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FDA NDA · NDA217564

FRUZAQLA

fruquintinib

Sponsor: TAKEDA PHARMS USA

APPLICATION
NDA217564
TYPE
NDA
ORIGINAL APPROVAL
2023-11-08
LATEST ACTION
2025-02-28
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription

Products

FRUZAQLA · ReferencePrescription
FRUQUINTINIB 1MG · CAPSULE · ORAL
FRUZAQLA · ReferencePrescription
FRUQUINTINIB 5MG · CAPSULE · ORAL

Approval history

2025-02-28Labeling · Supplement 2 · standard — Label ↗AP
2023-11-08Type 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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