Treats benign prostatic hyperplasia (BPH). ANDA 211060, held by Ajanta Pharma Ltd. Silodosin.
As of Nov 14, 2026, ANDA 211060 (Silodosin), held by Ajanta Pharma Ltd, was first approved by FDA on Dec 3, 2018, with 1 approved supplement and 0 published complete response letters.
Silodosin capsules, 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 |
| Jul 2, 2021 | Supplement 10Labeling · 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
