Treats Stage D 2 metastatic carcinoma of the prostate. ANDA 78917, held by Accord Hlthcare. Bicalutamide.
As of Nov 13, 2026, ANDA 78917 (Bicalutamide), held by Accord Hlthcare, was first approved by FDA on Jul 6, 2009, with 7 approved supplements and 0 published complete response letters.
1. INDICATIONS AND USAGE Bicalutamide tablets 50 mg daily is indicated for use in combination therapy with a luteinizing hormone-releasing hormone (LHRH) analog for the treatment of Stage D 2 metastatic carcinoma of the prostate. Bicalutamide tablets 150 mg daily is not approved for use alone or with other treatments. Bicalutamide tablets 50 mg is an androgen receptor inhibitor
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 6, 2009 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Bicalutamide50MG · tablet;oral | Bicalutamide | Rx |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 19, 2024 | Supplement 13Labeling · Standard review | Approved | None posted |
| Dec 30, 2018 | Supplement 7Labeling · Standard review | Approved | None posted |
| Dec 30, 2018 | Supplement 10Labeling · Standard review | Approved | None posted |
| May 10, 2016 | Supplement 6Labeling · Standard review | Approved | None posted |
| Jul 20, 2012 | Supplement 3Labeling · Standard review | Approved | None posted |
| Nov 2, 2011 | Supplement 2Labeling | Approved | None posted |
| Sep 15, 2009 | Supplement 1Labeling | Approved | None posted |
| Jul 6, 2009 | Original application | Approved |
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
