Gentamicin Sulfate

ANDA 62196, held by Sandoz. Gentamicin Sulfate.

As of Nov 15, 2026, ANDA 62196 (Gentamicin Sulfate), held by Sandoz, was first approved by FDA on Jul 2, 1980, with 14 approved supplements and 0 published complete response letters.

First approved: Jul 2, 1980
Supplements approved: 14
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE: Gentamicin Sulfate Ophthalmic Solution is indicated in the topical treatment of ocular bacterial infections, including conjunctivitis, keratitis, keratoconjunctivitis, corneal ulcers, blepharitis, blepharoconjunctivitis, acute meibomianitis, and dacryocystitis caused by susceptible strains of the following microorganisms: Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pyogenes, Streptococcus pneumoniae, Enterobacter aerogenes, Escherichia coli, Haemophilus influenzae, Klebsiella pneumoniae, Neisseria gonorrhoeae, Pseudomonas aeruginosa, and Serratia marcescens.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 15 submissions below

Date	Submission	Status	Documents
Jul 2, 1980	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Gentamicin SulfateEQ 0.3% BASE · solution/drops;ophthalmic	Gentamicin Sulfate	Rx

All 15 submissions, including labeling and manufacturing supplements


Dec 23, 2002	Supplement 15Manufacturing	Approved	None posted
Nov 17, 2000	Supplement 14Manufacturing	Approved	None posted
Sep 12, 2000	Supplement 13Manufacturing	Approved	None posted
Apr 28, 2000	Supplement 11Manufacturing	Approved	None posted
Apr 7, 2000	Supplement 12Manufacturing	Approved	None posted
May 7, 1999	Supplement 10Manufacturing	Approved	None posted
Sep 18, 1998	Supplement 5Labeling	Approved	None posted
Apr 3, 1998	Supplement 8Manufacturing	Approved	None posted
Jul 29, 1997	Supplement 7Manufacturing	Approved	None posted
Jul 29, 1997	Supplement 6Manufacturing	Approved	None posted
Jun 9, 1997	Supplement 4Manufacturing	Approved	None posted
Dec 9, 1996	Supplement 3Manufacturing	Approved	None posted
Jul 12, 1996	Supplement 2Manufacturing	Approved	None posted
Dec 28, 1995	Supplement 1Manufacturing	Approved	None posted
Jul 2, 1980	Original application	Approved	None posted

Identifiers

Application: ANDA 62196
Drugs@FDA: Overview at FDA
Company: Sandoz

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