🇺🇸 METHIMAZOLE in United States

FDA authorised METHIMAZOLE on 29 March 2000

Marketing authorisations

FDA — authorised 29 March 2000

  • Application: ANDA040350
  • Marketing authorisation holder: MYLAN
  • Status: supplemented

FDA — authorised 18 February 2005

  • Application: ANDA040547
  • Marketing authorisation holder: AIPING PHARM INC
  • Status: supplemented

FDA — authorised 7 March 2012

  • Application: ANDA202068
  • Marketing authorisation holder: RISING
  • Status: supplemented

FDA — authorised 24 May 2023

  • Application: ANDA209827
  • Marketing authorisation holder: MACLEODS PHARMS LTD
  • Status: approved

FDA — authorised 25 September 2023

  • Application: ANDA218149
  • Marketing authorisation holder: BIONPHARMA
  • Status: approved

FDA

  • Status: approved

METHIMAZOLE 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 METHIMAZOLE approved in United States?

Yes. FDA authorised it on 29 March 2000; FDA authorised it on 18 February 2005; FDA authorised it on 7 March 2012.

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

MYLAN holds the US marketing authorisation.