Application 204114

Type: NDA
Sponsor: NOVARTIS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MEKINIST	TRAMETINIB DIMETHYL SULFOXIDE	TABLET;ORAL	EQ 0.5MG	Yes	No
002	MEKINIST	TRAMETINIB DIMETHYL SULFOXIDE	TABLET;ORAL	EQ 1MG	Yes	No
003	MEKINIST	TRAMETINIB DIMETHYL SULFOXIDE	TABLET;ORAL	EQ 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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N204114-001	MEKINIST	TRAMETINIB DIMETHYL SULFOXIDE	EQ 0.5MG	TABLET / ORAL	RLD	2013-05-29
N204114-002	MEKINIST	TRAMETINIB DIMETHYL SULFOXIDE	EQ 1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2013-05-29
N204114-003	MEKINIST	TRAMETINIB DIMETHYL SULFOXIDE	EQ 2MG	TABLET / ORAL	RLD, RS	2013-05-29

Orange Book patents#

Current patent rows page 1 of 1 · 60 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N204114-001	7378423	2027-05-29		Drug substance, Drug product	2013-06-06
N204114-001	7378423*PED	2027-11-29		Pediatric extension
N204114-001	8703781	2030-10-15	U-1712	Drug substance, Drug product	2015-05-22
N204114-001	8703781	2030-10-15	U-2020	Drug substance, Drug product	2015-05-22
N204114-001	8703781	2030-10-15	U-2037	Drug substance, Drug product	2015-05-22
N204114-001	8703781	2030-10-15	U-2302	Drug substance, Drug product	2015-05-22
N204114-001	8703781	2030-10-15	U-2305	Drug substance, Drug product	2015-05-22
N204114-001	8952018	2030-10-15	U-2020		2016-09-22
N204114-001	8703781*PED	2031-04-15		Pediatric extension
N204114-001	8952018*PED	2031-04-15		Pediatric extension
N204114-001	8580304	2032-01-28		Drug product
N204114-001	9155706	2032-01-28		Drug product	2015-12-10
N204114-001	9271941	2032-01-28		Drug product	2016-04-08
N204114-001	9399021	2032-01-28		Drug product	2019-12-19
N204114-001	8580304*PED	2032-07-28		Pediatric extension
N204114-001	9155706*PED	2032-07-28		Pediatric extension
N204114-001	9271941*PED	2032-07-28		Pediatric extension
N204114-001	9399021*PED	2032-07-28		Pediatric extension
N204114-001	10869869	2033-08-30	U-3184		2021-08-18
N204114-001	10869869*PED	2034-02-28		Pediatric extension
N204114-002	7378423	2027-05-29		Drug substance, Drug product
N204114-002	7378423*PED	2027-11-29		Pediatric extension
N204114-002	8703781	2030-10-15	U-1712	Drug substance, Drug product	2015-05-22
N204114-002	8703781	2030-10-15	U-2020	Drug substance, Drug product	2015-05-22
N204114-002	8703781	2030-10-15	U-2037	Drug substance, Drug product	2015-05-22
N204114-002	8703781	2030-10-15	U-2302	Drug substance, Drug product	2015-05-22
N204114-002	8703781	2030-10-15	U-2305	Drug substance, Drug product	2015-05-22
N204114-002	8952018	2030-10-15	U-2020		2016-09-22
N204114-002	8703781*PED	2031-04-15		Pediatric extension
N204114-002	8952018*PED	2031-04-15		Pediatric extension
N204114-002	8580304	2032-01-28		Drug product
N204114-002	9155706	2032-01-28		Drug product	2016-09-22
N204114-002	9271941	2032-01-28		Drug product	2016-09-22
N204114-002	9399021	2032-01-28		Drug product	2019-12-19
N204114-002	8580304*PED	2032-07-28		Pediatric extension
N204114-002	9155706*PED	2032-07-28		Pediatric extension
N204114-002	9271941*PED	2032-07-28		Pediatric extension
N204114-002	9399021*PED	2032-07-28		Pediatric extension
N204114-002	10869869	2033-08-30	U-3184		2021-08-18
N204114-002	10869869*PED	2034-02-28		Pediatric extension
N204114-003	7378423	2027-05-29		Drug substance, Drug product
N204114-003	7378423*PED	2027-11-29		Pediatric extension
N204114-003	8703781	2030-10-15	U-1712	Drug substance, Drug product	2015-05-22
N204114-003	8703781	2030-10-15	U-2020	Drug substance, Drug product	2015-05-22
N204114-003	8703781	2030-10-15	U-2037	Drug substance, Drug product	2015-05-22
N204114-003	8703781	2030-10-15	U-2302	Drug substance, Drug product	2015-05-22
N204114-003	8703781	2030-10-15	U-2305	Drug substance, Drug product	2015-05-22
N204114-003	8952018	2030-10-15	U-2020		2016-09-22
N204114-003	8703781*PED	2031-04-15		Pediatric extension
N204114-003	8952018*PED	2031-04-15		Pediatric extension
N204114-003	8580304	2032-01-28		Drug product	2013-12-10
N204114-003	9155706	2032-01-28		Drug product	2015-12-10
N204114-003	9271941	2032-01-28		Drug product	2016-04-08
N204114-003	9399021	2032-01-28		Drug product	2019-12-19
N204114-003	8580304*PED	2032-07-28		Pediatric extension
N204114-003	9155706*PED	2032-07-28		Pediatric extension
N204114-003	9271941*PED	2032-07-28		Pediatric extension
N204114-003	9399021*PED	2032-07-28		Pediatric extension
N204114-003	10869869	2033-08-30	U-3184		2021-08-18
N204114-003	10869869*PED	2034-02-28		Pediatric extension

