Application 212608

Type: NDA
Sponsor: BLUEPRINT MEDICINES

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	AYVAKIT	AVAPRITINIB	TABLET;ORAL	100MG	Yes	No
002	AYVAKIT	AVAPRITINIB	TABLET;ORAL	200MG	Yes	No
003	AYVAKIT	AVAPRITINIB	TABLET;ORAL	300MG	Yes	Yes
004	AYVAKIT	AVAPRITINIB	TABLET;ORAL	25MG	Yes	No
005	AYVAKIT	AVAPRITINIB	TABLET;ORAL	50MG	Yes	No

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

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N212608-001	AYVAKIT	AVAPRITINIB	100MG	TABLET / ORAL	RLD	2020-01-09
N212608-002	AYVAKIT	AVAPRITINIB	200MG	TABLET / ORAL	RLD	2020-01-09
N212608-003	AYVAKIT	AVAPRITINIB	300MG	TABLET / ORAL	RLD, RS	2020-01-09
N212608-004	AYVAKIT	AVAPRITINIB	25MG	TABLET / ORAL	RLD	2021-06-16
N212608-005	AYVAKIT	AVAPRITINIB	50MG	TABLET / ORAL	RLD	2021-06-16

Orange Book patents#

Current patent rows page 1 of 1 · 39 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N212608-001	9200002	2034-10-15	U-2726	Drug substance, Drug product	2020-02-05
N212608-001	9200002	2034-10-15	U-3168	Drug substance, Drug product	2020-02-05
N212608-001	9944651	2034-10-15	U-2726	Drug substance, Drug product	2020-02-05
N212608-001	9944651	2034-10-15	U-3168	Drug substance, Drug product	2020-02-05
N212608-001	9994575	2034-10-15	U-2726	Drug substance, Drug product	2020-02-05
N212608-001	9994575	2034-10-15	U-3168	Drug substance, Drug product	2020-02-05
N212608-001	11964980	2040-04-10		Drug substance, Drug product	2024-04-23
N212608-001	11999744	2040-04-10	U-3168		2024-06-05
N212608-001	12060354	2042-03-08	U-2726		2024-08-14
N212608-002	9200002	2034-10-15	U-2726	Drug substance, Drug product	2020-02-05
N212608-002	9200002	2034-10-15	U-3168	Drug substance, Drug product	2020-02-05
N212608-002	9944651	2034-10-15	U-2726	Drug substance, Drug product	2020-02-05
N212608-002	9944651	2034-10-15	U-3168	Drug substance, Drug product	2020-02-05
N212608-002	9994575	2034-10-15	U-2726	Drug substance, Drug product	2020-02-05
N212608-002	9994575	2034-10-15	U-3168	Drug substance, Drug product	2020-02-05
N212608-002	11964980	2040-04-10		Drug substance, Drug product	2024-04-23
N212608-002	11999744	2040-04-10	U-3168		2024-06-05
N212608-002	12060354	2042-03-08	U-2726		2024-08-14
N212608-003	9200002	2034-10-15	U-2726	Drug substance, Drug product	2020-02-05
N212608-003	9944651	2034-10-15	U-2726	Drug substance, Drug product	2020-02-05
N212608-003	9994575	2034-10-15	U-2726	Drug substance, Drug product	2020-02-05
N212608-003	11964980	2040-04-10		Drug substance, Drug product	2024-04-23
N212608-003	12060354	2042-03-08	U-2726		2024-08-14
N212608-004	11827642	2034-10-15	U-3506	Drug substance, Drug product	2023-12-21
N212608-004	9200002	2034-10-15	U-3168	Drug substance, Drug product	2021-07-13
N212608-004	9200002	2034-10-15	U-3506	Drug substance, Drug product	2021-07-13
N212608-004	9944651	2034-10-15	U-3168	Drug substance, Drug product	2021-07-13
N212608-004	9944651	2034-10-15	U-3506	Drug substance, Drug product	2021-07-13
N212608-004	9994575	2034-10-15	U-3168	Drug substance, Drug product	2021-07-13
N212608-004	9994575	2034-10-15	U-3506	Drug substance, Drug product	2021-07-13
N212608-004	11964980	2040-04-10		Drug substance, Drug product	2024-04-23
N212608-004	11999744	2040-04-10	U-3168		2024-06-05
N212608-004	11999744	2040-04-10	U-3506		2024-06-05
N212608-004	12252494	2040-04-10	U-3506		2025-04-16
N212608-005	9200002	2034-10-15	U-3168	Drug substance, Drug product	2021-07-13
N212608-005	9944651	2034-10-15	U-3168	Drug substance, Drug product	2021-07-13
N212608-005	9994575	2034-10-15	U-3168	Drug substance, Drug product	2021-07-13
N212608-005	11964980	2040-04-10		Drug substance, Drug product	2024-04-23
N212608-005	11999744	2040-04-10	U-3168		2024-06-05

