Treats serious or severe infections caused by susceptible strains of…. ANDA 215821, held by Hainan Poly. Vancomycin Hydrochloride.
As of Nov 15, 2026, ANDA 215821 (Vancomycin Hydrochloride), held by Hainan Poly, was first approved by FDA on Nov 18, 2021, with 0 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 |
|---|---|---|---|
| Nov 18, 2021 | 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 |
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
