Bicalutamide

ANDA 78575, held by Sandoz. Bicalutamide.

As of Nov 13, 2026, ANDA 78575 (Bicalutamide), held by Sandoz, 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	Rx

All 6 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
May 11, 2020	Supplement 5Labeling · Standard review	Approved	None posted
May 11, 2020	Supplement 6Labeling · Standard review	Approved	None posted
May 9, 2016	Supplement 4Labeling · Standard review	Approved	None posted
Nov 14, 2014	Supplement 1Manufacturing	Approved	None posted
Oct 28, 2011	Supplement 2Labeling	Approved	None posted
Jul 6, 2009	Original application	Approved	Label Letter

Identifiers

Application: ANDA 78575
Drugs@FDA: Overview at FDA
Company: Sandoz

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