NDA 216165, held by Orchid Pharma. Cefepime Hydrochloride; Enmetazobactam.
As of Nov 13, 2026, NDA 216165 (Exblifep), held by Orchid Pharma, was first approved by FDA on Feb 22, 2024, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 22, 2024 | Original applicationNew molecular entity, new combination · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| ExblifepEQ 2GM BASE/VIAL;0.5GM/VIAL · powder;intravenous | Cefepime Hydrochloride; Enmetazobactam | DiscontinuedReference drug |
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
