FDA · United States
tolterodine tartrate — FDA regulatory status
tolterodine tartrate (TOLTERODINE TARTRATE) regulatory status in the United States is tracked from public FDA records and cross-linked clinical and patent datasets on NovaPharmaNews. Current status: FDA approved.
Status snapshot
- Status
- FDA approved
- Brand
- TOLTERODINE TARTRATE
- Originator
- Teva Pharma GmbH
- Mechanism
- Muscarinic acetylcholine receptor M2 antagonist
- Target
- Muscarinic acetylcholine receptor M2
- Structured fields
- 7
Sponsor / originator context: Teva Pharma GmbH. Pipeline programs and exclusivity signals below are joined from ClinicalTrials.gov-linked projects and USPTO/EPO patent rows associated with this INN.
Pharmacology context used for competitive intelligence: Muscarinic acetylcholine receptor M2 antagonist. Target: Muscarinic acetylcholine receptor M2. This page is a status aggregation for professional reference — not prescribing advice.
Regional decision snapshot — FDA: approved.
Linked evidence on this spoke: 1 published clinical program and 0 related patent records. Use the tables below for NCT identifiers, phases, and exclusivity dates; verify against primary sources before BD or medical decisions.
Regulatory timeline
| Regulator | Region | Status | Date | Source |
|---|---|---|---|---|
| FDA | United States | approved | — | Evidence |
Linked clinical programs
| Program | Phase | Sponsor | NCT |
|---|---|---|---|
| doxazosin plus tolterodine SR | Approved | Samsung Bioepis | NCT00922506 |
Related hubs
FAQ
What is the FDA approval status of tolterodine tartrate?
tolterodine tartrate currently shows FDA approved in our United States regulatory index. Confirm on the official FDA label or EPAR before clinical or commercial use.
Where does NovaPharmaNews get tolterodine tartrate regulatory data?
Status fields are joined from public sources (openFDA / EMA / regional agencies), ClinicalTrials.gov-linked programs, and patent registries. See /about/data-sources for attribution.
How many clinical programs are linked to tolterodine tartrate?
This spoke lists 1 published program associated with tolterodine tartrate in our pipeline index.