FDA — authorised 30 January 2004
- Application: NDA021395
- Marketing authorisation holder: BOEHRINGER INGELHEIM
- Local brand name: SPIRIVA
- Indication: POWDER — INHALATION
- Status: approved
FDA authorised Arformoterol and Tiotropium on 30 January 2004
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Yes. FDA authorised it on 30 January 2004; FDA has authorised it.
BOEHRINGER INGELHEIM holds the US marketing authorisation.