Netromycin

NDA 50544, held by Schering. Netilmicin Sulfate.

As of Nov 15, 2026, NDA 50544 (Netromycin), held by Schering, was first approved by FDA on Feb 28, 1983, with 13 approved supplements and 0 published complete response letters.

First approved: Feb 28, 1983
Review: Standard
Supplements approved: 13
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 14 submissions below

Date	Submission	Status	Documents
Feb 28, 1983	Original applicationNew molecular entity · Standard review	Approved	None posted

Products

3 strengths and forms


NetromycinEQ 10MG BASE/ML · injectable;injection	Netilmicin Sulfate	Discontinued
NetromycinEQ 25MG BASE/ML · injectable;injection	Netilmicin Sulfate	Discontinued
NetromycinEQ 100MG BASE/ML · injectable;injection	Netilmicin Sulfate	Discontinued

All 14 submissions, including labeling and manufacturing supplements


Jan 13, 1998	Supplement 16Manufacturing · Standard review	Approved	None posted
Nov 17, 1997	Supplement 15Manufacturing · Standard review	Approved	None posted
Jul 1, 1997	Supplement 14Manufacturing · Standard review	Approved	None posted
Nov 20, 1996	Supplement 13Manufacturing · Standard review	Approved	None posted
Feb 22, 1994	Supplement 12Manufacturing · Standard review	Approved	None posted
Feb 14, 1989	Supplement 11Manufacturing · Standard review	Approved	None posted
May 15, 1987	Supplement 10Labeling · Standard review	Approved	None posted
Mar 12, 1986	Supplement 9Manufacturing · Standard review	Approved	None posted
Jun 12, 1984	Supplement 8Manufacturing · Standard review	Approved	None posted
May 11, 1984	Supplement 6Manufacturing · Standard review	Approved	None posted
Feb 18, 1984	Supplement 4Labeling · Standard review	Approved	None posted
May 17, 1983	Supplement 5Manufacturing · Standard review	Approved	None posted
Mar 28, 1983	Supplement 1Manufacturing · Standard review	Approved	None posted
Feb 28, 1983	Original applicationNew molecular entity · Standard review	Approved	None posted

Identifiers

Application: NDA 50544
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