FDA — authorised 24 December 1981
- Application: NDA018207
- Marketing authorisation holder: PRAGMA
- Local brand name: DESYREL
- Indication: TABLET — ORAL
- Status: approved
FDA authorised Desyrel on 24 December 1981
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Yes. FDA authorised it on 24 December 1981; FDA has authorised it.
PRAGMA holds the US marketing authorisation.