Home Applications 218213 Application 218213
Type NDA
Sponsor BRISTOL Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 AUGTYRO REPOTRECTINIB CAPSULE;ORAL 40MG Yes Yes 002 AUGTYRO REPOTRECTINIB CAPSULE;ORAL 160MG 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 N218213-001 AUGTYRO REPOTRECTINIB 40MG CAPSULE / ORAL RLD, RS 2023-11-15 N218213-002 AUGTYRO REPOTRECTINIB 160MG CAPSULE / ORAL RLD, RS 2024-06-11
Orange Book patents# Current patent rows page 1 of 1 · 12 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N218213-001 RE50634 2035-01-23 Drug substance, Drug product 2025-11-12 N218213-001 10294242 2036-07-05 Drug substance 2023-12-12 N218213-001 12187739 2036-07-05 Drug product 2025-02-21 N218213-001 12310968 2036-07-20 U-3755 2025-06-25 N218213-001 11452725 2036-07-24 U-3755 2023-12-12 N218213-001 11452725 2036-07-24 U-3961 2023-12-12 N218213-002 RE50634 2035-01-23 Drug substance, Drug product 2025-11-12 N218213-002 10294242 2036-07-05 Drug substance 2024-07-10 N218213-002 12187739 2036-07-05 Drug product 2025-02-21 N218213-002 12310968 2036-07-20 U-3755 2025-06-25 N218213-002 11452725 2036-07-24 U-3755 2024-07-10 N218213-002 11452725 2036-07-24 U-3961 2024-07-10
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.
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 N218213-001 AUGTYRO 40MG CAPSULE / ORAL RLD, RS 2023-11-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218213-002 AUGTYRO 160MG CAPSULE / ORAL RLD, RS 2024-06-11 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N218213-001 AUGTYRO 40MG CAPSULE / ORAL RLD, RS 2023-11-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218213-002 AUGTYRO 160MG CAPSULE / ORAL RLD, RS 2024-06-11 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N218213-001 AUGTYRO 40MG CAPSULE / ORAL RLD, RS 2023-11-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N218213-002 AUGTYRO 160MG CAPSULE / ORAL RLD, RS 2024-06-11 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N218213-001 AUGTYRO 40MG CAPSULE / ORAL RLD, RS 2023-11-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N218213-002 AUGTYRO 160MG CAPSULE / ORAL RLD, RS 2024-06-11 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N218213-001 AUGTYRO 40MG CAPSULE / ORAL RLD, RS 2023-11-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N218213-002 AUGTYRO 160MG CAPSULE / ORAL RLD 2024-06-11 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N218213-001 AUGTYRO 40MG CAPSULE / ORAL RLD, RS 2023-11-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N218213-002 AUGTYRO 160MG CAPSULE / ORAL RLD 2024-06-11 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N218213-001 AUGTYRO 40MG CAPSULE / ORAL RLD, RS 2023-11-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N218213-002 AUGTYRO 160MG CAPSULE / ORAL RLD 2024-06-11 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N218213-001 AUGTYRO 40MG CAPSULE / ORAL RLD, RS 2023-11-15 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N218213-002 AUGTYRO 160MG CAPSULE / ORAL RLD 2024-06-11 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N218213-001 AUGTYRO 40MG CAPSULE / ORAL RLD, RS 2023-11-15 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N218213-002 AUGTYRO 160MG CAPSULE / ORAL RLD 2024-06-11 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N218213-001 AUGTYRO 40MG CAPSULE / ORAL RLD, RS 2023-11-15 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N218213-002 AUGTYRO 160MG CAPSULE / ORAL RLD 2024-06-11 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N218213-001 AUGTYRO 40MG CAPSULE / ORAL RLD, RS 2023-11-15 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N218213-002 AUGTYRO 160MG CAPSULE / ORAL RLD 2024-06-11 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N218213-001 AUGTYRO 40MG CAPSULE / ORAL RLD, RS 2023-11-15 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N218213-002 AUGTYRO 160MG CAPSULE / ORAL RLD 2024-06-11 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N218213-001 AUGTYRO 40MG CAPSULE / ORAL RLD, RS 2023-11-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N218213-001 AUGTYRO 40MG CAPSULE / ORAL RLD, RS 2023-11-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N218213-001 AUGTYRO 40MG CAPSULE / ORAL RLD, RS 2023-11-15 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N218213-001 AUGTYRO 40MG CAPSULE / ORAL RLD, RS 2023-11-15 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N218213-001 AUGTYRO 40MG CAPSULE / ORAL RLD, RS 2023-11-15 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N218213-001 AUGTYRO 40MG CAPSULE / ORAL RLD, RS 2023-11-15 ea1830bbd6c7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N218213-001 AUGTYRO 40MG CAPSULE / ORAL RLD, RS 2023-11-15 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N218213-002 AUGTYRO 160MG CAPSULE / ORAL RLD, RS 2024-06-11 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 