Application 216340

Type: NDA
Sponsor: MIRATI THERAPEUTICS, INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	KRAZATI (ADAGRASIB)	ADAGRASIB	TABLET;ORAL	200mg	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 45.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N216340-001	KRAZATI	ADAGRASIB	200MG	TABLET / ORAL		RLD, RS	2022-12-12

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N216340-001	10689377	2037-05-17	U-3490	Drug substance, Drug product	2022-12-20
N216340-001	10689377	2037-05-17	U-3953	Drug substance, Drug product	2022-12-20
N216340-001	12336995	2041-02-05	U-3953		2025-07-21
N216340-001	12281113	2041-09-10		Drug substance, Drug product	2025-05-21
N216340-001	12383503	2043-08-21		Drug product	2025-09-10
N216340-001	12653789	2043-08-21		Drug product	2026-07-10

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 2 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N216340-001	NCE	2027-12-12
N216340-001	ODE-352	2029-12-12

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-11-14 07:37:17	2026-10	N216340-001	KRAZATI	200MG	TABLET / ORAL	RLD, RS	2022-12-12	`d4dbc9d85df4…`
2026-10-15 13:18:30	2026-09	N216340-001	KRAZATI	200MG	TABLET / ORAL	RLD, RS	2022-12-12	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N216340-001	KRAZATI	200MG	TABLET / ORAL	RLD, RS	2022-12-12	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N216340-001	KRAZATI	200MG	TABLET / ORAL	RLD, RS	2022-12-12	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N216340-001	KRAZATI	200MG	TABLET / ORAL	RLD, RS	2022-12-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216340-001	KRAZATI	200MG	TABLET / ORAL	RLD, RS	2022-12-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N216340-001	KRAZATI	200MG	TABLET / ORAL	RLD, RS	2022-12-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216340-001	KRAZATI	200MG	TABLET / ORAL	RLD, RS	2022-12-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216340-001	KRAZATI	200MG	TABLET / ORAL	RLD, RS	2022-12-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N216340-001	KRAZATI	200MG	TABLET / ORAL	RLD, RS	2022-12-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N216340-001	KRAZATI	200MG	TABLET / ORAL	RLD, RS	2022-12-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N216340-001	KRAZATI	200MG	TABLET / ORAL	RLD, RS	2022-12-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N216340-001	KRAZATI	200MG	TABLET / ORAL	RLD, RS	2022-12-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N216340-001	KRAZATI	200MG	TABLET / ORAL	RLD, RS	2022-12-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N216340-001	KRAZATI	200MG	TABLET / ORAL	RLD, RS	2022-12-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N216340-001	KRAZATI	200MG	TABLET / ORAL	RLD, RS	2022-12-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N216340-001	KRAZATI	200MG	TABLET / ORAL	RLD, RS	2022-12-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N216340-001	KRAZATI	200MG	TABLET / ORAL	RLD, RS	2022-12-12	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N216340-001	KRAZATI	200MG	TABLET / ORAL	RLD, RS	2022-12-12	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N216340-001	KRAZATI	200MG	TABLET / ORAL	RLD, RS	2022-12-12	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N216340-001	KRAZATI	200MG	TABLET / ORAL	RLD, RS	2022-12-12	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N216340-001	KRAZATI	200MG	TABLET / ORAL	RLD, RS	2022-12-12	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N216340-001	KRAZATI	200MG	TABLET / ORAL	RLD, RS	2022-12-12	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N216340-001	KRAZATI	200MG	TABLET / ORAL	RLD, RS	2022-12-12	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N216340-001	KRAZATI	200MG	TABLET / ORAL	RLD, RS	2022-12-12	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N216340-001	KRAZATI	200MG	TABLET / ORAL	RLD, RS	2022-12-12	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N216340-001	KRAZATI	200MG	TABLET / ORAL	RLD, RS	2022-12-12	`3bdfa0b2c4d7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N216340-001	KRAZATI	200MG	TABLET / ORAL	RLD, RS	2022-12-12	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 72 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-11-14 07:37:17	2026-10	N216340-001	10689377	2037-05-17	U-3490	Drug substance, Drug product	2022-12-20	`d4dbc9d85df4…`
2026-11-14 07:37:17	2026-10	N216340-001	10689377	2037-05-17	U-3953	Drug substance, Drug product	2022-12-20	`d4dbc9d85df4…`
2026-11-14 07:37:17	2026-10	N216340-001	12336995	2041-02-05	U-3953		2025-07-21	`d4dbc9d85df4…`
2026-11-14 07:37:17	2026-10	N216340-001	12281113	2041-09-10		Drug substance, Drug product	2025-05-21	`d4dbc9d85df4…`
2026-11-14 07:37:17	2026-10	N216340-001	12383503	2043-08-21		Drug product	2025-09-10	`d4dbc9d85df4…`
2026-11-14 07:37:17	2026-10	N216340-001	12653789	2043-08-21		Drug product	2026-07-10	`d4dbc9d85df4…`
2026-10-15 13:18:30	2026-09	N216340-001	10689377	2037-05-17	U-3490	Drug substance, Drug product	2022-12-20	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N216340-001	10689377	2037-05-17	U-3953	Drug substance, Drug product	2022-12-20	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N216340-001	12336995	2041-02-05	U-3953		2025-07-21	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N216340-001	12281113	2041-09-10		Drug substance, Drug product	2025-05-21	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N216340-001	12383503	2043-08-21		Drug product	2025-09-10	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N216340-001	12653789	2043-08-21		Drug product	2026-07-10	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N216340-001	10689377	2037-05-17	U-3490	Drug substance, Drug product	2022-12-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216340-001	10689377	2037-05-17	U-3953	Drug substance, Drug product	2022-12-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216340-001	12336995	2041-02-05	U-3953		2025-07-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216340-001	12281113	2041-09-10		Drug substance, Drug product	2025-05-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216340-001	12383503	2043-08-21		Drug product	2025-09-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216340-001	12653789	2043-08-21		Drug product	2026-07-10	