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As of Nov 14, 2026, NDA 50749 (Omnicef), held by Abbvie, was first approved by FDA on Dec 4, 1997, with 11 approved supplements and 0 published complete response letters.
First approved: Dec 4, 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
Jul 14, 1999
Supplement 2Efficacy (new indication or use) · Standard review
Omnicef125MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · for suspension;oral
Omnicef250MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · for suspension;oral
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
