FDA NDA · NDA219097
IMKELDI
imatinib oral
Sponsor: SHORLA ONCOLOGY
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APPLICATION
NDA219097
TYPE
NDA
ORIGINAL APPROVAL
2024-11-22
LATEST ACTION
2026-10-16
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription
Products
IMKELDI · ReferencePrescription
IMATINIB MESYLATE EQ 80MG BASE/ML · SOLUTION · ORAL
Approval history
Source: FDA Drugs@FDA. Browse every approval SPEQ tracks →