Home Applications 208434 Application 208434
Type NDA
Sponsor HOFFMANN-LA ROCHE Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 ALECENSA ALECTINIB HYDROCHLORIDE CAPSULE;ORAL EQ 150MG BASE Yes Yes
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 N208434-001 ALECENSA ALECTINIB HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL RLD, RS 2015-12-11
Orange Book patents# Current patent rows page 1 of 1 · 5 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N208434-001 9440922 2030-06-09 Drug product 2016-10-12 N208434-001 9126931 2031-05-29 Drug substance 2015-12-22 N208434-001 9365514 2032-03-04 Drug product 2016-07-11 N208434-001 10350214 2035-04-24 Drug product 2020-03-09 N208434-001 11433076 2035-04-24 Drug product 2022-09-28
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 2 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N208434-001 I-947 2027-04-18 N208434-001 ODE-477 2031-04-18
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 · 43 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 2026-09-14 22:38:34 2026-08 N208434-001 ALECENSA EQ 150MG BASE CAPSULE / ORAL RLD, RS 2015-12-11 84e616aacf4f…2026-08-18 06:07:40 2026-07 N208434-001 ALECENSA EQ 150MG BASE CAPSULE / ORAL RLD, RS 2015-12-11 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N208434-001 ALECENSA EQ 150MG BASE CAPSULE / ORAL RLD, RS 2015-12-11 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208434-001 ALECENSA EQ 150MG BASE CAPSULE / ORAL RLD, RS 2015-12-11 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N208434-001 ALECENSA EQ 150MG BASE CAPSULE / ORAL RLD, RS 2015-12-11 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208434-001 ALECENSA EQ 150MG BASE CAPSULE / ORAL RLD, RS 2015-12-11 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208434-001 ALECENSA EQ 150MG BASE CAPSULE / ORAL RLD, RS 2015-12-11 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208434-001 ALECENSA EQ 150MG BASE CAPSULE / ORAL RLD, RS 2015-12-11 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N208434-001 ALECENSA EQ 150MG BASE CAPSULE / ORAL RLD, RS 2015-12-11 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N208434-001 ALECENSA EQ 150MG BASE CAPSULE / ORAL RLD, RS 2015-12-11 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N208434-001 ALECENSA EQ 150MG BASE CAPSULE / ORAL RLD, RS 2015-12-11 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N208434-001 ALECENSA EQ 150MG BASE CAPSULE / ORAL RLD, RS 2015-12-11 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N208434-001 ALECENSA EQ 150MG BASE CAPSULE / ORAL RLD, RS 2015-12-11 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N208434-001 ALECENSA EQ 150MG BASE CAPSULE / ORAL RLD, RS 2015-12-11 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N208434-001 ALECENSA EQ 150MG BASE CAPSULE / ORAL RLD, RS 2015-12-11 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N208434-001 ALECENSA EQ 150MG BASE CAPSULE / ORAL RLD, RS 2015-12-11 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N208434-001 ALECENSA EQ 150MG BASE CAPSULE / ORAL RLD, RS 2015-12-11 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N208434-001 ALECENSA EQ 150MG BASE CAPSULE / ORAL RLD, RS 2015-12-11 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N208434-001 ALECENSA EQ 150MG BASE CAPSULE / ORAL RLD, RS 2015-12-11 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N208434-001 ALECENSA EQ 150MG BASE CAPSULE / ORAL RLD, RS 2015-12-11 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N208434-001 ALECENSA EQ 150MG BASE CAPSULE / ORAL RLD, RS 2015-12-11 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N208434-001 ALECENSA EQ 150MG BASE CAPSULE / ORAL RLD, RS 2015-12-11 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N208434-001 ALECENSA EQ 150MG BASE CAPSULE / ORAL RLD, RS 2015-12-11 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N208434-001 ALECENSA EQ 150MG BASE CAPSULE / ORAL RLD, RS 2015-12-11 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N208434-001 ALECENSA EQ 150MG BASE CAPSULE / ORAL RLD, RS 2015-12-11 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N208434-001 ALECENSA EQ 150MG BASE CAPSULE / ORAL RLD, RS 2015-12-11 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N208434-001 ALECENSA EQ 150MG BASE CAPSULE / ORAL RLD, RS 2015-12-11 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N208434-001 ALECENSA EQ 150MG BASE CAPSULE / ORAL RLD, RS 2015-12-11 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N208434-001 ALECENSA EQ 150MG BASE CAPSULE / ORAL RLD, RS 2015-12-11 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N208434-001 ALECENSA EQ 150MG BASE CAPSULE / ORAL RLD, RS 2015-12-11 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N208434-001 ALECENSA EQ 150MG BASE CAPSULE / ORAL RLD, RS 2015-12-11 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N208434-001 ALECENSA EQ 150MG BASE CAPSULE / ORAL RLD, RS 2015-12-11 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N208434-001 ALECENSA EQ 150MG BASE CAPSULE / ORAL RLD, RS 2015-12-11 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N208434-001 ALECENSA EQ 150MG BASE CAPSULE / ORAL RLD, RS 2015-12-11 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N208434-001 ALECENSA EQ 150MG BASE CAPSULE / ORAL RLD, RS 2015-12-11 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N208434-001 ALECENSA EQ 150MG BASE CAPSULE / ORAL RLD, RS 2015-12-11 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N208434-001 ALECENSA EQ 150MG BASE CAPSULE / ORAL RLD, RS 2015-12-11 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N208434-001 ALECENSA EQ 150MG BASE CAPSULE / ORAL RLD, RS 2015-12-11 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N208434-001 ALECENSA EQ 150MG BASE CAPSULE / ORAL RLD, RS 2015-12-11 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N208434-001 ALECENSA EQ 150MG BASE CAPSULE / ORAL RLD, RS 2015-12-11 f41ea6bd6efb…
