Gentamicin Sulfate

ANDA 62612, held by Hospira. Gentamicin Sulfate.

As of Nov 15, 2026, ANDA 62612 (Gentamicin Sulfate), held by Hospira, was first approved by FDA on Feb 20, 1986, with 12 approved supplements and 0 published complete response letters.

First approved: Feb 20, 1986
Supplements approved: 12
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 13 submissions below

Date	Submission	Status	Documents
Feb 20, 1986	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Gentamicin SulfateEQ 10MG BASE/ML · injectable;injection	Gentamicin Sulfate	Discontinued

All 13 submissions, including labeling and manufacturing supplements


Mar 24, 2004	Supplement 16Labeling	Approved	None posted
Mar 6, 2003	Supplement 15Labeling	Approved	None posted
Apr 9, 2001	Supplement 14Manufacturing	Approved	None posted
Dec 9, 1998	Supplement 11Manufacturing	Approved	None posted
Sep 25, 1998	Supplement 12Manufacturing	Approved	None posted
Sep 25, 1998	Supplement 13Manufacturing	Approved	None posted
May 10, 1995	Supplement 9Manufacturing	Approved	None posted
Jan 14, 1994	Supplement 8Manufacturing	Approved	None posted
Oct 4, 1993	Supplement 7Manufacturing	Approved	None posted
Oct 30, 1992	Supplement 6Manufacturing	Approved	None posted
Apr 28, 1992	Supplement 5Manufacturing	Approved	None posted
Jun 20, 1991	Supplement 4Labeling	Approved	None posted
Feb 20, 1986	Original application	Approved	None posted

Identifiers

Application: ANDA 62612
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