Home Applications 214665 Application 214665
Type NDA
Sponsor AMGEN INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 LUMAKRAS SOTORASIB TABLET;ORAL 120MG No No 002 LUMAKRAS SOTORASIB TABLET;ORAL 320MG Yes Yes 003 LUMAKRAS SOTORASIB TABLET;ORAL 240MG Yes No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N214665-001 LUMAKRAS SOTORASIB 120MG TABLET / ORAL RLD 2021-05-28 N214665-002 LUMAKRAS SOTORASIB 320MG TABLET / ORAL RLD, RS 2023-01-20 N214665-003 LUMAKRAS SOTORASIB 240MG TABLET / ORAL RLD 2024-06-26
Orange Book patents# Current patent rows page 1 of 1 · 30 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N214665-001 10519146 2038-05-21 Drug substance, Drug product 2022-02-17 N214665-001 12280056 2039-11-18 U-4107 2025-05-12 N214665-001 11236091 2040-05-20 U-3306 Drug substance, Drug product 2022-02-23 N214665-001 11236091 2040-05-20 U-4107 Drug substance, Drug product 2022-02-23 N214665-001 11827635 2040-05-20 U-3306 Drug substance, Drug product 2023-12-18 N214665-001 11827635 2040-05-20 U-4107 Drug substance, Drug product 2023-12-18 N214665-001 12398133 2040-05-20 U-3306 Drug substance, Drug product 2025-09-03 N214665-001 12398133 2040-05-20 U-4107 Drug substance, Drug product 2025-09-03 N214665-001 11426404 2040-09-15 U-3306 2022-09-27 N214665-001 11426404 2040-09-15 U-4107 2022-09-27 N214665-002 10519146 2038-05-21 Drug substance, Drug product 2023-02-14 N214665-002 12280056 2039-11-18 U-4107 2025-05-12 N214665-002 11236091 2040-05-20 U-3306 Drug substance, Drug product 2023-02-14 N214665-002 11236091 2040-05-20 U-4107 Drug substance, Drug product 2023-02-14 N214665-002 11827635 2040-05-20 U-3306 Drug substance, Drug product 2023-12-18 N214665-002 11827635 2040-05-20 U-4107 Drug substance, Drug product 2023-12-18 N214665-002 12398133 2040-05-20 U-3306 Drug substance, Drug product 2025-09-03 N214665-002 12398133 2040-05-20 U-4107 Drug substance, Drug product 2025-09-03 N214665-002 11426404 2040-09-15 U-3306 2023-02-14 N214665-002 11426404 2040-09-15 U-4107 2023-02-14 N214665-003 10519146 2038-05-21 Drug substance, Drug product 2024-07-18 N214665-003 12280056 2039-11-18 U-4107 2025-05-12 N214665-003 11236091 2040-05-20 U-3306 Drug substance, Drug product 2024-07-18 N214665-003 11236091 2040-05-20 U-4107 Drug substance, Drug product 2024-07-18 N214665-003 11827635 2040-05-20 U-3306 Drug substance, Drug product 2024-07-18 N214665-003 11827635 2040-05-20 U-4107 Drug substance, Drug product 2024-07-18 N214665-003 12398133 2040-05-20 U-3306 Drug substance, Drug product 2025-09-03 N214665-003 12398133 2040-05-20 U-4107 Drug substance, Drug product 2025-09-03 N214665-003 11426404 2040-09-15 U-3306 2024-07-18 N214665-003 11426404 2040-09-15 U-4107 2024-07-18
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 12 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 2 · 68 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 N214665-001 LUMAKRAS 120MG TABLET / ORAL RLD 2021-05-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214665-002 LUMAKRAS 320MG TABLET / ORAL RLD, RS 2023-01-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214665-003 LUMAKRAS 240MG TABLET / ORAL RLD 2024-06-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214665-001 LUMAKRAS 120MG TABLET / ORAL RLD 2021-05-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214665-002 LUMAKRAS 320MG TABLET / ORAL RLD, RS 2023-01-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214665-003 LUMAKRAS 240MG TABLET / ORAL RLD 2024-06-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N214665-001 LUMAKRAS 120MG TABLET / ORAL RLD 2021-05-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214665-002 LUMAKRAS 320MG TABLET / ORAL RLD, RS 2023-01-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214665-003 LUMAKRAS 240MG TABLET / ORAL RLD 2024-06-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214665-001 LUMAKRAS 120MG TABLET / ORAL RLD 2021-05-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214665-002 LUMAKRAS 320MG TABLET / ORAL RLD, RS 2023-01-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214665-003 LUMAKRAS 240MG TABLET / ORAL RLD 2024-06-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N214665-001 LUMAKRAS 120MG TABLET / ORAL RLD 2021-05-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N214665-002 LUMAKRAS 320MG TABLET / ORAL RLD, RS 2023-01-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N214665-003 LUMAKRAS 240MG TABLET / ORAL RLD 2024-06-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N214665-001 LUMAKRAS 120MG TABLET / ORAL RLD 2021-05-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N214665-002 LUMAKRAS 320MG TABLET / ORAL RLD, RS 2023-01-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N214665-003 LUMAKRAS 240MG TABLET / ORAL RLD 2024-06-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N214665-001 LUMAKRAS 120MG TABLET / ORAL RLD 2021-05-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N214665-002 LUMAKRAS 320MG TABLET / ORAL RLD, RS 2023-01-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N214665-003 LUMAKRAS 240MG TABLET / ORAL RLD 2024-06-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N214665-001 LUMAKRAS 120MG TABLET / ORAL RLD 2021-05-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N214665-002 LUMAKRAS 320MG TABLET / ORAL RLD, RS 2023-01-20 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N214665-003 LUMAKRAS 240MG TABLET / ORAL RLD 2024-06-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N214665-001 LUMAKRAS 120MG TABLET / ORAL RLD 2021-05-28 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N214665-002 LUMAKRAS 320MG TABLET / ORAL RLD, RS 2023-01-20 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N214665-003 LUMAKRAS 240MG TABLET / ORAL RLD 2024-06-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N214665-001 LUMAKRAS 120MG TABLET / ORAL RLD 2021-05-28 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N214665-002 LUMAKRAS 320MG TABLET / ORAL RLD, RS 2023-01-20 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N214665-003 LUMAKRAS 240MG TABLET / ORAL RLD 2024-06-26 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N214665-001 LUMAKRAS 120MG TABLET / ORAL RLD 