Tobrex

NDA 50541, held by Novartis. Tobramycin.

As of Nov 13, 2026, NDA 50541 (Tobrex), held by Novartis, was first approved by FDA on Dec 12, 1980, with 21 approved supplements and 0 published complete response letters.

First approved: Dec 12, 1980
Review: Standard
Supplements approved: 21
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 22 submissions below

Date	Submission	Status	Documents
Dec 12, 1980	Original applicationNew dosage form · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Tobrex0.3% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · solution/drops;ophthalmic	Tobramycin	DiscontinuedReference drug

All 22 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
May 14, 2021	Supplement 31Labeling · Standard review	Approved	Letter Label
Apr 24, 2020	Supplement 30Labeling · Standard review	Approved	Letter Label
Dec 18, 2012	Supplement 23Manufacturing · Standard review	Approved	None posted
Dec 14, 2012	Supplement 24Labeling · Standard review	Approved	Label Letter
Jul 22, 2003	Supplement 17Labeling · Standard review	Approved	Letter Label
Dec 4, 2002	Supplement 19Manufacturing · Standard review	Approved	None posted
May 2, 2002	Supplement 18Manufacturing · Standard review	Approved	None posted
Feb 18, 2000	Supplement 15Manufacturing · Standard review	Approved	None posted
Aug 17, 1999	Supplement 14Manufacturing · Standard review	Approved	None posted
Mar 11, 1999	Supplement 12Manufacturing · Standard review	Approved	None posted
Feb 5, 1999	Supplement 13Manufacturing · Standard review	Approved	None posted
Dec 18, 1998	Supplement 11Manufacturing · Standard review	Approved	None posted
Aug 4, 1998	Supplement 10Manufacturing · Standard review	Approved	None posted
Jan 15, 1998	Supplement 9Manufacturing · Standard review	Approved	None posted
Jun 25, 1996	Supplement 7Manufacturing · Standard review	Approved	None posted
Mar 5, 1996	Supplement 6Manufacturing · Standard review	Approved	None posted
Nov 1, 1995	Supplement 5Manufacturing · Standard review	Approved	None posted
Nov 1, 1995	Supplement 4Manufacturing · Standard review	Approved	None posted
Jun 13, 1995	Supplement 1Manufacturing · Standard review	Approved	None posted
Jul 27, 1994	Supplement 3Manufacturing · Standard review	Approved	None posted
Jun 13, 1994	Supplement 2Labeling · Standard review	Approved	None posted
Dec 12, 1980	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 50541
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