FDA — authorised 11 June 2001
- Application: NDA020358
- Marketing authorisation holder: GLAXOSMITHKLINE
- Indication: Efficacy
- Status: approved
🇺🇸 BUPROPION in United States
FDA authorised BUPROPION on 11 June 2001
Marketing authorisations
FDA — authorised 26 May 2015
- Application: ANDA202304
- Marketing authorisation holder: PRINSTON INC
- Indication: Labeling
- Status: approved
FDA — authorised 17 August 2016
- Application: ANDA206122
- Marketing authorisation holder: SCIEGEN PHARMS
- Status: approved
FDA — authorised 8 June 2018
- Application: ANDA203013
- Marketing authorisation holder: ALEMBIC
- Status: supplemented
FDA — authorised 5 September 2019
- Application: ANDA211200
- Marketing authorisation holder: ZHEJIANG JUTAI PHARM
- 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 9 January 2023
- Application: ANDA216766
- Marketing authorisation holder: YICHANG HUMANWELL
- Status: supplemented
BUPROPION in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is BUPROPION approved in United States?
Yes. FDA authorised it on 11 June 2001; FDA authorised it on 26 May 2015; FDA authorised it on 17 August 2016.
Who is the marketing authorisation holder for BUPROPION in United States?
GLAXOSMITHKLINE holds the US marketing authorisation.