Gentamicin Sulfate In Sodium Chloride 0.9% In Plastic Container

ANDA 62588, held by Hospira. Gentamicin Sulfate.

As of Nov 15, 2026, ANDA 62588 (Gentamicin Sulfate In Sodium Chloride 0.9% In Plastic Container), held by Hospira, was first approved by FDA on Jan 6, 1986, with 8 approved supplements and 0 published complete response letters.

First approved: Jan 6, 1986
Supplements approved: 8
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 9 submissions below

Date	Submission	Status	Documents
Jan 6, 1986	Original application	Approved	None posted

Products

10 strengths and forms


Gentamicin Sulfate In Sodium Chloride 0.9% In Plastic ContainerEQ 1.2MG BASE/ML · injectable;injection	Gentamicin Sulfate	Discontinued
Gentamicin Sulfate In Sodium Chloride 0.9% In Plastic ContainerEQ 1.4MG BASE/ML · injectable;injection	Gentamicin Sulfate	Discontinued
Gentamicin Sulfate In Sodium Chloride 0.9% In Plastic ContainerEQ 1.6MG BASE/ML · injectable;injection	Gentamicin Sulfate	Discontinued
Gentamicin Sulfate In Sodium Chloride 0.9% In Plastic ContainerEQ 1.8MG BASE/ML · injectable;injection	Gentamicin Sulfate	Discontinued
Gentamicin Sulfate In Sodium Chloride 0.9% In Plastic ContainerEQ 2MG BASE/ML · 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 70MG BASE/100ML · injectable;injection	Gentamicin Sulfate	Discontinued
Gentamicin Sulfate In Sodium Chloride 0.9% In Plastic ContainerEQ 80MG BASE/100ML · injectable;injection	Gentamicin Sulfate	Discontinued
Gentamicin Sulfate In Sodium Chloride 0.9% In Plastic ContainerEQ 90MG BASE/100ML · injectable;injection	Gentamicin Sulfate	Discontinued
Gentamicin Sulfate In Sodium Chloride 0.9% In Plastic ContainerEQ 100MG BASE/100ML · injectable;injection	Gentamicin Sulfate	Discontinued

All 9 submissions, including labeling and manufacturing supplements


Dec 1, 1998	Supplement 13Manufacturing	Approved	None posted
Jun 2, 1997	Supplement 12Manufacturing	Approved	None posted
Jul 3, 1996	Supplement 9Manufacturing	Approved	None posted
Mar 12, 1996	Supplement 10Manufacturing	Approved	None posted
Aug 7, 1995	Supplement 8Manufacturing	Approved	None posted
Mar 10, 1992	Supplement 6Manufacturing	Approved	None posted
Apr 24, 1991	Supplement 7Manufacturing	Approved	None posted
Aug 2, 1990	Supplement 5Manufacturing	Approved	None posted
Jan 6, 1986	Original application	Approved	None posted

Identifiers

Application: ANDA 62588
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