Home Applications 212725 Application 212725
Type NDA
Sponsor GENENTECH INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 ROZLYTREK ENTRECTINIB CAPSULE;ORAL 100MG Yes No 002 ROZLYTREK ENTRECTINIB CAPSULE;ORAL 200MG Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 N212725-001 ROZLYTREK ENTRECTINIB 100MG CAPSULE / ORAL RLD 2019-08-15 N212725-002 ROZLYTREK ENTRECTINIB 200MG CAPSULE / ORAL RLD, RS 2019-08-15
Orange Book patents# Current patent rows page 1 of 1 · 38 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N212725-001 8673893 2028-07-08 U-2617 2019-09-13 N212725-001 8673893 2028-07-08 U-2618 2019-09-13 N212725-001 9029356 2028-07-08 Drug substance, Drug product 2019-09-13 N212725-001 9085558 2028-07-08 Drug product 2019-09-13 N212725-001 9255087 2028-07-08 U-2617 2019-09-13 N212725-001 9255087 2028-07-08 U-2618 2019-09-13 N212725-001 9616059 2028-07-08 U-2618 2019-09-13 N212725-001 8299057 2032-03-10 Drug substance, Drug product 2019-09-13 N212725-001 9085565 2033-05-22 Drug substance, Drug product 2019-09-13 N212725-001 9649306 2033-05-22 U-2617 2019-09-13 N212725-001 9649306 2033-05-22 U-2618 2019-09-13 N212725-001 10231965 2035-02-17 U-2617 2019-09-13 N212725-001 10231965 2035-02-17 U-2618 2019-09-13 N212725-001 10561651 2035-02-19 U-2745 2020-03-13 N212725-001 10738037 2037-05-18 U-2946 Drug substance, Drug product 2020-09-09 N212725-001 11091469 2037-05-18 U-2617 2021-09-10 N212725-001 11091469 2037-05-18 U-2618 2021-09-10 N212725-001 10398693 2038-07-18 Drug product 2019-09-13 N212725-001 11253515 2038-07-18 Drug product 2022-03-22 N212725-002 8673893 2028-07-08 U-2617 2019-09-13 N212725-002 8673893 2028-07-08 U-2618 2019-09-13 N212725-002 9029356 2028-07-08 Drug substance, Drug product 2019-09-13 N212725-002 9085558 2028-07-08 Drug product 2019-09-13 N212725-002 9255087 2028-07-08 U-2617 2019-09-13 N212725-002 9255087 2028-07-08 U-2618 2019-09-13 N212725-002 9616059 2028-07-08 U-2618 2019-09-13 N212725-002 8299057 2032-03-10 Drug substance, Drug product 2019-09-13 N212725-002 9085565 2033-05-22 Drug substance, Drug product 2019-09-13 N212725-002 9649306 2033-05-22 U-2617 2019-09-13 N212725-002 9649306 2033-05-22 U-2618 2019-09-13 N212725-002 10231965 2035-02-17 U-2617 2019-09-13 N212725-002 10231965 2035-02-17 U-2618 2019-09-13 N212725-002 10561651 2035-02-19 U-2745 2020-03-13 N212725-002 10738037 2037-05-18 U-2946 Drug substance, Drug product 2020-09-09 N212725-002 11091469 2037-05-18 U-2617 2021-09-10 N212725-002 11091469 2037-05-18 U-2618 2021-09-10 N212725-002 10398693 2038-07-18 Drug product 2019-09-13 N212725-002 11253515 2038-07-18 Drug product 2022-03-22
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 8 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 · 80 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 N212725-001 ROZLYTREK 100MG CAPSULE / ORAL RLD 2019-08-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212725-002 ROZLYTREK 200MG CAPSULE / ORAL RLD, RS 2019-08-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212725-001 ROZLYTREK 100MG CAPSULE / ORAL RLD 2019-08-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212725-002 ROZLYTREK 200MG CAPSULE / ORAL RLD, RS 2019-08-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N212725-001 ROZLYTREK 100MG CAPSULE / ORAL RLD 2019-08-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N212725-002 ROZLYTREK 200MG CAPSULE / ORAL RLD, RS 2019-08-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N212725-001 ROZLYTREK 100MG CAPSULE / ORAL RLD 2019-08-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N212725-002 ROZLYTREK 200MG CAPSULE / ORAL RLD, RS 2019-08-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N212725-001 ROZLYTREK 100MG CAPSULE / ORAL RLD 2019-08-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N212725-002 ROZLYTREK 200MG CAPSULE / ORAL RLD, RS 2019-08-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N212725-001 ROZLYTREK 100MG CAPSULE / ORAL RLD 2019-08-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N212725-002 ROZLYTREK 200MG CAPSULE / ORAL RLD, RS 2019-08-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N212725-001 ROZLYTREK 100MG CAPSULE / ORAL