🇺🇸 CHLORHEXIDINE GLUCONATE in United States

FDA authorised CHLORHEXIDINE GLUCONATE on 22 July 1986

Marketing authorisations

FDA — authorised 22 July 1986

  • Application: NDA019258
  • Marketing authorisation holder: ECOLAB
  • Status: supplemented

FDA — authorised 15 December 1995

  • Application: ANDA074522
  • Marketing authorisation holder: PHARM ASSOC
  • Status: supplemented

FDA — authorised 28 December 1995

  • Application: ANDA074291
  • Marketing authorisation holder: LYNE
  • Status: supplemented

FDA — authorised 11 September 1997

  • Application: NDA020111
  • Marketing authorisation holder: BAJAJ
  • Status: approved

FDA — authorised 18 June 2009

  • Application: ANDA077789
  • Marketing authorisation holder: PHARMOBEDIENT
  • Status: supplemented

FDA

  • Status: approved

CHLORHEXIDINE GLUCONATE 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 CHLORHEXIDINE GLUCONATE approved in United States?

Yes. FDA authorised it on 22 July 1986; FDA authorised it on 15 December 1995; FDA authorised it on 28 December 1995.

Who is the marketing authorisation holder for CHLORHEXIDINE GLUCONATE in United States?

ECOLAB holds the US marketing authorisation.