Application 202806

Type: NDA
Sponsor: NOVARTIS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TAFINLAR	DABRAFENIB MESYLATE	CAPSULE;ORAL	EQ 50MG BASE	Yes	No
002	TAFINLAR	DABRAFENIB MESYLATE	CAPSULE;ORAL	EQ 75MG BASE	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
N202806-001	TAFINLAR	DABRAFENIB MESYLATE	EQ 50MG BASE	CAPSULE / ORAL		RLD	2013-05-29
N202806-002	TAFINLAR	DABRAFENIB MESYLATE	EQ 75MG BASE	CAPSULE / ORAL		RLD, RS	2013-05-29

Orange Book patents#

Current patent rows page 1 of 1 · 48 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N202806-001	9233956	2029-05-04	U-1811		2016-02-24
N202806-001	9233956	2029-05-04	U-2031		2016-02-24
N202806-001	9233956	2029-05-04	U-2032		2016-02-24
N202806-001	9233956	2029-05-04	U-2296		2016-02-24
N202806-001	9233956*PED	2029-11-04		Pediatric extension
N202806-001	7994185	2030-01-20	U-1406	Drug substance, Drug product	2013-06-13
N202806-001	7994185	2030-01-20	U-2031	Drug substance, Drug product	2013-06-13
N202806-001	7994185	2030-01-20	U-2032	Drug substance, Drug product	2013-06-13
N202806-001	7994185	2030-01-20	U-2296	Drug substance, Drug product	2013-06-13
N202806-001	8415345	2030-01-20	U-1406	Drug substance, Drug product	2013-06-13
N202806-001	8415345	2030-01-20	U-2031	Drug substance, Drug product	2013-06-13
N202806-001	8415345	2030-01-20	U-2032	Drug substance, Drug product	2013-06-13
N202806-001	8415345	2030-01-20	U-2296	Drug substance, Drug product	2013-06-13
N202806-001	7994185*PED	2030-07-20		Pediatric extension
N202806-001	8415345*PED	2030-07-20		Pediatric extension
N202806-001	8703781	2030-10-15	U-1713	Drug substance, Drug product	2015-05-22
N202806-001	8703781	2030-10-15	U-2032	Drug substance, Drug product	2015-05-22
N202806-001	8703781	2030-10-15	U-2296	Drug substance, Drug product	2015-05-22
N202806-001	8703781	2030-10-15	U-2298	Drug substance, Drug product	2015-05-22
N202806-001	8952018	2030-10-15	U-2027		2017-07-18
N202806-001	8703781*PED	2031-04-15		Pediatric extension
N202806-001	8952018*PED	2031-04-15		Pediatric extension
N202806-001	10869869	2033-08-30	U-3185		2021-08-18
N202806-001	10869869*PED	2034-02-28		Pediatric extension
N202806-002	9233956	2029-05-04	U-1811		2016-02-24
N202806-002	9233956	2029-05-04	U-2031		2016-02-24
N202806-002	9233956	2029-05-04	U-2032		2016-02-24
N202806-002	9233956	2029-05-04	U-2296		2016-02-24
N202806-002	9233956*PED	2029-11-04		Pediatric extension
N202806-002	7994185	2030-01-20	U-1406	Drug substance, Drug product	2013-06-13
N202806-002	7994185	2030-01-20	U-2031	Drug substance, Drug product	2013-06-13
N202806-002	7994185	2030-01-20	U-2032	Drug substance, Drug product	2013-06-13
N202806-002	7994185	2030-01-20	U-2296	Drug substance, Drug product	2013-06-13
N202806-002	8415345	2030-01-20	U-1406	Drug substance, Drug product	2013-06-13
N202806-002	8415345	2030-01-20	U-2031	Drug substance, Drug product	2013-06-13
N202806-002	8415345	2030-01-20	U-2032	Drug substance, Drug product	2013-06-13
N202806-002	8415345	2030-01-20	U-2296	Drug substance, Drug product	2013-06-13
N202806-002	7994185*PED	2030-07-20		Pediatric extension
N202806-002	8415345*PED	2030-07-20		Pediatric extension
N202806-002	8703781	2030-10-15	U-1713	Drug substance, Drug product	2015-05-22
N202806-002	8703781	2030-10-15	U-2032	Drug substance, Drug product	2015-05-22
N202806-002	8703781	2030-10-15	U-2296	Drug substance, Drug product	2015-05-22
N202806-002	8703781	2030-10-15	U-2298	Drug substance, Drug product	2015-05-22
N202806-002	8952018	2030-10-15	U-2027		2017-07-18
N202806-002	8703781*PED	2031-04-15		Pediatric extension
N202806-002	8952018*PED	2031-04-15		Pediatric extension
N202806-002	10869869	2033-08-30	U-3185		2021-08-18
N202806-002	10869869*PED	2034-02-28		Pediatric extension

