Abiraterone Acetate

Treats Metastatic castration-resistant prostate cancer (CRPC) … prostate cancer (CSPC). ANDA 208453, held by Apotex. Abiraterone Acetate.

As of Nov 15, 2026, ANDA 208453 (Abiraterone Acetate), held by Apotex, was first approved by FDA on Oct 31, 2018, with 4 approved supplements and 0 published complete response letters.

First approved: Oct 31, 2018
Review: Standard
Supplements approved: 4
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Abiraterone acetate tablets are 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 5 submissions below

Date	Submission	Status	Documents
Oct 31, 2018	Original application	Approved	Letter

Products

1 strengths and forms

Product	Active ingredient	Marketing
Abiraterone Acetate250MG · tablet;oral	Abiraterone Acetate	Rx

All 5 submissions, including labeling and manufacturing supplements


Nov 22, 2021	Supplement 1Labeling · Standard review	Approved	None posted
Nov 22, 2021	Supplement 9Labeling · Standard review	Approved	None posted
Nov 22, 2021	Supplement 11Labeling · Standard review	Approved	None posted
Nov 22, 2021	Supplement 12Labeling · Standard review	Approved	None posted
Oct 31, 2018	Original application	Approved	Letter

Identifiers

Application: ANDA 208453
Drugs@FDA: Overview at FDA
Company: Apotex

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