APPLICATION
ANDA209624
TYPE
ANDA
ORIGINAL APPROVAL
2026-06-12
LATEST ACTION
2026-06-12
ROUTE
ORAL, FILM COATED
DOSAGE FORM
TABLET
MARKETING STATUS
None (Tentative Approval), Prescription
Products
BOSUTINIBNone (Tentative Approval)
BOSUTINIB MONOHYDRATE EQ 100MG BASE · TABLET · FILM COATED
BOSUTINIBNone (Tentative Approval)
BOSUTINIB MONOHYDRATE EQ 500MG BASE · TABLET · FILM COATED
BOSUTINIB MONOHYDRATEPrescription
BOSUTINIB MONOHYDRATE EQ 400MG BASE · TABLET · ORAL
Approval history
2026-06-12UNKNOWN · Original · standardTA
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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