Observed Orange Book patent history# Patent history page 1 of 5 · 196 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 N208434-001 9440922 2030-06-09 Drug product 2016-10-12 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208434-001 9126931 2031-05-29 Drug substance 2015-12-22 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208434-001 9365514 2032-03-04 Drug product 2016-07-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208434-001 10350214 2035-04-24 Drug product 2020-03-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208434-001 11433076 2035-04-24 Drug product 2022-09-28 84e616aacf4f…2026-08-18 06:07:40 2026-07 N208434-001 9440922 2030-06-09 Drug product 2016-10-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208434-001 9126931 2031-05-29 Drug substance 2015-12-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208434-001 9365514 2032-03-04 Drug product 2016-07-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208434-001 10350214 2035-04-24 Drug product 2020-03-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208434-001 11433076 2035-04-24 Drug product 2022-09-28 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N208434-001 9440922 2030-06-09 Drug product 2016-10-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208434-001 9126931 2031-05-29 Drug substance 2015-12-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208434-001 9365514 2032-03-04 Drug product 2016-07-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208434-001 10350214 2035-04-24 Drug product 2020-03-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208434-001 11433076 2035-04-24 Drug product 2022-09-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208434-001 9440922 2030-06-09 Drug product 2016-10-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208434-001 9126931 2031-05-29 Drug substance 2015-12-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208434-001 9365514 2032-03-04 Drug product 2016-07-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208434-001 10350214 2035-04-24 Drug product 2020-03-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208434-001 11433076 2035-04-24 Drug product 2022-09-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N208434-001 9440922 2030-06-09 Drug product 2016-10-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208434-001 9126931 2031-05-29 Drug substance 2015-12-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208434-001 9365514 2032-03-04 Drug product 2016-07-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208434-001 10350214 2035-04-24 Drug product 2020-03-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208434-001 11433076 2035-04-24 Drug product 2022-09-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208434-001 9440922 2030-06-09 Drug product 2016-10-12 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208434-001 9126931 2031-05-29 Drug substance 2015-12-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208434-001 9365514 2032-03-04 Drug product 2016-07-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208434-001 10350214 2035-04-24 Drug product 2020-03-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208434-001 11433076 2035-04-24 Drug product 2022-09-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208434-001 9440922 2030-06-09 Drug product 2016-10-12 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208434-001 9126931 2031-05-29 Drug substance 2015-12-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208434-001 9365514 2032-03-04 Drug product 2016-07-11 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208434-001 10350214 2035-04-24 Drug product 2020-03-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208434-001 11433076 2035-04-24 Drug product 2022-09-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208434-001 9440922 2030-06-09 Drug product 2016-10-12 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208434-001 9126931 2031-05-29 Drug substance 2015-12-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208434-001 9365514 2032-03-04 Drug product 2016-07-11 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208434-001 10350214 2035-04-24 Drug product 2020-03-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208434-001 11433076 2035-04-24 Drug product 2022-09-28 03ed91905a0d…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 3 · 97 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 · 9 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 50242-130 ALECENSA ALECTINIB HYDROCHLORIDE Genentech, Inc. NDA Current 50242-130 ALECENSA ALECTINIB HYDROCHLORIDE Genentech, Inc. NDA Current 50242-130 ALECENSA ALECTINIB HYDROCHLORIDE Genentech, Inc. NDA Current 50242-130 ALECENSA ALECTINIB HYDROCHLORIDE Genentech, Inc. NDA Current 50242-130 ALECENSA ALECTINIB HYDROCHLORIDE Genentech, Inc. NDA Current 50242-130 ALECENSA ALECTINIB HYDROCHLORIDE Genentech, Inc. NDA Current 50242-130 ALECENSA ALECTINIB HYDROCHLORIDE Genentech, Inc. NDA Current 50242-130 ALECENSA ALECTINIB HYDROCHLORIDE Genentech, Inc. NDA Current 50242-130 ALECENSA ALECTINIB HYDROCHLORIDE Genentech, Inc. NDA Current