APPLICATION
ANDA204285
TYPE
ANDA
ORIGINAL APPROVAL
2016-08-04
LATEST ACTION
2025-03-20
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
IMATINIB MESYLATEPrescription
IMATINIB MESYLATE EQ 400MG BASE · TABLET · ORAL
IMATINIB MESYLATEPrescription
IMATINIB MESYLATE EQ 100MG BASE · TABLET · ORAL
Approval history
2025-03-20Labeling · Supplement 15 · standardAP
2025-03-20Labeling · Supplement 18 · standardAP
2025-03-20Labeling · Supplement 12 · standardAP
2020-01-09Labeling · Supplement 4 · standardAP
2020-01-09Labeling · Supplement 2 · standardAP
2020-01-09Labeling · Supplement 7 · standardAP
2020-01-09Labeling · Supplement 5 · standardAP
2020-01-09Labeling · Supplement 3 · standardAP
2016-08-17Labeling · Supplement 1 · standardAP
2016-08-04UNKNOWN · 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.
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