Gentamicin Sulfate

ANDA 62366, held by Fresenius Kabi USA. Gentamicin Sulfate.

As of Nov 15, 2026, ANDA 62366 (Gentamicin Sulfate), held by Fresenius Kabi USA, was first approved by FDA on Aug 4, 1983, with 17 approved supplements and 0 published complete response letters.

First approved: Aug 4, 1983
Supplements approved: 17
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE: To reduce the development of drug-resistant bacteria and maintain the effectiveness of Gentamicin Injection, USP and other antibacterial drugs, Gentamicin Injection, USP 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.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 18 submissions below

Date	Submission	Status	Documents
Aug 4, 1983	Original application	Approved	None posted

Products

2 strengths and forms


Gentamicin SulfateEQ 40MG BASE/ML · injectable;injection	Gentamicin Sulfate	Rx
Gentamicin SulfateEQ 10MG BASE/ML · injectable;injection	Gentamicin Sulfate	Rx

All 18 submissions, including labeling and manufacturing supplements


Feb 10, 2023	Supplement 45Labeling · Standard review	Approved	None posted
Feb 10, 2023	Supplement 40Labeling · Standard review	Approved	None posted
Feb 10, 2023	Supplement 39Labeling · Standard review	Approved	None posted
Mar 7, 2014	Supplement 33Labeling	Approved	Label
Jul 26, 2013	Supplement 35Labeling	Approved	None posted
Mar 9, 2005	Supplement 26Labeling	Approved	None posted
May 3, 2004	Supplement 25Labeling	Approved	None posted
Dec 5, 2002	Supplement 24Manufacturing	Approved	None posted
Dec 28, 2001	Supplement 22Manufacturing	Approved	None posted
Mar 7, 2000	Supplement 20Manufacturing	Approved	None posted
Dec 6, 1994	Supplement 16Manufacturing	Approved	None posted
Jun 22, 1993	Supplement 18Labeling	Approved	None posted
Aug 27, 1992	Supplement 17Labeling	Approved	None posted
Nov 26, 1991	Supplement 11Manufacturing	Approved	None posted
Jun 19, 1991	Supplement 12Manufacturing	Approved	None posted
Mar 18, 1991	Supplement 15Labeling	Approved	None posted
Sep 11, 1990	Supplement 14Labeling	Approved	None posted
Aug 4, 1983	Original application	Approved	None posted

Identifiers

Application: ANDA 62366
Drugs@FDA: Overview at FDA
Company: Fresenius Kabi USA

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