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 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 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 · 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 N211349-001 XOSPATA EQ 40MG BASE TABLET / ORAL RLD, RS 2018-11-28 84e616aacf4f…2026-08-18 06:07:40 2026-07 N211349-001 XOSPATA EQ 40MG BASE TABLET / ORAL RLD, RS 2018-11-28 caaa826d4ba7…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…
Observed Orange Book patent history# Patent history page 1 of 6 · 210 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 N211349-001 9487491 2030-07-28 U-2456 2018-12-18 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211349-001 8969336 2032-11-28 Drug substance, Drug product 2018-12-18 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211349-001 10786500 2036-07-01 Drug product 2020-10-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211349-001 11938130 2036-07-01 Drug product 2024-04-25 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211349-001 11938131 2036-07-01 Drug product 2024-04-25 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211349-001 11938132 2036-07-01 Drug product 2024-04-25 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211349-001 11938133 2036-07-01 Drug product 2024-04-25 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211349-001 11944620 2036-07-01 Drug product 2024-04-25 84e616aacf4f…2026-08-18 06:07:40 2026-07 N211349-001 9487491 2030-07-28 U-2456 2018-12-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211349-001 8969336 2032-11-28 Drug substance, Drug product 2018-12-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211349-001 10786500 2036-07-01 Drug product 2020-10-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211349-001 11938130 2036-07-01 Drug product 2024-04-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211349-001 11938131 2036-07-01 Drug product 2024-04-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211349-001 11938132 2036-07-01 Drug product 2024-04-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211349-001 11938133 2036-07-01 Drug product 2024-04-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211349-001 11944620 2036-07-01 Drug product 2024-04-25 caaa826d4ba7…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…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 63 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 · 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