Bactroban

NDA 50703, held by Glaxosmithkline. Mupirocin Calcium.

As of Nov 13, 2026, NDA 50703 (Bactroban), held by Glaxosmithkline, was first approved by FDA on Sep 18, 1995, with 12 approved supplements and 0 published complete response letters.

First approved: Sep 18, 1995
Review: Standard
Supplements approved: 12
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 13 submissions below

Date	Submission	Status	Documents
Sep 18, 1995	Original applicationNew active ingredient · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
BactrobanEQ 2% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · ointment;nasal	Mupirocin Calcium	DiscontinuedReference drug

All 13 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Feb 19, 2020	Supplement 18Labeling · Standard review	Approved	Letter Label
May 8, 2017	Supplement 17Labeling · Standard review	Approved	Letter Label
May 14, 2015	Supplement 16Labeling · Standard review	Approved	Label Letter
May 22, 2014	Supplement 15Labeling · Standard review	Approved	Label Letter
Nov 15, 2001	Supplement 8Manufacturing · Standard review	Approved	None posted
Nov 9, 2001	Supplement 7Manufacturing · Standard review	Approved	None posted
Dec 13, 2000	Supplement 6Manufacturing · Standard review	Approved	None posted
Oct 6, 1999	Supplement 5Manufacturing · Standard review	Approved	None posted
May 19, 1999	Supplement 4Manufacturing · Standard review	Approved	None posted
Sep 4, 1998	Supplement 3Manufacturing · Standard review	Approved	None posted
Apr 3, 1996	Supplement 2Manufacturing · Standard review	Approved	None posted
Nov 20, 1995	Supplement 1Manufacturing · Standard review	Approved	None posted
Sep 18, 1995	Original applicationNew active ingredient · Standard review	Approved	None posted

Identifiers

Application: NDA 50703
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