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 12 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N204114-001	I-908	2026-03-16
N204114-001	PED	2026-09-16
N204114-001	ODE-428	2030-03-16
N204114-001	PED	2030-09-16
N204114-002	I-908	2026-03-16
N204114-002	PED	2026-09-16
N204114-002	ODE-428	2030-03-16
N204114-002	PED	2030-09-16
N204114-003	I-908	2026-03-16
N204114-003	PED	2026-09-16
N204114-003	ODE-428	2030-03-16
N204114-003	PED	2030-09-16

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.

Product history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N204114-001	MEKINIST	EQ 0.5MG	TABLET / ORAL		RLD	2013-05-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204114-002	MEKINIST	EQ 1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2013-05-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204114-003	MEKINIST	EQ 2MG	TABLET / ORAL		RLD, RS	2013-05-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204114-001	MEKINIST	EQ 0.5MG	TABLET / ORAL		RLD	2013-05-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204114-002	MEKINIST	EQ 1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2013-05-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204114-003	MEKINIST	EQ 2MG	TABLET / ORAL		RLD, RS	2013-05-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N204114-001	MEKINIST	EQ 0.5MG	TABLET / ORAL		RLD	2013-05-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204114-002	MEKINIST	EQ 1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2013-05-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204114-003	MEKINIST	EQ 2MG	TABLET / ORAL		RLD, RS	2013-05-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204114-001	MEKINIST	EQ 0.5MG	TABLET / ORAL		RLD	2013-05-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204114-002	MEKINIST	EQ 1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2013-05-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204114-003	MEKINIST	EQ 2MG	TABLET / ORAL		RLD, RS	2013-05-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204114-001	MEKINIST	EQ 0.5MG	TABLET / ORAL		RLD	2013-05-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204114-002	MEKINIST	EQ 1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2013-05-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204114-003	MEKINIST	EQ 2MG	TABLET / ORAL		RLD, RS	2013-05-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204114-001	MEKINIST	EQ 0.5MG	TABLET / ORAL		RLD	2013-05-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204114-002	MEKINIST	EQ 1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2013-05-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204114-003	MEKINIST	EQ 2MG	TABLET / ORAL		RLD, RS	2013-05-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204114-001	MEKINIST	EQ 0.5MG	TABLET / ORAL		RLD	2013-05-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204114-002	MEKINIST	EQ 1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2013-05-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204114-003	MEKINIST	EQ 2MG	TABLET / ORAL		RLD, RS	2013-05-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204114-001	MEKINIST	EQ 0.5MG	TABLET / ORAL		RLD	2013-05-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204114-002	MEKINIST	EQ 1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2013-05-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204114-003	MEKINIST	EQ 2MG	TABLET / ORAL		RLD, RS	2013-05-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N204114-001	MEKINIST	EQ 0.5MG	TABLET / ORAL		RLD	2013-05-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N204114-002	MEKINIST	EQ 1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2013-05-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N204114-003	MEKINIST	EQ 2MG	TABLET / ORAL		RLD, RS	2013-05-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N204114-001	MEKINIST	EQ 0.5MG	TABLET / ORAL		RLD	2013-05-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N204114-002	MEKINIST	EQ 1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2013-05-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N204114-003	MEKINIST	EQ 2MG	TABLET / ORAL		RLD, RS	2013-05-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N204114-001	MEKINIST	EQ 0.5MG	TABLET / ORAL	AB	RLD	2013-05-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N204114-002	MEKINIST	EQ 1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2013-05-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N204114-003	MEKINIST	EQ 2MG	TABLET / ORAL	AB	RLD, RS	2013-05-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N204114-001	MEKINIST	EQ 0.5MG	TABLET / ORAL		RLD	2013-05-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N204114-002	MEKINIST	EQ 1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2013-05-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N204114-003	MEKINIST	EQ 2MG	TABLET / ORAL		RLD, RS	2013-05-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N204114-001	MEKINIST	EQ 0.5MG	TABLET / ORAL		RLD	2013-05-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N204114-002	MEKINIST	EQ 1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2013-05-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N204114-003	MEKINIST	EQ 2MG	TABLET / ORAL		RLD, RS	2013-05-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N204114-001	MEKINIST	EQ 0.5MG	TABLET / ORAL		RLD	2013-05-29	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N204114-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N204114-003	AB	1	`79d66fd596c7…`

