28	Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021986-005	8680103	2025-02-04	Drug product	2014-04-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021986-005	8680103*PED	2025-08-04	Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021986-005	7491725	2026-03-28	Drug substance, Drug product		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021986-005	7491725*PED	2026-09-28	Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021986-006	8680103	2025-02-04	Drug product	2014-04-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021986-006	8680103*PED	2025-08-04	Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021986-006	7491725	2026-03-28	Drug substance, Drug product		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021986-006	7491725*PED	2026-09-28	Pediatric extension		`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021986-001	8680103	2025-02-04	Drug product	2014-04-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021986-001	8680103*PED	2025-08-04	Pediatric extension		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021986-001	7491725	2026-03-28	Drug substance, Drug product		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021986-001	7491725*PED	2026-09-28	Pediatric extension		`6a471c1ec25d…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 31 · 1,212 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N021986-001	ODE-225	2025-12-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021986-001	PED	2026-06-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021986-002	ODE-225	2025-12-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021986-002	PED	2026-06-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021986-003	ODE-225	2025-12-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021986-003	PED	2026-06-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021986-004	ODE-225	2025-12-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021986-004	PED	2026-06-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021986-005	ODE-225	2025-12-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021986-005	PED	2026-06-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021986-006	ODE-225	2025-12-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021986-006	PED	2026-06-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021986-001	ODE-164	2024-11-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021986-001	PED	2025-05-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021986-001	ODE-225	2025-12-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021986-001	PED	2026-06-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021986-002	ODE-164	2024-11-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021986-002	PED	2025-05-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021986-002	ODE-225	2025-12-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021986-002	PED	2026-06-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021986-003	ODE-164	2024-11-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021986-003	PED	2025-05-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021986-003	ODE-225	2025-12-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021986-003	PED	2026-06-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021986-004	ODE-164	2024-11-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021986-004	PED	2025-05-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021986-004	ODE-225	2025-12-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021986-004	PED	2026-06-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021986-005	ODE-164	2024-11-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021986-005	PED	2025-05-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021986-005	ODE-225	2025-12-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021986-005	PED	2026-06-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021986-006	ODE-164	2024-11-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021986-006	PED	2025-05-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021986-006	ODE-225	2025-12-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021986-006	PED	2026-06-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021986-001	ODE-164	2024-11-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021986-001	PED	2025-05-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021986-001	ODE-225	2025-12-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021986-001	PED	2026-06-21	`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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
