Orange Book product · Brand (NDA)
DETROL LA
TOLTERODINE TARTRATE
At a glance
Dec 22, 2000
Approved
Brand (NDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 22, 2000
25 yr 10 mo ago
Today
Pharmaceutical detail
Active ingredient
TOLTERODINE TARTRATE
Strength
4MG
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
TE code
AB
Application
NDA 021228
Product number
002
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 1998DETROLBrand (NDA)
NDA 020771 · UPJOHN
- 2024TOLTERODINE TARTRATEGeneric (ANDA)
ANDA 216917 · UNICHEM
- 2021TOLTERODINE TARTRATEGeneric (ANDA)
ANDA 204397 · HETERO LABS LTD V
- 2021TOLTERODINE TARTRATEGeneric (ANDA)
ANDA 213858 · UTOPIC PHARMS
- 2020TOLTERODINE TARTRATEGeneric (ANDA)
ANDA 205399 · UNICHEM
- 2020TOLTERODINE TARTRATEGeneric (ANDA)
ANDA 213397 · AJANTA PHARMA LTD
- 2020TOLTERODINE TARTRATEGeneric (ANDA)
ANDA 204721 · UNIQUE
- 2019TOLTERODINE TARTRATEGeneric (ANDA)
ANDA 210775 · RISING
- 2019TOLTERODINE TARTRATEGeneric (ANDA)
ANDA 204562 · INVENTIA HLTHCARE
- 2017TOLTERODINE TARTRATEGeneric (ANDA)
ANDA 206419 · HETERO LABS LTD III
- 2016TOLTERODINE TARTRATEGeneric (ANDA)
ANDA 079141 · TEVA PHARMS USA
- 2015TOLTERODINE TARTRATEGeneric (ANDA)
ANDA 203409 · MACLEODS PHARMS LTD
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

