Gentamicin Sulfate

ANDA 64048, held by Bausch And Lomb Inc. Gentamicin Sulfate.

As of Nov 15, 2026, ANDA 64048 (Gentamicin Sulfate), held by Bausch And Lomb Inc, was first approved by FDA on May 11, 1994, with 14 approved supplements and 0 published complete response letters.

First approved: May 11, 1994
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
May 11, 1994	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


Nov 27, 2001	Supplement 14Manufacturing	Approved	None posted
Aug 29, 2001	Supplement 13Manufacturing	Approved	None posted
Mar 7, 2001	Supplement 12Manufacturing	Approved	None posted
Oct 5, 2000	Supplement 11Manufacturing	Approved	None posted
Jun 27, 2000	Supplement 10Manufacturing	Approved	None posted
May 18, 2000	Supplement 7Manufacturing	Approved	None posted
May 15, 2000	Supplement 9Manufacturing	Approved	None posted
Apr 28, 2000	Supplement 8Manufacturing	Approved	None posted
Jun 7, 1999	Supplement 6Manufacturing	Approved	None posted
Nov 19, 1998	Supplement 5Manufacturing	Approved	None posted
May 4, 1998	Supplement 4Manufacturing	Approved	None posted
Jan 14, 1998	Supplement 3Manufacturing	Approved	None posted
Aug 26, 1996	Supplement 2Manufacturing	Approved	None posted
Sep 9, 1994	Supplement 1Manufacturing	Approved	None posted
May 11, 1994	Original application	Approved	None posted

Identifiers

Application: ANDA 64048
Drugs@FDA: Overview at FDA
Company: Bausch & Lomb

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