RLD 2019-08-15 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N212725-002 ROZLYTREK 200MG CAPSULE / ORAL RLD, RS 2019-08-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N212725-001 ROZLYTREK 100MG CAPSULE / ORAL RLD 2019-08-15 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N212725-002 ROZLYTREK 200MG CAPSULE / ORAL RLD, RS 2019-08-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N212725-001 ROZLYTREK 100MG CAPSULE / ORAL RLD 2019-08-15 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N212725-002 ROZLYTREK 200MG CAPSULE / ORAL RLD, RS 2019-08-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N212725-001 ROZLYTREK 100MG CAPSULE / ORAL RLD 2019-08-15 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N212725-002 ROZLYTREK 200MG CAPSULE / ORAL RLD, RS 2019-08-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N212725-001 ROZLYTREK 100MG CAPSULE / ORAL RLD 2019-08-15 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N212725-002 ROZLYTREK 200MG CAPSULE / ORAL RLD, RS 2019-08-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N212725-001 ROZLYTREK 100MG CAPSULE / ORAL RLD 2019-08-15 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N212725-002 ROZLYTREK 200MG CAPSULE / ORAL RLD, RS 2019-08-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N212725-001 ROZLYTREK 100MG CAPSULE / ORAL RLD 2019-08-15 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N212725-002 ROZLYTREK 200MG CAPSULE / ORAL RLD, RS 2019-08-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N212725-001 ROZLYTREK 100MG CAPSULE / ORAL RLD 2019-08-15 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N212725-002 ROZLYTREK 200MG CAPSULE / ORAL RLD, RS 2019-08-15 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N212725-001 ROZLYTREK 100MG CAPSULE / ORAL RLD 2019-08-15 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N212725-002 ROZLYTREK 200MG CAPSULE / ORAL RLD, RS 2019-08-15 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N212725-001 ROZLYTREK 100MG CAPSULE / ORAL RLD 2019-08-15 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N212725-002 ROZLYTREK 200MG CAPSULE / ORAL RLD, RS 2019-08-15 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N212725-001 ROZLYTREK 100MG CAPSULE / ORAL RLD 2019-08-15 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N212725-002 ROZLYTREK 200MG CAPSULE / ORAL RLD, RS 2019-08-15 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N212725-001 ROZLYTREK 100MG CAPSULE / ORAL RLD 2019-08-15 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N212725-002 ROZLYTREK 200MG CAPSULE / ORAL RLD, RS 2019-08-15 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N212725-001 ROZLYTREK 100MG CAPSULE / ORAL RLD 2019-08-15 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N212725-002 ROZLYTREK 200MG CAPSULE / ORAL RLD, RS 2019-08-15 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N212725-001 ROZLYTREK 100MG CAPSULE / ORAL RLD 2019-08-15 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N212725-002 ROZLYTREK 200MG CAPSULE / ORAL RLD, RS 2019-08-15 782e0a99824c…
Observed Orange Book patent history# Patent history page 1 of 36 · 1,432 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 N212725-001 8673893 2028-07-08 U-2618 2019-09-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212725-001 8673893 2028-07-08 U-2617 2019-09-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212725-001 9029356 2028-07-08 Drug substance, Drug product 2019-09-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212725-001 9085558 2028-07-08 Drug product 2019-09-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212725-001 9255087 2028-07-08 U-2618 2019-09-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212725-001 9255087 2028-07-08 U-2617 2019-09-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212725-001 9616059 2028-07-08 U-2618 2019-09-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212725-001 8299057 2032-03-10 Drug substance, Drug product 2019-09-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212725-001 9085565 2033-05-22 Drug substance, Drug product 2019-09-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212725-001 9649306 