← FDA DRUG APPROVALS

FDA NDA · NDA210308

YONSA

abiraterone acetate

Sponsor: SUN PHARM

APPLICATION
NDA210308
TYPE
NDA
ORIGINAL APPROVAL
2018-05-22
LATEST ACTION
2026-05-13
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

YONSA · ReferencePrescription
ABIRATERONE ACETATE 125MG · TABLET · ORAL

Approval history

2026-05-13Labeling · Supplement 10 · standard — Letter ↗AP
2022-03-24Labeling · Supplement 3 · standard — Letter ↗AP
2022-01-28Labeling · Supplement 2 · standard — Letter ↗AP
2020-09-17Labeling · Supplement 1 · standard — Letter ↗AP
2018-05-22Type 5 - New Formulation or New Manufacturer · Original · standard — Label ↗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 →