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Active ingredient

Abiraterone

43 finished FDA listings contain Abiraterone as their only active ingredient; 2 combination products also contain it.

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FDA NDC Directory

Ingredient names as written by FDA
ABIRATERONE, ABIRATERONE ACETATE
Dosage forms
Tablet, Tablet, Film Coated
Routes
Oral
Manufacturers / labelers
26
Strengths listed
125 mg/1 · 250 mg/1 · 500 mg/1
Brand names in FDA listings
Abiraterone, Abiraterone Acetate, Abirtega, Yonsa, Zytiga

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 1100072

Drugs@FDA applications

Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.

ApplicationSponsorOriginal approvalListings
NDA 202379JANSSEN BIOTECH2011-04-282
NDA 210308SUN PHARM2018-05-222
ANDA 208446MYLAN2018-10-314
ANDA 208339HIKMA2018-10-314
ANDA 208453APOTEX2018-10-312
ANDA 208327AMNEAL PHARMS2019-01-077
ANDA 208371RISING2019-02-251
ANDA 210686MSN2019-07-107
ANDA 212462QILU2019-09-272
ANDA 209227GLENMARK SPECLT2019-10-164
ANDA 208416DR REDDYS2020-05-185
ANDA 215947NOVUGEN2022-01-052
ANDA 215086REGCON HOLDINGS2023-03-231

Official labeling on DailyMed

Showing the 12 most recent of 31 labels.

Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.