ANDA 91377, held by Xellia Pharms Aps. Vancomycin Hydrochloride.
As of Nov 15, 2026, ANDA 91377 (Vancomycin Hydrochloride), held by Xellia Pharms Aps, was first approved by FDA on Sep 9, 2015, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 9, 2015 | Original application | Approved | None posted |
| Vancomycin HydrochlorideEQ 500MG BASE/VIAL · injectable;injection | Vancomycin Hydrochloride | Discontinued |
| Vancomycin HydrochlorideEQ 1GM BASE/VIAL · injectable;injection | Vancomycin Hydrochloride | Discontinued |
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
