FDA — authorised 27 June 2008
- Application: ANDA078292
- Marketing authorisation holder: SVC PHARMA
- Local brand name: DRONABINOL
- Indication: CAPSULE — ORAL
- Status: approved
🇺🇸 Namisol in United States
FDA authorised Namisol on 27 June 2008
Marketing authorisations
FDA — authorised 19 August 2011
- Application: ANDA078501
- Marketing authorisation holder: INSYS THERAP
- Local brand name: DRONABINOL
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 20 June 2014
- Application: ANDA079217
- Marketing authorisation holder: HIKMA
- Local brand name: DRONABINOL
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 7 February 2020
- Application: ANDA207421
- Marketing authorisation holder: ASCENT PHARMS INC
- Local brand name: DRONABINOL
- Indication: CAPSULE — ORAL
- Status: approved
Other Other approved in United States
Frequently asked questions
Is Namisol approved in United States?
Yes. FDA authorised it on 27 June 2008; FDA authorised it on 19 August 2011; FDA authorised it on 20 June 2014.
Who is the marketing authorisation holder for Namisol in United States?
SVC PHARMA holds the US marketing authorisation.