FDA — authorised 21 October 2015
- Application: NDA206628
- Marketing authorisation holder: HQ SPCLT PHARMA
- Status: supplemented
🇺🇸 dexmedetomidine (IN) in United States
FDA authorised dexmedetomidine (IN) on 21 October 2015
Marketing authorisation
Frequently asked questions
Is dexmedetomidine (IN) approved in United States?
Yes. FDA authorised it on 21 October 2015.
Who is the marketing authorisation holder for dexmedetomidine (IN) in United States?
HQ SPCLT PHARMA holds the US marketing authorisation.