APPLICATION
ANDA202103
TYPE
ANDA
ORIGINAL APPROVAL
2016-06-10
LATEST ACTION
2025-08-28
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
DASATINIBPrescription
DASATINIB 70MG · TABLET · ORAL
DASATINIBPrescription
DASATINIB 20MG · TABLET · ORAL
DASATINIBPrescription
DASATINIB 100MG · TABLET · ORAL
DASATINIBPrescription
DASATINIB 50MG · TABLET · ORAL
Approval history
2025-08-28Labeling · Supplement 11 · standardAP
2025-08-28Labeling · Supplement 10 · standardAP
2024-03-15Labeling · Supplement 7 · standardAP
2022-01-03Labeling · Supplement 2 · standardAP
2022-01-03Labeling · Supplement 5 · standardAP
2022-01-03Labeling · Supplement 3 · standardAP
2022-01-03Labeling · Supplement 1 · standardAP
2022-01-03Labeling · Supplement 6 · standardAP
2022-01-03Labeling · Supplement 4 · 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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