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N202806-001	I-908	2026-03-16
N202806-001	PED	2026-09-16
N202806-001	ODE-428	2030-03-16
N202806-001	PED	2030-09-16
N202806-002	I-908	2026-03-16
N202806-002	PED	2026-09-16
N202806-002	ODE-428	2030-03-16
N202806-002	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 3 · 82 observed 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	N202806-001	TAFINLAR	EQ 50MG BASE	CAPSULE / ORAL	RLD	2013-05-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202806-002	TAFINLAR	EQ 75MG BASE	CAPSULE / ORAL	RLD, RS	2013-05-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202806-001	TAFINLAR	EQ 50MG BASE	CAPSULE / ORAL	RLD	2013-05-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202806-002	TAFINLAR	EQ 75MG BASE	CAPSULE / ORAL	RLD, RS	2013-05-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N202806-001	TAFINLAR	EQ 50MG BASE	CAPSULE / ORAL	RLD	2013-05-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202806-002	TAFINLAR	EQ 75MG BASE	CAPSULE / ORAL	RLD, RS	2013-05-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202806-001	TAFINLAR	EQ 50MG BASE	CAPSULE / ORAL	RLD	2013-05-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202806-002	TAFINLAR	EQ 75MG BASE	CAPSULE / ORAL	RLD, RS	2013-05-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202806-001	TAFINLAR	EQ 50MG BASE	CAPSULE / ORAL	RLD	2013-05-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202806-002	TAFINLAR	EQ 75MG BASE	CAPSULE / ORAL	RLD, RS	2013-05-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202806-001	TAFINLAR	EQ 50MG BASE	CAPSULE / ORAL	RLD	2013-05-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202806-002	TAFINLAR	EQ 75MG BASE	CAPSULE / ORAL	RLD, RS	2013-05-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202806-001	TAFINLAR	EQ 50MG BASE	CAPSULE / ORAL	RLD	2013-05-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202806-002	TAFINLAR	EQ 75MG BASE	CAPSULE / ORAL	RLD, RS	2013-05-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202806-001	TAFINLAR	EQ 50MG BASE	CAPSULE / ORAL	RLD	2013-05-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202806-002	TAFINLAR	EQ 75MG BASE	CAPSULE / ORAL	RLD, RS	2013-05-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202806-001	TAFINLAR	EQ 50MG BASE	CAPSULE / ORAL	RLD	2013-05-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202806-002	TAFINLAR	EQ 75MG BASE	CAPSULE / ORAL	RLD, RS	2013-05-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N202806-001	TAFINLAR	EQ 50MG BASE	CAPSULE / ORAL	RLD	2013-05-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N202806-002	TAFINLAR	EQ 75MG BASE	CAPSULE / ORAL	RLD, RS	2013-05-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N202806-001	TAFINLAR	EQ 50MG BASE	CAPSULE / ORAL	RLD	2013-05-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N202806-002	TAFINLAR	EQ 75MG BASE	CAPSULE / ORAL	RLD, RS	2013-05-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N202806-001	TAFINLAR	EQ 50MG BASE	CAPSULE / ORAL	RLD	2013-05-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N202806-002	TAFINLAR	EQ 75MG BASE	CAPSULE / ORAL	RLD, RS	2013-05-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N202806-001	TAFINLAR	EQ 50MG BASE	CAPSULE / ORAL	RLD	2013-05-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N202806-002	TAFINLAR	EQ 75MG BASE	CAPSULE / ORAL	RLD, RS	2013-05-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N202806-001	TAFINLAR	EQ 50MG BASE	CAPSULE / ORAL	RLD	2013-05-29	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N202806-002	TAFINLAR	EQ 75MG BASE	CAPSULE / ORAL	RLD, RS	2013-05-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N202806-001	TAFINLAR	EQ 50MG BASE	CAPSULE / ORAL	RLD	2013-05-29	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N202806-002	TAFINLAR	EQ 75MG BASE	CAPSULE / ORAL	RLD, RS	2013-05-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N202806-001	TAFINLAR	EQ 50MG BASE	CAPSULE / ORAL	RLD	2013-05-29	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N202806-002	TAFINLAR	EQ 75MG BASE	CAPSULE / ORAL	RLD, RS	2013-05-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N202806-001	TAFINLAR	EQ 50MG BASE	CAPSULE / ORAL	RLD	2013-05-29	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N202806-002	TAFINLAR	EQ 75MG BASE	CAPSULE / ORAL	RLD, RS	2013-05-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N202806-001	TAFINLAR	EQ 50MG BASE	CAPSULE / ORAL	RLD	2013-05-29	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N202806-002	TAFINLAR	EQ 75MG BASE	CAPSULE / ORAL	RLD, RS	2013-05-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N202806-001	TAFINLAR	EQ 50MG BASE	CAPSULE / ORAL	RLD	2013-05-29	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N202806-002	TAFINLAR	EQ 75MG BASE	CAPSULE / ORAL	RLD, RS	2013-05-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N202806-001	TAFINLAR	EQ 50MG BASE	CAPSULE / ORAL	RLD	2013-05-29	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N202806-002	TAFINLAR	EQ 75MG BASE	CAPSULE / ORAL	RLD, RS	2013-05-29	`782e0a99824c…`

