Gentamicin Sulfate

ANDA 62477, held by Sun Pharma Canada. Gentamicin Sulfate.

As of Nov 15, 2026, ANDA 62477 (Gentamicin Sulfate), held by Sun Pharma Canada, was first approved by FDA on Dec 23, 1983, with 9 approved supplements and 0 published complete response letters.

First approved: Dec 23, 1983
Supplements approved: 9
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 10 submissions below

Date	Submission	Status	Documents
Dec 23, 1983	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Gentamicin SulfateEQ 0.1% BASE · ointment;topical	Gentamicin Sulfate	Discontinued

All 10 submissions, including labeling and manufacturing supplements


Jul 5, 1996	Supplement 24Labeling	Approved	None posted
Jul 5, 1996	Supplement 23Manufacturing	Approved	None posted
Mar 18, 1993	Supplement 22Labeling	Approved	None posted
Aug 27, 1992	Supplement 21Labeling	Approved	None posted
Aug 5, 1992	Supplement 20Labeling	Approved	None posted
Apr 26, 1991	Supplement 19Labeling	Approved	None posted
Nov 19, 1990	Supplement 18Manufacturing	Approved	None posted
Jun 30, 1989	Supplement 17Manufacturing	Approved	None posted
Nov 16, 1988	Supplement 16Manufacturing	Approved	None posted
Dec 23, 1983	Original application	Approved	None posted

Identifiers

Application: ANDA 62477
Drugs@FDA: Overview at FDA
Company: Sun Pharma Canada

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