Tobrex

Treats external infections of the eye and its adnexa caused by susceptible bacteria. ANDA 62535, held by Sandoz. Tobramycin.

As of Nov 15, 2026, ANDA 62535 (Tobrex), held by Sandoz, was first approved by FDA on Dec 13, 1984, with 22 approved supplements and 0 published complete response letters.

First approved: Dec 13, 1984
Supplements approved: 22
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Tobramycin ophthalmic solution, 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 tobramycin ophthalmic solution, 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 23 submissions below

Date	Submission	Status	Documents
Dec 13, 1984	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Tobrex0.3% · solution/drops;ophthalmic	Tobramycin	Rx

All 23 submissions, including labeling and manufacturing supplements


Jun 24, 2021	Supplement 33Labeling · Standard review	Approved	None posted
Jun 24, 2021	Supplement 31Labeling · Standard review	Approved	None posted
May 18, 2020	Supplement 30Labeling · Standard review	Approved	None posted
Aug 22, 2005	Supplement 23Labeling	Approved	None posted
Oct 13, 2004	Supplement 22Labeling	Approved	None posted
Dec 23, 2002	Supplement 21Manufacturing	Approved	None posted
Oct 3, 2002	Supplement 20Manufacturing	Approved	None posted
Oct 3, 2002	Supplement 19Manufacturing	Approved	None posted
Apr 28, 2000	Supplement 17Manufacturing	Approved	None posted
May 7, 1999	Supplement 14Manufacturing	Approved	None posted
Apr 21, 1999	Supplement 16Manufacturing	Approved	None posted
Mar 23, 1999	Supplement 15Manufacturing	Approved	None posted
Mar 4, 1999	Supplement 12Manufacturing	Approved	None posted
Dec 31, 1998	Supplement 13Manufacturing	Approved	None posted
Mar 19, 1997	Supplement 11Manufacturing	Approved	None posted
Apr 1, 1996	Supplement 9Manufacturing	Approved	None posted
Dec 6, 1995	Supplement 6Manufacturing	Approved	None posted
Dec 6, 1995	Supplement 5Manufacturing	Approved	None posted
Oct 5, 1995	Supplement 8Manufacturing	Approved	None posted
Aug 4, 1995	Supplement 7Manufacturing	Approved	None posted
Jul 14, 1994	Supplement 4Labeling	Approved	None posted
Dec 4, 1990	Supplement 3Manufacturing	Approved	None posted
Dec 13, 1984	Original application	Approved	None posted

Identifiers

Application: ANDA 62535
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