Application 220305

Type: NDA
Sponsor: KURA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	KOMZIFTI	ZIFTOMENIB	CAPSULE;ORAL	200MG	Yes	Yes

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

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
N220305-001	KOMZIFTI	ZIFTOMENIB	200MG	CAPSULE / ORAL		RLD, RS	2025-11-13

Orange Book patents#

Current patent rows page 1 of 1 · 13 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N220305-001	10077271	2036-03-16		Drug substance, Drug product	2025-12-10
N220305-001	10174041	2036-03-16	U-4350		2025-12-10
N220305-001	10174041	2036-03-16	U-4354		2025-12-10
N220305-001	10869868	2037-01-26	U-4352		2025-12-10
N220305-001	10869868	2037-01-26	U-4353		2025-12-10
N220305-001	10781218	2037-03-15		Drug substance, Drug product	2025-12-10
N220305-001	11673898	2037-03-15	U-4350		2025-12-10
N220305-001	11673898	2037-03-15	U-4351		2025-12-10
N220305-001	11944627	2038-09-06	U-4347		2025-12-10
N220305-001	11944627	2038-09-06	U-4349		2025-12-10
N220305-001	12410184	2044-07-16	U-4347	Drug substance, Drug product	2025-12-10
N220305-001	12410184	2044-07-16	U-4348	Drug substance, Drug product	2025-12-10
N220305-001	12521396	2044-07-16		Drug product	2026-01-21

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N220305-001	NCE	2030-11-13

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
2026-09-14 22:38:34	2026-08	N220305-001	KOMZIFTI	200MG	CAPSULE / ORAL	RLD, RS	2025-11-13	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N220305-001	KOMZIFTI	200MG	CAPSULE / ORAL	RLD, RS	2025-11-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N220305-001	KOMZIFTI	200MG	CAPSULE / ORAL	RLD, RS	2025-11-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N220305-001	KOMZIFTI	200MG	CAPSULE / ORAL	RLD, RS	2025-11-13	`31067a03dcf5…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N220305-001	KOMZIFTI	200MG	CAPSULE / ORAL	RLD, RS	2025-11-13	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 64 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	N220305-001	10077271	2036-03-16		Drug substance, Drug product	2025-12-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N220305-001	10174041	2036-03-16	U-4350		2025-12-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N220305-001	10174041	2036-03-16	U-4354		2025-12-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N220305-001	10869868	2037-01-26	U-4352		2025-12-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N220305-001	10869868	2037-01-26	U-4353		2025-12-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N220305-001	10781218	2037-03-15		Drug substance, Drug product	2025-12-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N220305-001	11673898	2037-03-15	U-4350		2025-12-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N220305-001	11673898	2037-03-15	U-4351		2025-12-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N220305-001	11944627	2038-09-06	U-4347		2025-12-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N220305-001	11944627	2038-09-06	U-4349		2025-12-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N220305-001	12410184	2044-07-16	U-4347	Drug substance, Drug product	2025-12-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N220305-001	12410184	2044-07-16	U-4348	Drug substance, Drug product	2025-12-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N220305-001	12521396	2044-07-16		Drug product	2026-01-21	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N220305-001	10077271	2036-03-16		Drug substance, Drug product	2025-12-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N220305-001	10174041	2036-03-16	U-4350		2025-12-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N220305-001	10174041	2036-03-16	U-4354		2025-12-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N220305-001	10869868	2037-01-26	U-4352		2025-12-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N220305-001	10869868	2037-01-26	U-4353		2025-12-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N220305-001	10781218	2037-03-15		Drug substance, Drug product	2025-12-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N220305-001	11673898	2037-03-15	U-4350		2025-12-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N220305-001	11673898	2037-03-15	U-4351		2025-12-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N220305-001	11944627	2038-09-06	U-4347		2025-12-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N220305-001	11944627	2038-09-06	U-4349		2025-12-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N220305-001	12410184	2044-07-16	U-4347	Drug substance, Drug product	2025-12-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N220305-001	12410184	2044-07-16	U-4348	Drug substance, Drug product	2025-12-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N220305-001	12521396	2044-07-16		Drug product	2026-01-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N220305-001	10077271	2036-03-16		Drug substance, Drug product	2025-12-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N220305-001	10174041	2036-03-16	U-4350		2025-12-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N220305-001	10174041	2036-03-16	U-4354		2025-12-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N220305-001	10869868	2037-01-26	U-4352		2025-12-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N220305-001	10869868	2037-01-26	U-4353		2025-12-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N220305-001	10781218	2037-03-15		Drug substance, Drug product	2025-12-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N220305-001	11673898	2037-03-15	U-4350		2025-12-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N220305-001	11673898	2037-03-15	U-4351		2025-12-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N220305-001	11944627	2038-09-06	U-4347		2025-12-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N220305-001	11944627	2038-09-06	U-4349		2025-12-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N220305-001	12410184	2044-07-16	U-4347	Drug substance, Drug product	2025-12-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N220305-001	12410184	2044-07-16	U-4348	Drug substance, Drug product	2025-12-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N220305-001	12521396	2044-07-16		Drug product	2026-01-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N220305-001	10077271	2036-03-16		Drug substance, Drug product	2025-12-10	`31067a03dcf5…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-09-14 22:38:34	2026-08	N220305-001	NCE	2030-11-13	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N220305-001	NCE	2030-11-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N220305-001	NCE	2030-11-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N220305-001	NCE	2030-11-13	`31067a03dcf5…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N220305-001	NCE	2030-11-13	`a50c72e98297…`

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
Komzifti	ZIFTOMENIB	Kura Oncology, Inc.	b650f696-3391-4274-8b55-a5f5e9d04769	2025-12-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 220305 application number: NDA220305

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
Document	Submission type	Date
84423	ORIG	2025-12-15
84392	ORIG	2025-12-12
84167	ORIG	2025-11-14