Treats serious or severe infections caused by susceptible strains of…. ANDA 206616, held by Hikma Pharms. Vancomycin Hydrochloride.
As of Nov 15, 2026, ANDA 206616 (Vancomycin Hydrochloride), held by Hikma Pharms, was first approved by FDA on Oct 3, 2018, with 2 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 (β-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 |
|---|---|---|---|
| Oct 3, 2018 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Vancomycin HydrochlorideEQ 750MG BASE/VIAL · injectable;injection | Vancomycin Hydrochloride | Rx |
| May 25, 2021 | Supplement 3Labeling · Standard review | Approved | None posted |
| Aug 20, 2020 | Supplement 1Labeling · Standard review | Approved | None posted |
| Oct 3, 2018 | 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
