Treats benign prostatic hyperplasia (BPH). ANDA 213230, held by Pharmazone. Silodosin.
As of Nov 14, 2026, ANDA 213230 (Silodosin), held by Pharmazone, was first approved by FDA on Jan 3, 2022, with 0 approved supplements 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 is not indicated for the treatment of hypertension. Silodosin capsules, an alpha‑1 adrenergic receptor antagonist, is
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 3, 2022 | 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
