Home Applications 213674 Application 213674
Type NDA
Sponsor ASTELLAS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 XTANDI ENZALUTAMIDE TABLET, FILM COATED 40MG Yes No 002 XTANDI ENZALUTAMIDE TABLET, FILM COATED 80MG Yes No
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 N213674-001 XTANDI ENZALUTAMIDE 40MG TABLET / ORAL AB RLD 2020-08-04 N213674-002 XTANDI ENZALUTAMIDE 80MG TABLET / ORAL AB RLD, RS 2020-08-04
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
Orange Book patents# Current patent rows page 1 of 1 · 33 matching rows.
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 2 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N213674-001 I-926 2026-11-17 N213674-002 I-926 2026-11-17
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 · 74 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 N213674-001 XTANDI 40MG TABLET / ORAL RLD 2020-08-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213674-002 XTANDI 80MG TABLET / ORAL RLD, RS 2020-08-04 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213674-001 XTANDI 40MG TABLET / ORAL RLD 2020-08-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213674-002 XTANDI 80MG TABLET / ORAL RLD, RS 2020-08-04 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N213674-001 XTANDI 40MG TABLET / ORAL RLD 2020-08-04 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213674-002 XTANDI 80MG TABLET / ORAL RLD, RS 2020-08-04 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213674-001 XTANDI 40MG TABLET / ORAL RLD 2020-08-04 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213674-002 XTANDI 80MG TABLET / ORAL RLD, RS 2020-08-04 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213674-001 XTANDI 40MG TABLET / ORAL RLD 2020-08-04 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213674-002 XTANDI 80MG TABLET / ORAL RLD, RS 2020-08-04 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N213674-001 XTANDI 40MG TABLET / ORAL RLD 2020-08-04 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N213674-002 XTANDI 80MG TABLET / ORAL RLD, RS 2020-08-04 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N213674-001 XTANDI 40MG TABLET / ORAL RLD 2020-08-04 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N213674-002 XTANDI 80MG TABLET / ORAL RLD, RS 2020-08-04 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N213674-001 XTANDI 40MG TABLET / ORAL RLD 2020-08-04 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N213674-002 XTANDI 80MG TABLET / ORAL RLD, RS 2020-08-04 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N213674-001 XTANDI 40MG TABLET / ORAL RLD 2020-08-04 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N213674-002 XTANDI 80MG TABLET / ORAL RLD, RS 2020-08-04 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N213674-001 XTANDI 40MG TABLET / ORAL RLD 2020-08-04 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N213674-002 XTANDI 80MG TABLET / ORAL RLD, RS 2020-08-04 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N213674-001 XTANDI 40MG TABLET / ORAL RLD 2020-08-04 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N213674-002 XTANDI 80MG TABLET / ORAL RLD, RS 2020-08-04 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N213674-001 XTANDI 40MG TABLET / ORAL RLD 2020-08-04 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N213674-002 XTANDI 80MG TABLET / ORAL RLD, RS 2020-08-04 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N213674-001 XTANDI 40MG TABLET / ORAL RLD 2020-08-04 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N213674-002 XTANDI 80MG TABLET / ORAL RLD, RS 2020-08-04 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N213674-001 XTANDI 40MG TABLET / ORAL RLD 2020-08-04 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N213674-002 XTANDI 80MG TABLET / ORAL RLD, RS 2020-08-04 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N213674-001 XTANDI 40MG TABLET / ORAL RLD 2020-08-04 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N213674-002 XTANDI 80MG TABLET / ORAL RLD, RS 2020-08-04 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N213674-001 XTANDI 40MG TABLET / ORAL RLD 2020-08-04 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N213674-002 XTANDI 80MG TABLET / ORAL RLD, RS 2020-08-04 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N213674-001 XTANDI 40MG TABLET / ORAL RLD 2020-08-04 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N213674-002 XTANDI 80MG TABLET / ORAL RLD, RS 2020-08-04 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 N213674-001 XTANDI 40MG TABLET / ORAL RLD 2020-08-04 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N213674-002 XTANDI 80MG TABLET / ORAL RLD, RS 2020-08-04 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N213674-001 XTANDI 40MG TABLET / ORAL RLD 2020-08-04 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N213674-002 XTANDI 80MG TABLET / ORAL RLD, RS 2020-08-04 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N213674-001 XTANDI 40MG TABLET / ORAL RLD 2020-08-04 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N213674-002 XTANDI 80MG TABLET / ORAL RLD, RS 2020-08-04 87673890dc5c…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N213674-001 AB 1 