FDA — authorised 31 May 2002
- Application: NDA021191
- Marketing authorisation holder: VESSELON SPV LLC
- Local brand name: IMAGENT
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA authorised DIMYRISTOYL LECITHIN on 31 May 2002
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Yes. FDA authorised it on 31 May 2002; FDA has authorised it.
VESSELON SPV LLC holds the US marketing authorisation.