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FDA NDA · NDA212904

FOTIVDA

tivozanib

Sponsor: AVEO PHARMS

APPLICATION
NDA212904
TYPE
NDA
ORIGINAL APPROVAL
2021-03-10
LATEST ACTION
2025-01-30
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription

Products

FOTIVDA · ReferencePrescription
TIVOZANIB HYDROCHLORIDE EQ 1.34MG BASE · CAPSULE · ORAL
FOTIVDA · ReferencePrescription
TIVOZANIB HYDROCHLORIDE EQ 0.89MG BASE · CAPSULE · ORAL

Approval history

2025-01-30Labeling · Supplement 3 · standard — Label ↗AP
2024-08-06Labeling · Supplement 2 · standard — Letter ↗AP
2021-03-10Type 1 - New Molecular Entity · Original · standard — Letter ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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