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N213674-002 AB 1 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 14 · 541 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 N213674-001 9126941 2026-05-15 U-2708 2020-09-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213674-001 9126941 2026-05-15 U-2345 2020-09-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213674-001 9126941 2026-05-15 U-3763 2020-09-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213674-001 8183274 2026-08-24 U-2345 2020-09-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213674-001 8183274 2026-08-24 U-2708 2020-09-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213674-001 8183274 2026-08-24 U-3763 2020-09-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213674-001 7709517 2027-08-13 Drug substance, Drug product 2020-09-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213674-001 11839689 2033-09-11 Drug product 2023-12-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213674-001 12502357 2033-09-11 U-4363 2026-01-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213674-001 12502357 2033-09-11 U-4364 2026-01-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213674-001 12502357 2033-09-11 U-4365 2026-01-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213674-001 12161628 2037-02-23 U-4101 2025-01-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213674-001 12161628 2037-02-23 U-4102 2025-01-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213674-001 12161628 2037-02-23 U-4103 2025-01-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213674-001 12161628 2037-02-23 U-4104 2025-01-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213674-002 9126941 2026-05-15 U-2708 2020-09-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213674-002 9126941 2026-05-15 U-2345 2020-09-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213674-002 9126941 2026-05-15 U-3763 2020-09-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213674-002 8183274 2026-08-24 U-2708 2020-09-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213674-002 8183274 2026-08-24 U-2345 2020-09-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213674-002 8183274 2026-08-24 U-3763 2020-09-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213674-002 7709517 2027-08-13 Drug substance, Drug product 2020-09-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213674-002 11839689 2033-09-11 Drug product 2023-12-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213674-002 12447128 2033-09-11 U-4312 2025-11-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213674-002 12447128 2033-09-11 U-4313 2025-11-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213674-002 12447128 2033-09-11 U-4314 2025-11-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213674-002 12502357 2033-09-11 U-4363 2026-01-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213674-002 12502357 2033-09-11 U-4364 2026-01-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213674-002 12502357 2033-09-11 U-4365 2026-01-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213674-002 12161628 2037-02-23 U-4102 2025-01-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213674-002 12161628 2037-02-23 U-4103 2025-01-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213674-002 12161628 2037-02-23 U-4104 2025-01-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213674-002 12161628 2037-02-23 U-4101 2025-01-08 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213674-001 9126941 2026-05-15 U-2708 2020-09-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213674-001 9126941 2026-05-15 U-2345 2020-09-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213674-001 9126941 2026-05-15 U-3763 2020-09-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213674-001 8183274 2026-08-24 U-2345 2020-09-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213674-001 8183274 2026-08-24 U-2708 2020-09-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213674-001 8183274 2026-08-24 U-3763 2020-09-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213674-001 7709517 2027-08-13 Drug substance, Drug product 2020-09-03 31067a03dcf5…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 68 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 0469-0625 Xtandi enzalutamide Astellas Pharma US, Inc. NDA Current 0469-0625 Xtandi enzalutamide Astellas Pharma US, Inc. NDA Current 0469-0625 Xtandi enzalutamide Astellas Pharma US, Inc. NDA Current 0469-0625 Xtandi enzalutamide Astellas Pharma US, Inc. NDA Current 0469-0625 Xtandi enzalutamide Astellas Pharma US, Inc. NDA Current 0469-0625 Xtandi enzalutamide Astellas Pharma US, Inc. NDA Current 0469-0725 Xtandi enzalutamide Astellas Pharma US, Inc. NDA Current 0469-0725 Xtandi enzalutamide Astellas Pharma US, Inc. NDA Current 0469-0725 Xtandi enzalutamide Astellas Pharma US, Inc. NDA Current 0469-0725 Xtandi enzalutamide Astellas Pharma US, Inc. NDA Current 0469-0725 Xtandi enzalutamide Astellas Pharma US, Inc. NDA Current 0469-0725 Xtandi enzalutamide Astellas Pharma US, Inc. NDA Current 0469-1725 Xtandi enzalutamide Astellas Pharma US, Inc. NDA Current 0469-1725 Xtandi enzalutamide Astellas Pharma US, Inc. NDA Current