Home Applications 206192 Application 206192
Type NDA
Sponsor GENENTECH INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 COTELLIC COBIMETINIB FUMARATE TABLET;ORAL EQ 20MG 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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N206192-001 COTELLIC COBIMETINIB FUMARATE EQ 20MG BASE TABLET / ORAL RLD, RS 2015-11-10
Orange Book patents# Current patent rows page 1 of 1 · 13 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N206192-001 11597699 2026-10-05 U-3554 2023-03-29 N206192-001 8362002 2026-10-05 U-1776 2015-12-09 N206192-001 8362002*PED 2027-04-05 Pediatric extension N206192-001 7803839 2029-11-10 Drug substance, Drug product 2015-12-09 N206192-001 7803839*PED 2030-05-10 Pediatric extension N206192-001 11087354 2034-06-22 U-1776 2021-09-08 N206192-001 11087354*PED 2034-12-22 Pediatric extension N206192-001 10478400 2036-06-29 U-1776 Drug substance, Drug product 2019-12-18 N206192-001 10590102 2036-06-30 U-1776 Drug substance, Drug product 2020-04-08 N206192-001 11254649 2036-06-30 U-1776 Drug substance, Drug product 2022-03-21 N206192-001 10478400*PED 2036-12-29 Pediatric extension N206192-001 10590102*PED 2036-12-30 Pediatric extension N206192-001 11254649*PED 2036-12-30 Pediatric extension
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 3 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N206192-001 M-278 2025-07-28 N206192-001 PED 2026-01-28 N206192-001 ODE-416 2029-10-28
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 Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N206192-001 COTELLIC EQ 20MG BASE TABLET / ORAL RLD, RS 2015-11-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206192-001 COTELLIC EQ 20MG BASE TABLET / ORAL RLD, RS 2015-11-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N206192-001 COTELLIC EQ 20MG BASE TABLET / ORAL RLD, RS 2015-11-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N206192-001 COTELLIC EQ 20MG BASE TABLET / ORAL RLD, RS 2015-11-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N206192-001 COTELLIC EQ 20MG BASE TABLET / ORAL RLD, RS 2015-11-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N206192-001 COTELLIC EQ 20MG BASE TABLET / ORAL RLD, RS 2015-11-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N206192-001 COTELLIC EQ 20MG BASE TABLET / ORAL RLD, RS 2015-11-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N206192-001 COTELLIC EQ 20MG BASE TABLET / ORAL RLD, RS 2015-11-10 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N206192-001 COTELLIC EQ 20MG BASE TABLET / ORAL RLD, RS 2015-11-10 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N206192-001 COTELLIC EQ 20MG BASE TABLET / ORAL RLD, RS 2015-11-10 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N206192-001 COTELLIC EQ 20MG BASE TABLET / ORAL RLD, RS 2015-11-10 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N206192-001 COTELLIC EQ 20MG BASE TABLET / ORAL RLD, RS 2015-11-10 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N206192-001 COTELLIC EQ 20MG BASE TABLET / ORAL RLD, RS 2015-11-10 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N206192-001 COTELLIC EQ 20MG BASE TABLET / ORAL RLD, RS 2015-11-10 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N206192-001 COTELLIC EQ 20MG BASE TABLET / ORAL RLD, RS 2015-11-10 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N206192-001 COTELLIC EQ 20MG BASE TABLET / ORAL RLD, RS 2015-11-10 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N206192-001 COTELLIC EQ 20MG BASE TABLET / ORAL RLD, RS 2015-11-10 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N206192-001 COTELLIC EQ 20MG BASE TABLET / ORAL RLD, RS 2015-11-10 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N206192-001 COTELLIC EQ 20MG BASE TABLET / ORAL RLD, RS 2015-11-10 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N206192-001 COTELLIC EQ 20MG BASE TABLET / ORAL RLD, RS 2015-11-10 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N206192-001 COTELLIC EQ 20MG BASE TABLET / ORAL RLD, RS 2015-11-10 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N206192-001 COTELLIC EQ 20MG BASE TABLET / ORAL RLD, RS 2015-11-10 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N206192-001 COTELLIC EQ 20MG BASE TABLET / ORAL RLD, RS 2015-11-10 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N206192-001 COTELLIC EQ 20MG BASE TABLET / ORAL RLD, RS 2015-11-10 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N206192-001 COTELLIC EQ 20MG BASE TABLET / ORAL RLD, RS 2015-11-10 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N206192-001 COTELLIC EQ 20MG BASE TABLET / ORAL RLD, RS 2015-11-10 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N206192-001 COTELLIC EQ 20MG BASE TABLET / ORAL RLD, RS 2015-11-10 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N206192-001 COTELLIC EQ 20MG BASE TABLET / ORAL RLD, RS 2015-11-10 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N206192-001 COTELLIC EQ 20MG BASE TABLET / ORAL RLD, RS 2015-11-10 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N206192-001 COTELLIC EQ 20MG BASE TABLET / ORAL RLD, RS 2015-11-10 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N206192-001 COTELLIC EQ 20MG BASE TABLET / ORAL RLD, RS 2015-11-10 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N206192-001 COTELLIC EQ 20MG BASE TABLET / ORAL RLD, RS 2015-11-10 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N206192-001 COTELLIC EQ 20MG BASE TABLET / ORAL RLD, RS 2015-11-10 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N206192-001 COTELLIC EQ 20MG BASE TABLET / ORAL RLD, RS 2015-11-10 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N206192-001 COTELLIC EQ 20MG BASE TABLET / ORAL RLD, RS 2015-11-10 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N206192-001 COTELLIC EQ 20MG BASE TABLET / ORAL RLD, RS 2015-11-10 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N206192-001 COTELLIC EQ 20MG BASE TABLET / ORAL RLD, RS 2015-11-10 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N206192-001 COTELLIC EQ 20MG BASE TABLET / ORAL RLD, RS 2015-11-10 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N206192-001 COTELLIC EQ 20MG BASE TABLET / ORAL RLD, RS 2015-11-10 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N206192-001 COTELLIC EQ 20MG BASE TABLET / ORAL RLD, RS 2015-11-10 cb3db0bc1861…
