🇺🇸 loperamide ("Seldiar") in United States

FDA authorised loperamide ("Seldiar") on 6 September 2006

Marketing authorisations

FDA — authorised 6 September 2006

  • Application: ANDA077500
  • Marketing authorisation holder: SUN PHARM INDS LTD
  • Status: supplemented

FDA — authorised 20 May 2011

  • Application: ANDA091292
  • Marketing authorisation holder: PERRIGO R AND D
  • Status: supplemented

FDA — authorised 5 September 2018

  • Application: ANDA209837
  • Marketing authorisation holder: PERRIGO R AND D
  • Status: approved

FDA — authorised 6 October 2021

  • Application: ANDA215001
  • Marketing authorisation holder: EDENBRIDGE PHARMS
  • Status: approved

FDA — authorised 5 September 2023

  • Application: ANDA218122
  • Marketing authorisation holder: AUROBINDO PHARMA LTD
  • Status: approved

Other Gastroenterology approved in United States

Frequently asked questions

Is loperamide ("Seldiar") approved in United States?

Yes. FDA authorised it on 6 September 2006; FDA authorised it on 20 May 2011; FDA authorised it on 5 September 2018.

Who is the marketing authorisation holder for loperamide ("Seldiar") in United States?

SUN PHARM INDS LTD holds the US marketing authorisation.