Treats serious or severe infections caused by susceptible strains of…. ANDA 91532, held by Samson Medcl. Vancomycin Hydrochloride.
As of Nov 15, 2026, ANDA 91532 (Vancomycin Hydrochloride), held by Samson Medcl, was first approved by FDA on Jan 6, 2016, 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 (beta-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. Vancomycin is indicated for initial therapy when methicillin-resistant staphylococci are suspected, but after susceptibility data are available, therapy should be adjusted accordingly.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 6, 2016 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Vancomycin HydrochlorideEQ 100GM BASE · powder;intravenous | Vancomycin Hydrochloride | Rx |
| Aug 13, 2020 | Supplement 2Labeling · Standard review | Approved | None posted |
| Feb 21, 2018 | Supplement 1Labeling · Standard review | Approved | None posted |
| Jan 6, 2016 | 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
