🇺🇸 Methylphenidate (MPH) in United States

FDA authorised Methylphenidate (MPH) on 3 April 2001

Marketing authorisation

FDA — authorised 3 April 2001

  • Application: NDA021259
  • Marketing authorisation holder: AYTU BIOPHARMA
  • Local brand name: METADATE CD
  • Indication: CAPSULE, EXTENDED RELEASE — ORAL
  • Status: approved

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Other Neurology; Psychiatry approved in United States

Frequently asked questions

Is Methylphenidate (MPH) approved in United States?

Yes. FDA authorised it on 3 April 2001.

Who is the marketing authorisation holder for Methylphenidate (MPH) in United States?

AYTU BIOPHARMA holds the US marketing authorisation.