APPLICATION
ANDA210686
TYPE
ANDA
ORIGINAL APPROVAL
2019-07-10
LATEST ACTION
2022-09-02
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
ABIRATERONE ACETATEPrescription
ABIRATERONE ACETATE 250MG · TABLET · ORAL
ABIRATERONE ACETATEPrescription
ABIRATERONE ACETATE 500MG · TABLET · ORAL
Approval history
2022-09-02Labeling · Supplement 4 · standardAP
2022-09-02Labeling · Supplement 5 · standardAP
2021-04-05Labeling · Supplement 2 · standardAP
2019-07-10UNKNOWN · Original · 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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