FDA — authorised 2 April 2014
- Application: ANDA091464
- Marketing authorisation holder: TEVA PHARMS USA
- Local brand name: SOLIFENACIN SUCCINATE
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Vesicare in United States
FDA authorised Vesicare on 2 April 2014
Marketing authorisations
FDA — authorised 20 May 2019
- Application: ANDA211657
- Marketing authorisation holder: SCIEGEN PHARMS
- Local brand name: SOLIFENACIN SUCCINATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 20 May 2019
- Application: ANDA205483
- Marketing authorisation holder: AJANTA PHARMA LTD
- Local brand name: SOLIFENACIN SUCCINATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 20 May 2019
- Application: ANDA205575
- Marketing authorisation holder: ALEMBIC
- Local brand name: SOLIFENACIN SUCCINATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 20 May 2019
- Application: ANDA210281
- Marketing authorisation holder: BOSTAL
- Local brand name: SOLIFENACIN SUCCINATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 20 May 2019
- Application: ANDA202551
- Marketing authorisation holder: WATSON LABS INC
- Local brand name: SOLIFENACIN SUCCINATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 20 May 2019
- Application: ANDA209719
- Marketing authorisation holder: AMNEAL PHARMS CO
- Local brand name: SOLIFENACIN SUCCINATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 27 August 2019
- Application: ANDA211701
- Marketing authorisation holder: UNICHEM
- Local brand name: SOLIFENACIN SUCCINATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 11 December 2019
- Application: ANDA211423
- Marketing authorisation holder: RISING
- Local brand name: SOLIFENACIN SUCCINATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 15 June 2022
- Application: ANDA215761
- Marketing authorisation holder: ANNORA PHARMA
- Local brand name: SOLIFENACIN SUCCINATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 27 December 2022
- Application: ANDA206817
- Marketing authorisation holder: AUROBINDO PHARMA
- Local brand name: SOLIFENACIN SUCCINATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 2 October 2024
- Application: ANDA205484
- Marketing authorisation holder: JUBILANT GENERICS
- Local brand name: SOLIFENACIN SUCCINATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 4 March 2025
- Application: ANDA209424
- Marketing authorisation holder: TORRENT
- Local brand name: SOLIFENACIN SUCCINATE
- Indication: TABLET — ORAL
- Status: approved
Other Urology approved in United States
Frequently asked questions
Is Vesicare approved in United States?
Yes. FDA authorised it on 2 April 2014; FDA authorised it on 20 May 2019; FDA authorised it on 20 May 2019.
Who is the marketing authorisation holder for Vesicare in United States?
TEVA PHARMS USA holds the US marketing authorisation.