Tobramycin

Treats external infections of the eye and its adnexa caused by susceptible bacteria. ANDA 207444, held by Somerset Theraps LLC. Tobramycin.

As of Nov 15, 2026, ANDA 207444 (Tobramycin), held by Somerset Theraps LLC, was first approved by FDA on Jun 28, 2017, with 3 approved supplements and 0 published complete response letters.

First approved: Jun 28, 2017
Review: Standard
Supplements approved: 3
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Tobramycin ophthalmic solution 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 4 submissions below

Date	Submission	Status	Documents
Jun 28, 2017	Original application	Approved	None posted

Products

1 strengths and forms

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

All 4 submissions, including labeling and manufacturing supplements


Feb 20, 2024	Supplement 1Labeling · Standard review	Approved	None posted
Feb 20, 2024	Supplement 3Labeling · Standard review	Approved	None posted
Feb 20, 2024	Supplement 4Labeling · Standard review	Approved	None posted
Jun 28, 2017	Original application	Approved	None posted

Identifiers

Application: ANDA 207444
Drugs@FDA: Overview at FDA
Company: Somerset Therapeutics

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