Application 202429

Type: NDA
Sponsor: HOFFMANN LA ROCHE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ZELBORAF	VEMURAFENIB	TABLET;ORAL	240MG	Yes	Yes

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N202429-001	ZELBORAF	VEMURAFENIB	240MG	TABLET / ORAL		RLD, RS	2011-08-17

Orange Book patents#

Current patent rows page 1 of 1 · 7 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N202429-001	8143271	2026-06-21		Drug substance, Drug product	2012-04-20
N202429-001	8470818	2026-08-02	U-1418		2013-07-23
N202429-001	8470818	2026-08-02	U-2164		2013-07-23
N202429-001	7504509	2026-10-22		Drug substance, Drug product
N202429-001	7863288	2029-06-20		Drug substance, Drug product
N202429-001	8741920	2030-07-27		Drug substance, Drug product	2014-09-03
N202429-001	9447089	2032-06-06		Drug product	2016-10-18

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 2 · 41 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	N202429-001	ZELBORAF	240MG	TABLET / ORAL	RLD, RS	2011-08-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202429-001	ZELBORAF	240MG	TABLET / ORAL	RLD, RS	2011-08-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N202429-001	ZELBORAF	240MG	TABLET / ORAL	RLD, RS	2011-08-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202429-001	ZELBORAF	240MG	TABLET / ORAL	RLD, RS	2011-08-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202429-001	ZELBORAF	240MG	TABLET / ORAL	RLD, RS	2011-08-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202429-001	ZELBORAF	240MG	TABLET / ORAL	RLD, RS	2011-08-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202429-001	ZELBORAF	240MG	TABLET / ORAL	RLD, RS	2011-08-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202429-001	ZELBORAF	240MG	TABLET / ORAL	RLD, RS	2011-08-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202429-001	ZELBORAF	240MG	TABLET / ORAL	RLD, RS	2011-08-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N202429-001	ZELBORAF	240MG	TABLET / ORAL	RLD, RS	2011-08-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N202429-001	ZELBORAF	240MG	TABLET / ORAL	RLD, RS	2011-08-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N202429-001	ZELBORAF	240MG	TABLET / ORAL	RLD, RS	2011-08-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N202429-001	ZELBORAF	240MG	TABLET / ORAL	RLD, RS	2011-08-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N202429-001	ZELBORAF	240MG	TABLET / ORAL	RLD, RS	2011-08-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N202429-001	ZELBORAF	240MG	TABLET / ORAL	RLD, RS	2011-08-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N202429-001	ZELBORAF	240MG	TABLET / ORAL	RLD, RS	2011-08-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N202429-001	ZELBORAF	240MG	TABLET / ORAL	RLD, RS	2011-08-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N202429-001	ZELBORAF	240MG	TABLET / ORAL	RLD, RS	2011-08-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N202429-001	ZELBORAF	240MG	TABLET / ORAL	RLD, RS	2011-08-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N202429-001	ZELBORAF	240MG	TABLET / ORAL	RLD, RS	2011-08-17	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N202429-001	ZELBORAF	240MG	TABLET / ORAL	RLD, RS	2011-08-17	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N202429-001	ZELBORAF	240MG	TABLET / ORAL	RLD, RS	2011-08-17	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N202429-001	ZELBORAF	240MG	TABLET / ORAL	RLD, RS	2011-08-17	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N202429-001	ZELBORAF	240MG	TABLET / ORAL	RLD, RS	2011-08-17	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N202429-001	ZELBORAF	240MG	TABLET / ORAL	RLD, RS	2011-08-17	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N202429-001	ZELBORAF	240MG	TABLET / ORAL	RLD, RS	2011-08-17	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N202429-001	ZELBORAF	240MG	TABLET / ORAL	RLD, RS	2011-08-17	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N202429-001	ZELBORAF	240MG	TABLET / ORAL	RLD, RS	2011-08-17	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N202429-001	ZELBORAF	240MG	TABLET / ORAL	RLD, RS	2011-08-17	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N202429-001	ZELBORAF	240MG	TABLET / ORAL	RLD, RS	2011-08-17	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N202429-001	ZELBORAF	240MG	TABLET / ORAL	RLD, RS	2011-08-17	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N202429-001	ZELBORAF	240MG	TABLET / ORAL	RLD, RS	2011-08-17	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N202429-001	ZELBORAF	240MG	TABLET / ORAL	RLD, RS	2011-08-17	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N202429-001	ZELBORAF	240MG	TABLET / ORAL	RLD, RS	2011-08-17	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N202429-001	ZELBORAF	240MG	TABLET / ORAL	RLD, RS	2011-08-17	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N202429-001	ZELBORAF	240MG	TABLET / ORAL	RLD, RS	2011-08-17	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N202429-001	ZELBORAF	240MG	TABLET / ORAL	RLD, RS	2011-08-17	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N202429-001	ZELBORAF	240MG	TABLET / ORAL	RLD, RS	2011-08-17	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N202429-001	ZELBORAF	240MG	TABLET / ORAL	RLD, RS	2011-08-17	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N202429-001	ZELBORAF	240MG	TABLET / ORAL	RLD, RS	2011-08-17	`cb3db0bc1861…`

