Bicalutamide

ANDA 78634, held by Watson Labs Teva. Bicalutamide.

As of Nov 13, 2026, ANDA 78634 (Bicalutamide), held by Watson Labs Teva, was first approved by FDA on Aug 28, 2009, with 4 approved supplements and 0 published complete response letters.

First approved: Aug 28, 2009
Supplements approved: 4
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 5 submissions below

Date	Submission	Status	Documents
Aug 28, 2009	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Bicalutamide50MG · tablet;oral	Bicalutamide	Rx

All 5 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Feb 7, 2019	Supplement 6Labeling · Standard review	Approved	None posted
May 10, 2016	Supplement 4Labeling · Standard review	Approved	None posted
May 10, 2016	Supplement 5Labeling · Standard review	Approved	None posted
Oct 14, 2011	Supplement 1Labeling	Approved	None posted
Aug 28, 2009	Original application	Approved	None posted

Identifiers

Application: ANDA 78634
Drugs@FDA: Overview at FDA
Company: Watson Labs Teva

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