FDA — authorised 31 December 1987
- Marketing authorisation holder: GLAXOSMITHKLINE
- Status: approved
🇺🇸 Bactroban in United States
FDA authorised Bactroban on 31 December 1987
Marketing authorisations
FDA — authorised 31 December 1987
- Application: NDA050591
- Marketing authorisation holder: GLAXOSMITHKLINE
- Local brand name: BACTROBAN
- Indication: OINTMENT — TOPICAL
- Status: approved
FDA — authorised 18 September 1995
- Application: NDA050703
- Marketing authorisation holder: GLAXOSMITHKLINE
- Local brand name: BACTROBAN
- Indication: OINTMENT — NASAL
- Status: approved
FDA — authorised 11 December 1997
- Application: NDA050746
- Marketing authorisation holder: GLAXOSMITHKLINE
- Local brand name: BACTROBAN
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 7 November 2003
- Application: ANDA065085
- Marketing authorisation holder: TEVA
- Local brand name: MUPIROCIN
- Indication: OINTMENT — TOPICAL
- Status: approved
FDA — authorised 7 November 2003
- Application: ANDA065123
- Marketing authorisation holder: PADAGIS ISRAEL
- Local brand name: MUPIROCIN
- Indication: OINTMENT — TOPICAL
- Status: approved
FDA — authorised 23 September 2005
- Application: ANDA065170
- Marketing authorisation holder: SUN PHARMA CANADA
- Local brand name: MUPIROCIN
- Indication: OINTMENT — TOPICAL
- Status: approved
FDA — authorised 8 June 2011
- Application: ANDA090480
- Marketing authorisation holder: GLENMARK PHARMS
- Local brand name: MUPIROCIN
- Indication: OINTMENT — TOPICAL
- Status: approved
FDA — authorised 24 January 2013
- Application: ANDA201587
- Marketing authorisation holder: GLENMARK PHARMS
- Local brand name: MUPIROCIN
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 27 April 2020
- Application: ANDA207116
- Marketing authorisation holder: SUN PHARMA CANADA
- Local brand name: MUPIROCIN
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 3 August 2022
- Application: ANDA212465
- Marketing authorisation holder: PADAGIS ISRAEL
- Local brand name: MUPIROCIN
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 15 November 2022
- Application: ANDA214811
- Marketing authorisation holder: AMNEAL
- Local brand name: MUPIROCIN
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 13 May 2025
- Application: ANDA217943
- Marketing authorisation holder: ENCUBE
- Local brand name: MUPIROCIN
- Indication: OINTMENT — TOPICAL
- Status: approved
Bactroban in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Immunology approved in United States
Frequently asked questions
Is Bactroban approved in United States?
Yes. FDA authorised it on 31 December 1987; FDA authorised it on 31 December 1987; FDA authorised it on 18 September 1995.
Who is the marketing authorisation holder for Bactroban in United States?
GLAXOSMITHKLINE holds the US marketing authorisation.