Nebcin

NDA 50477, held by Lilly. Tobramycin Sulfate.

As of Nov 13, 2026, NDA 50477 (Nebcin), held by Lilly, was first approved by FDA on Jun 11, 1975, with 24 approved supplements and 0 published complete response letters.

First approved: Jun 11, 1975
Review: Standard
Supplements approved: 24
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 25 submissions below

Date	Submission	Status	Documents
Oct 1, 1997	Supplement 21Efficacy (new indication or use) · Standard review	Approved	None posted
Sep 3, 1975	Supplement 10Efficacy (new indication or use)	Approved	None posted
Jun 11, 1975	Original applicationNew molecular entity · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
NebcinEQ 10MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · injectable;injection	Tobramycin Sulfate	DiscontinuedReference drug

All 25 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Dec 7, 2007	Supplement 22Labeling · Standard review	Approved	None posted
Apr 2, 2003	Supplement 24Labeling · Standard review	Approved	Letter
Mar 4, 1999	Supplement 23Manufacturing · Standard review	Approved	None posted
Oct 1, 1997	Supplement 21Efficacy (new indication or use) · Standard review	Approved	None posted
May 13, 1997	Supplement 17Labeling · Standard review	Approved	None posted
Apr 3, 1997	Supplement 20Manufacturing · Standard review	Approved	None posted
Mar 19, 1997	Supplement 18Labeling · Standard review	Approved	None posted
Oct 18, 1995	Supplement 19Manufacturing · Standard review	Approved	None posted
Apr 1, 1993	Supplement 16Labeling	Approved	None posted
Aug 6, 1992	Supplement 15Labeling	Approved	None posted
Oct 28, 1991	Supplement 8Manufacturing · Standard review	Approved	None posted
Oct 28, 1991	Supplement 7Labeling	Approved	None posted
Jul 21, 1987	Supplement 6Labeling	Approved	None posted
Apr 2, 1987	Supplement 5Labeling	Approved	None posted
Mar 5, 1987	Supplement 4Manufacturing · Standard review	Approved	None posted
Nov 4, 1985	Supplement 3Labeling	Approved	None posted
Sep 28, 1984	Supplement 2Manufacturing · Standard review	Approved	None posted
Feb 24, 1984	Supplement 1Manufacturing · Standard review	Approved	None posted
May 28, 1980	Supplement 14Manufacturing · Standard review	Approved	None posted
Jun 2, 1976	Supplement 13Labeling	Approved	None posted
Feb 23, 1976	Supplement 12Labeling	Approved	None posted
Jan 13, 1976	Supplement 11Manufacturing · Standard review	Approved	None posted
Sep 3, 1975	Supplement 10Efficacy (new indication or use)	Approved	None posted
Jul 30, 1975	Supplement 9Labeling	Approved	None posted
Jun 11, 1975	Original applicationNew molecular entity · Standard review	Approved	None posted

Identifiers

Application: NDA 50477
Drugs@FDA: Overview at FDA
Company: Lilly

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