Gentamicin Sulfate

ANDA 62251, held by Hikma. Gentamicin Sulfate.

As of Nov 15, 2026, ANDA 62251 (Gentamicin Sulfate), held by Hikma, was first approved by FDA on Jun 5, 1980, with 16 approved supplements and 0 published complete response letters.

First approved: Jun 5, 1980
Supplements approved: 16
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 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.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 17 submissions below

Date	Submission	Status	Documents
Jun 5, 1980	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 17 submissions, including labeling and manufacturing supplements


Feb 15, 2022	Supplement 30Labeling · Standard review	Approved	None posted
Jul 23, 2001	Supplement 28Manufacturing	Approved	None posted
Jul 23, 2001	Supplement 27Manufacturing	Approved	None posted
Jul 23, 2001	Supplement 26Manufacturing	Approved	None posted
Oct 14, 1999	Supplement 25Manufacturing	Approved	None posted
Feb 11, 1999	Supplement 24Manufacturing	Approved	None posted
Feb 3, 1994	Supplement 21Manufacturing	Approved	None posted
Sep 16, 1993	Supplement 20Manufacturing	Approved	None posted
Nov 18, 1991	Supplement 19Manufacturing	Approved	None posted
May 31, 1991	Supplement 17Manufacturing	Approved	None posted
May 17, 1991	Supplement 18Manufacturing	Approved	None posted
Feb 8, 1991	Supplement 16Manufacturing	Approved	None posted
Nov 19, 1990	Supplement 15Manufacturing	Approved	None posted
Jul 12, 1988	Supplement 14Manufacturing	Approved	None posted
Feb 22, 1988	Supplement 13Manufacturing	Approved	None posted
May 22, 1987	Supplement 11Manufacturing	Approved	None posted
Jun 5, 1980	Original application	Approved	None posted

Identifiers

Application: ANDA 62251
Drugs@FDA: Overview at FDA
Company: Hikma

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