Treats symptomatic benign prostatic hyperplasia (BPH). ANDA 204262, held by Onesource. Dutasteride.
As of Nov 15, 2026, ANDA 204262 (Dutasteride), held by Onesource, was first approved by FDA on Nov 20, 2015, with 1 approved supplement and 0 published complete response letters.
Dutasteride is a 5 alpha-reductase inhibitor indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to: improve symptoms, reduce the risk of acute urinary retention, and reduce the risk of the need for BPH-related surgery. Dutasteride in combination with the alpha-adrenergic antagonist, tamsulosin, is indicated for the treatment of symptomatic BPH in men with an enlarged prostate. Limitations of Use: Dutasteride is not approved for the prevention of prostate cancer. 1.1 Monotherapy
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 20, 2015 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Dutasteride0.5MG · capsule;oral | Dutasteride | Rx |
| Nov 16, 2021 | Supplement 9Labeling · Standard review | Approved | None posted |
| Nov 20, 2015 | Original application | Approved | None posted |
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
