Treats benign prostatic hyperplasia (BPH). ANDA 209745, held by Amneal Pharms Co. Silodosin.
As of Nov 14, 2026, ANDA 209745 (Silodosin), held by Amneal Pharms Co, was first approved by FDA on Dec 3, 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 3, 2018 | Original application | Approved | None posted |
| Nov 22, 2021 | Supplement 3Labeling · Standard review | Approved | None posted |
| Dec 3, 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
