🇺🇸 200mg in United States

FDA authorised 200mg on 21 June 2005

Marketing authorisations

FDA — authorised 21 June 2005

  • Application: ANDA077349
  • Marketing authorisation holder: PERRIGO R AND D
  • Status: supplemented

FDA — authorised 10 December 2010

  • Application: ANDA079174
  • Marketing authorisation holder: GRANULES INDIA
  • Status: approved

FDA — authorised 7 October 2016

  • Application: ANDA202312
  • Marketing authorisation holder: GRANULES
  • Status: approved

FDA — authorised 5 May 2017

  • Application: ANDA207095
  • Marketing authorisation holder: SHANDONG XINHUA
  • Status: approved

FDA

  • Status: approved

200mg 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 200mg approved in United States?

Yes. FDA authorised it on 21 June 2005; FDA authorised it on 10 December 2010; FDA authorised it on 7 October 2016.

Who is the marketing authorisation holder for 200mg in United States?

PERRIGO R AND D holds the US marketing authorisation.