Observed Orange Book patent history#

Patent history page 1 of 54 · 2,122 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	N202806-001	9233956	2029-05-04	U-2032		2016-02-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202806-001	9233956	2029-05-04	U-2296		2016-02-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202806-001	9233956	2029-05-04	U-2031		2016-02-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202806-001	9233956	2029-05-04	U-1811		2016-02-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202806-001	9233956*PED	2029-11-04		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202806-001	7994185	2030-01-20	U-2296	Drug substance, Drug product	2013-06-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202806-001	7994185	2030-01-20	U-2032	Drug substance, Drug product	2013-06-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202806-001	7994185	2030-01-20	U-1406	Drug substance, Drug product	2013-06-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202806-001	7994185	2030-01-20	U-2031	Drug substance, Drug product	2013-06-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202806-001	8415345	2030-01-20	U-2032	Drug substance, Drug product	2013-06-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202806-001	8415345	2030-01-20	U-2031	Drug substance, Drug product	2013-06-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202806-001	8415345	2030-01-20	U-1406	Drug substance, Drug product	2013-06-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202806-001	8415345	2030-01-20	U-2296	Drug substance, Drug product	2013-06-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202806-001	7994185*PED	2030-07-20		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202806-001	8415345*PED	2030-07-20		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202806-001	8703781	2030-10-15	U-2296	Drug substance, Drug product	2015-05-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202806-001	8703781	2030-10-15	U-1713	Drug substance, Drug product	2015-05-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202806-001	8703781	2030-10-15	U-2032	Drug substance, Drug product	2015-05-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202806-001	8703781	2030-10-15	U-2298	Drug substance, Drug product	2015-05-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202806-001	8952018	2030-10-15	U-2027		2017-07-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202806-001	8703781*PED	2031-04-15		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202806-001	8952018*PED	2031-04-15		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202806-001	10869869	2033-08-30	U-3185		2021-08-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202806-001	10869869*PED	2034-02-28		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202806-002	9233956	2029-05-04	U-1811		2016-02-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202806-002	9233956	2029-05-04	U-2296		2016-02-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202806-002	9233956	2029-05-04	U-2031		2016-02-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202806-002	9233956	2029-05-04	U-2032		2016-02-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202806-002	9233956*PED	2029-11-04		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202806-002	7994185	2030-01-20	U-2296	Drug substance, Drug product	2013-06-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202806-002	7994185	2030-01-20	U-2032	Drug substance, Drug product	2013-06-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202806-002	7994185	2030-01-20	U-1406	Drug substance, Drug product	2013-06-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202806-002	7994185	2030-01-20	U-2031	Drug substance, Drug product	2013-06-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202806-002	8415345	2030-01-20	U-1406	Drug substance, Drug product	2013-06-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202806-002	8415345	2030-01-20	U-2031	Drug substance, Drug product	2013-06-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202806-002	8415345	2030-01-20	U-2032	Drug substance, Drug product	2013-06-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202806-002	8415345	2030-01-20	U-2296	Drug substance, Drug product	2013-06-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202806-002	7994185*PED	2030-07-20		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202806-002	8415345*PED	2030-07-20		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202806-002	8703781	2030-10-15	U-1713	Drug substance, Drug product	2015-05-22	`011fe1cb6892…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 18 · 698 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	N202806-001	I-908	2026-03-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202806-001	PED	2026-09-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202806-001	ODE-428	2030-03-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202806-001	PED	2030-09-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202806-002	I-908	2026-03-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202806-002	PED	2026-09-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202806-002	ODE-428	2030-03-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202806-002	PED	2030-09-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202806-001	ODE-182	2025-04-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202806-001	ODE-183	2025-05-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202806-001	I-894	2025-06-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202806-001	PED	2025-10-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202806-001	PED	2025-11-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202806-001	PED	2025-12-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202806-001	I-908	2026-03-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202806-001	PED	2026-09-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202806-001	ODE-428	2030-03-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202806-001	PED	2030-09-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202806-002	ODE-182	2025-04-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202806-002	ODE-183	2025-05-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202806-002	I-894	2025-06-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202806-002	PED	2025-10-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202806-002	PED	2025-11-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202806-002	PED	2025-12-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202806-002	I-908	2026-03-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202806-002	PED	2026-09-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202806-002	ODE-428	2030-03-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202806-002	PED	2030-09-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N202806-001	ODE-182	2025-04-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202806-001	ODE-183	2025-05-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202806-001	I-894	2025-06-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202806-001	PED	2025-10-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202806-001	PED	2025-11-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202806-001	PED	2025-12-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202806-001	I-908	2026-03-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202806-001	PED	2026-09-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202806-001	ODE-428	2030-03-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202806-001	PED	2030-09-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202806-002	ODE-182	2025-04-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202806-002	ODE-183	2025-05-04	`6a471c1ec25d…`

