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Treats benign prostatic hyperplasia (BPH). ANDA 206541, held by Lupin. Silodosin.
As of Nov 14, 2026, ANDA 206541 (Silodosin), held by Lupin, was first approved by FDA on Dec 3, 2018, with 1 approved supplement and 0 published complete response letters.
First approved: Dec 3, 2018
Review: Standard
Supplements approved: 1
Complete response letters: 0
What It's For
From the FDA-approved label (Indications and Usage)
Silodosin capsules, an alpha-1 adrenergic receptor antagonist, is indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH). Silodosin capsule is not indicated for the treatment of hypertension.
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
