Bicalutamide

As of Nov 13, 2026, ANDA 76932 (Bicalutamide), held by Teva, was first approved by FDA on Jul 6, 2009, with 5 approved supplements and 0 published complete response letters.

First approved: Jul 6, 2009
Supplements approved: 5
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 6 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	Discontinued

All 6 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Mar 20, 2020	Supplement 7Labeling · Standard review	Approved	None posted
Mar 20, 2020	Supplement 8Labeling · Standard review	Approved	None posted
Apr 19, 2016	Supplement 5Labeling · Standard review	Approved	None posted
Dec 12, 2013	Supplement 4Labeling · Standard review	Approved	None posted
May 8, 2011	Supplement 2Labeling	Approved	None posted
Jul 6, 2009	Original application	Approved	Label Letter

Identifiers

Application: ANDA 76932
Drugs@FDA: Overview at FDA
Company: Teva Pharmaceutical Industries

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