Home Applications 211810 Application 211810
Type NDA
Sponsor DAIICHI SANKYO INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 TURALIO PEXIDARTINIB HYDROCHLORIDE CAPSULE;ORAL EQ 200MG BASE Yes Yes 002 TURALIO PEXIDARTINIB HYDROCHLORIDE CAPSULE;ORAL EQ 125MG BASE Yes No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 N211810-001 TURALIO PEXIDARTINIB HYDROCHLORIDE EQ 200MG BASE CAPSULE / ORAL RLD 2019-08-02 N211810-002 TURALIO PEXIDARTINIB HYDROCHLORIDE EQ 125MG BASE CAPSULE / ORAL RLD, RS 2022-10-14
Orange Book patents# Current patent rows page 1 of 1 · 24 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 N211810-001 ODE-250 2026-08-02 N211810-002 ODE* 2026-08-02
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 · 69 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 N211810-001 TURALIO EQ 200MG BASE CAPSULE / ORAL RLD 2019-08-02 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211810-002 TURALIO EQ 125MG BASE CAPSULE / ORAL RLD, RS 2022-10-14 84e616aacf4f…2026-08-18 06:07:40 2026-07 N211810-001 TURALIO EQ 200MG BASE CAPSULE / ORAL RLD 2019-08-02 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211810-002 TURALIO EQ 125MG BASE CAPSULE / ORAL RLD, RS 2022-10-14 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N211810-001 TURALIO EQ 200MG BASE CAPSULE / ORAL RLD 2019-08-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211810-002 TURALIO EQ 125MG BASE CAPSULE / ORAL RLD, RS 2022-10-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211810-001 TURALIO EQ 200MG BASE CAPSULE / ORAL RLD 2019-08-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211810-002 TURALIO EQ 125MG BASE CAPSULE / ORAL RLD, RS 2022-10-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N211810-001 TURALIO EQ 200MG BASE CAPSULE / ORAL RLD 2019-08-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N211810-002 TURALIO EQ 125MG BASE CAPSULE / ORAL RLD 2022-10-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N211810-001 TURALIO EQ 200MG BASE CAPSULE / ORAL RLD 2019-08-02 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N211810-002 TURALIO EQ 125MG BASE CAPSULE / ORAL RLD 2022-10-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N211810-001 TURALIO EQ 200MG BASE CAPSULE / ORAL RLD 2019-08-02 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N211810-002 TURALIO EQ 125MG BASE CAPSULE / ORAL RLD 2022-10-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N211810-001 TURALIO EQ 200MG BASE CAPSULE / ORAL RLD 2019-08-02 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N211810-002 TURALIO EQ 125MG BASE CAPSULE / ORAL RLD 2022-10-14 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N211810-001 TURALIO EQ 200MG BASE CAPSULE / ORAL RLD 2019-08-02 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N211810-002 TURALIO EQ 125MG BASE CAPSULE / ORAL RLD 2022-10-14 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N211810-001 TURALIO EQ 200MG BASE CAPSULE / ORAL RLD 2019-08-02 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N211810-002 TURALIO EQ 125MG BASE CAPSULE / ORAL RLD 2022-10-14 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N211810-001 TURALIO EQ 200MG BASE CAPSULE / ORAL RLD 2019-08-02 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N211810-002 TURALIO EQ 125MG BASE CAPSULE / ORAL RLD 2022-10-14 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N211810-001 TURALIO EQ 200MG BASE CAPSULE / ORAL RLD 2019-08-02 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N211810-002 TURALIO EQ 125MG BASE CAPSULE / ORAL RLD 2022-10-14 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N211810-001 TURALIO EQ 200MG BASE CAPSULE / ORAL RLD 2019-08-02 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N211810-002 TURALIO EQ 125MG BASE CAPSULE / ORAL RLD 2022-10-14 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N211810-001 TURALIO EQ 200MG BASE CAPSULE / ORAL RLD 2019-08-02 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N211810-002 TURALIO EQ 125MG BASE CAPSULE / ORAL RLD 2022-10-14 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N211810-001 TURALIO EQ 200MG BASE CAPSULE / ORAL RLD 2019-08-02 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N211810-002 TURALIO EQ 125MG BASE CAPSULE / ORAL RLD 2022-10-14 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N211810-001 TURALIO EQ 200MG BASE CAPSULE / ORAL RLD 2019-08-02 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N211810-002 TURALIO EQ 125MG BASE CAPSULE / ORAL RLD 2022-10-14 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N211810-001 TURALIO EQ 200MG BASE CAPSULE / ORAL RLD, RS 2019-08-02 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N211810-001 TURALIO EQ 200MG BASE CAPSULE / ORAL RLD, RS 2019-08-02 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N211810-001 TURALIO EQ 200MG BASE CAPSULE / ORAL RLD, RS 2019-08-02 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N211810-001 TURALIO EQ 200MG BASE CAPSULE / ORAL RLD, RS 2019-08-02 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N211810-001 TURALIO EQ 200MG BASE CAPSULE / ORAL RLD, RS 2019-08-02 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N211810-001 TURALIO EQ 200MG BASE CAPSULE / ORAL RLD, RS 2019-08-02 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N211810-001 TURALIO EQ 200MG BASE CAPSULE / ORAL RLD, RS 2019-08-02 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N211810-001 TURALIO EQ 200MG BASE CAPSULE / ORAL RLD, RS 2019-08-02 5aa47cf7b7d7…