Observed Orange Book patent history#

Patent history page 1 of 69 · 2,757 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	N204114-001	7378423	2027-05-29		Drug substance, Drug product	2013-06-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204114-001	7378423*PED	2027-11-29		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204114-001	8703781	2030-10-15	U-2305	Drug substance, Drug product	2015-05-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204114-001	8703781	2030-10-15	U-1712	Drug substance, Drug product	2015-05-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204114-001	8703781	2030-10-15	U-2020	Drug substance, Drug product	2015-05-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204114-001	8703781	2030-10-15	U-2302	Drug substance, Drug product	2015-05-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204114-001	8703781	2030-10-15	U-2037	Drug substance, Drug product	2015-05-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204114-001	8952018	2030-10-15	U-2020		2016-09-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204114-001	8703781*PED	2031-04-15		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204114-001	8952018*PED	2031-04-15		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204114-001	8580304	2032-01-28		Drug product		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204114-001	9155706	2032-01-28		Drug product	2015-12-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204114-001	9271941	2032-01-28		Drug product	2016-04-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204114-001	9399021	2032-01-28		Drug product	2019-12-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204114-001	8580304*PED	2032-07-28		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204114-001	9155706*PED	2032-07-28		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204114-001	9271941*PED	2032-07-28		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204114-001	9399021*PED	2032-07-28		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204114-001	10869869	2033-08-30	U-3184		2021-08-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204114-001	10869869*PED	2034-02-28		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204114-002	7378423	2027-05-29		Drug substance, Drug product		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204114-002	7378423*PED	2027-11-29		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204114-002	8703781	2030-10-15	U-2302	Drug substance, Drug product	2015-05-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204114-002	8703781	2030-10-15	U-2037	Drug substance, Drug product	2015-05-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204114-002	8703781	2030-10-15	U-1712	Drug substance, Drug product	2015-05-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204114-002	8703781	2030-10-15	U-2305	Drug substance, Drug product	2015-05-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204114-002	8703781	2030-10-15	U-2020	Drug substance, Drug product	2015-05-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204114-002	8952018	2030-10-15	U-2020		2016-09-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204114-002	8703781*PED	2031-04-15		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204114-002	8952018*PED	2031-04-15		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204114-002	8580304	2032-01-28		Drug product		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204114-002	9155706	2032-01-28		Drug product	2016-09-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204114-002	9271941	2032-01-28		Drug product	2016-09-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204114-002	9399021	2032-01-28		Drug product	2019-12-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204114-002	8580304*PED	2032-07-28		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204114-002	9155706*PED	2032-07-28		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204114-002	9271941*PED	2032-07-28		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204114-002	9399021*PED	2032-07-28		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204114-002	10869869	2033-08-30	U-3184		2021-08-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204114-002	10869869*PED	2034-02-28		Pediatric extension		`011fe1cb6892…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 26 · 1,017 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N204114-001	I-908	2026-03-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204114-001	PED	2026-09-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204114-001	ODE-428	2030-03-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204114-001	PED	2030-09-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204114-002	I-908	2026-03-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204114-002	PED	2026-09-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204114-002	ODE-428	2030-03-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204114-002	PED	2030-09-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204114-003	I-908	2026-03-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204114-003	PED	2026-09-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204114-003	ODE-428	2030-03-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204114-003	PED	2030-09-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204114-001	ODE-182	2025-04-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204114-001	ODE-183	2025-05-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204114-001	I-895	2025-06-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204114-001	PED	2025-10-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204114-001	PED	2025-11-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204114-001	PED	2025-12-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204114-001	I-908	2026-03-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204114-001	PED	2026-09-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204114-001	ODE-428	2030-03-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204114-001	PED	2030-09-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204114-002	ODE-182	2025-04-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204114-002	ODE-183	2025-05-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204114-002	I-895	2025-06-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204114-002	PED	2025-10-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204114-002	PED	2025-11-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204114-002	PED	2025-12-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204114-002	I-908	2026-03-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204114-002	PED	2026-09-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204114-002	ODE-428	2030-03-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204114-002	PED	2030-09-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204114-003	ODE-182	2025-04-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204114-003	ODE-183	2025-05-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204114-003	I-895	2025-06-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204114-003	PED	2025-10-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204114-003	PED	2025-11-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204114-003	PED	2025-12-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204114-003	I-908	2026-03-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204114-003	PED	2026-09-16	`31067a03dcf5…`

