🇺🇸 ADZENYS XR-ODT in United States

FDA authorised ADZENYS XR-ODT on 27 January 2016

Marketing authorisations

FDA — authorised 27 January 2016

  • Application: NDA204326
  • Marketing authorisation holder: NEOS THERAPS
  • Local brand name: ADZENYS XR-ODT
  • Indication: TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE — ORAL
  • Status: approved

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FDA

  • Status: approved

ADZENYS XR-ODT 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 ADZENYS XR-ODT approved in United States?

Yes. FDA authorised it on 27 January 2016; FDA has authorised it.

Who is the marketing authorisation holder for ADZENYS XR-ODT in United States?

NEOS THERAPS holds the US marketing authorisation.