Application 219616

Type: NDA
Sponsor: VERASTEM INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	AVMAPKI FAKZYNJA CO-PACK (COPACKAGED)	AVUTOMETINIB POTASSIUM; DEFACTINIB HYDROCHLORIDE	CAPSULE, TABLET;ORAL	EQ 0.8MG BASE;EQ 200MG BASE	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
N219616-001	AVMAPKI FAKZYNJA CO-PACK (COPACKAGED)	AVUTOMETINIB POTASSIUM; DEFACTINIB HYDROCHLORIDE	EQ 0.8MG BASE;EQ 200MG BASE	CAPSULE, TABLET / ORAL		RLD, RS	2025-05-08

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N219616-001	7897792	2027-02-09		Drug substance, Drug product	2025-06-03
N219616-001	8247411	2028-04-17		Drug substance, Drug product	2025-06-03
N219616-001	7928109	2029-08-21		Drug substance, Drug product	2025-06-03
N219616-001	11400090	2038-10-29	U-4196		2025-06-03
N219616-001	11517573	2040-09-11	U-4196		2025-06-03
N219616-001	11517573	2040-09-11	U-4205		2025-06-03
N219616-001	11873296	2042-12-29	U-4196	Drug product	2025-06-03
N219616-001	12509450	2042-12-29		Drug product	2026-01-28

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N219616-001	NCE	2030-05-08
N219616-001	ODE-525	2032-05-08

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	N219616-001	AVMAPKI FAKZYNJA CO-PACK (COPACKAGED)	EQ 0.8MG BASE;EQ 200MG BASE	CAPSULE, TABLET / ORAL	RLD, RS	2025-05-08	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N219616-001	AVMAPKI FAKZYNJA CO-PACK (COPACKAGED)	EQ 0.8MG BASE;EQ 200MG BASE	CAPSULE, TABLET / ORAL	RLD, RS	2025-05-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N219616-001	AVMAPKI FAKZYNJA CO-PACK (COPACKAGED)	EQ 0.8MG BASE;EQ 200MG BASE	CAPSULE, TABLET / ORAL	RLD, RS	2025-05-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219616-001	AVMAPKI FAKZYNJA CO-PACK (COPACKAGED)	EQ 0.8MG BASE;EQ 200MG BASE	CAPSULE, TABLET / ORAL	RLD, RS	2025-05-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N219616-001	AVMAPKI FAKZYNJA CO-PACK (COPACKAGED)	EQ 0.8MG BASE;EQ 200MG BASE	CAPSULE, TABLET / ORAL	RLD, RS	2025-05-08	`6a471c1ec25d…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219616-001	AVMAPKI FAKZYNJA CO-PACK (COPACKAGED)	EQ 0.8MG BASE;EQ 200MG BASE	CAPSULE, TABLET / ORAL	RLD, RS	2025-05-08	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 46 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	N219616-001	7897792	2027-02-09		Drug substance, Drug product	2025-06-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219616-001	8247411	2028-04-17		Drug substance, Drug product	2025-06-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219616-001	7928109	2029-08-21		Drug substance, Drug product	2025-06-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219616-001	11400090	2038-10-29	U-4196		2025-06-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219616-001	11517573	2040-09-11	U-4196		2025-06-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219616-001	11517573	2040-09-11	U-4205		2025-06-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219616-001	11873296	2042-12-29	U-4196	Drug product	2025-06-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219616-001	12509450	2042-12-29		Drug product	2026-01-28	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N219616-001	7897792	2027-02-09		Drug substance, Drug product	2025-06-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219616-001	8247411	2028-04-17		Drug substance, Drug product	2025-06-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219616-001	7928109	2029-08-21		Drug substance, Drug product	2025-06-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219616-001	11400090	2038-10-29	U-4196		2025-06-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219616-001	11517573	2040-09-11	U-4196		2025-06-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219616-001	11517573	2040-09-11	U-4205		2025-06-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219616-001	11873296	2042-12-29	U-4196	Drug product	2025-06-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219616-001	12509450	2042-12-29		Drug product	2026-01-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N219616-001	7897792	2027-02-09		Drug substance, Drug product	2025-06-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219616-001	8247411	2028-04-17		Drug substance, Drug product	2025-06-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219616-001	7928109	2029-08-21		Drug substance, Drug product	2025-06-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219616-001	11400090	2038-10-29	U-4196		2025-06-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219616-001	11517573	2040-09-11	U-4196		2025-06-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219616-001	11517573	2040-09-11	U-4205		2025-06-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219616-001	11873296	2042-12-29	U-4196	Drug product	2025-06-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219616-001	12509450	2042-12-29		Drug product	2026-01-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219616-001	7897792	2027-02-09		Drug substance, Drug product	2025-06-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219616-001	8247411	2028-04-17		Drug substance, Drug product	2025-06-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219616-001	7928109	2029-08-21		Drug substance, Drug product	2025-06-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219616-001	11400090	2038-10-29	U-4196		2025-06-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219616-001	11517573	2040-09-11	U-4196		2025-06-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219616-001	11517573	2040-09-11	U-4205		2025-06-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219616-001	11873296	2042-12-29	U-4196	Drug product	2025-06-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N219616-001	7897792	2027-02-09		Drug substance, Drug product	2025-06-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N219616-001	8247411	2028-04-17		Drug substance, Drug product	2025-06-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N219616-001	7928109	2029-08-21		Drug substance, Drug product	2025-06-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N219616-001	11400090	2038-10-29	U-4196		2025-06-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N219616-001	11517573	2040-09-11	U-4196		2025-06-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N219616-001	11517573	2040-09-11	U-4205		2025-06-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N219616-001	11873296	2042-12-29	U-4196	Drug product	2025-06-03	`6a471c1ec25d…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219616-001	7897792	2027-02-09		Drug substance, Drug product	2025-06-03	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219616-001	8247411	2028-04-17		Drug substance, Drug product	2025-06-03	`a50c72e98297…`

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	N219616-001	NCE	2030-05-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219616-001	ODE-525	2032-05-08	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N219616-001	NCE	2030-05-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219616-001	ODE-525	2032-05-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N219616-001	NCE	2030-05-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219616-001	NCE	2030-05-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N219616-001	NCE	2030-05-08	`6a471c1ec25d…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219616-001	NCE	2030-05-08	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219616-001	ODE-525	2032-05-08	`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
AVMAPKI FAKZYNJA CO-PACK	AVUTOMETINIB POTASSIUM AND DEFACTINIB HYDROCHLORIDE	Verastem Inc.	65889527-1406-45df-8a85-e2690dcf427d	2025-05-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 219616 application number: NDA219616

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
82627	ORIG	2025-06-20
82197	ORIG	2025-05-15
82255	ORIG	2025-05-08