Tobramycin

ANDA 63176, held by Alcon Pharms Ltd. Tobramycin.

As of Nov 15, 2026, ANDA 63176 (Tobramycin), held by Alcon Pharms Ltd, was first approved by FDA on May 25, 1994, with 4 approved supplements and 0 published complete response letters.

First approved: May 25, 1994
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
May 25, 1994	Original application	Approved	None posted

Products

1 strengths and forms

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

All 5 submissions, including labeling and manufacturing supplements


Feb 2, 1999	Supplement 3Manufacturing	Approved	None posted
Feb 2, 1999	Supplement 4Manufacturing	Approved	None posted
Dec 4, 1996	Supplement 2Manufacturing	Approved	None posted
Apr 16, 1996	Supplement 1Manufacturing	Approved	None posted
May 25, 1994	Original application	Approved	None posted

Identifiers

Application: ANDA 63176
Drugs@FDA: Overview at FDA
Company: Alcon Pharmaceuticals Ltd

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