Application 219389

Type: NDA
Sponsor: SPRINGWORKS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	GOMEKLI	MIRDAMETINIB	CAPSULE;ORAL	1MG	Yes	No
002	GOMEKLI	MIRDAMETINIB	CAPSULE;ORAL	2MG	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
N219389-001	GOMEKLI	MIRDAMETINIB	1MG	CAPSULE / ORAL		RLD	2025-02-11
N219389-002	GOMEKLI	MIRDAMETINIB	2MG	CAPSULE / ORAL		RLD, RS	2025-02-11

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
N219389-001	11066358	2041-02-17		Drug substance	2025-02-14
N219389-001	11084780	2041-02-17		Drug substance	2025-02-14
N219389-001	11453641	2041-02-17	U-4130		2025-02-14
N219389-001	11806321	2041-02-17	U-4130		2025-02-14
N219389-001	11819487	2041-02-17	U-4130		2025-02-14
N219389-001	12011424	2041-02-17	U-4130		2025-02-14
N219389-001	12037306	2041-02-17	U-4130		2025-02-14
N219389-001	12263146	2041-02-17	U-4130		2025-04-03
N219389-001	12275688	2041-02-17	U-4130	Drug product	2025-04-17
N219389-001	12295925	2041-02-17	U-4130		2025-05-15
N219389-001	11839595	2043-03-16	U-4130		2025-02-14
N219389-001	11883375	2043-03-16	U-4130		2025-02-14
N219389-001	12220390	2043-03-16	U-4130		2025-02-14
N219389-001	12257215	2043-03-16	U-4130		2025-04-03
N219389-001	12324791	2043-03-16	U-4130		2025-06-16
N219389-001	11806322	2043-04-09	U-4130		2025-02-14
N219389-001	12661330	2044-02-05	U-4130		2026-07-02
N219389-001	12029711	2044-03-15	U-4130	Drug product	2025-02-14
N219389-001	12383517	2044-03-15	U-4130	Drug product	2025-08-20
N219389-001	12390430	2044-10-10	U-4130		2025-08-20
N219389-002	11066358	2041-02-17		Drug substance	2025-02-14
N219389-002	11084780	2041-02-17		Drug substance	2025-02-14
N219389-002	11453641	2041-02-17	U-4130		2025-02-14
N219389-002	11806321	2041-02-17	U-4130		2025-02-14
N219389-002	11819487	2041-02-17	U-4130		2025-02-14
N219389-002	12037306	2041-02-17	U-4130		2025-02-14
N219389-002	12263146	2041-02-17	U-4130		2025-04-03
N219389-002	12275688	2041-02-17	U-4130	Drug product	2025-04-17
N219389-002	12295925	2041-02-17	U-4130		2025-05-15
N219389-002	11839595	2043-03-16	U-4130		2025-02-14
N219389-002	11883375	2043-03-16	U-4130		2025-02-14
N219389-002	12220390	2043-03-16	U-4130		2025-02-14
N219389-002	12257215	2043-03-16	U-4130		2025-04-03
N219389-002	12324791	2043-03-16	U-4130		2025-06-16
N219389-002	11806322	2043-04-09	U-4130		2025-02-14
N219389-002	12661330	2044-02-05	U-4130		2026-07-02
N219389-002	12029711	2044-03-15	U-4130	Drug product	2025-02-14
N219389-002	12383517	2044-03-15	U-4130	Drug product	2025-08-20
N219389-002	12390430	2044-10-10	U-4130		2025-08-20

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 4 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N219389-001	NCE	2030-02-11
N219389-001	ODE-488	2032-02-11
N219389-002	NCE	2030-02-11
N219389-002	ODE-488	2032-02-11

