Bactroban

NDA 50591, held by Glaxosmithkline. Mupirocin.

As of Nov 13, 2026, NDA 50591 (Bactroban), held by Glaxosmithkline, was first approved by FDA on Dec 31, 1987, with 21 approved supplements and 0 published complete response letters.

First approved: Dec 31, 1987
Review: Standard
Supplements approved: 21
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 22 submissions below

Date	Submission	Status	Documents
Apr 22, 1999	Supplement 22Efficacy (new indication or use) · Standard review	Approved	Review Letter
Dec 31, 1987	Original applicationNew molecular entity · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Bactroban2% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · ointment;topical	Mupirocin	DiscontinuedReference drug

All 22 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
May 8, 2017	Supplement 34Labeling · Standard review	Approved	Letter Label
Dec 14, 2015	Supplement 33Labeling · Standard review	Approved	Label
Mar 19, 2015	Supplement 30Labeling · Standard review	Approved	Letter Label
May 22, 2014	Supplement 32Labeling · Standard review	Approved	Label Letter
Nov 9, 2001	Supplement 26Manufacturing · Standard review	Approved	None posted
Sep 21, 2001	Supplement 25Manufacturing · Standard review	Approved	None posted
Sep 12, 2000	Supplement 24Manufacturing · Standard review	Approved	None posted
May 19, 1999	Supplement 23Manufacturing · Standard review	Approved	None posted
Apr 22, 1999	Supplement 22Efficacy (new indication or use) · Standard review	Approved	Review Letter
Dec 3, 1997	Supplement 21Manufacturing · Standard review	Approved	None posted
Dec 24, 1996	Supplement 20Manufacturing · Standard review	Approved	None posted
Jun 6, 1996	Supplement 19Manufacturing · Standard review	Approved	None posted
Feb 21, 1996	Supplement 15Labeling	Approved	None posted
Mar 24, 1994	Supplement 17Manufacturing · Standard review	Approved	None posted
Mar 24, 1994	Supplement 16Manufacturing · Standard review	Approved	None posted
Nov 2, 1993	Supplement 18Manufacturing · Standard review	Approved	None posted
Sep 30, 1991	Supplement 12Labeling	Approved	None posted
Apr 15, 1991	Supplement 13Labeling	Approved	None posted
Apr 15, 1991	Supplement 11Labeling	Approved	None posted
Apr 15, 1991	Supplement 10Labeling	Approved	None posted
Apr 15, 1991	Supplement 9Labeling	Approved	None posted
Dec 31, 1987	Original applicationNew molecular entity · Standard review	Approved	None posted

Identifiers

Application: NDA 50591
Drugs@FDA: Overview at FDA
Company: GlaxoSmithKline LLC

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