Home Applications 211349 Application 211349
Type NDA
Sponsor ASTELLAS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 XOSPATA GILTERITINIB FUMARATE TABLET;ORAL EQ 40MG BASE Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 N211349-001 XOSPATA GILTERITINIB FUMARATE EQ 40MG BASE TABLET / ORAL RLD, RS 2018-11-28
Orange Book patents# Current patent rows page 1 of 1 · 8 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N211349-001 9487491 2030-07-28 U-2456 2018-12-18 N211349-001 8969336 2032-11-28 Drug substance, Drug product 2018-12-18 N211349-001 10786500 2036-07-01 Drug product 2020-10-28 N211349-001 11938130 2036-07-01 Drug product 2024-04-25 N211349-001 11938131 2036-07-01 Drug product 2024-04-25 N211349-001 11938132 2036-07-01 Drug product 2024-04-25 N211349-001 11938133 2036-07-01 Drug product 2024-04-25 N211349-001 11944620 2036-07-01 Drug product 2024-04-25
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 · 41 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 N211349-001 XOSPATA EQ 40MG BASE TABLET / ORAL RLD, RS 2018-11-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211349-001 XOSPATA EQ 40MG BASE TABLET / ORAL RLD, RS 2018-11-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N211349-001 XOSPATA EQ 40MG BASE TABLET / ORAL RLD, RS 2018-11-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N211349-001 XOSPATA EQ 40MG BASE TABLET / ORAL RLD, RS 2018-11-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N211349-001 XOSPATA EQ 40MG BASE TABLET / ORAL RLD, RS 2018-11-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N211349-001 XOSPATA EQ 40MG BASE TABLET / ORAL RLD, RS 2018-11-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N211349-001 XOSPATA EQ 40MG BASE TABLET / ORAL RLD, RS 2018-11-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N211349-001 XOSPATA EQ 40MG BASE TABLET / ORAL RLD, RS 2018-11-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N211349-001 XOSPATA EQ 40MG BASE TABLET / ORAL RLD, RS 2018-11-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N211349-001 XOSPATA EQ 40MG BASE TABLET / ORAL RLD, RS 2018-11-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N211349-001 XOSPATA EQ 40MG BASE TABLET / ORAL RLD, RS 2018-11-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N211349-001 XOSPATA EQ 40MG BASE TABLET / ORAL RLD, RS 2018-11-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N211349-001 XOSPATA EQ 40MG BASE TABLET / ORAL RLD, RS 2018-11-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N211349-001 XOSPATA EQ 40MG BASE TABLET / ORAL RLD, RS 2018-11-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N211349-001 XOSPATA EQ 40MG BASE TABLET / ORAL RLD, RS 2018-11-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N211349-001 XOSPATA EQ 40MG BASE TABLET / ORAL RLD, RS 2018-11-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N211349-001 XOSPATA EQ 40MG BASE TABLET / ORAL RLD, RS 2018-11-28 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N211349-001 XOSPATA EQ 40MG BASE TABLET / ORAL RLD, RS 2018-11-28 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N211349-001 XOSPATA EQ 40MG BASE TABLET / ORAL RLD, RS 2018-11-28 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N211349-001 XOSPATA EQ 40MG BASE TABLET / ORAL RLD, RS 2018-11-28 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N211349-001 XOSPATA EQ 40MG BASE TABLET / ORAL RLD, RS 2018-11-28 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N211349-001 XOSPATA EQ 40MG BASE TABLET / ORAL RLD, RS 2018-11-28 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N211349-001 XOSPATA EQ 40MG BASE TABLET / ORAL RLD, RS 2018-11-28 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N211349-001 XOSPATA EQ 40MG BASE TABLET / ORAL RLD, RS 2018-11-28 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N211349-001 XOSPATA EQ 40MG BASE TABLET / ORAL RLD, RS 2018-11-28 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N211349-001 XOSPATA EQ 40MG BASE TABLET / ORAL RLD, RS 2018-11-28 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N211349-001 XOSPATA EQ 40MG BASE TABLET / ORAL RLD, RS 2018-11-28 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N211349-001 XOSPATA EQ 40MG BASE TABLET / ORAL RLD, RS 2018-11-28 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N211349-001 XOSPATA EQ 40MG BASE TABLET / ORAL RLD, RS 2018-11-28 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N211349-001 XOSPATA EQ 40MG BASE TABLET / ORAL RLD, RS 2018-11-28 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N211349-001 XOSPATA EQ 40MG BASE TABLET / ORAL RLD, RS 2018-11-28 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N211349-001 XOSPATA EQ 40MG BASE TABLET / ORAL RLD, RS 2018-11-28 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N211349-001 XOSPATA EQ 40MG BASE TABLET / ORAL RLD, RS 2018-11-28 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N211349-001 XOSPATA EQ 40MG BASE TABLET / ORAL RLD, RS 2018-11-28 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N211349-001 XOSPATA EQ 40MG BASE TABLET / ORAL RLD, RS 2018-11-28 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N211349-001 XOSPATA EQ 40MG BASE TABLET / ORAL RLD, RS 2018-11-28 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N211349-001 XOSPATA EQ 40MG BASE TABLET / ORAL RLD, RS 2018-11-28 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N211349-001 XOSPATA EQ 40MG BASE TABLET / ORAL RLD, RS 2018-11-28 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N211349-001 XOSPATA EQ 40MG BASE TABLET / ORAL RLD, RS 2018-11-28 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N211349-001 XOSPATA EQ 40MG BASE TABLET / ORAL RLD, RS 2018-11-28 cb3db0bc1861…
