Application 213756

Type: NDA
Sponsor: ASTRAZENECA LP

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	KOSELUGO	SELUMETINIB SULFATE	CAPSULE; ORAL	25MG	Yes	No
002	KOSELUGO	SELUMETINIB SULFATE	CAPSULE; ORAL	10MG	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
N213756-001	KOSELUGO	SELUMETINIB SULFATE	EQ 10MG BASE	CAPSULE / ORAL		RLD	2020-04-10
N213756-002	KOSELUGO	SELUMETINIB SULFATE	EQ 25MG BASE	CAPSULE / ORAL		RLD, RS	2020-04-10

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N213756-001	8178693	2026-03-13		Drug substance, Drug product	2020-05-06
N213756-001	9156795	2026-12-12		Drug substance, Drug product	2020-05-06
N213756-001	9562017	2026-12-12	U-4357	Drug substance	2020-05-06
N213756-001	7425637	2028-03-13		Drug substance	2020-05-06
N213756-001	11813246	2029-03-26		Drug product	2023-12-07
N213756-001	12220403	2029-03-26		Drug product	2025-02-14
N213756-001	12318367	2029-03-26		Drug product	2025-07-01
N213756-001	12364684	2029-03-26	U-4357		2025-08-19
N213756-002	8178693	2026-03-13		Drug substance, Drug product	2020-05-06
N213756-002	9156795	2026-12-12		Drug substance, Drug product	2020-05-06
N213756-002	9562017	2026-12-12	U-4357	Drug substance	2020-05-06
N213756-002	7425637	2028-03-13		Drug substance	2020-05-06
N213756-002	11813246	2029-03-26		Drug product	2023-12-07
N213756-002	12220403	2029-03-26		Drug product	2025-02-14
N213756-002	12318367	2029-03-26		Drug product	2025-07-01
N213756-002	12364684	2029-03-26	U-4357		2025-08-19

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N213756-001	ODE-288	2027-04-10
N213756-001	NPP	2028-09-10
N213756-001	NPP	2028-11-19
N213756-001	ODE-545	2032-11-19
N213756-002	ODE-288	2027-04-10
N213756-002	NPP	2028-09-10
N213756-002	NPP	2028-11-19
N213756-002	ODE-545	2032-11-19

