🇺🇸 ENJUVIA in United States

FDA authorised ENJUVIA on 10 May 2004

Marketing authorisations

FDA — authorised 10 May 2004

  • Application: NDA021443
  • Marketing authorisation holder: ASPEN
  • Local brand name: ENJUVIA
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 20 December 2004

  • Application: NDA021609
  • Marketing authorisation holder: DURAMED
  • Local brand name: ENJUVIA
  • Indication: TABLET — ORAL
  • Status: approved

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FDA

  • Status: approved

Other Other approved in United States

Frequently asked questions

Is ENJUVIA approved in United States?

Yes. FDA authorised it on 10 May 2004; FDA authorised it on 20 December 2004; FDA has authorised it.

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

ASPEN holds the US marketing authorisation.