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 43.

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-4590		2025-02-14
N219389-001	12011424	2041-02-17	U-4595		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-4590		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-4591		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-4590		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-4590		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-4591		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
2026-09-14 22:38:34	2026-08	N219389-001	GOMEKLI	1MG	CAPSULE / ORAL	RLD	2025-02-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219389-002	GOMEKLI	2MG	CAPSULE / ORAL	RLD, RS	2025-02-11	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N219389-001	GOMEKLI	1MG	CAPSULE / ORAL	RLD	2025-02-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219389-002	GOMEKLI	2MG	CAPSULE / ORAL	RLD, RS	2025-02-11	`caaa826d4ba7…`
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 7 · 247 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	N219389-001	11066358	2041-02-17		Drug substance	2025-02-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219389-001	11084780	2041-02-17		Drug substance	2025-02-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219389-001	11453641	2041-02-17	U-4130		2025-02-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219389-001	11806321	2041-02-17	U-4130		2025-02-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219389-001	11819487	2041-02-17	U-4590		2025-02-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219389-001	12011424	2041-02-17	U-4595		2025-02-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219389-001	12037306	2041-02-17	U-4130		2025-02-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219389-001	12263146	2041-02-17	U-4130		2025-04-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219389-001	12275688	2041-02-17	U-4130	Drug product	2025-04-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219389-001	12295925	2041-02-17	U-4590		2025-05-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219389-001	11839595	2043-03-16	U-4130		2025-02-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219389-001	11883375	2043-03-16	U-4130		2025-02-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219389-001	12220390	2043-03-16	U-4130		2025-02-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219389-001	12257215	2043-03-16	U-4130		2025-04-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219389-001	12324791	2043-03-16	U-4591		2025-06-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219389-001	11806322	2043-04-09	U-4130		2025-02-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219389-001	12661330	2044-02-05	U-4130		2026-07-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219389-001	12029711	2044-03-15	U-4130	Drug product	2025-02-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219389-001	12383517	2044-03-15	U-4130	Drug product	2025-08-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219389-001	12390430	2044-10-10	U-4130		2025-08-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219389-002	11066358	2041-02-17		Drug substance	2025-02-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219389-002	11084780	2041-02-17		Drug substance	2025-02-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219389-002	11453641	2041-02-17	U-4130		2025-02-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219389-002	11806321	2041-02-17	U-4130		2025-02-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219389-002	11819487	2041-02-17	U-4590		2025-02-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219389-002	12037306	2041-02-17	U-4130		2025-02-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219389-002	12263146	2041-02-17	U-4130		2025-04-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219389-002	12275688	2041-02-17	U-4130	Drug product	2025-04-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219389-002	12295925	2041-02-17	U-4590		2025-05-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219389-002	11839595	2043-03-16	U-4130		2025-02-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219389-002	11883375	2043-03-16	U-4130		2025-02-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219389-002	12220390	2043-03-16	U-4130		2025-02-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219389-002	12257215	2043-03-16	U-4130		2025-04-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219389-002	12324791	2043-03-16	U-4591		2025-06-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219389-002	11806322	2043-04-09	U-4130		2025-02-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219389-002	12661330	2044-02-05	U-4130		2026-07-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219389-002	12029711	2044-03-15	U-4130	Drug product	2025-02-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219389-002	12383517	2044-03-15	U-4130	Drug product	2025-08-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219389-002	12390430	2044-10-10	U-4130		2025-08-20	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N219389-001	11066358	2041-02-17		Drug substance	2025-02-14	`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	N219389-001	NCE	2030-02-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219389-001	ODE-488	2032-02-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219389-002	NCE	2030-02-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219389-002	ODE-488	2032-02-11	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N219389-001	NCE	2030-02-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219389-001	ODE-488	2032-02-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219389-002	NCE	2030-02-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219389-002	ODE-488	2032-02-11	`caaa826d4ba7…`
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…`

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
81693	ORIG	2025-03-24
81246	ORIG	2025-02-14
81230	ORIG	2025-02-12