Gentamicin Sulfate

ANDA 62531, held by Fougera Pharms Inc. Gentamicin Sulfate.

As of Nov 15, 2026, ANDA 62531 (Gentamicin Sulfate), held by Fougera Pharms Inc, was first approved by FDA on Jul 5, 1984, with 6 approved supplements and 0 published complete response letters.

First approved: Jul 5, 1984
Supplements approved: 6
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 7 submissions below

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

Products

1 strengths and forms

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

All 7 submissions, including labeling and manufacturing supplements


Oct 29, 2004	Supplement 8Labeling	Approved	None posted
Mar 19, 2002	Supplement 7Manufacturing	Approved	None posted
Mar 7, 1996	Supplement 6Manufacturing	Approved	None posted
Dec 29, 1993	Supplement 5Labeling	Approved	None posted
Feb 2, 1993	Supplement 4Labeling	Approved	None posted
Apr 26, 1989	Supplement 3Manufacturing	Approved	None posted
Jul 5, 1984	Original application	Approved	None posted

Identifiers

Application: ANDA 62531
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