FDA — authorised 1 July 2016
- Application: NDA205525
- Marketing authorisation holder: WELLHOUSE PHARMA
- Local brand name: SYNDROS
- Indication: SOLUTION — ORAL
- Status: approved
FDA authorised Dronabinol Capsules on 1 July 2016
Yes. FDA authorised it on 1 July 2016.
WELLHOUSE PHARMA holds the US marketing authorisation.