Home Applications 210496 Application 210496
Type NDA
Sponsor ARRAY BIOPHARMA INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 BRAFTOVI ENCORAFENIB CAPSULE;ORAL 50MG Yes No 002 BRAFTOVI ENCORAFENIB CAPSULE;ORAL 75MG Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 N210496-001 BRAFTOVI ENCORAFENIB 50MG CAPSULE / ORAL RLD 2018-06-27 N210496-002 BRAFTOVI ENCORAFENIB 75MG CAPSULE / ORAL RLD, RS 2018-06-27
Orange Book patents# Current patent rows page 1 of 1 · 47 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N210496-001 8946250 2029-07-23 Drug substance, Drug product 2018-07-25 N210496-001 8541575 2030-02-26 U-2335 Drug substance, Drug product 2018-07-25 N210496-001 10005761 2030-08-27 U-2335 2018-07-25 N210496-001 9593099 2030-08-27 Drug substance 2018-07-25 N210496-001 9593100 2030-08-27 Drug product 2018-07-25 N210496-001 9850229 2030-08-27 U-2337 2018-07-25 N210496-001 9850230 2030-08-27 U-2334 2018-07-25 N210496-001 9314464 2031-07-04 U-2336 2018-07-25 N210496-001 9387208 2032-11-21 Drug product 2018-07-25 N210496-001 9763941 2032-11-21 U-2335 2018-07-25 N210496-002 8946250 2029-07-23 Drug substance, Drug product 2018-07-25 N210496-002 8541575 2030-02-26 U-2335 Drug substance, Drug product 2018-07-25 N210496-002 8541575 2030-02-26 U-2802 Drug substance, Drug product 2018-07-25 N210496-002 8541575 2030-02-26 U-2803 Drug substance, Drug product 2018-07-25 N210496-002 8541575 2030-02-26 U-3738 Drug substance, Drug product 2018-07-25 N210496-002 8541575 2030-02-26 U-4051 Drug substance, Drug product 2018-07-25 N210496-002 8541575 2030-02-26 U-4440 Drug substance, Drug product 2018-07-25 N210496-002 RE49556 2030-02-27 Drug substance, Drug product 2023-07-19 N210496-002 10005761 2030-08-27 U-2335 2018-07-25 N210496-002 10005761 2030-08-27 U-2802 2018-07-25 N210496-002 10005761 2030-08-27 U-2803 2018-07-25 N210496-002 10005761 2030-08-27 U-3738 2018-07-25 N210496-002 10005761 2030-08-27 U-4051 2018-07-25 N210496-002 10005761 2030-08-27 U-4440 2018-07-25 N210496-002 9593099 2030-08-27 Drug substance 2018-07-25 N210496-002 9593100 2030-08-27 Drug product 2018-07-25 N210496-002 9850229 2030-08-27 U-2337 2018-07-25 N210496-002 9850230 2030-08-27 U-2334 2018-07-25 N210496-002 9850230 2030-08-27 U-2802 2018-07-25 N210496-002 9850230 2030-08-27 U-2803 2018-07-25 N210496-002 9850230 2030-08-27 U-3738 2018-07-25 N210496-002 9850230 2030-08-27 U-4051 2018-07-25 N210496-002 9850230 2030-08-27 U-4440 2018-07-25 N210496-002 9314464 2031-07-04 U-2336 2018-07-25 N210496-002 9314464 2031-07-04 U-2802 2018-07-25 N210496-002 9314464 2031-07-04 U-2803 2018-07-25 N210496-002 9314464 2031-07-04 U-3738 2018-07-25 N210496-002 9314464 2031-07-04 U-4051 2018-07-25 N210496-002 9314464 2031-07-04 U-4440 2018-07-25 N210496-002 10258622 2032-11-21 U-2802 2020-05-07 N210496-002 10258622 2032-11-21 U-4051 2020-05-07 N210496-002 10258622 2032-11-21 U-4439 2020-05-07 N210496-002 9387208 2032-11-21 Drug product 2018-07-25 N210496-002 9763941 2032-11-21 U-2335 2018-07-25 N210496-002 9474754 2033-08-05 U-2802 2020-05-07 N210496-002 9474754 2033-08-05 U-4051 2020-05-07 N210496-002 9474754 2033-08-05 U-4440 2020-05-07
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 6 matching rows.
