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Details for Generic Name: tolterodine tartrate

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Tolterodine tartrate is the generic ingredient in three branded drugs marketed by Pharmacia And Upjohn, Mylan Pharms Inc, Torrent Pharms Ltd, Apotex Corp, Ivax Sub Teva Pharms, and Macleods Pharms Ltd, and is included in eight NDAs. There are three patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

There are twenty-two drug master file entries for tolterodine tartrate. Eight suppliers are listed for this compound. There are two tentative approvals for this compound.

Summary for Generic Name: tolterodine tartrate

Drug Master File Entries: see list22
Suppliers / Packaging: see list47
Therapeutic Class:Genitourinary Agents
Formulation / Manufacturing:see details

Pharmacology for Ingredient: tolterodine tartrate

Tentative approvals for TOLTERODINE TARTRATE

Applicant Application No. Form Dosage
<disabled><disabled>TABLET; ORAL1MG
<disabled><disabled>TABLET; ORAL2MG
<disabled><disabled>TABLET; ORAL1MG

Clinical Trials for: tolterodine tartrate

Tolterodine Drug Use Investigation.(Post Marketing Commitment Plan)
Status: Completed Condition: Overactive Bladder

A Study to Test the Effects of Tolterodine Tartrate in Patients With Overactive Bladder (0000-107)
Status: Completed Condition: Overactive Bladder

Exploring Predictors of Symptoms Relapse After Discontinuation of Treatment in Overactive Bladder (OAB) Patients
Status: Completed Condition: Overactive Bladder

Dutasteride With Tolterodine ER or Placebo to Treat Lower Urinary Tract Symptoms (LUTS)
Status: Completed Condition: Benign Prostatic Hyperplasia (BPH)

A Study to Evaluate Tolerability and Patient Preference Between Myrbetriq® and Detrol® LA in Subjects With Overactive Bladder (OAB)
Status: Active, not recruiting Condition: Overactive Bladder (OAB)

Pharmacokinetics and Relative Bioavailability Study
Status: Completed Condition: Urinary Bladder, Overactive

Courtesy of
See more clinical trials for this drug
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mylan Pharms Inc
tolterodine tartrate
CAPSULE, EXTENDED RELEASE;ORAL201486-001Oct 31, 2013RXNo<disabled><disabled>
Torrent Pharms Ltd
tolterodine tartrate
CAPSULE, EXTENDED RELEASE;ORAL203016-001Aug 11, 2015RXNo<disabled><disabled>
Ivax Sub Teva Pharms
tolterodine tartrate
TABLET;ORAL077006-002Feb 23, 2015RXNo<disabled><disabled>
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ISSN: 2162-2639

Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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