Garamycin

NDA 50505, held by Schering. Gentamicin Sulfate.

As of Nov 14, 2026, NDA 50505 (Garamycin), held by Schering, was first approved by FDA on Oct 1, 1979, with 8 approved supplements and 0 published complete response letters.

First approved: Oct 1, 1979
Review: Standard
Supplements approved: 8
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 9 submissions below

Date	Submission	Status	Documents
Oct 1, 1979	Original applicationNew dosage form · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
GaramycinEQ 2MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · injectable;intrathecal	Gentamicin Sulfate	DiscontinuedReference drug

All 9 submissions, including labeling and manufacturing supplements


Feb 14, 1989	Supplement 7Manufacturing · Standard review	Approved	None posted
Mar 20, 1987	Supplement 6Manufacturing · Standard review	Approved	None posted
Mar 17, 1986	Supplement 5Manufacturing · Standard review	Approved	None posted
Oct 17, 1983	Supplement 4Labeling · Standard review	Approved	None posted
May 17, 1983	Supplement 3Labeling · Standard review	Approved	None posted
Oct 29, 1982	Supplement 1Labeling · Standard review	Approved	None posted
Oct 21, 1980	Supplement 10Labeling · Standard review	Approved	None posted
Mar 18, 1980	Supplement 9Labeling · Standard review	Approved	None posted
Oct 1, 1979	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 50505
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