Abiraterone Acetate

Treats Metastatic castration-resistant prostate cancer (CRPC) … prostate cancer (CSPC). ANDA 208416, held by Dr Reddys. Abiraterone Acetate.

As of Nov 15, 2026, ANDA 208416 (Abiraterone Acetate), held by Dr Reddys, was first approved by FDA on May 18, 2020, with 3 approved supplements and 0 published complete response letters.

First approved: May 18, 2020
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
May 18, 2020	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 4 submissions, including labeling and manufacturing supplements


Dec 20, 2021	Supplement 1Labeling · Standard review	Approved	None posted
Dec 20, 2021	Supplement 5Labeling · Standard review	Approved	None posted
Dec 1, 2021	Supplement 7Labeling · Standard review	Approved	None posted
May 18, 2020	Original application	Approved	None posted

Identifiers

Application: ANDA 208416
Drugs@FDA: Overview at FDA
Company: Dr. Reddy's Laboratories

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