Abiraterone Acetate

Treats Metastatic castration-resistant prostate cancer (CRPC) … prostate cancer (CSPC). ANDA 208327, held by Amneal Pharms. Abiraterone Acetate.

As of Nov 15, 2026, ANDA 208327 (Abiraterone Acetate), held by Amneal Pharms, was first approved by FDA on Jan 7, 2019, with 3 approved supplements and 0 published complete response letters.

First approved: Jan 7, 2019
Review: Standard
Supplements approved: 3
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 4 submissions below

Date	Submission	Status	Documents
Jan 7, 2019	Original application	Approved	Letter

Products

2 strengths and forms


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

All 4 submissions, including labeling and manufacturing supplements


Sep 2, 2022	Supplement 14Labeling · Standard review	Approved	None posted
Nov 20, 2020	Supplement 10Labeling · Standard review	Approved	None posted
Nov 4, 2019	Supplement 3Labeling · Standard review	Approved	None posted
Jan 7, 2019	Original application	Approved	Letter

Identifiers

Application: ANDA 208327
Drugs@FDA: Overview at FDA
Company: Amneal Pharmaceuticals

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