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FDA NDA · NDA218922

NILOTINIB

Sponsor: CIPLA

APPLICATION
NDA218922
TYPE
NDA
ORIGINAL APPROVAL
2025-02-19
LATEST ACTION
2025-07-10
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription

Products

NILOTINIB D-TARTRATE · ReferencePrescription
NILOTINIB D-TARTRATE EQ 150MG BASE · CAPSULE · ORAL
NILOTINIB D-TARTRATE · ReferencePrescription
NILOTINIB D-TARTRATE EQ 200MG BASE · CAPSULE · ORAL
NILOTINIB D-TARTRATE · ReferencePrescription
NILOTINIB D-TARTRATE EQ 50MG BASE · CAPSULE · ORAL

Approval history

2025-07-10Labeling · Supplement 1 · standard — Letter ↗AP
2025-02-19Type 3 - New Dosage Form · Original · standard — Label ↗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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