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Treats erectile dysfunction (ED). NDA 21368, held by Lilly. Tadalafil.
As of Nov 14, 2026, NDA 21368 (Cialis), held by Lilly, was first approved by FDA on Nov 21, 2003, with 21 approved supplements and 0 published complete response letters.
First approved: Nov 21, 2003
Review: Standard
Supplements approved: 21
Complete response letters: 0
What It's For
From the FDA-approved label (Indications and Usage)
CIALIS is a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of: erectile dysfunction (ED) the signs and symptoms of benign prostatic hyperplasia (BPH) ED and the signs and symptoms of BPH (ED/BPH) If CIALIS is used with finasteride to initiate BPH treatment, such use is recommended for up to 26 weeks. 1.1 Erectile Dysfunction CIALIS is indicated for the treatment of erectile dysfunction (ED). 1.2 Benign Prostatic Hyperplasia CIALIS is indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH). 1.3 Erectile Dysfunction and Benign Prostatic Hyperplasia CIALIS is indicated for the treatment of ED and the signs and symptoms of BPH (ED/BPH). 1.
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
