Application 219304

Type: NDA
Sponsor: DECIPHERA PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ROMVIMZA	VIMSELTINIB	CAPSULE;ORAL	14MG	Yes	No
002	ROMVIMZA	VIMSELTINIB	CAPSULE;ORAL	20MG	Yes	No
003	ROMVIMZA	VIMSELTINIB	CAPSULE;ORAL	30MG	Yes	Yes

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N219304-001	ROMVIMZA	VIMSELTINIB	14MG	CAPSULE / ORAL	RLD	2025-02-14
N219304-002	ROMVIMZA	VIMSELTINIB	20MG	CAPSULE / ORAL	RLD	2025-02-14
N219304-003	ROMVIMZA	VIMSELTINIB	30MG	CAPSULE / ORAL	RLD, RS	2025-02-14

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
N219304-001	9181223	2034-03-14		Drug substance, Drug product	2025-03-05
N219304-001	12285430	2039-12-23	U-4145		2025-05-02
N219304-001	12485120	2039-12-23	U-4145		2025-12-10
N219304-001	12582655	2039-12-23	U-4145		2026-04-06
N219304-001	11103507	2040-02-03	U-4145		2025-03-05
N219304-001	11679110	2040-02-03	U-4145		2025-03-05
N219304-001	12447149	2044-12-06		Drug product	2025-10-24
N219304-001	12528787	2044-12-06		Drug substance, Drug product	2026-02-02
N219304-001	12551483	2044-12-06		Drug product	2026-02-23
N219304-001	12617775	2044-12-06		Drug substance, Drug product	2026-05-20
N219304-001	12643883	2044-12-06		Drug substance, Drug product	2026-06-08
N219304-001	12509443	2045-04-30		Drug product	2026-01-14
N219304-001	12686672	2045-04-30		Drug product	2026-07-28
N219304-002	9181223	2034-03-14		Drug substance, Drug product	2025-03-05
N219304-002	12285430	2039-12-23	U-4145		2025-05-02
N219304-002	12485120	2039-12-23	U-4145		2025-12-10
N219304-002	12582655	2039-12-23	U-4145		2026-04-06
N219304-002	11103507	2040-02-03	U-4145		2025-03-05
N219304-002	11679110	2040-02-03	U-4145		2025-03-05
N219304-002	12447149	2044-12-06		Drug product	2025-10-24
N219304-002	12528787	2044-12-06		Drug substance, Drug product	2026-02-02
N219304-002	12551483	2044-12-06		Drug product	2026-02-23
N219304-002	12617775	2044-12-06		Drug substance, Drug product	2026-05-20
N219304-002	12643883	2044-12-06		Drug substance, Drug product	2026-06-08
N219304-002	12509443	2045-04-30		Drug product	2026-01-14
N219304-002	12686672	2045-04-30		Drug product	2026-07-28
N219304-003	9181223	2034-03-14		Drug substance, Drug product	2025-03-05
N219304-003	12285430	2039-12-23	U-4145		2025-05-02
N219304-003	12485120	2039-12-23	U-4145		2025-12-10
N219304-003	12582655	2039-12-23	U-4145		2026-04-06
N219304-003	11103507	2040-02-03	U-4145		2025-03-05
N219304-003	11679110	2040-02-03	U-4145		2025-03-05
N219304-003	12447149	2044-12-06		Drug product	2025-10-24
N219304-003	12528787	2044-12-06		Drug substance, Drug product	2026-02-02
N219304-003	12551483	2044-12-06		Drug product	2026-02-23
N219304-003	12617775	2044-12-06		Drug substance, Drug product	2026-05-20
N219304-003	12643883	2044-12-06		Drug substance, Drug product	2026-06-08
N219304-003	12509443	2045-04-30		Drug product	2026-01-14
N219304-003	12686672	2045-04-30		Drug product	2026-07-28

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 3 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N219304-001	NCE	2030-02-14
N219304-002	NCE	2030-02-14
N219304-003	NCE	2030-02-14

