Gentamicin Sulfate

ANDA 62356, held by Fresenius Kabi USA. Gentamicin Sulfate.

As of Nov 15, 2026, ANDA 62356 (Gentamicin Sulfate), held by Fresenius Kabi USA, was first approved by FDA on Mar 4, 1982, with 11 approved supplements and 0 published complete response letters.

First approved: Mar 4, 1982
Supplements approved: 11
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 12 submissions below

Date	Submission	Status	Documents
Mar 4, 1982	Original application	Approved	None posted

Products

2 strengths and forms


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

All 12 submissions, including labeling and manufacturing supplements


Sep 11, 2015	Supplement 24Labeling · Standard review	Approved	None posted
Jul 26, 2013	Supplement 23Labeling	Approved	None posted
Mar 9, 2005	Supplement 18Labeling	Approved	None posted
May 3, 2004	Supplement 17Labeling	Approved	None posted
Sep 7, 2000	Supplement 11Manufacturing	Approved	None posted
Mar 21, 2000	Supplement 10Manufacturing	Approved	None posted
Mar 7, 2000	Supplement 16Manufacturing	Approved	None posted
Feb 23, 1995	Supplement 13Manufacturing	Approved	None posted
Dec 6, 1994	Supplement 12Manufacturing	Approved	None posted
May 21, 1993	Supplement 14Labeling	Approved	None posted
Mar 18, 1991	Supplement 9Labeling	Approved	None posted
Mar 4, 1982	Original application	Approved	None posted

Identifiers

Application: ANDA 62356
Drugs@FDA: Overview at FDA
Company: Fresenius Kabi USA

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