NDA 213895, held by Hikma. Vancomycin.
As of Nov 13, 2026, NDA 213895 (Vancomycin), held by Hikma, was first approved by FDA on Aug 26, 2021, with 0 approved supplements and 1 published complete response letter.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 26, 2021 | Original applicationNew formulation or manufacturer · Priority review | Approved |
| Letter | Product | Now |
|---|---|---|
| Mar 20, 2020 | Vancomycin | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Vancomycin5GM/100ML (50MG/ML) · solution;intravenous, oral | Vancomycin | 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
