← FDA DRUG APPROVALS

FDA ANDA · ANDA208327

ABIRATERONE ACETATE

abiraterone

Sponsor: AMNEAL PHARMS

APPLICATION
ANDA208327
TYPE
ANDA
ORIGINAL APPROVAL
2019-01-07
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 14 · standardAP
2020-11-20Labeling · Supplement 10 · standardAP
2019-11-04Labeling · Supplement 3 · standardAP
2019-01-07UNKNOWN · Original · standard — Letter ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →