ANDA 215236, held by Eugia Pharma. Gentamicin Sulfate.
As of Nov 15, 2026, ANDA 215236 (Gentamicin Sulfate), held by Eugia Pharma, was first approved by FDA on Jan 8, 2024, with 0 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE: To reduce the development of drug-resistant bacteria and maintain the effectiveness of gentamicin injection and other antibacterial drugs, gentamicin injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 8, 2024 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Gentamicin SulfateEQ 10MG BASE/ML · injectable;injection | Gentamicin Sulfate | Discontinued |
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
