FDA — authorised 11 August 2021
- Application: ANDA201785
- Marketing authorisation holder: PH HEALTH
- Local brand name: VARENICLINE TARTRATE
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 VARENICLINE TARTRATE in United States
FDA authorised VARENICLINE TARTRATE on 11 August 2021 · 1,682 US adverse-event reports
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 July 2023
- Application: ANDA217151
- Marketing authorisation holder: KANCHAN HLTHCARE
- Status: approved
FDA — authorised 23 August 2023
- Application: ANDA214557
- Marketing authorisation holder: ALKEM LABS LTD
- 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
- Status: approved
FDA — authorised 29 October 2024
- Application: ANDA219106
- Marketing authorisation holder: REGCON HOLDINGS
- 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 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 18 December 2025
- Application: ANDA211862
- Marketing authorisation holder: LUPIN LTD
- Indication: Labeling
- Status: approved
The FDA approved VARENICLINE TARTRATE, manufactured by LUPIN LTD, on 18 December 2025. The approval was granted under the standard expedited pathway. The approved indication for VARENICLINE TARTRATE is listed in its labelling, but the specific indication is not reported in the available data.
FDA
- Application: ANDA201808
- Marketing authorisation holder: WATSON LABS INC
- Local brand name: VARENICLINE TARTRATE
- Indication: TABLET — ORAL
- Status: approved
Safety signals — FAERS
Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.
- Window: 20 April 2025 – 20 April 2026
- Total reports: 1,682
Most-reported reactions
- Nausea — 260 reports (15.46%)
- Drug Ineffective — 219 reports (13.02%)
- Dizziness — 173 reports (10.29%)
- Depression — 170 reports (10.11%)
- Headache — 163 reports (9.69%)
- Dyspnoea — 147 reports (8.74%)
- Anxiety — 144 reports (8.56%)
- Insomnia — 142 reports (8.44%)
- Fatigue — 135 reports (8.03%)
- Vomiting — 129 reports (7.67%)
VARENICLINE TARTRATE 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 VARENICLINE TARTRATE approved in United States?
Yes. FDA authorised it on 11 August 2021; FDA authorised it on 15 October 2021; FDA authorised it on 25 July 2023.
Who is the marketing authorisation holder for VARENICLINE TARTRATE in United States?
PH HEALTH holds the US marketing authorisation.