What is TOLTERODINE TARTRATE used for?

TOLTERODINE TARTRATE is an FDA-approved medication. See full prescribing information for approved uses.

Is TOLTERODINE TARTRATE FDA approved?

Yes, TOLTERODINE TARTRATE is FDA approved (first approved 2012-09-25) and manufactured by Apotex.

Who makes TOLTERODINE TARTRATE?

TOLTERODINE TARTRATE is manufactured by Apotex.

Data updated: Mar 10, 2026

TOLTERODINE TARTRATE

Approved 2012-09-25

Jump to: Indications Approvals Trials Competitors Safety Patents

Indications

Phase 3 Trials

Years on Market

Details

Status: Discontinued
First Approved: 2012-09-25
Routes: ORAL
Dosage Forms: TABLET, CAPSULE, EXTENDED RELEASE

Companies

Apotex Aurobindo Pharma RISING Teva TORRENT MACLEODS PHARMS LTD INVENTIA HLTHCARE UNICHEM PHARMOBEDIENT HETERO LABS LTD V HETERO LABS LTD III UTOPIC PHARMS IVAX SUB TEVA PHARMS Novartis PTS CONSULTING AJANTA PHARMA LTD

Active Ingredient: TOLTERODINE TARTRATE

TOLTERODINE TARTRATE Approval History

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What TOLTERODINE TARTRATE Treats

16 FDA approvals

Originally approved for its first indication in 2012 . Covers 16 distinct patient populations.

Other (16)

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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

Understanding FDA Approval Types

Count	Type	What it means
-	ORIG	Original approval - drug first enters market
-	SUPPL - Efficacy	New indication (new disease/condition approved)
-	SUPPL - Labeling	Label text changes (warnings, dosing updates)
-	SUPPL - Manufacturing	Production changes (new facility)
-	SUPPL - Chemistry	Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

TOLTERODINE TARTRATE FDA Label Details

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Data Sources

FDA Approval: ANDA200164 → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.