🇺🇸 "Probiotics" and "Metronidazole" in United States

FDA authorised "Probiotics" and "Metronidazole" on 28 August 1981

Marketing authorisations

FDA — authorised 28 August 1981

  • Application: ANDA086173
  • Marketing authorisation holder: FOSUN PHARMA
  • Status: supplemented

FDA — authorised 22 October 1982

  • Application: NDA018740
  • Marketing authorisation holder: FOSUN PHARMA
  • Status: supplemented

FDA — authorised 17 September 2010

  • Application: ANDA079025
  • Marketing authorisation holder: CHARTWELL RX
  • Status: approved

FDA — authorised 21 December 2011

  • Application: ANDA090653
  • Marketing authorisation holder: HOSPIRA INC
  • Status: approved

FDA — authorised 26 June 2012

  • Application: ANDA090979
  • Marketing authorisation holder: PADAGIS ISRAEL
  • Status: approved

Other Gastroenterology / Infectious Disease approved in United States

Frequently asked questions

Is "Probiotics" and "Metronidazole" approved in United States?

Yes. FDA authorised it on 28 August 1981; FDA authorised it on 22 October 1982; FDA authorised it on 17 September 2010.

Who is the marketing authorisation holder for "Probiotics" and "Metronidazole" in United States?

FOSUN PHARMA holds the US marketing authorisation.