FDA — authorised 22 October 2025
- Application: NDA212271
- Marketing authorisation holder: MEITHEAL
- Local brand name: CONTEPO
- Indication: POWDER — INTRAVENOUS
- Status: approved
FDA authorised ZTI-01 on 22 October 2025
Yes. FDA authorised it on 22 October 2025.
MEITHEAL holds the US marketing authorisation.