Bicalutamide

Treats Stage D 2 metastatic carcinoma of the prostate. ANDA 79089, held by Adaptis. Bicalutamide.

As of Nov 13, 2026, ANDA 79089 (Bicalutamide), held by Adaptis, was first approved by FDA on Jul 6, 2009, with 6 approved supplements and 0 published complete response letters.

First approved: Jul 6, 2009
Supplements approved: 6
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Bicalutamide tablets 50 mg daily is indicated for use in combination therapy with a luteinizing hormone-releasing hormone (LHRH) analog for the treatment of Stage D 2 metastatic carcinoma of the prostate. Bicalutamide tablets 150 mg daily is not approved for use alone or with other treatments.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 7 submissions below

Date	Submission	Status	Documents
Jul 6, 2009	Original application	Approved	Label Letter

Products

1 strengths and forms

Product	Active ingredient	Marketing
Bicalutamide50MG · tablet;oral	Bicalutamide	Rx

All 7 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Jan 3, 2025	Supplement 6Manufacturing	Approved	None posted
Apr 16, 2019	Supplement 4Labeling · Standard review	Approved	None posted
Apr 16, 2019	Supplement 5Labeling · Standard review	Approved	None posted
Jul 19, 2012	Supplement 3Labeling · Standard review	Approved	None posted
Jun 21, 2012	Supplement 2Labeling	Approved	None posted
Oct 14, 2011	Supplement 1Labeling	Approved	None posted
Jul 6, 2009	Original application	Approved	Label Letter

Identifiers

Application: ANDA 79089
Drugs@FDA: Overview at FDA
Company: Adaptis

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