SPRYCEL	DASATINIB	E.R. Squibb & Sons, L.L.C.	4764f37b-c9e6-4ede-bcc2-8a03b7c521df	2024-07-31	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021986 application number: NDA021986 ndc (product): 0003-0852 ndc (product): 0003-0524 ndc (product): 0003-0857 ndc (product): 0003-0528 ndc (product): 0003-0855 ndc (product): 0003-0527
Dasatinib	DASATINIB	Prasco Laboratories	1931e73f-918c-4d69-9543-de9643513d05	2024-07-09	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021986 application number: NDA021986

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 42 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0003-0524	SPRYCEL	dasatinib	E.R. Squibb & Sons, L.L.C.	NDA	Current
0003-0524	SPRYCEL	dasatinib	E.R. Squibb & Sons, L.L.C.	NDA	Current
0003-0524	SPRYCEL	dasatinib	E.R. Squibb & Sons, L.L.C.	NDA	Current
0003-0524	SPRYCEL	dasatinib	E.R. Squibb & Sons, L.L.C.	NDA	Current
0003-0524	SPRYCEL	dasatinib	E.R. Squibb & Sons, L.L.C.	NDA	Current
0003-0524	SPRYCEL	dasatinib	E.R. Squibb & Sons, L.L.C.	NDA	Current
0003-0524	SPRYCEL	dasatinib	E.R. Squibb & Sons, L.L.C.	NDA	Current
0003-0527	SPRYCEL	dasatinib	E.R. Squibb & Sons, L.L.C.	NDA	Current
0003-0527	SPRYCEL	dasatinib	E.R. Squibb & Sons, L.L.C.	NDA	Current
0003-0527	SPRYCEL	dasatinib	E.R. Squibb & Sons, L.L.C.	NDA	Current
0003-0527	SPRYCEL	dasatinib	E.R. Squibb & Sons, L.L.C.	NDA	Current
0003-0527	SPRYCEL	dasatinib	E.R. Squibb & Sons, L.L.C.	NDA	Current
0003-0527	SPRYCEL	dasatinib	E.R. Squibb & Sons, L.L.C.	NDA	Current
0003-0527	SPRYCEL	dasatinib	E.R. Squibb & Sons, L.L.C.	NDA	Current
0003-0528	SPRYCEL	dasatinib	E.R. Squibb & Sons, L.L.C.	NDA	Current
0003-0528	SPRYCEL	dasatinib	E.R. Squibb & Sons, L.L.C.	NDA	Current
0003-0528	SPRYCEL	dasatinib	E.R. Squibb & Sons, L.L.C.	NDA	Current
0003-0528	SPRYCEL	dasatinib	E.R. Squibb & Sons, L.L.C.	NDA	Current
0003-0528	SPRYCEL	dasatinib	E.R. Squibb & Sons, L.L.C.	NDA	Current
0003-0528	SPRYCEL	dasatinib	E.R. Squibb & Sons, L.L.C.	NDA	Current
0003-0528	SPRYCEL	dasatinib	E.R. Squibb & Sons, L.L.C.	NDA	Current
0003-0852	SPRYCEL	dasatinib	E.R. Squibb & Sons, L.L.C.	NDA	Current
0003-0852	SPRYCEL	dasatinib	E.R. Squibb & Sons, L.L.C.	NDA	Current
0003-0852	SPRYCEL	dasatinib	E.R. Squibb & Sons, L.L.C.	NDA	Current
0003-0852	SPRYCEL	dasatinib	E.R. Squibb & Sons, L.L.C.	NDA	Current
0003-0852	SPRYCEL	dasatinib	E.R. Squibb & Sons, L.L.C.	NDA	Current
0003-0852	SPRYCEL	dasatinib	E.R. Squibb & Sons, L.L.C.	NDA	Current
0003-0852	SPRYCEL	dasatinib	E.R. Squibb & Sons, L.L.C.	NDA	Current
0003-0855	SPRYCEL	dasatinib	E.R. Squibb & Sons, L.L.C.	NDA	Current
0003-0855	SPRYCEL	dasatinib	E.R. Squibb & Sons, L.L.C.	NDA	Current
0003-0855	SPRYCEL	dasatinib	E.R. Squibb & Sons, L.L.C.	NDA	Current
0003-0855	SPRYCEL	dasatinib	E.R. Squibb & Sons, L.L.C.	NDA	Current
0003-0855	SPRYCEL	dasatinib	E.R. Squibb & Sons, L.L.C.	NDA	Current
0003-0855	SPRYCEL	dasatinib	E.R. Squibb & Sons, L.L.C.	NDA	Current
0003-0855	SPRYCEL	dasatinib	E.R. Squibb & Sons, L.L.C.	NDA	Current
0003-0857	SPRYCEL	dasatinib	E.R. Squibb & Sons, L.L.C.	NDA	Current
0003-0857	SPRYCEL	dasatinib	E.R. Squibb & Sons, L.L.C.	NDA	Current
0003-0857	SPRYCEL	dasatinib	E.R. Squibb & Sons, L.L.C.	NDA	Current
0003-0857	SPRYCEL	dasatinib	E.R. Squibb & Sons, L.L.C.	NDA	Current
0003-0857	SPRYCEL	dasatinib	E.R. Squibb & Sons, L.L.C.	NDA	Current
0003-0857	SPRYCEL	dasatinib	E.R. Squibb & Sons, L.L.C.	NDA	Current
0003-0857	SPRYCEL	dasatinib	E.R. Squibb & Sons, L.L.C.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
79280	SUPPL	2024-08-02
79266	SUPPL	2024-08-02
73440	SUPPL	2023-02-09
73422	SUPPL	2023-02-09
67986	SUPPL	2021-06-30
67984	SUPPL	2021-06-30
57067	SUPPL	2018-12-30
57019	SUPPL	2018-12-26
56690	SUPPL	2018-12-07
56539	SUPPL	2018-11-23
50427	SUPPL	2017-11-15
50407	SUPPL	2017-11-14
49412	SUPPL	2017-08-15
49354	SUPPL	2017-08-14
45490	SUPPL	2016-09-30
45426	SUPPL	2016-09-29
28986	SUPPL	2015-08-14
6597	SUPPL	2015-08-14
38004	SUPPL	2015-08-13
16697	SUPPL	2015-08-13
38003	SUPPL	2014-05-12
6596	SUPPL	2014-04-14
28985	SUPPL	2013-06-18
38002	SUPPL	2013-06-17
28984	SUPPL	2011-10-13
6595	SUPPL	2011-10-13
38001	SUPPL	2011-10-12
16696	SUPPL	2011-10-12
42369	SUPPL	2011-09-22
21896	SUPPL	2011-09-22
28983	SUPPL	2010-11-03
6594	SUPPL	2010-11-03
38000	SUPPL	2010-10-28
16695	SUPPL	2010-10-28
28982	SUPPL	2010-08-09
37999	SUPPL	2010-07-31
6593	SUPPL	2009-05-29
16694	SUPPL	2009-05-25
6592	SUPPL	2008-06-03
28981	SUPPL	2007-11-19
6591	SUPPL	2007-11-19
37998	SUPPL	2007-11-13
21895	ORIG	2006-09-06
28980	ORIG	2006-07-03
16693	ORIG	2006-07-03
62938	SUPPL	1900-01-01
62937	SUPPL	1900-01-01