Gentamicin Sulfate

ANDA 63106, held by Teva Parenteral. Gentamicin Sulfate.

As of Nov 15, 2026, ANDA 63106 (Gentamicin Sulfate), held by Teva Parenteral, was first approved by FDA on Nov 21, 1991, with 5 approved supplements and 0 published complete response letters.

First approved: Nov 21, 1991
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
Nov 21, 1991	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Gentamicin SulfateEQ 40MG BASE/ML · injectable;injection	Gentamicin Sulfate	Discontinued

All 6 submissions, including labeling and manufacturing supplements


Oct 4, 1993	Supplement 4Manufacturing	Approved	None posted
May 28, 1993	Supplement 3Manufacturing	Approved	None posted
May 28, 1993	Supplement 5Manufacturing	Approved	None posted
Sep 23, 1992	Supplement 2Manufacturing	Approved	None posted
May 8, 1992	Supplement 1Manufacturing	Approved	None posted
Nov 21, 1991	Original application	Approved	None posted

Identifiers

Application: ANDA 63106
Drugs@FDA: Overview at FDA
Company: Teva Parenteral Medicines

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