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N212608-001	ODE-366	2027-01-09
N212608-001	ODE-356	2028-06-16
N212608-001	ODE-434	2030-05-22
N212608-002	ODE-366	2027-01-09
N212608-002	ODE-356	2028-06-16
N212608-002	ODE-434	2030-05-22
N212608-003	ODE-366	2027-01-09
N212608-003	ODE-356	2028-06-16
N212608-003	ODE-434	2030-05-22
N212608-004	I-912	2026-05-22
N212608-004	ODE-366	2027-01-09
N212608-004	ODE-356	2028-06-16
N212608-004	ODE-434	2030-05-22
N212608-005	ODE-366	2027-01-09
N212608-005	ODE-356	2028-06-16
N212608-005	ODE-434	2030-05-22

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 5 · 177 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N212608-001	AYVAKIT	100MG	TABLET / ORAL	RLD	2020-01-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212608-002	AYVAKIT	200MG	TABLET / ORAL	RLD	2020-01-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212608-003	AYVAKIT	300MG	TABLET / ORAL	RLD, RS	2020-01-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212608-004	AYVAKIT	25MG	TABLET / ORAL	RLD	2021-06-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212608-005	AYVAKIT	50MG	TABLET / ORAL	RLD	2021-06-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212608-001	AYVAKIT	100MG	TABLET / ORAL	RLD	2020-01-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212608-002	AYVAKIT	200MG	TABLET / ORAL	RLD	2020-01-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212608-003	AYVAKIT	300MG	TABLET / ORAL	RLD, RS	2020-01-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212608-004	AYVAKIT	25MG	TABLET / ORAL	RLD	2021-06-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212608-005	AYVAKIT	50MG	TABLET / ORAL	RLD	2021-06-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N212608-001	AYVAKIT	100MG	TABLET / ORAL	RLD	2020-01-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212608-002	AYVAKIT	200MG	TABLET / ORAL	RLD	2020-01-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212608-003	AYVAKIT	300MG	TABLET / ORAL	RLD, RS	2020-01-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212608-004	AYVAKIT	25MG	TABLET / ORAL	RLD	2021-06-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212608-005	AYVAKIT	50MG	TABLET / ORAL	RLD	2021-06-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212608-001	AYVAKIT	100MG	TABLET / ORAL	RLD	2020-01-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212608-002	AYVAKIT	200MG	TABLET / ORAL	RLD	2020-01-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212608-003	AYVAKIT	300MG	TABLET / ORAL	RLD, RS	2020-01-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212608-004	AYVAKIT	25MG	TABLET / ORAL	RLD	2021-06-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212608-005	AYVAKIT	50MG	TABLET / ORAL	RLD	2021-06-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212608-001	AYVAKIT	100MG	TABLET / ORAL	RLD	2020-01-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212608-002	AYVAKIT	200MG	TABLET / ORAL	RLD	2020-01-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212608-003	AYVAKIT	300MG	TABLET / ORAL	RLD, RS	2020-01-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212608-004	AYVAKIT	25MG	TABLET / ORAL	RLD	2021-06-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212608-005	AYVAKIT	50MG	TABLET / ORAL	RLD	2021-06-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212608-001	AYVAKIT	100MG	TABLET / ORAL	RLD	2020-01-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212608-002	AYVAKIT	200MG	TABLET / ORAL	RLD	2020-01-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212608-003	AYVAKIT	300MG	TABLET / ORAL	RLD, RS	2020-01-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212608-004	AYVAKIT	25MG	TABLET / ORAL	RLD	2021-06-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212608-005	AYVAKIT	50MG	TABLET / ORAL	RLD	2021-06-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212608-001	AYVAKIT	100MG	TABLET / ORAL	RLD	2020-01-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212608-002	AYVAKIT	200MG	TABLET / ORAL	RLD	2020-01-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212608-003	AYVAKIT	300MG	TABLET / ORAL	RLD, RS	2020-01-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212608-004	AYVAKIT	25MG	TABLET / ORAL	RLD	2021-06-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212608-005	AYVAKIT	50MG	TABLET / ORAL	RLD	2021-06-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212608-001	AYVAKIT	100MG	TABLET / ORAL	RLD	2020-01-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212608-002	AYVAKIT	200MG	TABLET / ORAL	RLD	2020-01-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212608-003	AYVAKIT	300MG	TABLET / ORAL	RLD, RS	2020-01-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212608-004	AYVAKIT	25MG	TABLET / ORAL	RLD	2021-06-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212608-005	AYVAKIT	50MG	TABLET / ORAL	RLD	2021-06-16	`5bbf6a4d5a75…`

