APPLICATION
ANDA208453
TYPE
ANDA
ORIGINAL APPROVAL
2018-10-31
LATEST ACTION
2021-11-22
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
ABIRATERONE ACETATEPrescription
ABIRATERONE ACETATE 250MG · TABLET · ORAL
Approval history
2021-11-22Labeling · Supplement 12 · standardAP
2021-11-22Labeling · Supplement 11 · standardAP
2021-11-22Labeling · Supplement 9 · standardAP
2021-11-22Labeling · Supplement 1 · 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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