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
2026-02-19 14:30 UTC	2026-02	N219389-001	GOMEKLI	1MG	CAPSULE / ORAL	RLD	2025-02-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219389-002	GOMEKLI	2MG	CAPSULE / ORAL	RLD, RS	2025-02-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219389-001	GOMEKLI	1MG	CAPSULE / ORAL	RLD	2025-02-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219389-002	GOMEKLI	2MG	CAPSULE / ORAL	RLD, RS	2025-02-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N219389-001	GOMEKLI	1MG	CAPSULE / ORAL	RLD	2025-02-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N219389-002	GOMEKLI	2MG	CAPSULE / ORAL	RLD, RS	2025-02-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N219389-001	GOMEKLI	1MG	CAPSULE / ORAL	RLD	2025-02-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N219389-002	GOMEKLI	2MG	CAPSULE / ORAL	RLD, RS	2025-02-11	`fd3edfee7708…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219389-001	GOMEKLI	1MG	CAPSULE / ORAL	RLD	2025-02-11	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219389-002	GOMEKLI	2MG	CAPSULE / ORAL	RLD, RS	2025-02-11	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 5 · 169 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N219389-001	11066358	2041-02-17		Drug substance	2025-02-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219389-001	11084780	2041-02-17		Drug substance	2025-02-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219389-001	11453641	2041-02-17	U-4130		2025-02-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219389-001	11806321	2041-02-17	U-4130		2025-02-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219389-001	11819487	2041-02-17	U-4130		2025-02-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219389-001	12011424	2041-02-17	U-4130		2025-02-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219389-001	12037306	2041-02-17	U-4130		2025-02-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219389-001	12263146	2041-02-17	U-4130		2025-04-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219389-001	12275688	2041-02-17	U-4130	Drug product	2025-04-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219389-001	12295925	2041-02-17	U-4130		2025-05-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219389-001	11839595	2043-03-16	U-4130		2025-02-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219389-001	11883375	2043-03-16	U-4130		2025-02-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219389-001	12220390	2043-03-16	U-4130		2025-02-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219389-001	12257215	2043-03-16	U-4130		2025-04-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219389-001	12324791	2043-03-16	U-4130		2025-06-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219389-001	11806322	2043-04-09	U-4130		2025-02-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219389-001	12029711	2044-03-15	U-4130	Drug product	2025-02-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219389-001	12383517	2044-03-15	U-4130	Drug product	2025-08-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219389-001	12390430	2044-10-10	U-4130		2025-08-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219389-002	11066358	2041-02-17		Drug substance	2025-02-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219389-002	11084780	2041-02-17		Drug substance	2025-02-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219389-002	11453641	2041-02-17	U-4130		2025-02-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219389-002	11806321	2041-02-17	U-4130		2025-02-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219389-002	11819487	2041-02-17	U-4130		2025-02-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219389-002	12037306	2041-02-17	U-4130		2025-02-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219389-002	12263146	2041-02-17	U-4130		2025-04-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219389-002	12275688	2041-02-17	U-4130	Drug product	2025-04-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219389-002	12295925	2041-02-17	U-4130		2025-05-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219389-002	11839595	2043-03-16	U-4130		2025-02-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219389-002	11883375	2043-03-16	U-4130		2025-02-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219389-002	12220390	2043-03-16	U-4130		2025-02-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219389-002	12257215	2043-03-16	U-4130		2025-04-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219389-002	12324791	2043-03-16	U-4130		2025-06-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219389-002	11806322	2043-04-09	U-4130		2025-02-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219389-002	12029711	2044-03-15	U-4130	Drug product	2025-02-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219389-002	12383517	2044-03-15	U-4130	Drug product	2025-08-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219389-002	12390430	2044-10-10	U-4130		2025-08-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219389-001	11066358	2041-02-17		Drug substance	2025-02-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219389-001	11084780	2041-02-17		Drug substance	2025-02-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219389-001	11453641	2041-02-17	U-4130		2025-02-14	`31067a03dcf5…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N219389-001	NCE	2030-02-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219389-001	ODE-488	2032-02-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219389-002	NCE	2030-02-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219389-002	ODE-488	2032-02-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219389-001	NCE	2030-02-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219389-001	ODE-488	2032-02-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219389-002	NCE	2030-02-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219389-002	ODE-488	2032-02-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N219389-001	NCE	2030-02-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N219389-001	ODE-488	2032-02-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N219389-002	NCE	2030-02-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N219389-002	ODE-488	2032-02-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N219389-001	NCE	2030-02-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N219389-002	NCE	2030-02-11	`fd3edfee7708…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219389-001	NCE	2030-02-11	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219389-001	ODE-488	2032-02-11	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219389-002	NCE	2030-02-11	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219389-002	ODE-488	2032-02-11	`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
Gomekli	MIRDAMETINIB	SpringWorks Therapeutics, Inc.	4c41bf90-5fa7-4935-a95c-e047ea6bbf8e	2026-07-10	Warnings, Adverse reactions	Exact identifier application applno (NDA): 219389 application number: NDA219389

Documents#

Document, Submission type, Date table
Document	Submission type	Date
81693	ORIG	2025-03-24
81246	ORIG	2025-02-14
81230	ORIG	2025-02-12