Tobrasone

NDA 50628, held by Harrow Eye. Fluorometholone Acetate; Tobramycin.

As of Nov 13, 2026, NDA 50628 (Tobrasone), held by Harrow Eye, was first approved by FDA on Jul 21, 1989, with 4 approved supplements and 0 published complete response letters.

First approved: Jul 21, 1989
Review: Standard
Supplements approved: 4
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 5 submissions below

Date	Submission	Status	Documents
Jul 21, 1989	Original applicationNew combination · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Tobrasone0.1%;0.3% · suspension/drops;ophthalmic	Fluorometholone Acetate; Tobramycin	Discontinued

All 5 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Dec 11, 2002	Supplement 4Manufacturing · Standard review	Approved	None posted
Dec 4, 2002	Supplement 3Manufacturing · Standard review	Approved	None posted
May 9, 2001	Supplement 2Manufacturing · Standard review	Approved	None posted
May 7, 2001	Supplement 1Labeling · Standard review	Approved	Label
Jul 21, 1989	Original applicationNew combination · Standard review	Approved	None posted

Identifiers

Application: NDA 50628
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