Treats serious or severe infections caused by susceptible strains of…. ANDA 91554, held by Mylan Labs Ltd. Vancomycin Hydrochloride.
As of Nov 15, 2026, ANDA 91554 (Vancomycin Hydrochloride), held by Mylan Labs Ltd, was first approved by FDA on Sep 19, 2011, with 6 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 |
|---|---|---|---|
| Sep 19, 2011 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Vancomycin HydrochlorideEQ 10GM BASE/VIAL · injectable;injection | Vancomycin Hydrochloride | Rx |
| Apr 7, 2021 | Supplement 15Labeling · Standard review | Approved | None posted |
| Apr 7, 2021 | Supplement 14Labeling · Standard review | Approved | None posted |
| Aug 19, 2020 | Supplement 13Labeling · Standard review | Approved | None posted |
| Aug 19, 2020 | Supplement 11Labeling · Standard review | Approved | None posted |
| Aug 19, 2020 | Supplement 6Labeling · Standard review | Approved | None posted |
| Nov 7, 2014 | Supplement 5Labeling · Standard review | Approved | None posted |
| Sep 19, 2011 | 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
