← FDA DRUG APPROVALS

FDA NDA · NDA211349

XOSPATA

gilteritinib

Sponsor: ASTELLAS

APPLICATION
NDA211349
TYPE
NDA
ORIGINAL APPROVAL
2018-11-28
LATEST ACTION
2022-01-12
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

XOSPATA · ReferencePrescription
GILTERITINIB FUMARATE EQ 40MG BASE · TABLET · ORAL

Approval history

2022-01-12Labeling · Supplement 3 · standard — Letter ↗AP
2019-05-29Efficacy · Supplement 1 · priority — Label ↗AP
2018-11-28Type 1 - New Molecular Entity · Original · priority — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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