Gentamicin Sulfate In Sodium Chloride 0.9% In Plastic Container

ANDA 62373, held by Baxter Hlthcare. Gentamicin Sulfate.

As of Nov 15, 2026, ANDA 62373 (Gentamicin Sulfate In Sodium Chloride 0.9% In Plastic Container), held by Baxter Hlthcare, was first approved by FDA on Sep 7, 1982, with 21 approved supplements and 0 published complete response letters.

First approved: Sep 7, 1982
Supplements approved: 21
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 Sulfate in 0.9% Sodium Chloride Injection and other antibacterial drugs, Gentamicin Sulfate in 0.9% Sodium Chloride 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. Gentamicin Sulfate in 0.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 22 submissions below

Date	Submission	Status	Documents
Sep 7, 1982	Original application	Approved	None posted

Products

10 strengths and forms


Gentamicin Sulfate In Sodium Chloride 0.9% In Plastic ContainerEQ 0.8MG BASE/ML · injectable;injection	Gentamicin Sulfate	Discontinued
Gentamicin Sulfate In Sodium Chloride 0.9% In Plastic ContainerEQ 80MG BASE/100ML · injectable;injection	Gentamicin Sulfate	Rx
Gentamicin Sulfate In Sodium Chloride 0.9% In Plastic ContainerEQ 40MG BASE/100ML · injectable;injection	Gentamicin Sulfate	Discontinued
Gentamicin Sulfate In Sodium Chloride 0.9% In Plastic ContainerEQ 60MG BASE/100ML · injectable;injection	Gentamicin Sulfate	Discontinued
Gentamicin Sulfate In Sodium Chloride 0.9% In Plastic ContainerEQ 100MG BASE/100ML · injectable;injection	Gentamicin Sulfate	Rx
Gentamicin Sulfate In Sodium Chloride 0.9% In Plastic ContainerEQ 120MG BASE/100ML · injectable;injection	Gentamicin Sulfate	Rx
Gentamicin Sulfate In Sodium Chloride 0.9% In Plastic ContainerEQ 1.2MG BASE/ML · injectable;injection	Gentamicin Sulfate	Rx
Gentamicin Sulfate In Sodium Chloride 0.9% In Plastic ContainerEQ 1.6MG BASE/ML · injectable;injection	Gentamicin Sulfate	Rx
Gentamicin Sulfate In Sodium Chloride 0.9% In Plastic ContainerEQ 2MG BASE/ML · injectable;injection	Gentamicin Sulfate	Rx
Gentamicin Sulfate In Sodium Chloride 0.9% In Plastic ContainerEQ 2.4MG BASE/ML · injectable;injection	Gentamicin Sulfate	Discontinued

All 22 submissions, including labeling and manufacturing supplements


Feb 10, 2023	Supplement 44Labeling · Standard review	Approved	None posted
Jan 31, 2023	Supplement 42Labeling · Standard review	Approved	None posted
Jan 31, 2023	Supplement 40Labeling · Standard review	Approved	None posted
Dec 11, 2015	Supplement 39Labeling · Standard review	Approved	None posted
Jul 30, 2013	Supplement 35Labeling	Approved	None posted
Nov 30, 2009	Supplement 33Labeling	Approved	None posted
Nov 5, 2007	Supplement 32Labeling	Approved	None posted
Aug 31, 2004	Supplement 31Labeling	Approved	None posted
Dec 29, 1997	Supplement 27Manufacturing	Approved	None posted
May 21, 1997	Supplement 26Manufacturing	Approved	None posted
Jan 27, 1995	Supplement 24Manufacturing	Approved	None posted
Oct 17, 1994	Supplement 25Manufacturing	Approved	None posted
Oct 17, 1994	Supplement 21Manufacturing	Approved	None posted
Jun 28, 1994	Supplement 23Manufacturing	Approved	None posted
Feb 25, 1994	Supplement 22Manufacturing	Approved	None posted
Aug 4, 1993	Supplement 20Manufacturing	Approved	None posted
Sep 10, 1991	Supplement 19Labeling	Approved	None posted
Jun 6, 1991	Supplement 18Manufacturing	Approved	None posted
Mar 20, 1991	Supplement 17Manufacturing	Approved	None posted
Feb 7, 1991	Supplement 16Manufacturing	Approved	None posted
May 12, 1989	Supplement 15Manufacturing	Approved	None posted
Sep 7, 1982	Original application	Approved	None posted

Identifiers

Application: ANDA 62373
Drugs@FDA: Overview at FDA
Company: Baxter Healthcare

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