FDA — authorised 2 August 1976
- Application: NDA017078
- Marketing authorisation holder: IMPAX LABS INC
- Status: supplemented
🇺🇸 Dexedrine in United States
FDA authorised Dexedrine on 2 August 1976
Marketing authorisations
FDA
- Status: approved
Other Other approved in United States
Frequently asked questions
Is Dexedrine approved in United States?
Yes. FDA authorised it on 2 August 1976; FDA has authorised it.
Who is the marketing authorisation holder for Dexedrine in United States?
IMPAX LABS INC holds the US marketing authorisation.