APPLICATION
ANDA209543
TYPE
ANDA
ORIGINAL APPROVAL
2025-05-23
LATEST ACTION
2025-05-23
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
BOSUTINIB MONOHYDRATEPrescription
BOSUTINIB MONOHYDRATE EQ 500MG BASE · TABLET · ORAL
BOSUTINIB MONOHYDRATEPrescription
BOSUTINIB MONOHYDRATE EQ 100MG BASE · TABLET · ORAL
Approval history
2026-06-12Manufacturing (CMC) · Supplement 1 · unknownTA
2025-05-23UNKNOWN · 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.
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.