Observed Orange Book patent history#

Patent history page 1 of 25 · 991 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N212608-001	9200002	2034-10-15	U-2726	Drug substance, Drug product	2020-02-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212608-001	9200002	2034-10-15	U-3168	Drug substance, Drug product	2020-02-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212608-001	9944651	2034-10-15	U-2726	Drug substance, Drug product	2020-02-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212608-001	9944651	2034-10-15	U-3168	Drug substance, Drug product	2020-02-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212608-001	9994575	2034-10-15	U-2726	Drug substance, Drug product	2020-02-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212608-001	9994575	2034-10-15	U-3168	Drug substance, Drug product	2020-02-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212608-001	11964980	2040-04-10		Drug substance, Drug product	2024-04-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212608-001	11999744	2040-04-10	U-3168		2024-06-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212608-001	12060354	2042-03-08	U-2726		2024-08-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212608-002	9200002	2034-10-15	U-2726	Drug substance, Drug product	2020-02-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212608-002	9200002	2034-10-15	U-3168	Drug substance, Drug product	2020-02-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212608-002	9944651	2034-10-15	U-2726	Drug substance, Drug product	2020-02-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212608-002	9944651	2034-10-15	U-3168	Drug substance, Drug product	2020-02-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212608-002	9994575	2034-10-15	U-2726	Drug substance, Drug product	2020-02-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212608-002	9994575	2034-10-15	U-3168	Drug substance, Drug product	2020-02-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212608-002	11964980	2040-04-10		Drug substance, Drug product	2024-04-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212608-002	11999744	2040-04-10	U-3168		2024-06-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212608-002	12060354	2042-03-08	U-2726		2024-08-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212608-003	9200002	2034-10-15	U-2726	Drug substance, Drug product	2020-02-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212608-003	9944651	2034-10-15	U-2726	Drug substance, Drug product	2020-02-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212608-003	9994575	2034-10-15	U-2726	Drug substance, Drug product	2020-02-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212608-003	11964980	2040-04-10		Drug substance, Drug product	2024-04-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212608-003	12060354	2042-03-08	U-2726		2024-08-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212608-004	11827642	2034-10-15	U-3506	Drug substance, Drug product	2023-12-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212608-004	9200002	2034-10-15	U-3168	Drug substance, Drug product	2021-07-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212608-004	9200002	2034-10-15	U-3506	Drug substance, Drug product	2021-07-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212608-004	9944651	2034-10-15	U-3168	Drug substance, Drug product	2021-07-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212608-004	9944651	2034-10-15	U-3506	Drug substance, Drug product	2021-07-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212608-004	9994575	2034-10-15	U-3168	Drug substance, Drug product	2021-07-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212608-004	9994575	2034-10-15	U-3506	Drug substance, Drug product	2021-07-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212608-004	11964980	2040-04-10		Drug substance, Drug product	2024-04-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212608-004	11999744	2040-04-10	U-3168		2024-06-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212608-004	11999744	2040-04-10	U-3506		2024-06-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212608-004	12252494	2040-04-10	U-3506		2025-04-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212608-005	9200002	2034-10-15	U-3168	Drug substance, Drug product	2021-07-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212608-005	9944651	2034-10-15	U-3168	Drug substance, Drug product	2021-07-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212608-005	9994575	2034-10-15	U-3168	Drug substance, Drug product	2021-07-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212608-005	11964980	2040-04-10		Drug substance, Drug product	2024-04-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212608-005	11999744	2040-04-10	U-3168		2024-06-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212608-001	9200002	2034-10-15	U-2726	Drug substance, Drug product	2020-02-05	`31067a03dcf5…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 21 · 828 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	N212608-001	ODE-366	2027-01-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212608-001	ODE-356	2028-06-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212608-001	ODE-434	2030-05-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212608-002	ODE-366	2027-01-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212608-002	ODE-356	2028-06-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212608-002	ODE-434	2030-05-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212608-003	ODE-366	2027-01-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212608-003	ODE-356	2028-06-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212608-003	ODE-434	2030-05-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212608-004	I-912	2026-05-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212608-004	ODE-366	2027-01-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212608-004	ODE-356	2028-06-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212608-004	ODE-434	2030-05-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212608-005	ODE-366	2027-01-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212608-005	ODE-356	2028-06-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212608-005	ODE-434	2030-05-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212608-001	NCE	2025-01-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212608-001	ODE-366	2027-01-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212608-001	ODE-356	2028-06-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212608-001	ODE-434	2030-05-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212608-002	NCE	2025-01-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212608-002	ODE-366	2027-01-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212608-002	ODE-356	2028-06-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212608-002	ODE-434	2030-05-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212608-003	NCE	2025-01-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212608-003	ODE-366	2027-01-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212608-003	ODE-356	2028-06-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212608-003	ODE-434	2030-05-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212608-004	NCE	2025-01-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212608-004	I-912	2026-05-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212608-004	ODE-366	2027-01-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212608-004	ODE-356	2028-06-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212608-004	ODE-434	2030-05-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212608-005	NCE	2025-01-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212608-005	ODE-366	2027-01-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212608-005	ODE-356	2028-06-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212608-005	ODE-434	2030-05-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N212608-001	NCE	2025-01-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212608-001	ODE-366	2027-01-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212608-001	ODE-356	2028-06-16	`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
Ayvakit	AVAPRITINIB	Blueprint Medicines Corporation	645c887c-8cd4-4623-8da9-ac223d71a8b9	2026-08-05	Warnings, Adverse reactions	Exact identifier application applno (NDA): 212608 application number: NDA212608 ndc (product): 72064-150 ndc (product): 72064-120 ndc (product): 72064-125 ndc (product): 72064-130 ndc (product): 72064-110

