Home Applications 210498 Application 210498
Type NDA
Sponsor ARRAY BIOPHARMA INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 MEKTOVI BINIMETINIB TABLET;ORAL 15MG 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 N210498-001 MEKTOVI BINIMETINIB 15MG TABLET / ORAL RLD, RS 2018-06-27
Orange Book patents# Current patent rows page 1 of 1 · 9 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N210498-001 7777050 2027-03-13 Drug substance, Drug product 2018-07-25 N210498-001 10005761 2030-08-27 U-2331 2018-07-25 N210498-001 10005761 2030-08-27 U-3737 2018-07-25 N210498-001 9850229 2030-08-27 U-2333 2018-07-25 N210498-001 9314464 2031-07-04 U-2332 2018-07-25 N210498-001 9314464 2031-07-04 U-3737 2018-07-25 N210498-001 9562016 2033-10-18 Drug substance, Drug product 2018-07-25 N210498-001 9598376 2033-10-18 U-2330 2018-07-25 N210498-001 9980944 2033-10-18 U-2334 2018-07-25
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 1 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N210498-001 I-928 2026-10-11
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 N210498-001 MEKTOVI 15MG TABLET / ORAL RLD, RS 2018-06-27 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N210498-001 MEKTOVI 15MG TABLET / ORAL RLD, RS 2018-06-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210498-001 MEKTOVI 15MG TABLET / ORAL RLD, RS 2018-06-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N210498-001 MEKTOVI 15MG TABLET / ORAL RLD, RS 2018-06-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210498-001 MEKTOVI 15MG TABLET / ORAL RLD, RS 2018-06-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210498-001 MEKTOVI 15MG TABLET / ORAL RLD, RS 2018-06-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N210498-001 MEKTOVI 15MG TABLET / ORAL RLD, RS 2018-06-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N210498-001 MEKTOVI 15MG TABLET / ORAL RLD, RS 2018-06-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N210498-001 MEKTOVI 15MG TABLET / ORAL RLD, RS 2018-06-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N210498-001 MEKTOVI 15MG TABLET / ORAL RLD, RS 2018-06-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N210498-001 MEKTOVI 15MG TABLET / ORAL RLD, RS 2018-06-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N210498-001 MEKTOVI 15MG TABLET / ORAL RLD, RS 2018-06-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N210498-001 MEKTOVI 15MG TABLET / ORAL RLD, RS 2018-06-27 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N210498-001 MEKTOVI 15MG TABLET / ORAL RLD, RS 2018-06-27 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N210498-001 MEKTOVI 15MG TABLET / ORAL RLD, RS 2018-06-27 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N210498-001 MEKTOVI 15MG TABLET / ORAL RLD, RS 2018-06-27 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N210498-001 MEKTOVI 15MG TABLET / ORAL RLD, RS 2018-06-27 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N210498-001 MEKTOVI 15MG TABLET / ORAL RLD, RS 2018-06-27 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N210498-001 MEKTOVI 15MG TABLET / ORAL RLD, RS 2018-06-27 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N210498-001 MEKTOVI 15MG TABLET / ORAL RLD, RS 2018-06-27 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N210498-001 MEKTOVI 15MG TABLET / ORAL RLD, RS 2018-06-27 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N210498-001 MEKTOVI 15MG TABLET / ORAL RLD, RS 2018-06-27 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N210498-001 MEKTOVI 15MG TABLET / ORAL RLD, RS 2018-06-27 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N210498-001 MEKTOVI 15MG TABLET / ORAL RLD, RS 2018-06-27 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N210498-001 MEKTOVI 15MG TABLET / ORAL RLD, RS 2018-06-27 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N210498-001 MEKTOVI 15MG TABLET / ORAL RLD, RS 2018-06-27 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N210498-001 MEKTOVI 15MG TABLET / ORAL RLD, RS 2018-06-27 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N210498-001 MEKTOVI 15MG TABLET / ORAL RLD, RS 2018-06-27 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N210498-001 MEKTOVI 15MG TABLET / ORAL RLD, RS 2018-06-27 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N210498-001 MEKTOVI 15MG TABLET / ORAL RLD, RS 2018-06-27 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N210498-001 MEKTOVI 15MG TABLET / ORAL RLD, RS 2018-06-27 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N210498-001 MEKTOVI 15MG TABLET / ORAL RLD, RS 2018-06-27 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N210498-001 MEKTOVI 15MG TABLET / ORAL RLD, RS 2018-06-27 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N210498-001 MEKTOVI 15MG TABLET / ORAL RLD, RS 2018-06-27 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N210498-001 MEKTOVI 15MG TABLET / ORAL RLD, RS 2018-06-27 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N210498-001 MEKTOVI 15MG TABLET / ORAL RLD, RS 2018-06-27 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N210498-001 MEKTOVI 15MG TABLET / ORAL RLD, RS 2018-06-27 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N210498-001 MEKTOVI 15MG TABLET / ORAL RLD, RS 2018-06-27 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N210498-001 MEKTOVI 15MG TABLET / ORAL RLD, RS 2018-06-27 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N210498-001 MEKTOVI 15MG TABLET / ORAL RLD, RS 2018-06-27 e64feba35796…
