Home Applications 216340 Application 216340
Type NDA
Sponsor MIRATI THERAPEUTICS, INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 KRAZATI (ADAGRASIB) ADAGRASIB TABLET;ORAL 200mg No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 N216340-001 KRAZATI ADAGRASIB 200MG TABLET / ORAL RLD, RS 2022-12-12
Orange Book patents# Current patent rows page 1 of 1 · 6 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N216340-001 10689377 2037-05-17 U-3490 Drug substance, Drug product 2022-12-20 N216340-001 10689377 2037-05-17 U-3953 Drug substance, Drug product 2022-12-20 N216340-001 12336995 2041-02-05 U-3953 2025-07-21 N216340-001 12281113 2041-09-10 Drug substance, Drug product 2025-05-21 N216340-001 12383503 2043-08-21 Drug product 2025-09-10 N216340-001 12653789 2043-08-21 Drug product 2026-07-10
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 2 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N216340-001 NCE 2027-12-12 N216340-001 ODE-352 2029-12-12
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.
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 2026-09-14 22:38:34 2026-08 N216340-001 KRAZATI 200MG TABLET / ORAL RLD, RS 2022-12-12 84e616aacf4f…2026-08-18 06:07:40 2026-07 N216340-001 KRAZATI 200MG TABLET / ORAL RLD, RS 2022-12-12 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N216340-001 KRAZATI 200MG TABLET / ORAL RLD, RS 2022-12-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216340-001 KRAZATI 200MG TABLET / ORAL RLD, RS 2022-12-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N216340-001 KRAZATI 200MG TABLET / ORAL RLD, RS 2022-12-12 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N216340-001 KRAZATI 200MG TABLET / ORAL RLD, RS 2022-12-12 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N216340-001 KRAZATI 200MG TABLET / ORAL RLD, RS 2022-12-12 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N216340-001 KRAZATI 200MG TABLET / ORAL RLD, RS 2022-12-12 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N216340-001 KRAZATI 200MG TABLET / ORAL RLD, RS 2022-12-12 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N216340-001 KRAZATI 200MG TABLET / ORAL RLD, RS 2022-12-12 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N216340-001 KRAZATI 200MG TABLET / ORAL RLD, RS 2022-12-12 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N216340-001 KRAZATI 200MG TABLET / ORAL RLD, RS 2022-12-12 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N216340-001 KRAZATI 200MG TABLET / ORAL RLD, RS 2022-12-12 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N216340-001 KRAZATI 200MG TABLET / ORAL RLD, RS 2022-12-12 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N216340-001 KRAZATI 200MG TABLET / ORAL RLD, RS 2022-12-12 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N216340-001 KRAZATI 200MG TABLET / ORAL RLD, RS 2022-12-12 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N216340-001 KRAZATI 200MG TABLET / ORAL RLD, RS 2022-12-12 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N216340-001 KRAZATI 200MG TABLET / ORAL RLD, RS 2022-12-12 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N216340-001 KRAZATI 200MG TABLET / ORAL RLD, RS 2022-12-12 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N216340-001 KRAZATI 200MG TABLET / ORAL RLD, RS 2022-12-12 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N216340-001 KRAZATI 200MG TABLET / ORAL RLD, RS 2022-12-12 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N216340-001 KRAZATI 200MG TABLET / ORAL RLD, RS 2022-12-12 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N216340-001 KRAZATI 200MG TABLET / ORAL RLD, RS 2022-12-12 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N216340-001 KRAZATI 200MG TABLET / ORAL RLD, RS 2022-12-12 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N216340-001 KRAZATI 200MG TABLET / ORAL RLD, RS 2022-12-12 3bdfa0b2c4d7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N216340-001 KRAZATI 200MG TABLET / ORAL RLD, RS 2022-12-12 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 2 · 60 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-09-14 22:38:34 2026-08 N216340-001 10689377 2037-05-17 U-3490 Drug substance, Drug product 2022-12-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216340-001 10689377 2037-05-17 U-3953 Drug substance, Drug product 2022-12-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216340-001 12336995 2041-02-05 U-3953 2025-07-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216340-001 12281113 2041-09-10 Drug substance, Drug product 2025-05-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216340-001 12383503 2043-08-21 Drug product 2025-09-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216340-001 