Home Applications 208051 Application 208051
Type NDA
Sponsor PUMA BIOTECH Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 NERLYNX NERATINIB MALEATE TABLET;ORAL EQ 40MG 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 N208051-001 NERLYNX NERATINIB MALEATE EQ 40MG BASE TABLET / ORAL RLD, RS 2017-07-17
Orange Book patents# Current patent rows page 1 of 1 · 20 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 · 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 N208051-001 NERLYNX EQ 40MG BASE TABLET / ORAL RLD, RS 2017-07-17 84e616aacf4f…2026-08-18 06:07:40 2026-07 N208051-001 NERLYNX EQ 40MG BASE TABLET / ORAL RLD, RS 2017-07-17 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N208051-001 NERLYNX EQ 40MG BASE TABLET / ORAL RLD, RS 2017-07-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208051-001 NERLYNX EQ 40MG BASE TABLET / ORAL RLD, RS 2017-07-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N208051-001 NERLYNX EQ 40MG BASE TABLET / ORAL RLD, RS 2017-07-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208051-001 NERLYNX EQ 40MG BASE TABLET / ORAL RLD, RS 2017-07-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208051-001 NERLYNX EQ 40MG BASE TABLET / ORAL RLD, RS 2017-07-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208051-001 NERLYNX EQ 40MG BASE TABLET / ORAL RLD, RS 2017-07-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N208051-001 NERLYNX EQ 40MG BASE TABLET / ORAL RLD, RS 2017-07-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N208051-001 NERLYNX EQ 40MG BASE TABLET / ORAL RLD, RS 2017-07-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N208051-001 NERLYNX EQ 40MG BASE TABLET / ORAL RLD, RS 2017-07-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N208051-001 NERLYNX EQ 40MG BASE TABLET / ORAL RLD, RS 2017-07-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N208051-001 NERLYNX EQ 40MG BASE TABLET / ORAL RLD, RS 2017-07-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N208051-001 NERLYNX EQ 40MG BASE TABLET / ORAL RLD, RS 2017-07-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N208051-001 NERLYNX EQ 40MG BASE TABLET / ORAL RLD, RS 2017-07-17 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N208051-001 NERLYNX EQ 40MG BASE TABLET / ORAL RLD, RS 2017-07-17 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N208051-001 NERLYNX EQ 40MG BASE TABLET / ORAL RLD, RS 2017-07-17 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N208051-001 NERLYNX EQ 40MG BASE TABLET / ORAL RLD, RS 2017-07-17 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N208051-001 NERLYNX EQ 40MG BASE TABLET / ORAL RLD, RS 2017-07-17 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N208051-001 NERLYNX EQ 40MG BASE TABLET / ORAL RLD, RS 2017-07-17 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N208051-001 NERLYNX EQ 40MG BASE TABLET / ORAL RLD, RS 2017-07-17 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N208051-001 NERLYNX EQ 40MG BASE TABLET / ORAL RLD, RS 2017-07-17 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N208051-001 NERLYNX EQ 40MG BASE TABLET / ORAL RLD, RS 2017-07-17 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N208051-001 NERLYNX EQ 40MG BASE TABLET / ORAL RLD, RS 2017-07-17 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N208051-001 NERLYNX EQ 40MG BASE TABLET / ORAL RLD, RS 2017-07-17 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N208051-001 NERLYNX EQ 40MG BASE TABLET / ORAL RLD, RS 2017-07-17 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N208051-001 NERLYNX EQ 40MG BASE TABLET / ORAL RLD, RS 2017-07-17 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N208051-001 NERLYNX EQ 40MG BASE TABLET / ORAL RLD, RS 2017-07-17 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N208051-001 NERLYNX EQ 40MG BASE TABLET / ORAL RLD, RS 2017-07-17 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N208051-001 NERLYNX EQ 40MG BASE TABLET / ORAL RLD, RS 2017-07-17 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N208051-001 NERLYNX EQ 40MG BASE TABLET / ORAL RLD, RS 2017-07-17 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N208051-001 NERLYNX EQ 40MG BASE TABLET / ORAL RLD, RS 2017-07-17 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N208051-001 NERLYNX EQ 40MG BASE TABLET / ORAL RLD, RS 2017-07-17 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N208051-001 NERLYNX EQ 40MG BASE TABLET / ORAL RLD, RS 2017-07-17 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N208051-001 NERLYNX EQ 40MG BASE TABLET / ORAL RLD, RS 2017-07-17 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N208051-001 NERLYNX EQ 40MG BASE TABLET / ORAL RLD, RS 2017-07-17 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N208051-001 NERLYNX EQ 40MG BASE TABLET / ORAL RLD, RS 2017-07-17 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N208051-001 NERLYNX EQ 40MG BASE TABLET / ORAL RLD, RS 2017-07-17 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N208051-001 NERLYNX EQ 40MG BASE TABLET / ORAL RLD, RS 2017-07-17 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N208051-001 NERLYNX EQ 40MG BASE TABLET / ORAL RLD, RS 2017-07-17 f41ea6bd6efb…
