🇺🇸 Xylocaine in United States

FDA authorised Xylocaine on 19 November 1948

Marketing authorisations

FDA — authorised 19 November 1948

  • Application: NDA006488
  • Marketing authorisation holder: FRESENIUS KABI USA
  • Status: supplemented

FDA — authorised 22 January 1985

  • Application: ANDA088390
  • Marketing authorisation holder: DEPROCO
  • Status: supplemented

FDA — authorised 14 January 1986

  • Application: ANDA088389
  • Marketing authorisation holder: DEPROCO
  • Status: supplemented

FDA

  • Status: approved

Other Other approved in United States

Frequently asked questions

Is Xylocaine approved in United States?

Yes. FDA authorised it on 19 November 1948; FDA authorised it on 22 January 1985; FDA authorised it on 14 January 1986.

Who is the marketing authorisation holder for Xylocaine in United States?

FRESENIUS KABI USA holds the US marketing authorisation.