APPLICATION
ANDA207586
TYPE
ANDA
ORIGINAL APPROVAL
2018-07-13
LATEST ACTION
2024-03-28
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
IMATINIB MESYLATEDiscontinued
IMATINIB MESYLATE EQ 400MG BASE · TABLET · ORAL
IMATINIB MESYLATEDiscontinued
IMATINIB MESYLATE EQ 100MG BASE · TABLET · ORAL
Approval history
2024-03-28Labeling · Supplement 4 · standardAP
2024-03-28Labeling · Supplement 5 · standardAP
2024-03-28Labeling · Supplement 3 · standardAP
2018-11-20Labeling · Supplement 2 · standardAP
2018-11-20Manufacturing (CMC) · Supplement 1 · unknownAP
2018-07-13UNKNOWN · Original · standardAP
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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