2021-05-28 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N214665-002 LUMAKRAS 320MG TABLET / ORAL RLD, RS 2023-01-20 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N214665-003 LUMAKRAS 240MG TABLET / ORAL RLD 2024-06-26 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N214665-001 LUMAKRAS 120MG TABLET / ORAL RLD 2021-05-28 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N214665-002 LUMAKRAS 320MG TABLET / ORAL RLD, RS 2023-01-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N214665-001 LUMAKRAS 120MG TABLET / ORAL RLD 2021-05-28 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N214665-002 LUMAKRAS 320MG TABLET / ORAL RLD, RS 2023-01-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N214665-001 LUMAKRAS 120MG TABLET / ORAL RLD 2021-05-28 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N214665-002 LUMAKRAS 320MG TABLET / ORAL RLD, RS 2023-01-20 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N214665-001 LUMAKRAS 120MG TABLET / ORAL RLD, RS 2021-05-28 5c6f7cd8ea54…
Observed Orange Book patent history# Patent history page 1 of 9 · 323 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 N214665-001 10519146 2038-05-21 Drug substance, Drug product 2022-02-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214665-001 12280056 2039-11-18 U-4107 2025-05-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214665-001 11236091 2040-05-20 U-4107 Drug substance, Drug product 2022-02-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214665-001 11236091 2040-05-20 U-3306 Drug substance, Drug product 2022-02-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214665-001 11827635 2040-05-20 U-4107 Drug substance, Drug product 2023-12-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214665-001 11827635 2040-05-20 U-3306 Drug substance, Drug product 2023-12-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214665-001 12398133 2040-05-20 U-3306 Drug substance, Drug product 2025-09-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214665-001 12398133 2040-05-20 U-4107 Drug substance, Drug product 2025-09-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214665-001 11426404 2040-09-15 U-3306 2022-09-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214665-001 11426404 2040-09-15 U-4107 2022-09-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214665-002 10519146 2038-05-21 Drug substance, Drug product 2023-02-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214665-002 12280056 2039-11-18 U-4107 2025-05-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214665-002 11236091 2040-05-20 U-3306 Drug substance, Drug product 2023-02-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214665-002 11236091 2040-05-20 U-4107 Drug substance, Drug product 2023-02-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214665-002 11827635 2040-05-20 U-4107 Drug substance, Drug product 2023-12-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214665-002 11827635 2040-05-20 U-3306 Drug substance, Drug product 2023-12-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214665-002 12398133 2040-05-20 U-4107 Drug substance, Drug product 2025-09-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214665-002 12398133 2040-05-20 U-3306 Drug substance, Drug product 2025-09-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214665-002 11426404 2040-09-15 U-3306 2023-02-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214665-002 11426404 2040-09-15 U-4107 2023-02-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214665-003 10519146 2038-05-21 Drug substance, Drug product 2024-07-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214665-003 12280056 2039-11-18 U-4107 2025-05-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214665-003 11236091 2040-05-20 U-4107 Drug substance, Drug product 2024-07-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214665-003 11236091 2040-05-20 U-3306 Drug substance, Drug product 2024-07-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214665-003 11827635 2040-05-20 U-4107 Drug substance, Drug product 2024-07-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214665-003 11827635 2040-05-20 U-3306 Drug substance, Drug product 2024-07-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214665-003 12398133 2040-05-20 U-4107 Drug substance, Drug product 2025-09-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214665-003 12398133 2040-05-20 U-3306 Drug substance, Drug product 2025-09-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214665-003 11426404 2040-09-15 U-4107 2024-07-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214665-003 11426404 2040-09-15 U-3306 2024-07-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214665-001 10519146 2038-05-21 Drug substance, Drug product 2022-02-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214665-001 12280056 2039-11-18 U-4107 2025-05-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214665-001 11236091 2040-05-20 U-4107 Drug substance, Drug product 2022-02-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214665-001 11236091 2040-05-20 U-3306 Drug substance, Drug product 2022-02-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214665-001 11827635 2040-05-20 U-4107 Drug substance, Drug product 2023-12-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214665-001 11827635 2040-05-20 U-3306 Drug substance, Drug product 2023-12-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214665-001 12398133 2040-05-20 U-3306 Drug substance, Drug product 2025-09-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214665-001 12398133 2040-05-20 U-4107 Drug substance, Drug product 2025-09-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214665-001 11426404 2040-09-15 U-3306 2022-09-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214665-001 11426404 2040-09-15 U-4107 2022-09-27 31067a03dcf5…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 5 · 163 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 55513-488 LUMAKRAS sotorasib Amgen Inc NDA Current 55513-488 LUMAKRAS sotorasib Amgen Inc NDA Current 55513-488 LUMAKRAS sotorasib Amgen Inc NDA Current 55513-488 LUMAKRAS sotorasib Amgen Inc NDA Current