Abiraterone Acetate

Treats Metastatic castration-resistant prostate cancer (CRPC) … prostate cancer (CSPC). ANDA 212462, held by Qilu. Abiraterone Acetate.

As of Nov 15, 2026, ANDA 212462 (Abiraterone Acetate), held by Qilu, was first approved by FDA on Sep 27, 2019, with 2 approved supplements and 0 published complete response letters.

First approved: Sep 27, 2019
Review: Standard
Supplements approved: 2
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Abiraterone acetate is indicated in combination with prednisone for the treatment of patients with Metastatic castration-resistant prostate cancer (CRPC) Metastatic high-risk castration-sensitive prostate cancer (CSPC)

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 submissions below

Date	Submission	Status	Documents
Sep 27, 2019	Original application	Approved	None posted

Products

2 strengths and forms


Abiraterone Acetate250MG · tablet;oral	Abiraterone Acetate	Rx
Abiraterone Acetate500MG · tablet;oral	Abiraterone Acetate	Rx

All 3 submissions, including labeling and manufacturing supplements


Mar 28, 2022	Supplement 4Labeling · Standard review	Approved	None posted
Apr 5, 2021	Supplement 1Labeling · Standard review	Approved	None posted
Sep 27, 2019	Original application	Approved	None posted

Identifiers

Application: ANDA 212462
Drugs@FDA: Overview at FDA
Company: Qilu

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters