Garamycin

NDA 50039, held by Schering. Gentamicin Sulfate.

As of Nov 13, 2026, NDA 50039 (Garamycin), held by Schering, was first approved by FDA on Jun 19, 1970, with 19 approved supplements and 0 published complete response letters.

First approved: Jun 19, 1970
Supplements approved: 19
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 20 submissions below

Date	Submission	Status	Documents
Jun 19, 1970	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
GaramycinEQ 0.3% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · solution/drops;ophthalmic	Gentamicin Sulfate	DiscontinuedReference drug

All 20 submissions, including labeling and manufacturing supplements


Oct 18, 1999	Supplement 21Manufacturing	Approved	None posted
Sep 20, 1999	Supplement 20Manufacturing	Approved	None posted
Jul 28, 1999	Supplement 19Manufacturing	Approved	None posted
Aug 21, 1997	Supplement 17Manufacturing	Approved	None posted
Jul 29, 1997	Supplement 16Labeling	Approved	None posted
Nov 13, 1996	Supplement 15Manufacturing	Approved	None posted
Mar 17, 1992	Supplement 6Labeling	Approved	None posted
Feb 14, 1989	Supplement 5Manufacturing	Approved	None posted
Mar 20, 1987	Supplement 4Manufacturing	Approved	None posted
May 15, 1986	Supplement 1Manufacturing	Approved	None posted
Mar 12, 1986	Supplement 3Manufacturing	Approved	None posted
Oct 25, 1985	Supplement 2Manufacturing	Approved	None posted
Jul 13, 1981	Supplement 14Manufacturing	Approved	None posted
Feb 24, 1981	Supplement 13Manufacturing	Approved	None posted
Jun 24, 1980	Supplement 12Labeling	Approved	None posted
Sep 18, 1979	Supplement 11Labeling	Approved	None posted
Jan 25, 1979	Supplement 10Manufacturing	Approved	None posted
Mar 27, 1974	Supplement 8Manufacturing	Approved	None posted
Apr 11, 1972	Supplement 7Manufacturing	Approved	None posted
Jun 19, 1970	Original application	Approved	None posted

Identifiers

Application: NDA 50039
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