Treats symptomatic benign prostatic hyperplasia (BPH). ANDA 204376, held by Pharmazone. Dutasteride.
As of Nov 15, 2026, ANDA 204376 (Dutasteride), held by Pharmazone, was first approved by FDA on Apr 7, 2017, with 1 approved supplement and 0 published complete response letters.
1.1 Monotherapy Dutasteride Capsules are 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 (AUR), and · reduce the risk of the need for BPH-related surgery. 1.2 Combination with Alpha-adrenergic Antagonist Dutasteride Capsules in combination with the alpha-adrenergic antagonist, tamsulosin, is indicated for the treatment of symptomatic BPH in men with an enlarged prostate. 1.3 Limitations of Use Dutasteride Capsules are not approved for the prevention of prostate cancer. Dutasteride Capsules are a 5 alpha-reductase inhibitor
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 7, 2017 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Dutasteride0.5MG · capsule;oral | Dutasteride | Rx |
| Nov 14, 2024 | Supplement 1Labeling · Standard review | Approved | None posted |
| Apr 7, 2017 | 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
