Tobramycin

Treats external infections of the eye and its adnexa caused by susceptible bacteria. ANDA 64052, held by Bausch And Lomb Inc. Tobramycin.

As of Nov 15, 2026, ANDA 64052 (Tobramycin), held by Bausch And Lomb Inc, was first approved by FDA on Nov 29, 1993, with 21 approved supplements and 0 published complete response letters.

First approved: Nov 29, 1993
Supplements approved: 21
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. 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 22 submissions below

Date	Submission	Status	Documents
Nov 29, 1993	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Tobramycin0.3% · solution/drops;ophthalmic	Tobramycin	Rx

All 22 submissions, including labeling and manufacturing supplements


Jun 21, 2021	Supplement 39Labeling · Standard review	Approved	None posted
Jun 21, 2021	Supplement 38Labeling · Standard review	Approved	None posted
May 8, 2020	Supplement 32Labeling · Standard review	Approved	None posted
Nov 27, 2001	Supplement 20Manufacturing	Approved	None posted
Mar 7, 2001	Supplement 18Manufacturing	Approved	None posted
Oct 5, 2000	Supplement 17Manufacturing	Approved	None posted
Jul 3, 2000	Supplement 14Manufacturing	Approved	None posted
Jun 27, 2000	Supplement 16Manufacturing	Approved	None posted
May 18, 2000	Supplement 12Manufacturing	Approved	None posted
May 15, 2000	Supplement 15Manufacturing	Approved	None posted
Apr 28, 2000	Supplement 13Manufacturing	Approved	None posted
Jun 7, 1999	Supplement 11Manufacturing	Approved	None posted
Nov 19, 1998	Supplement 10Manufacturing	Approved	None posted
Oct 13, 1998	Supplement 9Manufacturing	Approved	None posted
Oct 13, 1998	Supplement 6Manufacturing	Approved	None posted
Jan 21, 1998	Supplement 8Manufacturing	Approved	None posted
Aug 26, 1996	Supplement 7Manufacturing	Approved	None posted
Apr 26, 1995	Supplement 5Manufacturing	Approved	None posted
Apr 26, 1995	Supplement 4Manufacturing	Approved	None posted
Jun 10, 1994	Supplement 1Manufacturing	Approved	None posted
Mar 10, 1994	Supplement 2Manufacturing	Approved	None posted
Nov 29, 1993	Original application	Approved	None posted

Identifiers

Application: ANDA 64052
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