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FDA NDA · NDA211810

TURALIO

pexidartinib hydrochloride

Sponsor: DAIICHI SANKYO INC

APPLICATION
NDA211810
TYPE
NDA
ORIGINAL APPROVAL
2019-08-02
LATEST ACTION
2025-08-27
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription, Discontinued

Products

TURALIO · ReferencePrescription
PEXIDARTINIB HYDROCHLORIDE EQ 125MG BASE · CAPSULE · ORAL
TURALIO · ReferenceDiscontinued
PEXIDARTINIB HYDROCHLORIDE EQ 200MG BASE · CAPSULE · ORAL

Approval history

2025-08-27REMS · Supplement 14 — Letter ↗AP
2025-01-03Labeling · Supplement 13 · standard — Label ↗AP
2023-11-16Labeling · Supplement 12 · standard — Label ↗AP
2023-04-17REMS · Supplement 11AP
2022-10-14Efficacy · Supplement 9 · standard — Letter ↗AP
2022-10-06Efficacy · Supplement 8 · standard — Letter ↗AP
2022-07-14Labeling · Supplement 10 · standard — Letter ↗AP
2021-10-20Labeling · Supplement 7 · standard — Label ↗AP
2020-12-16REMS · Supplement 6 — Letter ↗AP
2020-08-04REMS · Supplement 5 — Letter ↗AP
2020-04-17Labeling · Supplement 3 · standard — Letter ↗AP
2020-04-10Labeling · Supplement 4 · standardAP
2019-11-19REMS · Supplement 2 — Letter ↗AP
2019-11-19REMS · Supplement 1 — Letter ↗AP
2019-08-02Type 1 - New Molecular Entity · Original · priority — Label ↗AP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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