APPLICATION
ANDA079110
TYPE
ANDA
ORIGINAL APPROVAL
2009-07-06
LATEST ACTION
2025-03-11
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
BICALUTAMIDEPrescription
BICALUTAMIDE 50MG · TABLET · ORAL
Approval history
2025-03-11Labeling · Supplement 11 · standardAP
2020-03-20Labeling · Supplement 3 · standardAP
2011-06-30Labeling · Supplement 1AP
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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