APPLICATION
ANDA212135
TYPE
ANDA
ORIGINAL APPROVAL
2022-06-21
LATEST ACTION
2023-08-29
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
2023-08-29Labeling · Supplement 2 · standardAP
2022-06-21UNKNOWN · 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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