Treats serious or severe infections caused by susceptible strains of…. ANDA 204360, held by Hikma. Vancomycin Hydrochloride.
As of Nov 15, 2026, ANDA 204360 (Vancomycin Hydrochloride), held by Hikma, was first approved by FDA on Oct 15, 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 15, 2018 | Original application | Approved | None posted |
| Vancomycin HydrochlorideEQ 5GM BASE/VIAL · injectable;injection | Vancomycin Hydrochloride | Rx |
| Vancomycin HydrochlorideEQ 10GM BASE/VIAL · injectable;injection | Vancomycin Hydrochloride | Rx |
| May 25, 2021 | Supplement 9Labeling · Standard review | Approved | None posted |
| Aug 27, 2020 | Supplement 1Labeling · Standard review | Approved | None posted |
| Oct 15, 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