2033-05-22 U-2618 2019-09-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212725-001 9649306 2033-05-22 U-2617 2019-09-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212725-001 10231965 2035-02-17 U-2618 2019-09-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212725-001 10231965 2035-02-17 U-2617 2019-09-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212725-001 10561651 2035-02-19 U-2745 2020-03-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212725-001 10738037 2037-05-18 U-2946 Drug substance, Drug product 2020-09-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212725-001 11091469 2037-05-18 U-2617 2021-09-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212725-001 11091469 2037-05-18 U-2618 2021-09-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212725-001 10398693 2038-07-18 Drug product 2019-09-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212725-001 11253515 2038-07-18 Drug product 2022-03-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212725-002 8673893 2028-07-08 U-2618 2019-09-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212725-002 8673893 2028-07-08 U-2617 2019-09-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212725-002 9029356 2028-07-08 Drug substance, Drug product 2019-09-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212725-002 9085558 2028-07-08 Drug product 2019-09-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212725-002 9255087 2028-07-08 U-2618 2019-09-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212725-002 9255087 2028-07-08 U-2617 2019-09-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212725-002 9616059 2028-07-08 U-2618 2019-09-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212725-002 8299057 2032-03-10 Drug substance, Drug product 2019-09-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212725-002 9085565 2033-05-22 Drug substance, Drug product 2019-09-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212725-002 9649306 2033-05-22 U-2618 2019-09-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212725-002 9649306 2033-05-22 U-2617 2019-09-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212725-002 10231965 2035-02-17 U-2618 2019-09-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212725-002 10231965 2035-02-17 U-2617 2019-09-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212725-002 10561651 2035-02-19 U-2745 2020-03-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212725-002 10738037 2037-05-18 U-2946 Drug substance, Drug product 2020-09-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212725-002 11091469 2037-05-18 U-2617 2021-09-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212725-002 11091469 2037-05-18 U-2618 2021-09-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212725-002 10398693 2038-07-18 Drug product 2019-09-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212725-002 11253515 2038-07-18 Drug product 2022-03-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212725-001 8673893 2028-07-08 U-2618 2019-09-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212725-001 8673893 2028-07-08 U-2617 2019-09-13 31067a03dcf5…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 8 · 290 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 · 14 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 50242-091 Rozlytrek ENTRECTINIB Genentech, Inc. NDA Current 50242-091 Rozlytrek ENTRECTINIB Genentech Inc. NDA Current 50242-091 Rozlytrek ENTRECTINIB Genentech, Inc. NDA Current 50242-091 Rozlytrek ENTRECTINIB Genentech, Inc. NDA Current 50242-091 Rozlytrek ENTRECTINIB Genentech Inc. NDA Current 50242-091 Rozlytrek ENTRECTINIB Genentech Inc. NDA Current 50242-091 Rozlytrek ENTRECTINIB Genentech Inc. NDA Current 50242-094 Rozlytrek ENTRECTINIB Genentech, Inc. NDA Current 50242-094 Rozlytrek ENTRECTINIB Genentech Inc. NDA Current 50242-094 Rozlytrek ENTRECTINIB Genentech, Inc. NDA Current 50242-094 Rozlytrek ENTRECTINIB Genentech, Inc. NDA Current 50242-094 Rozlytrek ENTRECTINIB Genentech Inc. NDA Current 50242-094 Rozlytrek ENTRECTINIB Genentech Inc. NDA Current 50242-094 Rozlytrek ENTRECTINIB Genentech Inc. NDA Current