FDA — authorised 7 November 2003
- Application: ANDA065085
- Marketing authorisation holder: TEVA
- Local brand name: MUPIROCIN
- Indication: OINTMENT — TOPICAL
- Status: approved
🇺🇸 Mupirocin calcium 2 % ointment in United States
FDA authorised Mupirocin calcium 2 % ointment on 7 November 2003
Marketing authorisations
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
- Status: approved
Mupirocin calcium 2 % ointment in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is Mupirocin calcium 2 % ointment approved in United States?
Yes. FDA authorised it on 7 November 2003; FDA authorised it on 8 June 2011; FDA authorised it on 24 January 2013.
Who is the marketing authorisation holder for Mupirocin calcium 2 % ointment in United States?
TEVA holds the US marketing authorisation.