Observed Orange Book patent history# Patent history page 1 of 11 · 416 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 N210498-001 7777050 2027-03-13 Drug substance, Drug product 2018-07-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N210498-001 10005761 2030-08-27 U-2331 2018-07-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N210498-001 10005761 2030-08-27 U-3737 2018-07-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N210498-001 9850229 2030-08-27 U-2333 2018-07-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N210498-001 9314464 2031-07-04 U-2332 2018-07-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N210498-001 9314464 2031-07-04 U-3737 2018-07-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N210498-001 9562016 2033-10-18 Drug substance, Drug product 2018-07-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N210498-001 9598376 2033-10-18 U-2330 2018-07-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N210498-001 9980944 2033-10-18 U-2334 2018-07-25 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N210498-001 7777050 2026-03-13 Drug substance, Drug product 2018-07-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210498-001 10005761 2030-08-27 U-2331 2018-07-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210498-001 10005761 2030-08-27 U-3737 2018-07-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210498-001 9850229 2030-08-27 U-2333 2018-07-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210498-001 9314464 2031-07-04 U-2332 2018-07-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210498-001 9314464 2031-07-04 U-3737 2018-07-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210498-001 9562016 2033-10-18 Drug substance, Drug product 2018-07-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210498-001 9598376 2033-10-18 U-2330 2018-07-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210498-001 9980944 2033-10-18 U-2334 2018-07-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210498-001 7777050 2026-03-13 Drug substance, Drug product 2018-07-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210498-001 10005761 2030-08-27 U-2331 2018-07-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210498-001 10005761 2030-08-27 U-3737 2018-07-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210498-001 9850229 2030-08-27 U-2333 2018-07-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210498-001 9314464 2031-07-04 U-2332 2018-07-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210498-001 9314464 2031-07-04 U-3737 2018-07-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210498-001 9562016 2033-10-18 Drug substance, Drug product 2018-07-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210498-001 9598376 2033-10-18 U-2330 2018-07-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210498-001 9980944 2033-10-18 U-2334 2018-07-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N210498-001 7777050 2026-03-13 Drug substance, Drug product 2018-07-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210498-001 10005761 2030-08-27 U-2331 2018-07-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210498-001 10005761 2030-08-27 U-3737 2018-07-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210498-001 9850229 2030-08-27 U-2333 2018-07-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210498-001 9314464 2031-07-04 U-2332 2018-07-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210498-001 9314464 2031-07-04 U-3737 2018-07-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210498-001 9562016 2033-10-18 Drug substance, Drug product 2018-07-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210498-001 9598376 2033-10-18 U-2330 2018-07-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210498-001 9980944 2033-10-18 U-2334 2018-07-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210498-001 7777050 2025-03-13 Drug substance, Drug product 2018-07-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210498-001 10005761 2030-08-27 U-2331 2018-07-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210498-001 10005761 2030-08-27 U-3737 2018-07-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210498-001 9850229 2030-08-27 U-2333 2018-07-25 fd3edfee7708…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 3 · 81 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 · 5 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 70255-010 MEKTOVI BINIMETINIB Array BioPharma Inc. NDA Current 70255-010 MEKTOVI BINIMETINIB Array BioPharma Inc. NDA Current 70255-010 MEKTOVI BINIMETINIB Array BioPharma Inc. NDA Current 70255-010 MEKTOVI BINIMETINIB Array BioPharma Inc. NDA Current 70255-010 MEKTOVI BINIMETINIB Array BioPharma Inc. NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 81579 SUPPL 2025-03-17 81578 SUPPL 2025-03-17 81565 SUPPL 2025-03-14 79616 SUPPL 2024-09-16 79590 SUPPL 2024-09-16 75722 SUPPL 2023-10-13 75712 SUPPL 2023-10-12 60092 ORIG 2019-09-23 60091 ORIG 2019-09-23 57548 SUPPL 2019-02-13 54696 SUPPL 2019-01-23 55266 ORIG 2018-08-22