Treats Stage D 2 metastatic carcinoma of the prostate. ANDA 79110, held by Sun Pharm. Bicalutamide.
As of Nov 13, 2026, ANDA 79110 (Bicalutamide), held by Sun Pharm, was first approved by FDA on Jul 6, 2009, with 3 approved supplements and 0 published complete response letters.
Bicalutamide tablets, USP 50 mg daily are 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, USP 150 mg daily are not approved for use alone or with other treatments.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 6, 2009 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Bicalutamide50MG · tablet;oral | Bicalutamide | Rx |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 11, 2025 | Supplement 11Labeling · Standard review | Approved | None posted |
| Mar 20, 2020 | Supplement 3Labeling · Standard review | Approved | None posted |
| Jun 30, 2011 | 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
