Orange Book product · Brand (NDA)
SANCTURA
TROSPIUM CHLORIDE
At a glance
May 28, 2004
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
May 28, 2004
22 yr 5 mo ago
Today
Pharmaceutical detail
Active ingredient
TROSPIUM CHLORIDE
Strength
20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 021595
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
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.
- 2007SANCTURA XRBrand (NDA)
NDA 022103 · ALLERGAN
- 2024TROSPIUM CHLORIDEGeneric (ANDA)
ANDA 206472 · MACLEODS PHARMS LTD
- 2022TROSPIUM CHLORIDEGeneric (ANDA)
ANDA 215781 · ZAMEER PHARMS
- 2021TROSPIUM CHLORIDEGeneric (ANDA)
ANDA 214760 · UTOPIC PHARMS
- 2020TROSPIUM CHLORIDEGeneric (ANDA)
ANDA 213185 · GRANULES
- 2016TROSPIUM CHLORIDEGeneric (ANDA)
ANDA 204945 · HERITAGE PHARMS INC
- 2016TROSPIUM CHLORIDEGeneric (ANDA)
ANDA 091688 · INVAGEN PHARMS
- 2015TROSPIUM CHLORIDEGeneric (ANDA)
ANDA 091635 · UPSHER SMITH LABS
- 2013TROSPIUM CHLORIDEGeneric (ANDA)
ANDA 201291 · PADAGIS US
- 2012TROSPIUM CHLORIDEGeneric (ANDA)
ANDA 091289 · ACTAVIS LABS FL INC
- 2011TROSPIUM CHLORIDEGeneric (ANDA)
ANDA 091513 · APOTEX
- 2010TROSPIUM CHLORIDEGeneric (ANDA)
ANDA 091573 · PADAGIS US
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.
