🇺🇸 Paliperidone, oral formulation in United States

FDA authorised Paliperidone, oral formulation on 19 December 2006

Marketing authorisation

FDA — authorised 19 December 2006

  • Application: NDA021999
  • Marketing authorisation holder: JANSSEN PHARMS
  • Local brand name: INVEGA
  • Indication: TABLET, EXTENDED RELEASE — ORAL
  • Status: approved

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Frequently asked questions

Is Paliperidone, oral formulation approved in United States?

Yes. FDA authorised it on 19 December 2006.

Who is the marketing authorisation holder for Paliperidone, oral formulation in United States?

JANSSEN PHARMS holds the US marketing authorisation.