FDA — authorised 26 July 2002
- Application: NDA021409
- Marketing authorisation holder: ORGANON
- Local brand name: SINGULAIR
- Indication: GRANULE — ORAL
- Status: approved
FDA authorised Asmakast on 26 July 2002
Yes. FDA authorised it on 26 July 2002.
ORGANON holds the US marketing authorisation.