Treats benign prostatic hyperplasia (BPH). ANDA 210626, held by Aurobindo Pharma Ltd. Silodosin.
As of Nov 14, 2026, ANDA 210626 (Silodosin), held by Aurobindo Pharma Ltd, was first approved by FDA on Dec 10, 2018, with 1 approved supplement and 0 published complete response letters.
Silodosin, a selective alpha-1 adrenergic receptor antagonist, is indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH). Silodosin capsules are not indicated for the treatment of hypertension.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 10, 2018 | Original application | Approved | None posted |
| Jul 2, 2021 | Supplement 3Labeling · Standard review | Approved | None posted |
| Dec 10, 2018 | 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