4 · 146 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 N218213-001 RE50634 2035-01-23 Drug substance, Drug product 2025-11-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218213-001 10294242 2036-07-05 Drug substance 2023-12-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218213-001 12187739 2036-07-05 Drug product 2025-02-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218213-001 12310968 2036-07-20 U-3755 2025-06-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218213-001 11452725 2036-07-24 U-3961 2023-12-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218213-001 11452725 2036-07-24 U-3755 2023-12-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218213-002 RE50634 2035-01-23 Drug substance, Drug product 2025-11-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218213-002 10294242 2036-07-05 Drug substance 2024-07-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218213-002 12187739 2036-07-05 Drug product 2025-02-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218213-002 12310968 2036-07-20 U-3755 2025-06-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218213-002 11452725 2036-07-24 U-3755 2024-07-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218213-002 11452725 2036-07-24 U-3961 2024-07-10 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N218213-001 RE50634 2035-01-23 Drug substance, Drug product 2025-11-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218213-001 10294242 2036-07-05 Drug substance 2023-12-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218213-001 12187739 2036-07-05 Drug product 2025-02-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218213-001 12310968 2036-07-20 U-3755 2025-06-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218213-001 11452725 2036-07-24 U-3961 2023-12-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218213-001 11452725 2036-07-24 U-3755 2023-12-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218213-002 RE50634 2035-01-23 Drug substance, Drug product 2025-11-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218213-002 10294242 2036-07-05 Drug substance 2024-07-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218213-002 12187739 2036-07-05 Drug product 2025-02-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218213-002 12310968 2036-07-20 U-3755 2025-06-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218213-002 11452725 2036-07-24 U-3755 2024-07-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218213-002 11452725 2036-07-24 U-3961 2024-07-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N218213-001 RE50634 2035-01-23 Drug substance, Drug product 2025-11-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N218213-001 10294242 2036-07-05 Drug substance 2023-12-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N218213-001 12187739 2036-07-05 Drug product 2025-02-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N218213-001 12310968 2036-07-20 U-3755 2025-06-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N218213-001 11452725 2036-07-24 U-3961 2023-12-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N218213-001 11452725 2036-07-24 U-3755 2023-12-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N218213-002 RE50634 2035-01-23 Drug substance, Drug product 2025-11-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N218213-002 10294242 2036-07-05 Drug substance 2024-07-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N218213-002 12187739 2036-07-05 Drug product 2025-02-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N218213-002 12310968 2036-07-20 U-3755 2025-06-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N218213-002 11452725 2036-07-24 U-3755 2024-07-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N218213-002 11452725 2036-07-24 U-3961 2024-07-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N218213-001 9714258 2035-01-23 Drug substance, Drug product 2023-12-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N218213-001 10294242 2036-07-05 Drug substance 2023-12-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N218213-001 12187739 2036-07-05 Drug product 2025-02-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N218213-001 12310968 2036-07-20 U-3755 2025-06-25 6a471c1ec25d…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 3 · 93 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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Augtyro REPOTRECTINIB E.R. Squibb & Sons, L.L.C. fb526827-40ba-4462-94cf-179ae3b0cb8a 2024-06-13 Warnings, Adverse reactions Exact identifier application applno (NDA): 218213 application number: NDA218213
Documents# Document, Submission type, Date table Document Submission type Date 80451 SUPPL 2024-11-29 78801 SUPPL 2024-06-14 78797 SUPPL 2024-06-13 77169 ORIG 2023-12-29 77171 ORIG 2023-11-16 77170 ORIG 2023-11-16