Garamycin

ANDA 61716, held by Schering. Gentamicin Sulfate.

As of Nov 15, 2026, ANDA 61716 (Garamycin), held by Schering, was first approved by FDA on Mar 3, 1981, with 4 approved supplements and 0 published complete response letters.

First approved: Mar 3, 1981
Supplements approved: 4
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 5 submissions below

Date	Submission	Status	Documents
Mar 3, 1981	Original application	Approved	None posted

Products

2 strengths and forms


GaramycinEQ 40MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · injectable;injection	Gentamicin Sulfate	Discontinued
GaramycinEQ 1MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · injectable;injection	Gentamicin Sulfate	Discontinued

All 5 submissions, including labeling and manufacturing supplements


Jan 4, 1999	Supplement 7Manufacturing	Approved	None posted
Sep 8, 1997	Supplement 5Manufacturing	Approved	None posted
Nov 29, 1996	Supplement 4Manufacturing	Approved	None posted
Feb 14, 1989	Supplement 3Manufacturing	Approved	None posted
Mar 3, 1981	Original application	Approved	None posted

Identifiers

Application: ANDA 61716
Drugs@FDA: Overview at FDA
Company: Schering Corporation

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