Gentamicin Sulfate

ANDA 62523, held by Alcon Pharms Ltd. Gentamicin Sulfate.

As of Nov 15, 2026, ANDA 62523 (Gentamicin Sulfate), held by Alcon Pharms Ltd, was first approved by FDA on Nov 25, 1985, with 13 approved supplements and 0 published complete response letters.

First approved: Nov 25, 1985
Supplements approved: 13
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 14 submissions below

Date	Submission	Status	Documents
Nov 25, 1985	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Gentamicin SulfateEQ 0.3% BASE · solution/drops;ophthalmic	Gentamicin Sulfate	Discontinued

All 14 submissions, including labeling and manufacturing supplements


Jun 16, 1999	Supplement 21Manufacturing	Approved	None posted
Feb 19, 1999	Supplement 19Manufacturing	Approved	None posted
Feb 2, 1999	Supplement 16Manufacturing	Approved	None posted
Dec 4, 1996	Supplement 15Manufacturing	Approved	None posted
Apr 16, 1996	Supplement 14Manufacturing	Approved	None posted
Mar 27, 1995	Supplement 13Manufacturing	Approved	None posted
Oct 18, 1994	Supplement 12Labeling	Approved	None posted
Jan 27, 1994	Supplement 11Labeling	Approved	None posted
Feb 11, 1992	Supplement 7Manufacturing	Approved	None posted
Feb 11, 1992	Supplement 8Labeling	Approved	None posted
Nov 22, 1991	Supplement 9Manufacturing	Approved	None posted
Oct 16, 1991	Supplement 10Labeling	Approved	None posted
Jul 29, 1988	Supplement 6Manufacturing	Approved	None posted
Nov 25, 1985	Original application	Approved	None posted

Identifiers

Application: ANDA 62523
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