Treats serious or severe infections caused by susceptible strains of…. ANDA 204107, held by Hikma. Vancomycin Hydrochloride.
As of Nov 15, 2026, ANDA 204107 (Vancomycin Hydrochloride), held by Hikma, was first approved by FDA on Dec 28, 2015, with 3 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Vancomycin Hydrochloride for Injection USP is indicated for the treatment of serious or severe infections caused by susceptible strains of methicillin-resistant (ß-lactam-resistant) staphylococci. It is indicated for penicillin-allergic patients, for patients who cannot receive or who have failed to respond to other drugs, including the penicillins or cephalosporins, and for infections caused by vancomycin-susceptible organisms that are resistant to other antimicrobial drugs.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 28, 2015 | Original application | Approved | None posted |
| Vancomycin HydrochlorideEQ 500MG BASE/VIAL · injectable;injection | Vancomycin Hydrochloride | Rx |
| Vancomycin HydrochlorideEQ 1GM BASE/VIAL · injectable;injection | Vancomycin Hydrochloride | Rx |
| Sep 20, 2021 | Supplement 11Labeling · Standard review | Approved | None posted |
| Aug 19, 2020 | Supplement 3Labeling · Standard review | Approved | None posted |
| Aug 19, 2020 | Supplement 5Labeling · Standard review | Approved | None posted |
| Dec 28, 2015 | Original application | Approved | None posted |
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
