General MedicationsORALStandard
IMKELDI
IMATINIB MESYLATE
Standard Dose
EQ 80MG BASE/ML
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary
Approval overview IMKELDI is listed in Drugs@FDA under application 219097 (NDA).
Review priority: STANDARD Marketing status: Prescription Active ingredient IMATINIB MESYLATE Form and strength SOLUTION;ORAL - EQ 80MG BASE/ML Sponsor SHORLA ONCOLOGY Submission history Latest submission status date: 2024-11-22 00:00:00.
Structured Monograph
Clinical summary
Approval overview IMKELDI is listed in Drugs@FDA under application 219097 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient IMATINIB MESYLATE Form and strength SOLUTION;ORAL - EQ 80MG BASE/ML Sponsor SHORLA ONCOLOGY Submission history Latest submission status date: 2024-11-22 00:00:00. Submission type: ORIG.
Monitoring
- • Marketing status: Prescription
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.