THALLOUS CHLORIDE TL 201
Details
- Status
- Prescription
- First Approved
- 1977-12-16
- Routes
- INJECTION, INTRAVENOUS
- Dosage Forms
- INJECTABLE
THALLOUS CHLORIDE TL 201 Approval History
What THALLOUS CHLORIDE TL 201 Treats
10 FDA approvalsOriginally approved for its first indication in 1977 . Covers 10 distinct patient populations.
- Other (10)
Other
(10 approvals)- • Approved indication (Dec 1977) Priority
- • Approved indication (Oct 1979)
- • Approved indication (Feb 1982)
- • Approved indication (Dec 1982)
- • Approved indication (Dec 1986)
- • Approved indication (Dec 1993)
- • Approved indication (Feb 1995)
- • Approved indication (Nov 2001)Letter
- • Approved indication (Jul 2004)Label Letter
- • Approved indication (Nov 2006)
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
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.
THALLOUS CHLORIDE TL 201 FDA Label Details
ProIndications & Usage
FDA Label (PDF)Thallous Chloride Tl 201 Injection is indicated for use with planar scintigraphy or single-photon emission computed tomography (SPECT) for the following applications: Myocardial perfusion imaging in adults for the diagnosis of coronary artery disease by localization of: Non-reversible defects (myocardial infarction) Reversible defects (myocardial ischemia) when used in conjunction with exercise or pharmacologic stress Localization of sites of parathyroid hyperactivity pre- and post-operatively in adults with elevated serum calcium and parathyroid hormone levels Thallous Chloride Tl 201 Injecti...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.