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 · 84 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 N210496-001 BRAFTOVI 50MG CAPSULE / ORAL RLD 2018-06-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N210496-002 BRAFTOVI 75MG CAPSULE / ORAL RLD, RS 2018-06-27 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N210496-001 BRAFTOVI 50MG CAPSULE / ORAL RLD 2018-06-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210496-002 BRAFTOVI 75MG CAPSULE / ORAL RLD, RS 2018-06-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210496-001 BRAFTOVI 50MG CAPSULE / ORAL RLD 2018-06-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210496-002 BRAFTOVI 75MG CAPSULE / ORAL RLD, RS 2018-06-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N210496-001 BRAFTOVI 50MG CAPSULE / ORAL RLD 2018-06-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210496-002 BRAFTOVI 75MG CAPSULE / ORAL RLD, RS 2018-06-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210496-001 BRAFTOVI 50MG CAPSULE / ORAL RLD 2018-06-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210496-002 BRAFTOVI 75MG CAPSULE / ORAL RLD, RS 2018-06-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210496-001 BRAFTOVI 50MG CAPSULE / ORAL RLD 2018-06-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210496-002 BRAFTOVI 75MG CAPSULE / ORAL RLD, RS 2018-06-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N210496-001 BRAFTOVI 50MG CAPSULE / ORAL RLD 2018-06-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N210496-002 BRAFTOVI 75MG CAPSULE / ORAL RLD, RS 2018-06-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N210496-001 BRAFTOVI 50MG CAPSULE / ORAL RLD 2018-06-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N210496-002 BRAFTOVI 75MG CAPSULE / ORAL RLD, RS 2018-06-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N210496-001 BRAFTOVI 50MG CAPSULE / ORAL RLD 2018-06-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N210496-002 BRAFTOVI 75MG CAPSULE / ORAL RLD, RS 2018-06-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N210496-001 BRAFTOVI 50MG CAPSULE / ORAL RLD 2018-06-27 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N210496-002 BRAFTOVI 75MG CAPSULE / ORAL RLD, RS 2018-06-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N210496-001 BRAFTOVI 50MG CAPSULE / ORAL RLD 2018-06-27 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N210496-002 BRAFTOVI 75MG CAPSULE / ORAL RLD, RS 2018-06-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N210496-001 BRAFTOVI 50MG CAPSULE / ORAL RLD 2018-06-27 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N210496-002 BRAFTOVI 75MG CAPSULE / ORAL RLD, RS 2018-06-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N210496-001 BRAFTOVI 50MG CAPSULE / ORAL RLD 2018-06-27 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N210496-002 BRAFTOVI 75MG CAPSULE / ORAL RLD, RS 2018-06-27 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N210496-001 BRAFTOVI 50MG CAPSULE / ORAL RLD 2018-06-27 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N210496-002 BRAFTOVI 75MG CAPSULE / ORAL RLD, RS 2018-06-27 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N210496-001 BRAFTOVI 50MG CAPSULE / ORAL RLD 2018-06-27 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N210496-002 BRAFTOVI 75MG CAPSULE / ORAL RLD, RS 2018-06-27 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N210496-001 BRAFTOVI 50MG CAPSULE / ORAL RLD 2018-06-27 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N210496-002 BRAFTOVI 75MG CAPSULE / ORAL RLD, RS 2018-06-27 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N210496-001 BRAFTOVI 50MG CAPSULE / ORAL RLD 2018-06-27 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N210496-002 BRAFTOVI 75MG CAPSULE / ORAL RLD, RS 2018-06-27 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N210496-001 BRAFTOVI 50MG CAPSULE / ORAL RLD 2018-06-27 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N210496-002 BRAFTOVI 75MG CAPSULE / ORAL RLD, RS 2018-06-27 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N210496-001 BRAFTOVI 50MG CAPSULE / ORAL RLD 2018-06-27 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N210496-002 BRAFTOVI 75MG CAPSULE / ORAL RLD, RS 2018-06-27 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N210496-001 BRAFTOVI 50MG CAPSULE / ORAL RLD 2018-06-27 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N210496-002 BRAFTOVI 75MG CAPSULE / ORAL RLD, RS 2018-06-27 bb7c543d1eb4…
