Treats symptomatic benign prostatic hyperplasia (BPH). ANDA 209909, held by Humanwell Puracap. Dutasteride.
As of Nov 15, 2026, ANDA 209909 (Dutasteride), held by Humanwell Puracap, was first approved by FDA on Nov 21, 2017, with 1 approved supplement and 0 published complete response letters.
Dutasteride capsules 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 capsules 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 is not approved for the prevention of prostate cancer. 1.1 Monotherapy
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 21, 2017 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Dutasteride0.5MG · capsule;oral | Dutasteride | Rx |
| May 26, 2021 | Supplement 4Labeling · Standard review | Approved | None posted |
| Nov 21, 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
