Maxitrol

NDA 50023, held by Harrow Eye. Dexamethasone; Neomycin Sulfate; Polymyxin B Sulfate.

As of Nov 15, 2026, NDA 50023 (Maxitrol), held by Harrow Eye, was first approved by FDA on Jun 6, 1963, with 26 approved supplements and 0 published complete response letters.

First approved: Jun 6, 1963
Supplements approved: 26
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE For steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where bacterial infection or a risk of bacterial infection exists. Ocular corticosteroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe where the inherent risk of corticosteroids use in certain infective conjunctivitides is accepted to obtain a diminution in edema and inflammation. They are also indicated in chronic anterior uveitis and corneal injury from chemical, radiation or thermal burns; or penetration of foreign bodies.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 27 submissions below

Date	Submission	Status	Documents
Jun 6, 1963	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Maxitrol0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML · suspension/drops;ophthalmic	Dexamethasone; Neomycin Sulfate; Polymyxin B Sulfate	RxReference drug

All 27 submissions, including labeling and manufacturing supplements


May 14, 2021	Supplement 37Labeling · Standard review	Approved	Letter Label
Dec 18, 2017	Supplement 36Labeling · Standard review	Approved	Letter Label
Apr 10, 2017	Supplement 32Labeling · Standard review	Approved	Letter Label
May 27, 2015	Supplement 31Manufacturing	Approved	None posted
Apr 24, 2008	Supplement 25Labeling · Standard review	Approved	Label Letter
Dec 11, 2002	Supplement 23Manufacturing	Approved	None posted
Dec 4, 2002	Supplement 22Manufacturing	Approved	None posted
Oct 10, 2000	Supplement 21Manufacturing	Approved	None posted
Feb 25, 2000	Supplement 20Manufacturing	Approved	None posted
Aug 17, 1999	Supplement 19Manufacturing	Approved	None posted
Mar 11, 1999	Supplement 17Manufacturing	Approved	None posted
Feb 5, 1999	Supplement 18Manufacturing	Approved	None posted
Aug 4, 1998	Supplement 16Manufacturing	Approved	None posted
Mar 18, 1996	Supplement 14Manufacturing	Approved	None posted
Nov 1, 1995	Supplement 13Manufacturing	Approved	None posted
Nov 1, 1995	Supplement 12Manufacturing	Approved	None posted
Aug 30, 1995	Supplement 11Labeling · Standard review	Approved	None posted
Jun 13, 1995	Supplement 8Manufacturing	Approved	None posted
Jul 27, 1994	Supplement 10Manufacturing	Approved	None posted
Jan 22, 1993	Supplement 9Manufacturing	Approved	None posted
Mar 3, 1989	Supplement 6Manufacturing	Approved	None posted
Mar 25, 1977	Supplement 5Manufacturing	Approved	None posted
Mar 1, 1976	Supplement 4Manufacturing	Approved	None posted
Feb 20, 1973	Supplement 3Manufacturing	Approved	None posted
Oct 14, 1971	Supplement 2Manufacturing	Approved	None posted
Dec 14, 1966	Supplement 1Manufacturing	Approved	None posted
Jun 6, 1963	Original application	Approved	None posted

Identifiers

Application: NDA 50023
Drugs@FDA: Overview at FDA
Company: Harrow Eye LLC

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