FDA — authorised 11 June 2001
- Application: NDA020358
- Marketing authorisation holder: GLAXOSMITHKLINE
- Indication: Efficacy
- Status: approved
🇺🇸 Wellbutrin in United States
FDA authorised Wellbutrin on 11 June 2001
Marketing authorisations
FDA — authorised 23 April 2008
- Application: NDA022108
- Marketing authorisation holder: BAUSCH
- Local brand name: APLENZIN
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 14 December 2017
- Application: ANDA202304
- Marketing authorisation holder: PRINSTON INC
- Indication: Labeling
- Status: approved
FDA — authorised 13 December 2022
- Application: ANDA210497
- Marketing authorisation holder: ACCORD HLTHCARE
- Indication: Labeling
- Status: approved
FDA — authorised 13 December 2022
- Application: ANDA200216
- Marketing authorisation holder: SUN PHARM
- Indication: Labeling
- Status: approved
FDA — authorised 1 October 2024
- Application: ANDA211200
- Marketing authorisation holder: ZHEJIANG JUTAI PHARM
- Indication: Labeling
- Status: approved
The FDA approved Wellbutrin for labeling indications on 2024-10-01. The marketing authorisation holder is ZHEJIANG JUTAI PHARM. This approval was granted under the standard expedited pathway.
Wellbutrin in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Metabolic approved in United States
Frequently asked questions
Is Wellbutrin approved in United States?
Yes. FDA authorised it on 11 June 2001; FDA authorised it on 23 April 2008; FDA authorised it on 14 December 2017.
Who is the marketing authorisation holder for Wellbutrin in United States?
GLAXOSMITHKLINE holds the US marketing authorisation.