APPLICATION
ANDA209651
TYPE
ANDA
ORIGINAL APPROVAL
2025-11-19
LATEST ACTION
2025-11-19
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription, None (Tentative Approval)
Products
NILOTINIB HYDROCHLORIDEPrescription
NILOTINIB HYDROCHLORIDE EQ 200MG BASE · CAPSULE · ORAL
NILOTINIB HYDROCHLORIDE DIHYDRATENone (Tentative Approval)
NILOTINIB HYDROCHLORIDE DIHYDRATE 150MG · CAPSULE
NILOTINIB HYDROCHLORIDEPrescription
NILOTINIB HYDROCHLORIDE EQ 150MG BASE · CAPSULE · ORAL
Approval history
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.