Neomycin Sulfate

Reduces ammonia-forming bacteria in the intestinal tract. ANDA 60304, held by Teva. Neomycin Sulfate.

As of Nov 15, 2026, ANDA 60304 (Neomycin Sulfate), held by Teva, was first approved by FDA on Sep 2, 1964, with 17 approved supplements and 0 published complete response letters.

First approved: Sep 2, 1964
Supplements approved: 17
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE To reduce the development of drug-resistant bacteria and maintain the effectiveness of neomycin sulfate tablets, USP and other antibacterial drugs, neomycin sulfate tablets, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 18 submissions below

Date	Submission	Status	Documents
Sep 2, 1964	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Neomycin Sulfate500MG · tablet;oral	Neomycin Sulfate	Rx

All 18 submissions, including labeling and manufacturing supplements


Feb 10, 2023	Supplement 52Labeling · Standard review	Approved	None posted
Aug 13, 2020	Supplement 50Labeling · Standard review	Approved	None posted
Feb 8, 2012	Supplement 47Labeling	Approved	None posted
Dec 3, 2007	Supplement 42Labeling	Approved	None posted
Nov 4, 2003	Supplement 34Labeling	Approved	None posted
Feb 27, 2002	Supplement 32Manufacturing	Approved	None posted
Sep 25, 2000	Supplement 31Manufacturing	Approved	None posted
Jul 7, 2000	Supplement 30Manufacturing	Approved	None posted
May 16, 2000	Supplement 29Manufacturing	Approved	None posted
Jun 18, 1997	Supplement 28Manufacturing	Approved	None posted
Apr 26, 1996	Supplement 27Manufacturing	Approved	None posted
Oct 26, 1995	Supplement 26Labeling	Approved	None posted
Feb 16, 1995	Supplement 25Manufacturing	Approved	None posted
Jan 11, 1995	Supplement 23Manufacturing	Approved	None posted
Sep 6, 1994	Supplement 24Manufacturing	Approved	None posted
Sep 9, 1993	Supplement 22Labeling	Approved	None posted
Oct 30, 1992	Supplement 21Labeling	Approved	None posted
Sep 2, 1964	Original application	Approved	None posted

Identifiers

Application: ANDA 60304
Drugs@FDA: Overview at FDA
Company: Teva Pharmaceutical Industries

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