🇺🇸 SIMETHICONE in United States

FDA authorised SIMETHICONE on 6 September 2006

Marketing authorisations

FDA — authorised 6 September 2006

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

FDA — authorised 5 September 2018

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

FDA — authorised 14 December 2020

  • Application: ANDA211059
  • Marketing authorisation holder: AUROBINDO PHARMA LTD
  • Status: approved

FDA — authorised 10 September 2021

  • Application: ANDA213484
  • Marketing authorisation holder: BIONPHARMA
  • Status: approved

FDA — authorised 29 August 2022

  • Application: ANDA215981
  • Marketing authorisation holder: GRANULES
  • Status: approved

FDA

  • Status: approved

SIMETHICONE in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Frequently asked questions

Is SIMETHICONE approved in United States?

Yes. FDA authorised it on 6 September 2006; FDA authorised it on 5 September 2018; FDA authorised it on 14 December 2020.

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

SUN PHARM INDS LTD holds the US marketing authorisation.