🇺🇸 protamine in United States

FDA authorised protamine on 7 April 1987

Marketing authorisations

FDA — authorised 7 April 1987

  • Application: ANDA089454
  • Marketing authorisation holder: FRESENIUS KABI USA
  • Status: supplemented

FDA — authorised 22 December 1999

  • Application: BLA021017
  • Marketing authorisation holder: LILLY
  • Status: approved

FDA — authorised 1 November 2001

  • Application: BLA021172
  • Marketing authorisation holder: NOVO NORDISK INC
  • Status: supplemented

FDA

  • Status: approved

Other Other approved in United States

Frequently asked questions

Is protamine approved in United States?

Yes. FDA authorised it on 7 April 1987; FDA authorised it on 22 December 1999; FDA authorised it on 1 November 2001.

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

FRESENIUS KABI USA holds the US marketing authorisation.