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FDA NDA · NDA216993

VANFLYTA

quizartinib

Sponsor: DAIICHI SANKYO INC

APPLICATION
NDA216993
TYPE
NDA
ORIGINAL APPROVAL
2023-07-20
LATEST ACTION
2026-04-29
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

VANFLYTA · ReferencePrescription
QUIZARTINIB DIHYDROCHLORIDE EQ 26.5MG BASE · TABLET · ORAL
VANFLYTA · ReferencePrescription
QUIZARTINIB DIHYDROCHLORIDE EQ 17.7MG BASE · TABLET · ORAL

Approval history

2026-04-29REMS · Supplement 3 — Letter ↗AP
2026-04-13Labeling · Supplement 2 · standard — Letter ↗AP
2024-06-25Labeling · Supplement 1 · standard — Letter ↗AP
2023-07-20Type 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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