APPLICATION
ANDA079179
TYPE
ANDA
ORIGINAL APPROVAL
2016-08-05
LATEST ACTION
2020-07-08
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
2020-07-08Labeling · Supplement 8 · standardAP
2020-07-08Labeling · Supplement 6 · standardAP
2020-07-08Labeling · Supplement 4 · standardAP
2020-07-08Labeling · Supplement 3 · standardAP
2020-07-08Labeling · Supplement 10 · standardAP
2016-08-17Labeling · Supplement 2 · standardAP
2016-08-05OriginalAP
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.