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
Mekinist	TRAMETINIB	Novartis Pharmaceuticals Corporation	0002ad27-779d-42ab-83b5-bc65453412a1	2026-05-07	Warnings, Adverse reactions	Exact identifier application applno (NDA): 204114 application number: NDA204114 ndc (product): 0078-1105 ndc (product): 0078-1112

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 30 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0078-0666	Mekinist	trametinib	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0666	Mekinist	trametinib	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0666	Mekinist	trametinib	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0666	Mekinist	trametinib	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0666	Mekinist	trametinib	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0666	Mekinist	trametinib	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0666	Mekinist	trametinib	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0666	Mekinist	trametinib	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0666	Mekinist	trametinib	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0666	Mekinist	trametinib	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0666	Mekinist	trametinib	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0668	Mekinist	trametinib	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0668	Mekinist	trametinib	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0668	Mekinist	trametinib	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0668	Mekinist	trametinib	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0668	Mekinist	trametinib	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0668	Mekinist	trametinib	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0668	Mekinist	trametinib	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0668	Mekinist	trametinib	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0668	Mekinist	trametinib	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0668	Mekinist	trametinib	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0668	Mekinist	trametinib	Novartis Pharmaceuticals Corporation	NDA	Current
0078-1105	Mekinist	trametinib	Novartis Pharmaceuticals Corporation	NDA	Current
0078-1105	Mekinist	trametinib	Novartis Pharmaceuticals Corporation	NDA	Current
0078-1105	Mekinist	trametinib	Novartis Pharmaceuticals Corporation	NDA	Current
0078-1105	Mekinist	trametinib	Novartis Pharmaceuticals Corporation	NDA	Current
0078-1112	Mekinist	trametinib	Novartis Pharmaceuticals Corporation	NDA	Current
0078-1112	Mekinist	trametinib	Novartis Pharmaceuticals Corporation	NDA	Current
0078-1112	Mekinist	trametinib	Novartis Pharmaceuticals Corporation	NDA	Current
0078-1112	Mekinist	trametinib	Novartis Pharmaceuticals Corporation	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
85933	SUPPL	2026-05-18
85868	SUPPL	2026-05-11
85591	SUPPL	2026-03-30
85569	SUPPL	2026-03-30
81989	SUPPL	2025-04-25
81987	SUPPL	2025-04-25
81910	SUPPL	2025-04-09
81836	SUPPL	2025-04-08
81666	SUPPL	2025-03-21
81524	SUPPL	2025-03-21
81656	SUPPL	2025-03-20
81512	SUPPL	2025-03-11
81290	SUPPL	2025-02-20
81256	SUPPL	2025-02-14
79969	SUPPL	2024-10-24
79810	SUPPL	2024-10-03
79093	SUPPL	2024-07-15
79057	SUPPL	2024-07-12
78023	SUPPL	2024-04-01
78011	SUPPL	2024-04-01
77646	SUPPL	2024-02-28
77636	SUPPL	2024-02-28
75347	SUPPL	2023-09-01
75338	SUPPL	2023-09-01
74402	SUPPL	2023-05-30
74401	SUPPL	2023-05-30
74396	SUPPL	2023-05-30
73796	SUPPL	2023-03-17
73778	SUPPL	2023-03-16
71433	SUPPL	2022-06-23
71429	SUPPL	2022-06-23
71197	SUPPL	2022-06-01
71172	SUPPL	2022-05-31
70039	SUPPL	2022-02-01
70034	SUPPL	2022-02-01
70016	SUPPL	2022-01-31
70015	SUPPL	2022-01-31
69500	SUPPL	2021-12-07
69490	SUPPL	2021-12-07
67462	SUPPL	2021-05-12
67452	SUPPL	2021-05-11
63690	SUPPL	2020-06-24
63681	SUPPL	2020-06-24
62575	SUPPL	2020-04-15
62538	SUPPL	2020-04-10
60458	SUPPL	2019-10-09
60265	SUPPL	2019-10-07
59368	SUPPL	2019-07-18
59366	SUPPL	2019-07-17
54043	SUPPL	2018-05-08
54016	SUPPL	2018-05-04
53991	SUPPL	2018-05-03
53872	SUPPL	2018-04-30
52996	SUPPL	2018-03-15
52922	SUPPL	2018-03-13
48835	SUPPL	2017-06-27
48810	SUPPL	2017-06-22
47436	SUPPL	2017-03-03
47338	SUPPL	2017-02-27
32513	SUPPL	2015-11-23
40356	SUPPL	2015-11-20
32512	SUPPL	2014-01-10
40355	SUPPL	2014-01-09
43456	ORIG	2013-07-08
24458	ORIG	2013-06-07
24120	ORIG	2013-06-07
32511	ORIG	2013-05-30
19528	ORIG	2013-05-29