FDA — authorised 31 December 1984
- Application: NDA018719
- Marketing authorisation holder: BIOENVISION
- Local brand name: MODRASTANE
- Indication: CAPSULE — ORAL
- Status: approved
FDA authorised Desopan on 31 December 1984
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 December 1984; FDA has authorised it.
BIOENVISION holds the US marketing authorisation.