APPLICATION
ANDA203180
TYPE
ANDA
ORIGINAL APPROVAL
2021-11-23
LATEST ACTION
2025-08-28
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
DASATINIBPrescription
DASATINIB 140MG · TABLET · ORAL
DASATINIBPrescription
DASATINIB 80MG · TABLET · ORAL
Approval history
2025-08-28Labeling · Supplement 4 · standardAP
2025-08-28Labeling · Supplement 3 · standardAP
2023-09-22Labeling · Supplement 1 · 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.
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.