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As of Nov 14, 2026, NDA 20799 (Floxin Otic), held by Daiichi, was first approved by FDA on Dec 16, 1997, with 11 approved supplements and 0 published complete response letters.
First approved: Dec 16, 1997
Review: Standard
Supplements approved: 11
Complete response letters: 0
Approvals and New Uses
The original application and every efficacy supplement, newest first; all 12 submissions below
Sep 30, 2003
Supplement 6Efficacy (new indication or use) · Standard review
Floxin Otic0.3% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · solution/drops;otic
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
