APPLICATION
ANDA204644
TYPE
ANDA
ORIGINAL APPROVAL
2017-06-21
LATEST ACTION
2024-12-09
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
IMATINIB MESYLATEPrescription
IMATINIB MESYLATE EQ 100MG BASE · TABLET · ORAL
IMATINIB MESYLATEPrescription
IMATINIB MESYLATE EQ 400MG BASE · TABLET · ORAL
Approval history
2024-12-09Labeling · Supplement 18 · standardAP
2024-01-05Labeling · Supplement 8 · standardAP
2024-01-05Labeling · Supplement 2 · standardAP
2024-01-05Labeling · Supplement 15 · standardAP
2024-01-05Labeling · Supplement 11 · standardAP
2024-01-05Labeling · Supplement 5 · standardAP
2024-01-05Labeling · Supplement 3 · standardAP
2017-06-21UNKNOWN · OriginalAP
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.