FDA — authorised 23 May 1980
- Application: NDA018300
- Marketing authorisation holder: MOLNLYCKE HLTH
- Local brand name: HIBISTAT
- Indication: SOLUTION — TOPICAL
- Status: approved
🇺🇸 mupirocin and chlorhexidine in United States
FDA authorised mupirocin and chlorhexidine on 23 May 1980
Marketing authorisations
FDA — authorised 17 December 1985
- Application: NDA019422
- Marketing authorisation holder: XTTRIUM
- Local brand name: DYNA-HEX 2
- Indication: SOLUTION — TOPICAL
- Status: approved
FDA — authorised 24 July 1986
- Application: ANDA070104
- Marketing authorisation holder: MATRIX MEDCL
- Local brand name: STERI-STAT
- Indication: SOLUTION — TOPICAL
- Status: approved
FDA — authorised 17 December 1987
- Application: ANDA071419
- Marketing authorisation holder: SOAPCO
- Local brand name: BRIAN CARE
- Indication: SOLUTION — TOPICAL
- Status: approved
FDA — authorised 31 March 1989
- Application: NDA019822
- Marketing authorisation holder: GRIFFEN
- Local brand name: BIOSCRUB
- Indication: SPONGE — TOPICAL
- Status: approved
FDA — authorised 24 October 1989
- Application: ANDA072525
- Marketing authorisation holder: BECTON DICKINSON
- Local brand name: CHLORHEXIDINE GLUCONATE
- Indication: SPONGE — TOPICAL
- Status: approved
FDA — authorised 15 December 1995
- Application: ANDA074522
- Marketing authorisation holder: PHARM ASSOC
- Local brand name: CHLORHEXIDINE GLUCONATE
- Indication: SOLUTION — DENTAL
- Status: approved
FDA — authorised 28 December 1995
- Application: ANDA074291
- Marketing authorisation holder: LYNE
- Local brand name: CHLORHEXIDINE GLUCONATE
- Indication: SOLUTION — DENTAL
- Status: approved
FDA — authorised 7 May 1996
- Application: ANDA074356
- Marketing authorisation holder: SCIEGEN PHARMS
- Local brand name: CHLORHEXIDINE GLUCONATE
- Indication: SOLUTION — DENTAL
- Status: approved
FDA — authorised 14 March 2000
- Application: ANDA073416
- Marketing authorisation holder: BECTON DICKINSON
- Local brand name: E-Z SCRUB
- Indication: SPONGE — TOPICAL
- Status: approved
FDA — authorised 14 November 2000
- Application: ANDA075561
- Marketing authorisation holder: BAJAJ
- Local brand name: CHLORHEXIDINE GLUCONATE
- Indication: SOLUTION — DENTAL
- Status: approved
FDA — authorised 8 August 2018
- Application: NDA208288
- Marketing authorisation holder: SOLVENTUM
- Local brand name: SOLUPREP S
- Indication: SOLUTION — TOPICAL
- Status: approved
FDA — authorised 20 November 2018
- Application: NDA207964
- Marketing authorisation holder: MEDLINE INDUSTRIES
- Local brand name: READYPREP CHG
- Indication: CLOTH — TOPICAL
- Status: approved
FDA
- Status: approved
FDA
- Application: NDA019490
- Marketing authorisation holder: KENDALL IL
- Local brand name: CHLORHEXIDINE GLUCONATE
- Indication: SPONGE — TOPICAL
- Status: approved
mupirocin and chlorhexidine 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 and chlorhexidine approved in United States?
Yes. FDA authorised it on 23 May 1980; FDA authorised it on 17 December 1985; FDA authorised it on 24 July 1986.
Who is the marketing authorisation holder for mupirocin and chlorhexidine in United States?
MOLNLYCKE HLTH holds the US marketing authorisation.