FDA — authorised 11 August 2021
- Application: ANDA201785
- Marketing authorisation holder: PH HEALTH
- Local brand name: VARENICLINE TARTRATE
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Champix in United States
FDA authorised Champix on 11 August 2021
Marketing authorisations
FDA — authorised 15 October 2021
- Application: NDA213978
- Marketing authorisation holder: OYSTER POINT PHARMA
- Local brand name: TYRVAYA
- Indication: SPRAY — NASAL
- Status: approved
FDA — authorised 25 January 2023
- Application: ANDA201962
- Marketing authorisation holder: APOTEX
- Local brand name: VARENICLINE TARTRATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 12 June 2023
- Application: ANDA216723
- Marketing authorisation holder: ZYDUS
- Local brand name: VARENICLINE TARTRATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 25 July 2023
- Application: ANDA217151
- Marketing authorisation holder: KANCHAN HLTHCARE
- Local brand name: VARENICLINE TARTRATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 23 August 2023
- Application: ANDA214557
- Marketing authorisation holder: ALKEM LABS LTD
- Local brand name: VARENICLINE TARTRATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 23 October 2023
- Application: ANDA214571
- Marketing authorisation holder: HETERO LABS LTD III
- Local brand name: VARENICLINE TARTRATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 4 December 2023
- Application: ANDA211862
- Marketing authorisation holder: LUPIN
- Local brand name: VARENICLINE TARTRATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 29 February 2024
- Application: ANDA202019
- Marketing authorisation holder: PHARMOBEDIENT
- Local brand name: VARENICLINE TARTRATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 6 March 2024
- Application: ANDA217283
- Marketing authorisation holder: NE RX PHARMA
- Local brand name: VARENICLINE TARTRATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 19 March 2024
- Application: ANDA213019
- Marketing authorisation holder: AJANTA PHARMA LTD
- Local brand name: VARENICLINE TARTRATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 23 July 2024
- Application: ANDA217115
- Marketing authorisation holder: PIRAMAL
- Local brand name: VARENICLINE TARTRATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 8 April 2025
- Application: ANDA216615
- Marketing authorisation holder: SHILPA
- Local brand name: VARENICLINE TARTRATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 2 May 2025
- Application: ANDA214595
- Marketing authorisation holder: AUROBINDO PHARMA
- Local brand name: VARENICLINE TARTRATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 6 May 2025
- Application: ANDA212879
- Marketing authorisation holder: VIWIT PHARM
- Local brand name: VARENICLINE TARTRATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 21 May 2025
- Application: ANDA213268
- Marketing authorisation holder: RHODES PHARMS
- Local brand name: VARENICLINE TARTRATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 29 October 2025
- Application: ANDA218302
- Marketing authorisation holder: MICRO LABS
- Local brand name: VARENICLINE TARTRATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 9 January 2026
- Application: ANDA218985
- Marketing authorisation holder: UMEDICA
- Local brand name: VARENICLINE TARTRATE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Status: approved
FDA
- Application: ANDA201808
- Marketing authorisation holder: WATSON LABS INC
- Local brand name: VARENICLINE TARTRATE
- Indication: TABLET — ORAL
- Status: approved
Other Neuroscience approved in United States
Frequently asked questions
Is Champix approved in United States?
Yes. FDA authorised it on 11 August 2021; FDA authorised it on 15 October 2021; FDA authorised it on 25 January 2023.
Who is the marketing authorisation holder for Champix in United States?
PH HEALTH holds the US marketing authorisation.