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As of Nov 14, 2026, NDA 20665 (Diovan), held by Novartis, was first approved by FDA on Dec 23, 1996, with 25 approved supplements and 0 published complete response letters.
First approved: Dec 23, 1996
Review: Standard
Supplements approved: 25
Complete response letters: 0
Approvals and New Uses
The original application and every efficacy supplement, newest first; all 26 submissions below
Aug 14, 2002
Supplement 16Efficacy (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
