Treats septicemia. ANDA 215324, held by Steriscience. Vancomycin Hydrochloride.
As of Nov 15, 2026, ANDA 215324 (Vancomycin Hydrochloride), held by Steriscience, was first approved by FDA on Oct 2, 2025, with 0 approved supplements and 0 published complete response letters.
Vancomycin Hydrochloride for Injection is a glycopeptide antibacterial indicated in adult and pediatric patients (neonates and older) for the treatment of: Septicemia Infective Endocarditis Skin and Skin Structure Infections Bone Infections Lower Respiratory Tract Infections To reduce the development of drug-resistant bacteria and maintain the effectiveness of vancomycin hydrochloride for injection and other antibacterial drugs, vancomycin hydrochloride for injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. 1.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 2, 2025 | Original application | Approved | None posted |
| Vancomycin HydrochlorideEQ 750MG BASE/VIAL · powder;intravenous | Vancomycin Hydrochloride | Rx |
| Vancomycin HydrochlorideEQ 1.25GM BASE/VIAL · powder;intravenous | Vancomycin Hydrochloride | Rx |
| Vancomycin HydrochlorideEQ 1.5GM BASE/VIAL · powder;intravenous | 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
