FDA — authorised 4 October 1996
- Application: NDA020358
- Marketing authorisation holder: GLAXOSMITHKLINE
- Local brand name: WELLBUTRIN SR
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
🇺🇸 Bupropion Hydrochloride Controlled-release in United States
FDA authorised Bupropion Hydrochloride Controlled-release on 4 October 1996
Marketing authorisations
FDA — authorised 10 November 2011
- Application: NDA022497
- Marketing authorisation holder: TWI PHARMS
- Local brand name: FORFIVO XL
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
Other Psychiatry / Neurology approved in United States
Frequently asked questions
Is Bupropion Hydrochloride Controlled-release approved in United States?
Yes. FDA authorised it on 4 October 1996; FDA authorised it on 10 November 2011.
Who is the marketing authorisation holder for Bupropion Hydrochloride Controlled-release in United States?
GLAXOSMITHKLINE holds the US marketing authorisation.