Observed Orange Book patent history# Patent history page 1 of 36 · 1,419 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 N210496-001 8946250 2029-07-23 Drug substance, Drug product 2018-07-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N210496-001 8541575 2030-02-26 U-2335 Drug substance, Drug product 2018-07-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N210496-001 10005761 2030-08-27 U-2335 2018-07-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N210496-001 9593099 2030-08-27 Drug substance 2018-07-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N210496-001 9593100 2030-08-27 Drug product 2018-07-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N210496-001 9850229 2030-08-27 U-2337 2018-07-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N210496-001 9850230 2030-08-27 U-2334 2018-07-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N210496-001 9314464 2031-07-04 U-2336 2018-07-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N210496-001 9387208 2032-11-21 Drug product 2018-07-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N210496-001 9763941 2032-11-21 U-2335 2018-07-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N210496-002 8946250 2029-07-23 Drug substance, Drug product 2018-07-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N210496-002 8541575 2030-02-26 U-2335 Drug substance, Drug product 2018-07-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N210496-002 8541575 2030-02-26 U-4440 Drug substance, Drug product 2018-07-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N210496-002 8541575 2030-02-26 U-2803 Drug substance, Drug product 2018-07-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N210496-002 8541575 2030-02-26 U-2802 Drug substance, Drug product 2018-07-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N210496-002 8541575 2030-02-26 U-3738 Drug substance, Drug product 2018-07-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N210496-002 8541575 2030-02-26 U-4051 Drug substance, Drug product 2018-07-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N210496-002 RE49556 2030-02-27 Drug substance, Drug product 2023-07-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N210496-002 10005761 2030-08-27 U-2335 2018-07-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N210496-002 10005761 2030-08-27 U-4440 2018-07-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N210496-002 10005761 2030-08-27 U-2802 2018-07-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N210496-002 10005761 2030-08-27 U-2803 2018-07-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N210496-002 10005761 2030-08-27 U-3738 2018-07-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N210496-002 10005761 2030-08-27 U-4051 2018-07-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N210496-002 9593099 2030-08-27 Drug substance 2018-07-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N210496-002 9593100 2030-08-27 Drug product 2018-07-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N210496-002 9850229 2030-08-27 U-2337 2018-07-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N210496-002 9850230 2030-08-27 U-2334 2018-07-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N210496-002 9850230 2030-08-27 U-4440 2018-07-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N210496-002 9850230 2030-08-27 U-2802 2018-07-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N210496-002 9850230 2030-08-27 U-2803 2018-07-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N210496-002 9850230 2030-08-27 U-3738 2018-07-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N210496-002 9850230 2030-08-27 U-4051 2018-07-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N210496-002 9314464 2031-07-04 U-2336 2018-07-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N210496-002 9314464 2031-07-04 U-4440 2018-07-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N210496-002 9314464 2031-07-04 U-2802 2018-07-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N210496-002 9314464 2031-07-04 U-2803 2018-07-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N210496-002 9314464 2031-07-04 U-3738 2018-07-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N210496-002 9314464 2031-07-04 U-4051 2018-07-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N210496-002 10258622 2032-11-21 U-4439 2020-05-07 caaa826d4ba7…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 7 · 252 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 · 12 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 70255-020 BRAFTOVI Encorafenib Array BioPharma Inc. NDA Current 70255-020 BRAFTOVI Encorafenib Array BioPharma Inc. NDA Current 70255-025 BRAFTOVI Encorafenib Array BioPharma Inc. NDA Current 70255-025 BRAFTOVI Encorafenib Array BioPharma Inc. NDA Current 70255-025 BRAFTOVI Encorafenib Array BioPharma Inc. NDA Current 70255-025 BRAFTOVI Encorafenib Array BioPharma Inc. NDA Current 70255-025 BRAFTOVI Encorafenib Array BioPharma Inc. NDA Current 70255-025 BRAFTOVI Encorafenib Array BioPharma Inc. NDA Current 70255-025 BRAFTOVI Encorafenib Array BioPharma Inc. NDA Current 70255-025 BRAFTOVI Encorafenib Array BioPharma Inc. NDA Current 70255-025 BRAFTOVI Encorafenib Array BioPharma Inc. NDA Current 70255-025 BRAFTOVI Encorafenib Array BioPharma Inc. NDA Current