Observed Orange Book patent history# Patent history page 1 of 11 · 404 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 N206192-001 11597699 2026-10-05 U-3554 2023-03-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206192-001 8362002 2026-10-05 U-1776 2015-12-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206192-001 8362002*PED 2027-04-05 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206192-001 7803839 2029-11-10 Drug substance, Drug product 2015-12-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206192-001 7803839*PED 2030-05-10 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206192-001 11087354 2034-06-22 U-1776 2021-09-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206192-001 11087354*PED 2034-12-22 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206192-001 10478400 2036-06-29 U-1776 Drug substance, Drug product 2019-12-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206192-001 10590102 2036-06-30 U-1776 Drug substance, Drug product 2020-04-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206192-001 11254649 2036-06-30 U-1776 Drug substance, Drug product 2022-03-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206192-001 10478400*PED 2036-12-29 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206192-001 10590102*PED 2036-12-30 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206192-001 11254649*PED 2036-12-30 Pediatric extension 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206192-001 11597699 2026-10-05 U-3554 2023-03-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206192-001 8362002 2026-10-05 U-1776 2015-12-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206192-001 8362002*PED 2027-04-05 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206192-001 7803839 2029-11-10 Drug substance, Drug product 2015-12-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206192-001 7803839*PED 2030-05-10 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206192-001 11087354 2034-06-22 U-1776 2021-09-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206192-001 11087354*PED 2034-12-22 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206192-001 10478400 2036-06-29 U-1776 Drug substance, Drug product 2019-12-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206192-001 10590102 2036-06-30 U-1776 Drug substance, Drug product 2020-04-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206192-001 11254649 2036-06-30 U-1776 Drug substance, Drug product 2022-03-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206192-001 10478400*PED 2036-12-29 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206192-001 10590102*PED 2036-12-30 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206192-001 11254649*PED 2036-12-30 Pediatric extension 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N206192-001 11597699 2026-10-05 U-3554 2023-03-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N206192-001 8362002 2026-10-05 U-1776 2015-12-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N206192-001 8362002*PED 2027-04-05 Pediatric extension 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N206192-001 7803839 2029-11-10 Drug substance, Drug product 2015-12-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N206192-001 7803839*PED 2030-05-10 Pediatric extension 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N206192-001 11087354 2034-06-22 U-1776 2021-09-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N206192-001 11087354*PED 2034-12-22 Pediatric extension 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N206192-001 10478400 2036-06-29 U-1776 Drug substance, Drug product 2019-12-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N206192-001 10590102 2036-06-30 U-1776 Drug substance, Drug product 2020-04-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N206192-001 11254649 2036-06-30 U-1776 Drug substance, Drug product 2022-03-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N206192-001 10478400*PED 2036-12-29 Pediatric extension 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N206192-001 10590102*PED 2036-12-30 Pediatric extension 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N206192-001 11254649*PED 2036-12-30 Pediatric extension 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N206192-001 11597699 2026-10-05 U-3554 2023-03-29 fd3edfee7708…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 4 · 121 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 · 6 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 50242-717 Cotellic COBIMETINIB Genentech, Inc. NDA Current 50242-717 Cotellic COBIMETINIB Genentech, Inc. NDA Current 50242-717 Cotellic COBIMETINIB Genentech, Inc. NDA Current 50242-717 Cotellic COBIMETINIB Genentech, Inc. NDA Current 50242-717 Cotellic COBIMETINIB Genentech, Inc. NDA Current 50242-717 Cotellic COBIMETINIB Genentech, Inc. NDA Current