FDA — authorised 10 May 2006
- Marketing authorisation holder: PFIZER INC
- Status: approved
🇺🇸 Chantix in United States
FDA authorised Chantix on 10 May 2006
Marketing authorisations
FDA — authorised 10 May 2006
- Application: NDA021928
- Marketing authorisation holder: PF PRISM CV
- Local brand name: CHANTIX
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 12 June 2023
- Application: ANDA216723
- Marketing authorisation holder: ZYDUS
- Status: approved
FDA — authorised 25 July 2023
- Application: ANDA217151
- Marketing authorisation holder: KANCHAN HLTHCARE
- Status: approved
FDA — authorised 23 July 2024
- Application: ANDA217115
- Marketing authorisation holder: PIRAMAL
- Status: approved
FDA — authorised 18 December 2025
- Application: ANDA211862
- Marketing authorisation holder: LUPIN LTD
- Indication: Labeling
- Status: approved
LUPIN LTD was granted marketing authorisation for Chantix in the United States on 18 December 2025. The approval was based on a standard expedited pathway application (ANDA211862). Chantix is indicated for use in labelling.
FDA — authorised 9 January 2026
- Application: ANDA218985
- Marketing authorisation holder: UMEDICA
- Status: approved
FDA
- Application: ANDA201920
- Marketing authorisation holder: TEVA PHARMS USA
- Local brand name: VARENICLINE
- Indication: TABLET — ORAL
- Status: approved
Chantix in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Neuroscience approved in United States
Frequently asked questions
Is Chantix approved in United States?
Yes. FDA authorised it on 10 May 2006; FDA authorised it on 10 May 2006; FDA authorised it on 12 June 2023.
Who is the marketing authorisation holder for Chantix in United States?
PFIZER INC holds the US marketing authorisation.