12653789 2043-08-21 Drug product 2026-07-10 84e616aacf4f…2026-08-18 06:07:40 2026-07 N216340-001 10689377 2037-05-17 U-3490 Drug substance, Drug product 2022-12-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216340-001 10689377 2037-05-17 U-3953 Drug substance, Drug product 2022-12-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216340-001 12336995 2041-02-05 U-3953 2025-07-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216340-001 12281113 2041-09-10 Drug substance, Drug product 2025-05-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216340-001 12383503 2043-08-21 Drug product 2025-09-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216340-001 12653789 2043-08-21 Drug product 2026-07-10 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N216340-001 10689377 2037-05-17 U-3490 Drug substance, Drug product 2022-12-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N216340-001 10689377 2037-05-17 U-3953 Drug substance, Drug product 2022-12-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N216340-001 12336995 2041-02-05 U-3953 2025-07-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N216340-001 12281113 2041-09-10 Drug substance, Drug product 2025-05-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N216340-001 12383503 2043-08-21 Drug product 2025-09-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216340-001 10689377 2037-05-17 U-3490 Drug substance, Drug product 2022-12-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216340-001 10689377 2037-05-17 U-3953 Drug substance, Drug product 2022-12-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216340-001 12336995 2041-02-05 U-3953 2025-07-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216340-001 12281113 2041-09-10 Drug substance, Drug product 2025-05-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216340-001 12383503 2043-08-21 Drug product 2025-09-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N216340-001 10689377 2037-05-17 U-3490 Drug substance, Drug product 2022-12-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N216340-001 10689377 2037-05-17 U-3953 Drug substance, Drug product 2022-12-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N216340-001 12336995 2041-02-05 U-3953 2025-07-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N216340-001 12281113 2041-09-10 Drug substance, Drug product 2025-05-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N216340-001 10689377 2037-05-17 U-3490 Drug substance, Drug product 2022-12-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N216340-001 10689377 2037-05-17 U-3953 Drug substance, Drug product 2022-12-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N216340-001 10689377 2037-05-17 U-3490 Drug substance, Drug product 2022-12-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N216340-001 10689377 2037-05-17 U-3953 Drug substance, Drug product 2022-12-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N216340-001 10689377 2037-05-17 U-3490 Drug substance, Drug product 2022-12-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N216340-001 10689377 2037-05-17 U-3953 Drug substance, Drug product 2022-12-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N216340-001 10689377 2037-05-17 U-3490 Drug substance, Drug product 2022-12-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N216340-001 10689377 2037-05-17 U-3953 Drug substance, Drug product 2022-12-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N216340-001 10689377 2037-05-17 U-3490 Drug substance, Drug product 2022-12-20 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N216340-001 10689377 2037-05-17 U-3953 Drug substance, Drug product 2022-12-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N216340-001 10689377 2037-05-17 U-3490 Drug substance, Drug product 2022-12-20 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N216340-001 10689377 2037-05-17 U-3953 Drug substance, Drug product 2022-12-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N216340-001 10689377 2037-05-17 U-3490 Drug substance, Drug product 2022-12-20 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N216340-001 10689377 2037-05-17 U-3953 Drug substance, Drug product 2022-12-20 d06236e962d9…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 50 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.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 1 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 80739-812 KRAZATI adagrasib Mirati Therapeutics, Inc NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 85544 SUPPL 2026-03-27 85543 SUPPL 2026-03-27 80194 SUPPL 2024-11-12 79124 SUPPL 2024-07-18 78862 SUPPL 2024-06-21 73141 ORIG 2023-01-11 72870 ORIG 2022-12-13 72869 ORIG 2022-12-12