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As of Nov 14, 2026, NDA 22106 (Doribax), held by Shionogi, was first approved by FDA on Oct 12, 2007, with 11 approved supplements and 0 published complete response letters.
First approved: Oct 12, 2007
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
Date
Submission
Status
Documents
Oct 12, 2007
Original applicationNew molecular entity · Standard review
Doribax500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · injectable;intravenous
Doribax250MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · injectable;intravenous
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
