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FDA NDA · NDA217379

CAVHANZA

Sponsor: FLEX PHARMA

APPLICATION
NDA217379
TYPE
NDA
ORIGINAL APPROVAL
2026-05-29
LATEST ACTION
2026-07-29
ROUTE
ORAL
DOSAGE FORM
TABLET, ORALLY DISINTEGRATING
MARKETING STATUS
Prescription

Products

CAVHANZA · ReferencePrescription
NILOTINIB 80MG · TABLET, ORALLY DISINTEGRATING · ORAL
CAVHANZA · ReferencePrescription
NILOTINIB 60MG · TABLET, ORALLY DISINTEGRATING · ORAL

Approval history

2026-07-29Labeling · Supplement 2 · standardAP
2026-05-29Type 5 - New Formulation or New Manufacturer · Original · standard — 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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