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As of Nov 13, 2026, NDA 202276 (Stendra), held by Vivus LLC, was first approved by FDA on Apr 27, 2012, with 16 approved supplements and 0 published complete response letters.
First approved: Apr 27, 2012
Review: Standard
Supplements approved: 16
Complete response letters: 0
Approvals and New Uses
The original application and every efficacy supplement, newest first; all 17 submissions below
Oct 18, 2022
Supplement 20Efficacy (new indication or use) · Standard review
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
