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FDA NDA · NDA219293

DANZITEN

nilotinib

Sponsor: AZURITY

APPLICATION
NDA219293
TYPE
NDA
ORIGINAL APPROVAL
2024-11-07
LATEST ACTION
2026-04-14
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

DANZITEN · ReferencePrescription
NILOTINIB TARTRATE EQ 95MG BASE · TABLET · ORAL
DANZITEN · ReferencePrescription
NILOTINIB TARTRATE EQ 71MG BASE · TABLET · ORAL

Approval history

2026-04-14Labeling · Supplement 6 · standard — Medication Guide ↗AP
2025-11-14Labeling · Supplement 5 · standard — Letter ↗AP
2024-11-07Type 3 - New Dosage Form · Original · standard — Label ↗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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