Observed Orange Book patent history# Patent history page 1 of 5 · 194 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 N211349-001 9487491 2030-07-28 U-2456 2018-12-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211349-001 8969336 2032-11-28 Drug substance, Drug product 2018-12-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211349-001 10786500 2036-07-01 Drug product 2020-10-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211349-001 11938130 2036-07-01 Drug product 2024-04-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211349-001 11938131 2036-07-01 Drug product 2024-04-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211349-001 11938132 2036-07-01 Drug product 2024-04-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211349-001 11938133 2036-07-01 Drug product 2024-04-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211349-001 11944620 2036-07-01 Drug product 2024-04-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211349-001 9487491 2030-07-28 U-2456 2018-12-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211349-001 8969336 2032-11-28 Drug substance, Drug product 2018-12-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211349-001 10786500 2036-07-01 Drug product 2020-10-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211349-001 11938130 2036-07-01 Drug product 2024-04-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211349-001 11938131 2036-07-01 Drug product 2024-04-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211349-001 11938132 2036-07-01 Drug product 2024-04-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211349-001 11938133 2036-07-01 Drug product 2024-04-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211349-001 11944620 2036-07-01 Drug product 2024-04-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N211349-001 9487491 2030-07-28 U-2456 2018-12-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N211349-001 8969336 2032-11-28 Drug substance, Drug product 2018-12-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N211349-001 10786500 2036-07-01 Drug product 2020-10-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N211349-001 11938130 2036-07-01 Drug product 2024-04-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N211349-001 11938131 2036-07-01 Drug product 2024-04-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N211349-001 11938132 2036-07-01 Drug product 2024-04-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N211349-001 11938133 2036-07-01 Drug product 2024-04-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N211349-001 11944620 2036-07-01 Drug product 2024-04-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N211349-001 9487491 2030-07-28 U-2456 2018-12-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N211349-001 8969336 2032-11-28 Drug substance, Drug product 2018-12-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N211349-001 10786500 2036-07-01 Drug product 2020-10-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N211349-001 11938130 2036-07-01 Drug product 2024-04-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N211349-001 11938131 2036-07-01 Drug product 2024-04-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N211349-001 11938132 2036-07-01 Drug product 2024-04-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N211349-001 11938133 2036-07-01 Drug product 2024-04-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N211349-001 11944620 2036-07-01 Drug product 2024-04-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N211349-001 9487491 2030-07-28 U-2456 2018-12-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N211349-001 8969336 2032-11-28 Drug substance, Drug product 2018-12-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N211349-001 10786500 2036-07-01 Drug product 2020-10-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N211349-001 11938130 2036-07-01 Drug product 2024-04-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N211349-001 11938131 2036-07-01 Drug product 2024-04-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N211349-001 11938132 2036-07-01 Drug product 2024-04-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N211349-001 11938133 2036-07-01 Drug product 2024-04-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N211349-001 11944620 2036-07-01 Drug product 2024-04-25 b8a1b40f171c…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 63 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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Xospata GILTERITINIB Astellas Pharma US, Inc. b5ff59aa-9c0d-49a8-9053-1f179b482383 2022-01-01 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 211349 application number: NDA211349 ndc (product): 0469-1425
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 5 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0469-1425 Xospata gilteritinib Astellas Pharma US, Inc. NDA Current 0469-1425 Xospata gilteritinib Astellas Pharma US, Inc. NDA Current 0469-1425 Xospata gilteritinib Astellas Pharma US, Inc. NDA Current 0469-1425 Xospata gilteritinib Astellas Pharma US, Inc. NDA Current 0469-1425 Xospata gilteritinib Astellas Pharma US, Inc. NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 69874 SUPPL 2022-01-13 69873 SUPPL 2022-01-13 69868 SUPPL 2022-01-13 64574 SUPPL 2020-09-14 58934 SUPPL 2019-06-04 58880 SUPPL 2019-05-30 58879 SUPPL 2019-05-30 56985 ORIG 2018-12-21 56610 ORIG 2018-11-30 56581 ORIG 2018-11-28