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FDA NDA · NDA218033

OJEMDA

tovorafenib

Sponsor: DAY ONE BIOPHARMS

APPLICATION
NDA218033
TYPE
NDA
ORIGINAL APPROVAL
2024-04-23
LATEST ACTION
2025-08-27
ROUTE
ORAL
DOSAGE FORM
FOR SUSPENSION
MARKETING STATUS
Prescription

Products

OJEMDA · ReferencePrescription
TOVORAFENIB 25MG/ML · FOR SUSPENSION · ORAL

Approval history

2025-08-27Efficacy · Supplement 2 · standard — Label ↗AP
2025-08-27Labeling · Supplement 3 · standard — Label ↗AP
2024-06-26Labeling · Supplement 1 · standard — Letter ↗AP
2024-04-23Type 3 - New Dosage Form · Original · priority — Letter ↗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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