Bicalutamide

ANDA 77973, held by Synthon Pharms. Bicalutamide.

As of Nov 13, 2026, ANDA 77973 (Bicalutamide), held by Synthon Pharms, was first approved by FDA on Jul 6, 2009, with 2 approved supplements and 0 published complete response letters.

First approved: Jul 6, 2009
Supplements approved: 2
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 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 3 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Apr 26, 2011	Supplement 3Labeling	Approved	None posted
Jan 7, 2011	Supplement 2Manufacturing	Approved	None posted
Jul 6, 2009	Original application	Approved	Label Letter

Identifiers

Application: ANDA 77973
Drugs@FDA: Overview at FDA
Company: Synthon

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