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	N219304-001	ROMVIMZA	14MG	CAPSULE / ORAL	RLD	2025-02-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219304-002	ROMVIMZA	20MG	CAPSULE / ORAL	RLD	2025-02-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219304-003	ROMVIMZA	30MG	CAPSULE / ORAL	RLD, RS	2025-02-14	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N219304-001	ROMVIMZA	14MG	CAPSULE / ORAL	RLD	2025-02-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219304-002	ROMVIMZA	20MG	CAPSULE / ORAL	RLD	2025-02-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219304-003	ROMVIMZA	30MG	CAPSULE / ORAL	RLD, RS	2025-02-14	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N219304-001	ROMVIMZA	14MG	CAPSULE / ORAL	RLD	2025-02-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219304-002	ROMVIMZA	20MG	CAPSULE / ORAL	RLD	2025-02-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219304-003	ROMVIMZA	30MG	CAPSULE / ORAL	RLD, RS	2025-02-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219304-001	ROMVIMZA	14MG	CAPSULE / ORAL	RLD	2025-02-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219304-002	ROMVIMZA	20MG	CAPSULE / ORAL	RLD	2025-02-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219304-003	ROMVIMZA	30MG	CAPSULE / ORAL	RLD, RS	2025-02-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N219304-001	ROMVIMZA	14MG	CAPSULE / ORAL	RLD	2025-02-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N219304-002	ROMVIMZA	20MG	CAPSULE / ORAL	RLD	2025-02-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N219304-003	ROMVIMZA	30MG	CAPSULE / ORAL	RLD, RS	2025-02-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N219304-001	ROMVIMZA	14MG	CAPSULE / ORAL	RLD	2025-02-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N219304-002	ROMVIMZA	20MG	CAPSULE / ORAL	RLD	2025-02-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N219304-003	ROMVIMZA	30MG	CAPSULE / ORAL	RLD, RS	2025-02-14	`fd3edfee7708…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219304-001	ROMVIMZA	14MG	CAPSULE / ORAL	RLD	2025-02-14	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219304-002	ROMVIMZA	20MG	CAPSULE / ORAL	RLD	2025-02-14	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219304-003	ROMVIMZA	30MG	CAPSULE / ORAL	RLD, RS	2025-02-14	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 5 · 177 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	N219304-001	9181223	2034-03-14		Drug substance, Drug product	2025-03-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219304-001	12285430	2039-12-23	U-4145		2025-05-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219304-001	12485120	2039-12-23	U-4145		2025-12-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219304-001	12582655	2039-12-23	U-4145		2026-04-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219304-001	11103507	2040-02-03	U-4145		2025-03-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219304-001	11679110	2040-02-03	U-4145		2025-03-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219304-001	12447149	2044-12-06		Drug product	2025-10-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219304-001	12528787	2044-12-06		Drug substance, Drug product	2026-02-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219304-001	12551483	2044-12-06		Drug product	2026-02-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219304-001	12617775	2044-12-06		Drug substance, Drug product	2026-05-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219304-001	12643883	2044-12-06		Drug substance, Drug product	2026-06-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219304-001	12509443	2045-04-30		Drug product	2026-01-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219304-001	12686672	2045-04-30		Drug product	2026-07-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219304-002	9181223	2034-03-14		Drug substance, Drug product	2025-03-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219304-002	12285430	2039-12-23	U-4145		2025-05-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219304-002	12485120	2039-12-23	U-4145		2025-12-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219304-002	12582655	2039-12-23	U-4145		2026-04-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219304-002	11103507	2040-02-03	U-4145		2025-03-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219304-002	11679110	2040-02-03	U-4145		2025-03-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219304-002	12447149	2044-12-06		Drug product	2025-10-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219304-002	12528787	2044-12-06		Drug substance, Drug product	2026-02-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219304-002	12551483	2044-12-06		Drug product	2026-02-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219304-002	12617775	2044-12-06		Drug substance, Drug product	2026-05-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219304-002	12643883	2044-12-06		Drug substance, Drug product	2026-06-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219304-002	12509443	2045-04-30		Drug product	2026-01-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219304-002	12686672	2045-04-30		Drug product	2026-07-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219304-003	9181223	2034-03-14		Drug substance, Drug product	2025-03-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219304-003	12285430	2039-12-23	U-4145		2025-05-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219304-003	12485120	2039-12-23	U-4145		2025-12-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219304-003	12582655	2039-12-23	U-4145		2026-04-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219304-003	11103507	2040-02-03	U-4145		2025-03-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219304-003	11679110	2040-02-03	U-4145		2025-03-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219304-003	12447149	2044-12-06		Drug product	2025-10-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219304-003	12528787	2044-12-06		Drug substance, Drug product	2026-02-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219304-003	12551483	2044-12-06		Drug product	2026-02-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219304-003	12617775	2044-12-06		Drug substance, Drug product	2026-05-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219304-003	12643883	2044-12-06		Drug substance, Drug product	2026-06-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219304-003	12509443	2045-04-30		Drug product	2026-01-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219304-003	12686672	2045-04-30		Drug product	2026-07-28	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N219304-001	9181223	2034-03-14		Drug substance, Drug product	2025-03-05	`caaa826d4ba7…`

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	N219304-001	NCE	2030-02-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219304-002	NCE	2030-02-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219304-003	NCE	2030-02-14	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N219304-001	NCE	2030-02-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219304-002	NCE	2030-02-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219304-003	NCE	2030-02-14	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N219304-001	NCE	2030-02-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219304-002	NCE	2030-02-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219304-003	NCE	2030-02-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219304-001	NCE	2030-02-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219304-002	NCE	2030-02-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219304-003	NCE	2030-02-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N219304-001	NCE	2030-02-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N219304-002	NCE	2030-02-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N219304-003	NCE	2030-02-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N219304-001	NCE	2030-02-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N219304-002	NCE	2030-02-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N219304-003	NCE	2030-02-14	`fd3edfee7708…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219304-001	NCE	2030-02-14	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219304-002	NCE	2030-02-14	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219304-003	NCE	2030-02-14	`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
ROMVIMZA	VIMSELTINIB	Deciphera Pharmaceuticals, LLC	f73c7a62-9601-4df0-810f-100f515d79ea	2026-06-26	Warnings, Adverse reactions	Exact identifier application applno (NDA): 219304 application number: NDA219304

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
85996	SUPPL	2026-05-21
84415	SUPPL	2025-12-15
81610	ORIG	2025-03-17
81268	ORIG	2025-02-18
81267	ORIG	2025-02-18
81265	ORIG	2025-02-18