🇺🇸 5 mg in United States

FDA authorised 5 mg on 7 April 2010

Marketing authorisations

FDA — authorised 7 April 2010

  • Application: ANDA078414
  • Marketing authorisation holder: OXFORD PHARMS
  • Status: supplemented

FDA — authorised 15 June 2010

  • Application: ANDA078933
  • Marketing authorisation holder: MARKSANS PHARMA
  • Status: approved

FDA — authorised 5 December 2023

  • Application: ANDA212629
  • Marketing authorisation holder: POINTVIEW HLDINGS
  • Status: supplemented

FDA

  • Status: approved

5 mg 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 5 mg approved in United States?

Yes. FDA authorised it on 7 April 2010; FDA authorised it on 15 June 2010; FDA authorised it on 5 December 2023.

Who is the marketing authorisation holder for 5 mg in United States?

OXFORD PHARMS holds the US marketing authorisation.