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 2 · 76 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	N213756-001	KOSELUGO	EQ 10MG BASE	CAPSULE / ORAL	RLD	2020-04-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213756-002	KOSELUGO	EQ 25MG BASE	CAPSULE / ORAL	RLD, RS	2020-04-10	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N213756-001	KOSELUGO	EQ 10MG BASE	CAPSULE / ORAL	RLD	2020-04-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213756-002	KOSELUGO	EQ 25MG BASE	CAPSULE / ORAL	RLD, RS	2020-04-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213756-001	KOSELUGO	EQ 10MG BASE	CAPSULE / ORAL	RLD	2020-04-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213756-002	KOSELUGO	EQ 25MG BASE	CAPSULE / ORAL	RLD, RS	2020-04-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N213756-001	KOSELUGO	EQ 10MG BASE	CAPSULE / ORAL	RLD	2020-04-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213756-002	KOSELUGO	EQ 25MG BASE	CAPSULE / ORAL	RLD, RS	2020-04-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213756-001	KOSELUGO	EQ 10MG BASE	CAPSULE / ORAL	RLD	2020-04-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213756-002	KOSELUGO	EQ 25MG BASE	CAPSULE / ORAL	RLD, RS	2020-04-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213756-001	KOSELUGO	EQ 10MG BASE	CAPSULE / ORAL	RLD	2020-04-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213756-002	KOSELUGO	EQ 25MG BASE	CAPSULE / ORAL	RLD, RS	2020-04-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213756-001	KOSELUGO	EQ 10MG BASE	CAPSULE / ORAL	RLD	2020-04-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213756-002	KOSELUGO	EQ 25MG BASE	CAPSULE / ORAL	RLD, RS	2020-04-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213756-001	KOSELUGO	EQ 10MG BASE	CAPSULE / ORAL	RLD	2020-04-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213756-002	KOSELUGO	EQ 25MG BASE	CAPSULE / ORAL	RLD, RS	2020-04-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N213756-001	KOSELUGO	EQ 10MG BASE	CAPSULE / ORAL	RLD	2020-04-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N213756-002	KOSELUGO	EQ 25MG BASE	CAPSULE / ORAL	RLD, RS	2020-04-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N213756-001	KOSELUGO	EQ 10MG BASE	CAPSULE / ORAL	RLD	2020-04-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N213756-002	KOSELUGO	EQ 25MG BASE	CAPSULE / ORAL	RLD, RS	2020-04-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N213756-001	KOSELUGO	EQ 10MG BASE	CAPSULE / ORAL	RLD	2020-04-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N213756-002	KOSELUGO	EQ 25MG BASE	CAPSULE / ORAL	RLD, RS	2020-04-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N213756-001	KOSELUGO	EQ 10MG BASE	CAPSULE / ORAL	RLD	2020-04-10	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N213756-002	KOSELUGO	EQ 25MG BASE	CAPSULE / ORAL	RLD, RS	2020-04-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N213756-001	KOSELUGO	EQ 10MG BASE	CAPSULE / ORAL	RLD	2020-04-10	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N213756-002	KOSELUGO	EQ 25MG BASE	CAPSULE / ORAL	RLD, RS	2020-04-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N213756-001	KOSELUGO	EQ 10MG BASE	CAPSULE / ORAL	RLD	2020-04-10	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N213756-002	KOSELUGO	EQ 25MG BASE	CAPSULE / ORAL	RLD, RS	2020-04-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N213756-001	KOSELUGO	EQ 10MG BASE	CAPSULE / ORAL	RLD	2020-04-10	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N213756-002	KOSELUGO	EQ 25MG BASE	CAPSULE / ORAL	RLD, RS	2020-04-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N213756-001	KOSELUGO	EQ 10MG BASE	CAPSULE / ORAL	RLD	2020-04-10	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N213756-002	KOSELUGO	EQ 25MG BASE	CAPSULE / ORAL	RLD, RS	2020-04-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N213756-001	KOSELUGO	EQ 10MG BASE	CAPSULE / ORAL	RLD	2020-04-10	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N213756-002	KOSELUGO	EQ 25MG BASE	CAPSULE / ORAL	RLD, RS	2020-04-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N213756-001	KOSELUGO	EQ 10MG BASE	CAPSULE / ORAL	RLD	2020-04-10	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N213756-002	KOSELUGO	EQ 25MG BASE	CAPSULE / ORAL	RLD, RS	2020-04-10	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N213756-001	KOSELUGO	EQ 10MG BASE	CAPSULE / ORAL	RLD	2020-04-10	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N213756-002	KOSELUGO	EQ 25MG BASE	CAPSULE / ORAL	RLD, RS	2020-04-10	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N213756-001	KOSELUGO	EQ 10MG BASE	CAPSULE / ORAL	RLD	2020-04-10	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N213756-002	KOSELUGO	EQ 25MG BASE	CAPSULE / ORAL	RLD, RS	2020-04-10	`782e0a99824c…`

