🇺🇸 METHYLPREDNISOLONE SODIUM SUCCINATE in United States

FDA authorised METHYLPREDNISOLONE SODIUM SUCCINATE on 30 July 2004

Marketing authorisations

FDA — authorised 30 July 2004

  • Application: ANDA040583
  • Marketing authorisation holder: FRESENIUS KABI USA
  • Status: approved

FDA — authorised 12 August 2004

  • Application: ANDA040612
  • Marketing authorisation holder: FRESENIUS KABI USA
  • Status: supplemented

FDA — authorised 15 December 2015

  • Application: ANDA207667
  • Marketing authorisation holder: EUGIA PHARMA
  • Status: approved

FDA — authorised 16 February 2016

  • Application: ANDA202691
  • Marketing authorisation holder: HIKMA
  • Status: supplemented

FDA — authorised 26 September 2022

  • Application: ANDA203125
  • Marketing authorisation holder: HIKMA
  • Status: approved

FDA

  • Status: approved

METHYLPREDNISOLONE SODIUM SUCCINATE 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 METHYLPREDNISOLONE SODIUM SUCCINATE approved in United States?

Yes. FDA authorised it on 30 July 2004; FDA authorised it on 12 August 2004; FDA authorised it on 15 December 2015.

Who is the marketing authorisation holder for METHYLPREDNISOLONE SODIUM SUCCINATE in United States?

FRESENIUS KABI USA holds the US marketing authorisation.