Genoptic

ANDA 62452, held by Allergan. Gentamicin Sulfate.

As of Nov 15, 2026, ANDA 62452 (Genoptic), held by Allergan, was first approved by FDA on Oct 10, 1984, with 18 approved supplements and 0 published complete response letters.

First approved: Oct 10, 1984
Supplements approved: 18
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS & USAGE SECTION Gentamicin sulfate ophthalmic solution, USP 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 19 submissions below

Date	Submission	Status	Documents
Oct 10, 1984	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
GenopticEQ 0.3% BASE · solution/drops;ophthalmic	Gentamicin Sulfate	Discontinued

All 19 submissions, including labeling and manufacturing supplements


Feb 20, 2004	Supplement 19Labeling	Approved	None posted
Nov 15, 2002	Supplement 22Manufacturing	Approved	None posted
Jul 3, 2002	Supplement 21Manufacturing	Approved	None posted
Aug 15, 2001	Supplement 20Manufacturing	Approved	None posted
Dec 8, 2000	Supplement 17Manufacturing	Approved	None posted
Oct 16, 1998	Supplement 16Manufacturing	Approved	None posted
Apr 3, 1998	Supplement 13Manufacturing	Approved	None posted
Feb 24, 1998	Supplement 15Manufacturing	Approved	None posted
Oct 22, 1997	Supplement 14Manufacturing	Approved	None posted
Jan 31, 1995	Supplement 12Labeling	Approved	None posted
Sep 27, 1994	Supplement 10Manufacturing	Approved	None posted
Jul 1, 1994	Supplement 11Manufacturing	Approved	None posted
Sep 27, 1993	Supplement 9Labeling	Approved	None posted
Feb 28, 1992	Supplement 8Labeling	Approved	None posted
Apr 11, 1991	Supplement 5Manufacturing	Approved	None posted
Feb 26, 1991	Supplement 7Manufacturing	Approved	None posted
Apr 5, 1989	Supplement 6Manufacturing	Approved	None posted
Nov 22, 1988	Supplement 4Manufacturing	Approved	None posted
Oct 10, 1984	Original application	Approved	None posted

Identifiers

Application: ANDA 62452
Drugs@FDA: Overview at FDA
Company: Allergan

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