Observed Orange Book patent history#

Patent history page 1 of 8 · 287 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	N202429-001	8143271	2026-06-21		Drug substance, Drug product	2012-04-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202429-001	8470818	2026-08-02	U-2164		2013-07-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202429-001	8470818	2026-08-02	U-1418		2013-07-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202429-001	7504509	2026-10-22		Drug substance, Drug product		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202429-001	7863288	2029-06-20		Drug substance, Drug product		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202429-001	8741920	2030-07-27		Drug substance, Drug product	2014-09-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202429-001	9447089	2032-06-06		Drug product	2016-10-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202429-001	8143271	2026-06-21		Drug substance, Drug product	2012-04-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202429-001	8470818	2026-08-02	U-2164		2013-07-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202429-001	8470818	2026-08-02	U-1418		2013-07-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202429-001	7504509	2026-10-22		Drug substance, Drug product		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202429-001	7863288	2029-06-20		Drug substance, Drug product		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202429-001	8741920	2030-07-27		Drug substance, Drug product	2014-09-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202429-001	9447089	2032-06-06		Drug product	2016-10-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N202429-001	8143271	2026-06-21		Drug substance, Drug product	2012-04-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202429-001	8470818	2026-08-02	U-2164		2013-07-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202429-001	8470818	2026-08-02	U-1418		2013-07-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202429-001	7504509	2026-10-22		Drug substance, Drug product		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202429-001	7863288	2029-06-20		Drug substance, Drug product		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202429-001	8741920	2030-07-27		Drug substance, Drug product	2014-09-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202429-001	9447089	2032-06-06		Drug product	2016-10-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202429-001	8143271	2026-06-21		Drug substance, Drug product	2012-04-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202429-001	8470818	2026-08-02	U-2164		2013-07-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202429-001	8470818	2026-08-02	U-1418		2013-07-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202429-001	7504509	2026-10-22		Drug substance, Drug product		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202429-001	7863288	2029-06-20		Drug substance, Drug product		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202429-001	8741920	2030-07-27		Drug substance, Drug product	2014-09-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202429-001	9447089	2032-06-06		Drug product	2016-10-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202429-001	8143271	2026-06-21		Drug substance, Drug product	2012-04-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202429-001	8470818	2026-08-02	U-2164		2013-07-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202429-001	8470818	2026-08-02	U-1418		2013-07-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202429-001	7504509	2026-10-22		Drug substance, Drug product		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202429-001	7863288	2029-06-20		Drug substance, Drug product		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202429-001	8741920	2030-07-27		Drug substance, Drug product	2014-09-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202429-001	9447089	2032-06-06		Drug product	2016-10-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202429-001	8143271	2026-06-21		Drug substance, Drug product	2012-04-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202429-001	8470818	2026-08-02	U-2164		2013-07-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202429-001	8470818	2026-08-02	U-1418		2013-07-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202429-001	7504509	2026-10-22		Drug substance, Drug product		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202429-001	7863288	2029-06-20		Drug substance, Drug product		`03ed91905a0d…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 45 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202429-001	ODE-158	2024-11-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202429-001	ODE-158	2024-11-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202429-001	ODE-158	2024-11-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202429-001	ODE-158	2024-11-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N202429-001	ODE-158	2024-11-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N202429-001	ODE-158	2024-11-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N202429-001	ODE-158	2024-11-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N202429-001	ODE-158	2024-11-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N202429-001	ODE-158	2024-11-06	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N202429-001	ODE-158	2024-11-06	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N202429-001	ODE-158	2024-11-06	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N202429-001	ODE-158	2024-11-06	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N202429-001	M-184	2019-08-31	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N202429-001	I-757	2020-11-06	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N202429-001	ODE-158	2024-11-06	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N202429-001	ODE-158	2024-11-06	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N202429-001	ODE-158	2024-11-06	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N202429-001	ODE-158	2024-11-06	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N202429-001	ODE-158	2024-11-06	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N202429-001	I-757	2020-11-06	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N202429-001	ODE-158	2024-11-06	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N202429-001	I-757	2020-11-06	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N202429-001	ODE-158	2024-11-06	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N202429-001	M-184	2019-08-31	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N202429-001	I-757	2020-11-06	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N202429-001	ODE-158	2024-11-06	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N202429-001	M-184	2019-08-31	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N202429-001	I-757	2020-11-06	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N202429-001	ODE-158	2024-11-06	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N202429-001	M-184	2019-08-31	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N202429-001	I-757	2020-11-06	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N202429-001	ODE-158	2024-11-06	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N202429-001	ODE-158	2024-11-06	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N202429-001	ODE-158	2024-11-06	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N202429-001	ODE-158	2024-11-06	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N202429-001	ODE-158	2024-11-06	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N202429-001	ODE-158	2024-11-06	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N202429-001	ODE-158	2024-11-06	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N202429-001	ODE-158	2024-11-06	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N202429-001	ODE-158	2024-11-06	`053a50430f4f…`

