FDA — authorised 25 September 2012
- Application: ANDA200164
- Marketing authorisation holder: APOTEX CORP
- Local brand name: TOLTERODINE TARTRATE
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 TT in United States
FDA authorised TT on 25 September 2012
Marketing authorisations
FDA — authorised 27 November 2012
- Application: ANDA202641
- Marketing authorisation holder: PHARMOBEDIENT
- Local brand name: TOLTERODINE TARTRATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 22 November 2016
- Application: ANDA079141
- Marketing authorisation holder: TEVA PHARMS USA
- Local brand name: TOLTERODINE TARTRATE
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 12 December 2017
- Application: ANDA206419
- Marketing authorisation holder: HETERO LABS LTD III
- Local brand name: TOLTERODINE TARTRATE
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 30 December 2019
- Application: ANDA210775
- Marketing authorisation holder: RISING
- Local brand name: TOLTERODINE TARTRATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 24 January 2020
- Application: ANDA204721
- Marketing authorisation holder: UNIQUE
- Local brand name: TOLTERODINE TARTRATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 2 February 2021
- Application: ANDA213858
- Marketing authorisation holder: UTOPIC PHARMS
- Local brand name: TOLTERODINE TARTRATE
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 2 August 2021
- Application: ANDA204397
- Marketing authorisation holder: HETERO LABS LTD V
- Local brand name: TOLTERODINE TARTRATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 27 August 2024
- Application: ANDA216917
- Marketing authorisation holder: UNICHEM
- Local brand name: TOLTERODINE TARTRATE
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
Other Immunology / Infectious Disease approved in United States
Frequently asked questions
Is TT approved in United States?
Yes. FDA authorised it on 25 September 2012; FDA authorised it on 27 November 2012; FDA authorised it on 22 November 2016.
Who is the marketing authorisation holder for TT in United States?
APOTEX CORP holds the US marketing authorisation.