APPLICATION
ANDA077973
TYPE
ANDA
ORIGINAL APPROVAL
2009-07-06
LATEST ACTION
2011-04-26
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
BICALUTAMIDEDiscontinued
BICALUTAMIDE 50MG · TABLET · ORAL
Approval history
2011-04-26Labeling · Supplement 3AP
2011-01-07Manufacturing (CMC) · Supplement 2AP
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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