FDA — authorised 4 October 1996
- Application: NDA020358
- Marketing authorisation holder: GLAXOSMITHKLINE
- Status: supplemented
🇺🇸 Wellbutrin in United States
FDA authorised Wellbutrin on 4 October 1996
Marketing authorisations
FDA — authorised 28 August 2003
- Application: NDA021515
- Marketing authorisation holder: BAUSCH
- Status: supplemented
FDA
- Status: approved
Other Metabolic approved in United States
Frequently asked questions
Is Wellbutrin approved in United States?
Yes. FDA authorised it on 4 October 1996; FDA authorised it on 28 August 2003; FDA has authorised it.
Who is the marketing authorisation holder for Wellbutrin in United States?
GLAXOSMITHKLINE holds the US marketing authorisation.