Treats serious or severe infections caused by susceptible strains of…. ANDA 65432, held by Mylan Labs Ltd. Vancomycin Hydrochloride.
As of Nov 15, 2026, ANDA 65432 (Vancomycin Hydrochloride), held by Mylan Labs Ltd, was first approved by FDA on Dec 30, 2008, with 7 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 |
|---|---|---|---|
| Dec 30, 2008 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Vancomycin HydrochlorideEQ 5GM BASE/VIAL · injectable;injection | Vancomycin Hydrochloride | Rx |
| Jun 4, 2021 | Supplement 28Labeling · Standard review | Approved | None posted |
| Aug 19, 2020 | Supplement 16Labeling · Standard review | Approved | None posted |
| Aug 19, 2020 | Supplement 20Labeling · Standard review | Approved | None posted |
| Aug 19, 2020 | Supplement 21Labeling · Standard review | Approved | None posted |
| Aug 19, 2020 | Supplement 23Labeling · Standard review | Approved | None posted |
| Jun 23, 2009 | Supplement 2Labeling | Approved | None posted |
| Jun 23, 2009 | Supplement 3Labeling | Approved | None posted |
| Dec 30, 2008 | 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
