Treats benign prostatic hyperplasia (BPH). ANDA 204793, held by Hetero Labs Ltd V. Silodosin.
As of Nov 14, 2026, ANDA 204793 (Silodosin), held by Hetero Labs Ltd V, was first approved by FDA on Feb 14, 2020, 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 |
|---|---|---|---|
| Feb 14, 2020 | Original application | Approved | None posted |
| Aug 16, 2024 | Supplement 1Labeling · Standard review | Approved | None posted |
| Feb 14, 2020 | 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
