🇺🇸 Ribavirin "loading" dose given in United States

FDA authorised Ribavirin "loading" dose given on 31 December 1985

Marketing authorisations

FDA — authorised 31 December 1985

  • Application: NDA018859
  • Marketing authorisation holder: BAUSCH
  • Status: supplemented

FDA — authorised 17 September 2009

  • Application: ANDA079117
  • Marketing authorisation holder: AUROBINDO PHARMA
  • Status: supplemented

FDA — authorised 17 September 2009

  • Application: ANDA079111
  • Marketing authorisation holder: AUROBINDO PHARMA
  • Status: supplemented

FDA — authorised 6 October 2016

  • Application: ANDA207366
  • Marketing authorisation holder: NAVINTA LLC
  • Status: approved

Other Virology/Infectious Disease approved in United States

Frequently asked questions

Is Ribavirin "loading" dose given approved in United States?

Yes. FDA authorised it on 31 December 1985; FDA authorised it on 17 September 2009; FDA authorised it on 17 September 2009.

Who is the marketing authorisation holder for Ribavirin "loading" dose given in United States?

BAUSCH holds the US marketing authorisation.