Tobrex

Treats external infections of the eye and its adnexa caused by susceptible bacteria. NDA 50555, held by Novartis. Tobramycin.

As of Nov 13, 2026, NDA 50555 (Tobrex), held by Novartis, was first approved by FDA on Nov 25, 1981, with 16 approved supplements and 0 published complete response letters.

First approved: Nov 25, 1981
Review: Standard
Supplements approved: 16
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE TOBREX (tobramycin ophthalmic ointment) 0.3 % is a topical antibiotic indicated in the treatment of external infections of the eye and its adnexa caused by susceptible bacteria. Appropriate monitoring of bacterial response to topical antibiotic therapy should accompany the use of TOBREX (tobramycin ophthalmic ointment) 0.3%. Clinical studies have shown tobramycin to be safe and effective for use in children.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 17 submissions below

Date	Submission	Status	Documents
Nov 25, 1981	Original applicationNew dosage form · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Tobrex0.3% · ointment;ophthalmic	Tobramycin	RxReference drug

All 17 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
May 14, 2021	Supplement 38Labeling · Standard review	Approved	Letter Label
Apr 24, 2020	Supplement 37Labeling · Standard review	Approved	Label Letter
Sep 10, 2015	Supplement 35Manufacturing · Standard review	Approved	None posted
Jul 15, 2004	Supplement 21Labeling · Standard review	Approved	Letter Label
Jul 15, 2004	Supplement 22Manufacturing · Standard review	Approved	Letter Label
Mar 18, 2003	Supplement 17Labeling · Standard review	Approved	Letter Label
Mar 18, 2003	Supplement 18Manufacturing · Standard review	Approved	Letter Label
Mar 18, 2003	Supplement 19Labeling · Standard review	Approved	Letter Label
Sep 28, 1999	Supplement 16Manufacturing · Standard review	Approved	None posted
Apr 7, 1999	Supplement 15Manufacturing · Standard review	Approved	None posted
Feb 5, 1999	Supplement 14Manufacturing · Standard review	Approved	None posted
May 29, 1998	Supplement 13Manufacturing · Standard review	Approved	None posted
Nov 29, 1996	Supplement 11Manufacturing · Standard review	Approved	None posted
May 18, 1994	Supplement 10Labeling · Standard review	Approved	None posted
Sep 17, 1992	Supplement 8Manufacturing · Standard review	Approved	None posted
Feb 3, 1992	Supplement 9Manufacturing · Standard review	Approved	None posted
Nov 25, 1981	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 50555
Drugs@FDA: Overview at FDA
Company: Novartis Pharmaceuticals Corporation

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