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 13 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
72064-110	Ayvakit	avapritinib	Blueprint Medicines Corporation	NDA	Current
72064-110	Ayvakit	avapritinib	Blueprint Medicines Corporation	NDA	Current
72064-110	Ayvakit	avapritinib	Blueprint Medicines Corporation	NDA	Current
72064-120	Ayvakit	avapritinib	Blueprint Medicines Corporation	NDA	Current
72064-120	Ayvakit	avapritinib	Blueprint Medicines Corporation	NDA	Current
72064-120	Ayvakit	avapritinib	Blueprint Medicines Corporation	NDA	Current
72064-125	Ayvakit	avapritinib	Blueprint Medicines Corporation	NDA	Current
72064-125	Ayvakit	avapritinib	Blueprint Medicines Corporation	NDA	Current
72064-130	Ayvakit	avapritinib	Blueprint Medicines Corporation	NDA	Current
72064-130	Ayvakit	avapritinib	Blueprint Medicines Corporation	NDA	Current
72064-130	Ayvakit	avapritinib	Blueprint Medicines Corporation	NDA	Current
72064-150	Ayvakit	avapritinib	Blueprint Medicines Corporation	NDA	Current
72064-150	Ayvakit	avapritinib	Blueprint Medicines Corporation	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
85121	SUPPL	2026-02-24
80197	SUPPL	2024-11-12
80191	SUPPL	2024-11-12
75936	SUPPL	2023-10-25
74352	SUPPL	2023-05-23
74350	SUPPL	2023-05-23
73736	SUPPL	2023-03-10
73725	SUPPL	2023-03-10
72842	SUPPL	2022-12-09
67843	SUPPL	2021-06-17
67839	SUPPL	2021-06-17
67833	SUPPL	2021-06-16
67832	SUPPL	2021-06-16
61883	ORIG	2020-02-13
61544	ORIG	2020-01-10
61542	ORIG	2020-01-09