Observed Orange Book patent history#

Patent history page 1 of 10 · 370 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	N213756-001	8178693	2026-03-13		Drug substance, Drug product	2020-05-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213756-001	9156795	2026-12-12		Drug substance, Drug product	2020-05-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213756-001	9562017	2026-12-12	U-4357	Drug substance	2020-05-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213756-001	7425637	2028-03-13		Drug substance	2020-05-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213756-001	11813246	2029-03-26		Drug product	2023-12-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213756-001	12220403	2029-03-26		Drug product	2025-02-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213756-001	12318367	2029-03-26		Drug product	2025-07-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213756-001	12364684	2029-03-26	U-4357		2025-08-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213756-002	8178693	2026-03-13		Drug substance, Drug product	2020-05-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213756-002	9156795	2026-12-12		Drug substance, Drug product	2020-05-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213756-002	9562017	2026-12-12	U-4357	Drug substance	2020-05-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213756-002	7425637	2028-03-13		Drug substance	2020-05-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213756-002	11813246	2029-03-26		Drug product	2023-12-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213756-002	12220403	2029-03-26		Drug product	2025-02-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213756-002	12318367	2029-03-26		Drug product	2025-07-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213756-002	12364684	2029-03-26	U-4357		2025-08-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N213756-001	8178693	2026-03-13		Drug substance, Drug product	2020-05-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213756-001	9156795	2026-12-12		Drug substance, Drug product	2020-05-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213756-001	9562017	2026-12-12	U-4357	Drug substance	2020-05-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213756-001	7425637	2028-03-13		Drug substance	2020-05-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213756-001	11813246	2029-03-26		Drug product	2023-12-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213756-001	12220403	2029-03-26		Drug product	2025-02-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213756-001	12318367	2029-03-26		Drug product	2025-07-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213756-001	12364684	2029-03-26	U-4357		2025-08-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213756-002	8178693	2026-03-13		Drug substance, Drug product	2020-05-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213756-002	9156795	2026-12-12		Drug substance, Drug product	2020-05-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213756-002	9562017	2026-12-12	U-4357	Drug substance	2020-05-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213756-002	7425637	2028-03-13		Drug substance	2020-05-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213756-002	11813246	2029-03-26		Drug product	2023-12-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213756-002	12220403	2029-03-26		Drug product	2025-02-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213756-002	12318367	2029-03-26		Drug product	2025-07-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213756-002	12364684	2029-03-26	U-4357		2025-08-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213756-001	7425637	2026-03-13		Drug substance	2020-05-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213756-001	8178693	2026-03-13		Drug substance, Drug product	2020-05-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213756-001	9156795	2026-12-12		Drug substance, Drug product	2020-05-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213756-001	9562017	2026-12-12	U-4274	Drug substance	2020-05-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213756-001	11813246	2029-03-26		Drug product	2023-12-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213756-001	12220403	2029-03-26		Drug product	2025-02-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213756-001	12318367	2029-03-26		Drug product	2025-07-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213756-001	12364684	2029-03-26	U-4274		2025-08-19	`31067a03dcf5…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 5 · 164 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	N213756-001	ODE-288	2027-04-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213756-001	NPP	2028-09-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213756-001	NPP	2028-11-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213756-001	ODE-545	2032-11-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213756-002	ODE-288	2027-04-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213756-002	NPP	2028-09-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213756-002	NPP	2028-11-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213756-002	ODE-545	2032-11-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N213756-001	ODE-288	2027-04-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213756-001	NPP	2028-09-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213756-001	NPP	2028-11-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213756-002	ODE-288	2027-04-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213756-002	NPP	2028-09-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213756-002	NPP	2028-11-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213756-001	NCE	2025-04-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213756-001	ODE-288	2027-04-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213756-001	NPP	2028-09-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213756-002	NCE	2025-04-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213756-002	ODE-288	2027-04-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213756-002	NPP	2028-09-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N213756-001	NCE	2025-04-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213756-001	ODE-288	2027-04-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213756-002	NCE	2025-04-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213756-002	ODE-288	2027-04-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213756-001	NCE	2025-04-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213756-001	ODE-288	2027-04-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213756-002	NCE	2025-04-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213756-002	ODE-288	2027-04-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213756-001	NCE	2025-04-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213756-001	ODE-288	2027-04-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213756-002	NCE	2025-04-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213756-002	ODE-288	2027-04-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213756-001	NCE	2025-04-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213756-001	ODE-288	2027-04-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213756-002	NCE	2025-04-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213756-002	ODE-288	2027-04-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213756-001	NCE	2025-04-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213756-001	ODE-288	2027-04-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213756-002	NCE	2025-04-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213756-002	ODE-288	2027-04-10	`2680178bc6a6…`

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
KOSELUGO	SELUMETINIB	AstraZeneca Pharmaceuticals LP	7d042c61-f28f-4ab5-ab10-d7558c0d49ff	2026-05-26	Warnings, Adverse reactions	Exact identifier application applno (NDA): 213756 application number: NDA213756 ndc (product): 0310-0610 ndc (product): 0310-0625

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0310-0610	KOSELUGO	SELUMETINIB	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-0610	KOSELUGO	SELUMETINIB	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-0610	KOSELUGO	SELUMETINIB	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-0610	KOSELUGO	SELUMETINIB	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-0625	KOSELUGO	SELUMETINIB	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-0625	KOSELUGO	SELUMETINIB	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-0625	KOSELUGO	SELUMETINIB	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-0625	KOSELUGO	SELUMETINIB	AstraZeneca Pharmaceuticals LP	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
84242	SUPPL	2025-11-21
84234	SUPPL	2025-11-20
83366	SUPPL	2025-09-17
83365	SUPPL	2025-09-17
77298	SUPPL	2024-01-25
77292	SUPPL	2024-01-25
69750	SUPPL	2021-12-23
69749	SUPPL	2021-12-23
62883	ORIG	2020-05-11
62549	ORIG	2020-04-13
62540	ORIG	2020-04-10