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
Tafinlar	DABRAFENIB	Novartis Pharmaceuticals Corporation	fee1e6b1-e1a5-4254-9f2e-a70e0f8dbdea	2026-05-20	Warnings, Adverse reactions	Exact identifier application applno (NDA): 202806 application number: NDA202806 ndc (product): 0078-0682 ndc (product): 0078-0681

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 24 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0078-0681	Tafinlar	dabrafenib	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0681	Tafinlar	dabrafenib	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0681	Tafinlar	dabrafenib	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0681	Tafinlar	dabrafenib	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0681	Tafinlar	dabrafenib	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0681	Tafinlar	dabrafenib	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0681	Tafinlar	dabrafenib	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0681	Tafinlar	dabrafenib	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0681	Tafinlar	dabrafenib	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0681	Tafinlar	dabrafenib	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0681	Tafinlar	dabrafenib	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0681	Tafinlar	dabrafenib	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0682	Tafinlar	dabrafenib	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0682	Tafinlar	dabrafenib	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0682	Tafinlar	dabrafenib	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0682	Tafinlar	dabrafenib	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0682	Tafinlar	dabrafenib	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0682	Tafinlar	dabrafenib	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0682	Tafinlar	dabrafenib	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0682	Tafinlar	dabrafenib	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0682	Tafinlar	dabrafenib	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0682	Tafinlar	dabrafenib	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0682	Tafinlar	dabrafenib	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0682	Tafinlar	dabrafenib	Novartis Pharmaceuticals Corporation	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
85589	SUPPL	2026-03-30
85568	SUPPL	2026-03-30
81913	SUPPL	2025-04-09
81838	SUPPL	2025-04-08
81669	SUPPL	2025-03-21
81668	SUPPL	2025-03-21
81520	SUPPL	2025-03-11
81514	SUPPL	2025-03-11
81071	SUPPL	2025-02-06
80970	SUPPL	2025-02-05
79094	SUPPL	2024-07-15
79055	SUPPL	2024-07-12
78022	SUPPL	2024-04-01
78012	SUPPL	2024-04-01
77644	SUPPL	2024-02-28
77638	SUPPL	2024-02-28
75348	SUPPL	2023-09-01
75339	SUPPL	2023-09-01
74400	SUPPL	2023-05-30
74393	SUPPL	2023-05-30
73794	SUPPL	2023-03-17
73779	SUPPL	2023-03-16
71446	SUPPL	2022-06-24
71432	SUPPL	2022-06-23
71430	SUPPL	2022-06-23
71198	SUPPL	2022-06-01
71171	SUPPL	2022-05-31
70110	SUPPL	2022-02-08
70109	SUPPL	2022-02-08
70037	SUPPL	2022-02-01
70036	SUPPL	2022-02-01
70020	SUPPL	2022-02-01
69489	SUPPL	2021-12-07
69488	SUPPL	2021-12-07
67464	SUPPL	2021-05-12
67463	SUPPL	2021-05-12
67451	SUPPL	2021-05-11
62577	SUPPL	2020-04-15
62576	SUPPL	2020-04-15
62525	SUPPL	2020-04-10
60457	SUPPL	2019-10-09
60267	SUPPL	2019-10-07
60266	SUPPL	2019-10-07
59365	SUPPL	2019-07-17
59362	SUPPL	2019-07-17
58717	SUPPL	2019-05-15
54044	SUPPL	2018-05-08
54017	SUPPL	2018-05-04
53990	SUPPL	2018-05-03
53873	SUPPL	2018-04-30
53786	SUPPL	2018-04-23
53744	SUPPL	2018-04-20
48829	SUPPL	2017-06-26
48808	SUPPL	2017-06-22
48758	SUPPL	2017-06-19
19380	SUPPL	2016-06-21
10113	SUPPL	2015-11-23
19379	SUPPL	2015-11-20
32308	SUPPL	2014-01-14
19378	SUPPL	2014-01-10
10112	SUPPL	2013-12-31
40222	SUPPL	2013-12-30
43413	ORIG	2013-07-05
44866	ORIG	2013-06-07
24107	ORIG	2013-06-07
32307	ORIG	2013-05-30
40221	ORIG	2013-05-29