Observed Orange Book patent history# Patent history page 1 of 20 · 799 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 N211810-001 8404700 2027-11-21 Drug substance 2019-08-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211810-001 8722702 2027-11-21 Drug substance 2019-08-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211810-001 9169250 2027-11-21 Drug substance 2019-08-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211810-001 8461169 2028-04-19 U-2606 2019-08-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211810-001 7893075 2033-05-04 Drug substance 2019-08-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211810-001 9358235 2033-06-08 U-2606 2019-08-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211810-001 10189833 2036-05-05 U-2606 2019-08-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211810-001 10730876 2036-05-05 Drug substance 2020-08-31 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211810-001 9802932 2036-05-05 Drug substance 2019-08-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211810-001 10435404 2038-07-24 Drug product 2019-10-22 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211810-001 10941142 2038-07-24 Drug product 2021-03-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211810-001 10961240 2038-07-24 U-2606 2021-04-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211810-002 8404700 2027-11-21 Drug substance 2022-11-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211810-002 8722702 2027-11-21 Drug substance 2022-11-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211810-002 9169250 2027-11-21 Drug substance 2022-11-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211810-002 8461169 2028-04-19 U-2606 2022-11-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211810-002 7893075 2033-05-04 Drug substance 2022-11-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211810-002 9358235 2033-06-08 U-2606 2022-11-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211810-002 10189833 2036-05-05 U-2606 2022-11-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211810-002 10730876 2036-05-05 Drug substance 2022-11-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211810-002 9802932 2036-05-05 Drug substance 2022-11-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211810-002 10435404 2038-07-24 Drug product 2022-11-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211810-002 10941142 2038-07-24 Drug product 2022-11-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211810-002 10961240 2038-07-24 U-2606 2022-11-14 84e616aacf4f…2026-08-18 06:07:40 2026-07 N211810-001 8404700 2027-11-21 Drug substance 2019-08-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211810-001 8722702 2027-11-21 Drug substance 2019-08-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211810-001 9169250 2027-11-21 Drug substance 2019-08-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211810-001 8461169 2028-04-19 U-2606 2019-08-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211810-001 7893075 2033-05-04 Drug substance 2019-08-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211810-001 9358235 2033-06-08 U-2606 2019-08-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211810-001 10189833 2036-05-05 U-2606 2019-08-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211810-001 10730876 2036-05-05 Drug substance 2020-08-31 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211810-001 9802932 2036-05-05 Drug substance 2019-08-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211810-001 10435404 2038-07-24 Drug product 2019-10-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211810-001 10941142 2038-07-24 Drug product 2021-03-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211810-001 10961240 2038-07-24 U-2606 2021-04-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211810-002 8404700 2027-11-21 Drug substance 2022-11-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211810-002 8722702 2027-11-21 Drug substance 2022-11-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211810-002 9169250 2027-11-21 Drug substance 2022-11-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211810-002 8461169 2028-04-19 U-2606 2022-11-14 caaa826d4ba7…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 3 · 119 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 Turalio PEXIDARTINIB HYDROCHLORIDE Daiichi Sankyo Inc. 7b0ec4bf-b2ac-49ee-96af-7740ad3f2e16 2025-01-16 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 211810 application number: NDA211810
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 · 6 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 65597-402 Turalio pexidartinib Daiichi Sankyo Inc. NDA Current 65597-402 Turalio pexidartinib Daiichi Sankyo Inc. NDA Current 65597-402 Turalio pexidartinib Daiichi Sankyo, Inc. NDA Current 65597-402 Turalio pexidartinib Daiichi Sankyo Inc. NDA Current 65597-402 Turalio pexidartinib Daiichi Sankyo, Inc. NDA Current 65597-402 Turalio pexidartinib Daiichi Sankyo Inc. NDA Current