APPLICATION
ANDA218532
TYPE
ANDA
ORIGINAL APPROVAL
2025-12-15
LATEST ACTION
2025-12-15
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
None (Tentative Approval), Prescription
Products
NILOTINIBNone (Tentative Approval)
NILOTINIB 200MG · CAPSULE
NILOTINIB HYDROCHLORIDEPrescription
NILOTINIB HYDROCHLORIDE EQ 150MG BASE · CAPSULE · ORAL
NILOTINIB HYDROCHLORIDEPrescription
NILOTINIB HYDROCHLORIDE EQ 200MG BASE · CAPSULE · ORAL
Approval history
2025-12-15UNKNOWN · Original · standardAP
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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