Gentamicin Sulfate

ANDA 62533, held by Fougera Pharms Inc. Gentamicin Sulfate.

As of Nov 15, 2026, ANDA 62533 (Gentamicin Sulfate), held by Fougera Pharms Inc, was first approved by FDA on Oct 5, 1984, with 5 approved supplements and 0 published complete response letters.

First approved: Oct 5, 1984
Supplements approved: 5
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 6 submissions below

Date	Submission	Status	Documents
Oct 5, 1984	Original application	Approved	None posted

Products

1 strengths and forms

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

All 6 submissions, including labeling and manufacturing supplements


Oct 29, 2004	Supplement 6Labeling	Approved	None posted
Mar 19, 2002	Supplement 5Manufacturing	Approved	None posted
Mar 7, 1996	Supplement 4Manufacturing	Approved	None posted
Feb 2, 1996	Supplement 3Manufacturing	Approved	None posted
Apr 26, 1989	Supplement 2Manufacturing	Approved	None posted
Oct 5, 1984	Original application	Approved	None posted

Identifiers

Application: ANDA 62533
Drugs@FDA: Overview at FDA
Company: Fougera Pharmaceuticals Inc.

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