Gentamicin Sulfate

ANDA 62420, held by Hospira. Gentamicin Sulfate.

As of Nov 15, 2026, ANDA 62420 (Gentamicin Sulfate), held by Hospira, was first approved by FDA on Aug 15, 1983, with 14 approved supplements and 0 published complete response letters.

First approved: Aug 15, 1983
Supplements approved: 14
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 and other antibacterial drugs, gentamicin 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 15 submissions below

Date	Submission	Status	Documents
Aug 15, 1983	Original application	Approved	None posted

Products

2 strengths and forms


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

All 15 submissions, including labeling and manufacturing supplements


Feb 10, 2023	Supplement 31Labeling · Standard review	Approved	None posted
Feb 1, 2023	Supplement 25Labeling · Standard review	Approved	None posted
Apr 21, 2004	Supplement 14Labeling	Approved	None posted
Oct 25, 2002	Supplement 13Manufacturing	Approved	None posted
Mar 22, 2001	Supplement 12Manufacturing	Approved	None posted
Mar 22, 2001	Supplement 11Manufacturing	Approved	None posted
Jan 7, 2000	Supplement 10Labeling	Approved	None posted
Jan 7, 2000	Supplement 9Manufacturing	Approved	None posted
Dec 9, 1998	Supplement 7Manufacturing	Approved	None posted
Sep 18, 1998	Supplement 8Manufacturing	Approved	None posted
Oct 22, 1996	Supplement 4Manufacturing	Approved	None posted
Oct 3, 1996	Supplement 5Manufacturing	Approved	None posted
Oct 4, 1993	Supplement 2Manufacturing	Approved	None posted
Jul 13, 1993	Supplement 1Labeling	Approved	None posted
Aug 15, 1983	Original application	Approved	None posted

Identifiers

Application: ANDA 62420
Drugs@FDA: Overview at FDA
Company: Hospira

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