APPLICATION
ANDA078917
TYPE
ANDA
ORIGINAL APPROVAL
2009-07-06
LATEST ACTION
2024-03-19
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
BICALUTAMIDEPrescription
BICALUTAMIDE 50MG · TABLET · ORAL
Approval history
2024-03-19Labeling · Supplement 13 · standardAP
2018-12-30Labeling · Supplement 10 · standardAP
2018-12-30Labeling · Supplement 7 · standardAP
2016-05-10Labeling · Supplement 6 · standardAP
2012-07-20Labeling · Supplement 3 · standardAP
2011-11-02Labeling · Supplement 2AP
2009-09-15Labeling · 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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