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N216340-001	10689377	2037-05-17	U-3490	Drug substance, Drug product	2022-12-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216340-001	10689377	2037-05-17	U-3953	Drug substance, Drug product	2022-12-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216340-001	12336995	2041-02-05	U-3953		2025-07-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216340-001	12281113	2041-09-10		Drug substance, Drug product	2025-05-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216340-001	12383503	2043-08-21		Drug product	2025-09-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216340-001	12653789	2043-08-21		Drug product	2026-07-10	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N216340-001	10689377	2037-05-17	U-3490	Drug substance, Drug product	2022-12-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216340-001	10689377	2037-05-17	U-3953	Drug substance, Drug product	2022-12-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216340-001	12336995	2041-02-05	U-3953		2025-07-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216340-001	12281113	2041-09-10		Drug substance, Drug product	2025-05-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216340-001	12383503	2043-08-21		Drug product	2025-09-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216340-001	10689377	2037-05-17	U-3490	Drug substance, Drug product	2022-12-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216340-001	10689377	2037-05-17	U-3953	Drug substance, Drug product	2022-12-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216340-001	12336995	2041-02-05	U-3953		2025-07-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216340-001	12281113	2041-09-10		Drug substance, Drug product	2025-05-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216340-001	12383503	2043-08-21		Drug product	2025-09-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N216340-001	10689377	2037-05-17	U-3490	Drug substance, Drug product	2022-12-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216340-001	10689377	2037-05-17	U-3953	Drug substance, Drug product	2022-12-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216340-001	12336995	2041-02-05	U-3953		2025-07-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216340-001	12281113	2041-09-10		Drug substance, Drug product	2025-05-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216340-001	10689377	2037-05-17	U-3490	Drug substance, Drug product	2022-12-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216340-001	10689377	2037-05-17	U-3953	Drug substance, Drug product	2022-12-20	`fd3edfee7708…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 54 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-11-14 07:37:17	2026-10	N216340-001	NCE	2027-12-12	`d4dbc9d85df4…`
2026-11-14 07:37:17	2026-10	N216340-001	ODE-352	2029-12-12	`d4dbc9d85df4…`
2026-10-15 13:18:30	2026-09	N216340-001	NCE	2027-12-12	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N216340-001	ODE-352	2029-12-12	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N216340-001	NCE	2027-12-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216340-001	ODE-352	2029-12-12	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N216340-001	NCE	2027-12-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216340-001	ODE-352	2029-12-12	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N216340-001	NCE	2027-12-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216340-001	ODE-352	2029-12-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216340-001	NCE	2027-12-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216340-001	ODE-352	2029-12-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N216340-001	NCE	2027-12-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216340-001	ODE-352	2029-12-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216340-001	NCE	2027-12-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216340-001	ODE-352	2029-12-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216340-001	NCE	2027-12-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216340-001	ODE-352	2029-12-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N216340-001	NCE	2027-12-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N216340-001	ODE-352	2029-12-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N216340-001	NCE	2027-12-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N216340-001	ODE-352	2029-12-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N216340-001	NCE	2027-12-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N216340-001	ODE-352	2029-12-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N216340-001	NCE	2027-12-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N216340-001	ODE-352	2029-12-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N216340-001	NCE	2027-12-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N216340-001	ODE-352	2029-12-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N216340-001	NCE	2027-12-12	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N216340-001	ODE-352	2029-12-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N216340-001	NCE	2027-12-12	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N216340-001	ODE-352	2029-12-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N216340-001	NCE	2027-12-12	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N216340-001	ODE-352	2029-12-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N216340-001	NCE	2027-12-12	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N216340-001	ODE-352	2029-12-12	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N216340-001	NCE	2027-12-12	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N216340-001	ODE-352	2029-12-12	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N216340-001	NCE	2027-12-12	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N216340-001	ODE-352	2029-12-12	`1c564ffb4f44…`

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 · 1 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
80739-812	KRAZATI	adagrasib	Mirati Therapeutics, Inc	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
85544	SUPPL	2026-03-27
85543	SUPPL	2026-03-27
80194	SUPPL	2024-11-12
79124	SUPPL	2024-07-18
78862	SUPPL	2024-06-21
73141	ORIG	2023-01-11
72870	ORIG	2022-12-13
72869	ORIG	2022-12-12