Bicalutamide

ANDA 79185, held by Rising. Bicalutamide.

As of Nov 13, 2026, ANDA 79185 (Bicalutamide), held by Rising, was first approved by FDA on Jul 6, 2009, with 4 approved supplements and 0 published complete response letters.

First approved: Jul 6, 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
Jul 6, 2009	Original application	Approved	Label Letter

Products

1 strengths and forms

Product	Active ingredient	Marketing
Bicalutamide50MG · tablet;oral	Bicalutamide	Discontinued

All 5 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Mar 20, 2020	Supplement 5Labeling · Standard review	Approved	None posted
Mar 20, 2020	Supplement 6Labeling · Standard review	Approved	None posted
May 10, 2016	Supplement 2Labeling · Standard review	Approved	None posted
May 10, 2016	Supplement 3Labeling · Standard review	Approved	None posted
Jul 6, 2009	Original application	Approved	Label Letter

Identifiers

Application: ANDA 79185
Drugs@FDA: Overview at FDA
Company: Rising Pharmaceuticals

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