FDA — authorised 30 January 2004
- Application: NDA021395
- Marketing authorisation holder: BOEHRINGER INGELHEIM
- Local brand name: SPIRIVA
- Indication: POWDER — INHALATION
- Status: approved
FDA authorised Tiotropium Handihaler on 30 January 2004
Yes. FDA authorised it on 30 January 2004.
BOEHRINGER INGELHEIM holds the US marketing authorisation.