APPLICATION
ANDA079089
TYPE
ANDA
ORIGINAL APPROVAL
2009-07-06
LATEST ACTION
2025-01-03
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
BICALUTAMIDEPrescription
BICALUTAMIDE 50MG · TABLET · ORAL
Approval history
2025-01-03Manufacturing (CMC) · Supplement 6 · unknownAP
2019-04-16Labeling · Supplement 5 · standardAP
2019-04-16Labeling · Supplement 4 · standardAP
2012-07-19Labeling · Supplement 3 · standardAP
2012-06-21Labeling · Supplement 2AP
2011-10-14Labeling · 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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