APPLICATION
ANDA208339
TYPE
ANDA
ORIGINAL APPROVAL
2018-10-31
LATEST ACTION
2024-10-28
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
ABIRATERONE ACETATEPrescription
ABIRATERONE ACETATE 250MG · TABLET · ORAL
Approval history
2024-10-28Labeling · Supplement 12 · standardAP
2024-08-22Labeling · Supplement 8 · standardAP
2021-07-02Labeling · Supplement 1 · standardAP
2021-07-02Labeling · Supplement 2 · standardAP
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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