🇺🇸 "AS-Probionorm" in United States

FDA authorised "AS-Probionorm" on 1 November 1950

Marketing authorisations

FDA — authorised 1 November 1950

  • Application: ANDA060286
  • Marketing authorisation holder: PFIZER
  • Status: approved

FDA — authorised 18 April 2000

  • Application: NDA021131
  • Marketing authorisation holder: PFIZER
  • Status: approved

FDA — authorised 17 February 2005

  • Application: NDA020645
  • Marketing authorisation holder: BAUSCH
  • Status: supplemented

FDA — authorised 18 June 2009

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

FDA — authorised 24 March 2010

  • Application: NDA022554
  • Marketing authorisation holder: SALIX PHARMS
  • Status: approved

Other Gastroenterology approved in United States

Frequently asked questions

Is "AS-Probionorm" approved in United States?

Yes. FDA authorised it on 1 November 1950; FDA authorised it on 18 April 2000; FDA authorised it on 17 February 2005.

Who is the marketing authorisation holder for "AS-Probionorm" in United States?

PFIZER holds the US marketing authorisation.