Treats serious or severe infections caused by susceptible strains of…. ANDA 205780, held by Eugia Pharma. Vancomycin Hydrochloride.
As of Nov 15, 2026, ANDA 205780 (Vancomycin Hydrochloride), held by Eugia Pharma, was first approved by FDA on Mar 31, 2016, with 2 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Vancomycin Hydrochloride for Injection 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 |
|---|---|---|---|
| Mar 31, 2016 | Original application | Approved | None posted |
| Vancomycin HydrochlorideEQ 500MG BASE/VIAL · injectable;injection | Vancomycin Hydrochloride | Rx |
| Vancomycin HydrochlorideEQ 1GM BASE/VIAL · injectable;injection | Vancomycin Hydrochloride | Rx |
| Aug 17, 2020 | Supplement 1Labeling · Standard review | Approved | None posted |
| Aug 17, 2020 | Supplement 2Labeling · Standard review | Approved | None posted |
| Mar 31, 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