Observed Orange Book patent history# Patent history page 1 of 22 · 878 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 N208051-001 10035788 2028-10-15 U-2043 2018-08-03 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208051-001 10035788 2028-10-15 U-3047 2018-08-03 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208051-001 10035788 2028-10-15 U-3097 2018-08-03 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208051-001 9139558 2028-10-15 U-3097 2017-08-08 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208051-001 9139558 2028-10-15 U-3047 2017-08-08 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208051-001 9139558 2028-10-15 U-2043 2017-08-08 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208051-001 9630946 2028-10-15 U-2043 2017-08-08 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208051-001 9630946 2028-10-15 U-3047 2017-08-08 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208051-001 9630946 2028-10-15 U-3097 2017-08-08 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208051-001 9265784 2029-08-04 U-3047 2021-01-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208051-001 9211291 2030-03-24 U-2043 2017-08-08 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208051-001 9211291 2030-03-24 U-3097 2017-08-08 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208051-001 8790708 2030-11-05 U-2043 Drug product 2017-08-08 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208051-001 8790708 2030-11-05 U-3097 Drug product 2017-08-08 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208051-001 8790708 2030-11-05 U-3047 Drug product 2017-08-08 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208051-001 8518446 2030-11-20 U-2043 Drug product 2017-08-08 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208051-001 8518446 2030-11-20 U-3097 Drug product 2017-08-08 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208051-001 8518446 2030-11-20 U-3047 Drug product 2017-08-08 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208051-001 7399865 2030-12-29 Drug substance, Drug product 2017-08-08 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208051-001 8669273 2031-07-18 U-3047 2021-01-29 84e616aacf4f…2026-08-18 06:07:40 2026-07 N208051-001 10035788 2028-10-15 U-2043 2018-08-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208051-001 10035788 2028-10-15 U-3047 2018-08-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208051-001 10035788 2028-10-15 U-3097 2018-08-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208051-001 9139558 2028-10-15 U-3097 2017-08-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208051-001 9139558 2028-10-15 U-3047 2017-08-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208051-001 9139558 2028-10-15 U-2043 2017-08-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208051-001 9630946 2028-10-15 U-2043 2017-08-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208051-001 9630946 2028-10-15 U-3047 2017-08-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208051-001 9630946 2028-10-15 U-3097 2017-08-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208051-001 9265784 2029-08-04 U-3047 2021-01-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208051-001 9211291 2030-03-24 U-2043 2017-08-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208051-001 9211291 2030-03-24 U-3097 2017-08-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208051-001 8790708 2030-11-05 U-2043 Drug product 2017-08-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208051-001 8790708 2030-11-05 U-3097 Drug product 2017-08-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208051-001 8790708 2030-11-05 U-3047 Drug product 2017-08-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208051-001 8518446 2030-11-20 U-2043 Drug product 2017-08-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208051-001 8518446 2030-11-20 U-3097 Drug product 2017-08-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208051-001 8518446 2030-11-20 U-3047 Drug product 2017-08-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208051-001 7399865 2030-12-29 Drug substance, Drug product 2017-08-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208051-001 8669273 2031-07-18 U-3047 2021-01-29 caaa826d4ba7…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 65 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 · 10 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 70437-240 Nerlynx neratinib Puma Biotechnology, Inc. NDA Current 70437-240 Nerlynx neratinib Puma Biotechnology, Inc. NDA Current 70437-240 Nerlynx neratinib Puma Biotechnology, Inc. NDA Current 70437-240 Nerlynx neratinib Puma Biotechnology, Inc. NDA Current 70437-240 Nerlynx neratinib Puma Biotechnology, Inc. NDA Current 70437-240 Nerlynx neratinib Puma Biotechnology, Inc. NDA Current 70437-240 Nerlynx neratinib Puma Biotechnology, Inc. NDA Current 70437-240 Nerlynx neratinib Puma Biotechnology, Inc. NDA Current 70437-240 Nerlynx neratinib Puma Biotechnology, Inc. NDA Current 70437-240 Nerlynx neratinib Puma Biotechnology, Inc. NDA Current