FDA — authorised 10 May 2004
- Application: NDA021443
- Marketing authorisation holder: ASPEN
- Local brand name: ENJUVIA
- Indication: TABLET — ORAL
- Status: approved
FDA authorised ENJUVIA on 10 May 2004
Yes. FDA authorised it on 10 May 2004; FDA authorised it on 20 December 2004; FDA has authorised it.
ASPEN holds the US marketing authorisation.