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 44 .
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 3 · 86 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 2026-10-15 13:18:30 2026-09 N212725-001 ROZLYTREK 100MG CAPSULE / ORAL RLD 2019-08-15 c2088c7a36db…2026-10-15 13:18:30 2026-09 N212725-002 ROZLYTREK 200MG CAPSULE / ORAL RLD, RS 2019-08-15 c2088c7a36db…2026-09-14 22:38:34 2026-08 N212725-001 ROZLYTREK 100MG CAPSULE / ORAL RLD 2019-08-15 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212725-002 ROZLYTREK 200MG CAPSULE / ORAL RLD, RS 2019-08-15 84e616aacf4f…2026-08-18 06:07:40 2026-07 N212725-001 ROZLYTREK 100MG CAPSULE / ORAL RLD 2019-08-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212725-002 ROZLYTREK 200MG CAPSULE / ORAL RLD, RS 2019-08-15 caaa826d4ba7…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…
Observed Orange Book patent history# Patent history page 2 of 39 · 1,546 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 N212725-001 9029356 2028-07-08 Drug substance, Drug product 2019-09-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212725-001 9085558 2028-07-08 Drug product 2019-09-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212725-001 9255087 2028-07-08 U-2618 2019-09-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212725-001 9255087 2028-07-08 U-2617 2019-09-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212725-001 9616059 2028-07-08 U-2618 2019-09-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212725-001 8299057 2032-03-10 Drug substance, Drug product 2019-09-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212725-001 9085565 2033-05-22 Drug substance, Drug product 2019-09-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212725-001 9649306 2033-05-22 U-2618 2019-09-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212725-001 9649306 2033-05-22 U-2617 2019-09-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212725-001 10231965 2035-02-17 U-2618 2019-09-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212725-001 10231965 2035-02-17 U-2617 2019-09-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212725-001 10561651 2035-02-19 U-2745 2020-03-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212725-001 10738037 2037-05-18 U-2946 Drug substance, Drug product 2020-09-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212725-001 11091469 2037-05-18 U-2617 2021-09-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212725-001 11091469 2037-05-18 U-2618 2021-09-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212725-001 10398693 2038-07-18 Drug product 2019-09-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212725-001 11253515 2038-07-18 Drug product 2022-03-22 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212725-002 8673893 2028-07-08 U-2618 2019-09-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212725-002 8673893 2028-07-08 U-2617 2019-09-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212725-002 9029356 2028-07-08 Drug substance, Drug product 2019-09-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212725-002 9085558 2028-07-08 Drug product 2019-09-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212725-002 9255087 2028-07-08 U-2618 2019-09-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212725-002 9255087 2028-07-08 U-2617 2019-09-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212725-002 9616059 2028-07-08 U-2618 2019-09-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212725-002 8299057 2032-03-10 Drug substance, Drug product 2019-09-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212725-002 9085565 2033-05-22 Drug substance, Drug product 2019-09-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212725-002 9649306 2033-05-22 U-2618 2019-09-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212725-002 9649306 2033-05-22 U-2617 2019-09-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212725-002 10231965 2035-02-17 U-2618 2019-09-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212725-002 10231965 2035-02-17 U-2617 2019-09-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212725-002 10561651 2035-02-19 U-2745 2020-03-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212725-002 10738037 2037-05-18 U-2946 Drug substance, Drug product 2020-09-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212725-002 11091469 2037-05-18 U-2617 2021-09-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212725-002 11091469 2037-05-18 U-2618 2021-09-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212725-002 10398693 2038-07-18 Drug product 2019-09-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212725-002 11253515 2038-07-18 Drug product 2022-03-22 84e616aacf4f…2026-08-18 06:07:40 2026-07 N212725-001 8673893 2028-07-08 U-2618 2019-09-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212725-001 8673893 2028-07-08 U-2617 2019-09-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212725-001 9029356 2028-07-08 Drug substance, Drug product 2019-09-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212725-001 9085558 2028-07-08 Drug product 2019-09-13 caaa826d4ba7…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 8 · 314 observed states.
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 · 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