🇺🇸 150mg in United States

FDA authorised 150mg on 12 December 2016

Marketing authorisations

FDA — authorised 12 December 2016

  • Application: ANDA207456
  • Marketing authorisation holder: SHILPA
  • Status: supplemented

FDA

  • Status: approved

150mg 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 150mg approved in United States?

Yes. FDA authorised it on 12 December 2016; FDA has authorised it.

Who is the marketing authorisation holder for 150mg in United States?

SHILPA holds the US marketing authorisation.