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
ZELBORAF	VEMURAFENIB	Genentech, Inc.	38eea320-7e0c-485a-bc30-98c3c45e2763	2025-12-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 202429 application number: NDA202429 ndc (product): 50242-090

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50242-090	ZELBORAF	Vemurafenib	Genentech, Inc.	NDA	Current
50242-090	ZELBORAF	Vemurafenib	Genentech, Inc.	NDA	Current
50242-090	ZELBORAF	Vemurafenib	Genentech, Inc.	NDA	Current
50242-090	ZELBORAF	Vemurafenib	Genentech, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
63336	SUPPL	2020-05-29
63096	SUPPL	2020-05-19
54732	SUPPL	2018-07-02
50355	SUPPL	2017-11-09
50293	SUPPL	2017-11-06
50292	SUPPL	2017-11-06
49805	SUPPL	2017-09-19
49804	SUPPL	2017-09-19
48062	SUPPL	2017-04-18
48055	SUPPL	2017-04-18
45192	SUPPL	2016-08-31
45161	SUPPL	2016-08-31
19347	SUPPL	2016-05-11
10048	SUPPL	2016-05-11
40183	SUPPL	2015-08-12
32258	SUPPL	2015-08-12
40182	SUPPL	2014-12-03
10047	SUPPL	2014-11-28
32257	SUPPL	2014-03-20
19345	SUPPL	2014-03-20
10046	SUPPL	2014-02-11
19346	SUPPL	2014-02-07
40181	SUPPL	2013-07-05
32256	SUPPL	2013-07-05
19344	SUPPL	2013-07-05
10045	SUPPL	2013-07-05
43401	ORIG	2011-10-21
40180	ORIG	2011-08-17
32255	ORIG	2011-08-17
24417	ORIG	2011-08-17