Home Applications 202429 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 42 .
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 · 42 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 2026-08-18 06:07:40 2026-07 N202429-001 ZELBORAF 240MG TABLET / ORAL RLD, RS 2011-08-17 caaa826d4ba7…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…
Observed Orange Book patent history# Patent history page 1 of 8 · 294 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-18 06:07:40 2026-07 N202429-001 8143271 2026-06-21 Drug substance, Drug product 2012-04-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N202429-001 8470818 2026-08-02 U-2164 2013-07-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N202429-001 8470818 2026-08-02 U-1418 2013-07-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N202429-001 7504509 2026-10-22 Drug substance, Drug product caaa826d4ba7…2026-08-18 06:07:40 2026-07 N202429-001 7863288 2029-06-20 Drug substance, Drug product caaa826d4ba7…2026-08-18 06:07:40 2026-07 N202429-001 8741920 2030-07-27 Drug substance, Drug product 2014-09-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N202429-001 9447089 2032-06-06 Drug product 2016-10-18 caaa826d4ba7…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…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 45 observed states.
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.
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