Bactroban

NDA 50746, held by Glaxosmithkline. Mupirocin Calcium.

As of Nov 14, 2026, NDA 50746 (Bactroban), held by Glaxosmithkline, was first approved by FDA on Dec 11, 1997, with 15 approved supplements and 0 published complete response letters.

First approved: Dec 11, 1997
Review: Standard
Supplements approved: 15
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 16 submissions below

Date	Submission	Status	Documents
Dec 11, 1997	Original applicationNew dosage form · Standard review	Approved	Review

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BactrobanEQ 2% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · cream;topical	Mupirocin Calcium	DiscontinuedReference drug

All 16 submissions, including labeling and manufacturing supplements


Feb 19, 2020	Supplement 22Labeling · Standard review	Approved	Letter Label
May 8, 2017	Supplement 21Labeling · Standard review	Approved	Letter Label
Dec 16, 2015	Supplement 19Manufacturing · Standard review	Approved	None posted
Dec 14, 2015	Supplement 20Labeling · Standard review	Approved	Label Letter
Mar 19, 2015	Supplement 13Labeling · Standard review	Approved	Letter Label
May 22, 2014	Supplement 18Labeling · Standard review	Approved	Label Letter
Nov 15, 2001	Supplement 9Manufacturing · Standard review	Approved	None posted
Nov 9, 2001	Supplement 8Manufacturing · Standard review	Approved	None posted
Sep 21, 2001	Supplement 7Manufacturing · Standard review	Approved	None posted
Dec 13, 2000	Supplement 6Manufacturing · Standard review	Approved	None posted
Jul 14, 2000	Supplement 5Manufacturing · Standard review	Approved	None posted
Oct 6, 1999	Supplement 4Manufacturing · Standard review	Approved	None posted
May 19, 1999	Supplement 3Manufacturing · Standard review	Approved	None posted
Sep 4, 1998	Supplement 2Manufacturing · Standard review	Approved	None posted
Jun 10, 1998	Supplement 1Manufacturing · Standard review	Approved	None posted
Dec 11, 1997	Original applicationNew dosage form · Standard review	Approved	Review

Identifiers

Application: NDA 50746
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