APPLICATION
ANDA208446
TYPE
ANDA
ORIGINAL APPROVAL
2018-10-31
LATEST ACTION
2025-05-19
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
ABIRATERONE ACETATEPrescription
ABIRATERONE ACETATE 500MG · TABLET · ORAL
ABIRATERONE ACETATEPrescription
ABIRATERONE ACETATE 250MG · TABLET · ORAL
Approval history
2025-05-19Manufacturing (CMC) · Supplement 14 · unknownAP
2022-08-31Labeling · Supplement 9 · standardAP
2022-08-31Labeling · Supplement 6 · standardAP
2020-12-14Manufacturing (CMC) · Supplement 4 · unknownAP
2019-11-01Labeling · Supplement 3 · 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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