FDA — authorised 28 October 1981
- Application: NDA018557
- Marketing authorisation holder: ROCHE
- Local brand name: FANSIDAR
- Indication: TABLET — ORAL
- Status: approved
FDA authorised SP, amodiaquine, piperaquine, dihdroartemisinin on 28 October 1981
Yes. FDA authorised it on 28 October 1981.
ROCHE holds the US marketing authorisation.