Treats symptomatic benign prostatic hyperplasia (BPH). ANDA 202660, held by Aurobindo Pharma Ltd. Dutasteride.
As of Nov 15, 2026, ANDA 202660 (Dutasteride), held by Aurobindo Pharma Ltd, was first approved by FDA on Nov 20, 2015, with 1 approved supplement and 0 published complete response letters.
Dutasteride capsules are 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 capsules are 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 |
| Apr 26, 2023 | Supplement 3Labeling · 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
